VAERS Line List Report: Vax Type: HPV4 Status Date: 01-JAN-11 - 30-APR-11 All Comb. w/AND

FDA Freedom of Information Distribution
Report run on: 22 SEP 2011 08:06
VAERS Line List Report

Vax Type: HPV4 Status Date: 01-JAN-11 - 30-APR-11 All comb. w/AND
Page 1
Vaers Id: 370371-2 (S) Related reports: 370371-1 Age Gender Vaccine Date Onset Date F 29-Sep-2009 29-Sep-2009 16.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Status Date State Received Date 11-Apr-2011 US 10-Mar-2011 Lot Prev Doses Site AHAVB312AA 0 Right arm 0216Y U3015A 0 0 Right arm Unknown
Mfr Report Id 201002320 Route Unknown Unknown Unknown
Last Edit Date 11-Apr-2011 Other Vaccine
Abasia, Aphasia, Arthralgia, Delirium, Dizziness, Gaze palsy, Hydrocephalus, Immediate post-injection reaction, Injection site haemorrhage, Pain in extremity
Symptom Text: Initial report received from another manufacturer on 20 April 2010, under reference number WAES 1004USA00917 (VAERS number 370371). The following narrative is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A mother reported that she brought her 16 year old daughter to hospital for "immunizations". It was reported that her 16 year old daughter with allergies to red dye and codeine who was given the first dose of GARDASIL (lot number 663451/0216Y) into right arm, the first dose of MENACTRA (lot number U3015AA, MFR. Sanofi Pasteur) and the first dose of HAVRIX (lot number AHAVB312AA, MFR. GSK) into her left arm at about 5 pm on Tuesday 29-SEP-2009. The mother commented "they talked to me to getting the meningitis one". She said that the daughter got "dizzy" right away and had commented that she felt the meningitis shot "in elbow". The mom reported that her daughter said her knees hurt on the way home and was rubbing her knees and legs in the car. The mother took her daughter to the emergency room at around 9pm. She said that her daughter was "delirious", she "couldn't walk or talk", and her "eyes were rolling back in her head". The mom denied fever, respiratory distress or seizure activity in her daughter at that time. The patient was admitted to hospital on 29-SEP-2009 and kept for 24 hours while "tests" were run. The mother stated that the doctor was called in "consult" and that her daughter's MRI showed "fluid in the brain". Her symptomology resolved spontaneously according to her mother, "going backwards" with the last symptoms resolving first and finally the pain in legs, knees, and her arm resolving. The mother said that the doctor told her this could only happen if the meningitis had been given "directIV". At this time the mother was mainly concerned because her daughter's arm bled and she didn't know if that meant the shot went into her vein or not. It was reassured that the bleeding from the injection site after an immunization was not uncommon and did not mean that the vaccine accessed the vein. The listing indicated that one or more of the events required hospitalization. No further information is available". "This was originally reported by the patient's mother. The VAER ID number is 370371". 05 January 2011: A corrective version has been created in order to change the case to "not medically confirmed", as the event was originally reported by the patient's parent, who was not a health care professional. No new relevant medical information has been added to the case. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Patient had a history of allergies to red dye and codeine.


Page 2
Vaers Id: 381305-3 (D) Related reports: 381305-1; 381305-2 Age Gender Vaccine Date Onset Date Days F 26-Jun-2007 12-Feb-2010 962 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT DIED, LIFE THREATENING, SERIOUS
Status Date State Received Date 14-Mar-2011 US 10-Mar-2011 Lot Prev Doses Site NULL 0 Unknown U2324AA 0 Left arm
Mfr Report Id 201001159 Route Intramuscular Intramuscular
Last Edit Date 14-Mar-2011 Other Vaccine
Bacterial infection, Death, Headache, Joint sprain, Meningitis, Meningococcal infection, Nausea, Petechiae, Vomiting
Symptom Text: Initial report received on 19 February 2010 from a health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of Neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. Follow-up information received on 08 November 2010 from another manufacture (manufacturer report number WAES 1010USA03110) who had received the report from a FDA line listing (VAERS identification number 381305). The following is verbatim from the other manufactures report. "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female who on 26-JUN-2007 was vaccinated with GARDASIL IM with the first dose. Second suspect therapy included MENACTRA (lot number U2324AA) IM into the left arm with the first dose. Concomitant therapy possibly included lithium. In the evening of 12-FEB-2010, the patient experienced headache, nausea, vomiting. In the morning of 13-FEB-2010 the patient was found dead. Autopsy performed 14-FEB-2010 meningococcal disease determined to be cause of death, Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist. Neisseria meningitidis serogroup C confirmed by polymerase chain reaction (PCR) on brain stem tissue on 14-FEB-2010. The listing indicated that one or more of the events resulted in death was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS identification number is 381305." It is noted the subject's correct age is 16 years old as calculated from birth date to onset of events. The age of 13 years old as reported in the other manufacturer's report was the subject's age at the time of the vaccination. List of Documents held by Sender: lab results. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Lithium Autopsy spinal tap revealed gram negative rods, meningococcal type C. 14/Feb/2010: Neisseria Meningitidis PCR and Neisseria Meningitidis Serogroup PCR of the brain : Neisseria Meningitidis serogroup C DNA detected. No illness at the time of vaccination. Medical history was unknown.


Page 3
Vaers Id: 385808-3 (S) Related reports: 385808-1; 385808-2 Age Gender Vaccine Date Onset Date Days F 26-Dec-2008 26-Dec-2008 0 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT
Status Date State Received Date 12-Apr-2011 US 10-Mar-2011 Lot Prev Doses Site 0570X Right arm NULL Unknown
Mfr Report Id 201003238 Route Unknown Unknown
HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Activities of daily living impaired, Alopecia, Amnesia, Ataxia, Burning sensation, Condition aggravated, Conversion disorder, Deafness, Dizziness, Dyspnoea, Eating disorder, Erythema, Fatigue, Feeling cold, Gait disturbance, Headache, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Menstruation irregular, Migraine, Muscle spasms, Muscular weakness, Nausea, Nervous system disorder, Pain, Pallor, Palpitations, Paraesthesia, Phonophobia, Pyrexia, Rash, Rhinorrhoea, Screaming, Skin warm, Stress, Swelling, Tremor, Upper respiratory tract infection, Vision blurred, Wrong drug administered
Symptom Text: Initial report received on 07 June 2010 from another manufacturer, report# WAES 1005USA04222. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female with conversion disorder and had an allergy of rash to red food dyes and a history of central auditory processing defect who on 31-DEC-2008 was vaccinated in right arm with a dose of GARDASIL (LOT# 660616/0570X). Secondary suspected vaccination included a dose of MENACTRA. A 14 year old female experienced activities of daily living impaired, alopecia, amnesia, ataxia, burning sensation, conversion disorder, deafness, dizziness, dyspnoea, eating disorder, erythema, fatigue, feeling cold, gait disturbance, headache, hyperhidrosis, hypersomnia, hypoaesthesia, menstruation irregular, migraine, muscle spasms, muscular weakness, nausea, nervous system disorder, neurological examination abnormal, pain, pallor, palpitations, paraesthesia, phonophobia, pyrexia, rash, rhinorrhoea, screaming, skin warm, stress, swelling, tremor, upper respiratory tract infection, vision blurred and wrong drug administered. On 26-DEC-2008, the patient was given a wrong shot (another meningitis shot given, instead of the third dose of GARDASIL. On 06-JAN-2009, the patient experienced upper respiratory infection, headache. On 14-JAN-2009 headaches worsen. Respiratory cleared up with antibiotics/looked like pneumonia. On 15-JAN-2009, the patient experienced dizziness. On 28-JAN-2009, headaches spike to levels 5-7 out of 10, 100% of the time. Ibuprofen did not work (800 mg). In the middle of February: the patient saw doctor. Augmentin was given for possible sinus infection. Headaches worsen, nasal fluid leakage continued. Augmentin did nothing. CAT scan MRI to be ordered within 5 days of Augmentin. Headaches spike to 7-8 100% of the time. Dizzy, no focus, loss of memory. The patient then removed from school. Saw chiropractor - no one could touch the back of her head (meninga area) without her screaming. Said her head felt swollen and numb. Spine started to bum. On 15-FEB-2009 at 8:00 pm, headaches go to 10/10, patient screaming. Considered possibility of brain tumor and taken her to ER. She had trouble walking in straight line. CAT scan ordered by ER. Doctor sent her home and told her to take TYLENOL and 3 Ibuprofen's. CAT scan was normal. On 17-FEB-2009 saw pediatrician again. Full blood work ordered: tests vitamin D, thyroid function, regular blood-work, and was referred to neurologist. 19-FEB-2009 Doctor agreed problem could have been caused by cross reactions of GARDASIL and MENACTRA: given her TOPAMAX at 50 mg/day and ordered MRI. On 20-FEB-2009: MRI looks normal. There was spine still burning, back of head untouchable, having more trouble walking in a straight line. On 23-FEB-2009 second day of [Due to memory limitations, the remainder of this text could not be compared.] of TOPAMAX, can only walk in 45 degree angles... cannot walk to bathroom. Went to ER, where she was seen by a team on neurologists and admitted to hospital for next 3 days. Ibuprofen administered via IV. No response. Second day: dihydroerogotamine mesylate (DHE) administered, which took effect and after third day she was released. March and April 2009: patient can get through 2-4 hours of school each day and in the midst of that, needed a 1 hour rest on couch in office at school. Most days the parent picked her up at lunch. She was pale and very dizzy, with headaches reoccurring daily. Typically levels 4-5, with 7-8 spikes. She lose. The labs included CAT scan, MRI, thyroid testing, blood-work, heart monitoring... 26-APR-2010 and 05MAY-2010 PCP records December 2008, MR, for 23-FEB-2009 to 25-FEB-2009, Neurologist consulted 03-APR-2009, diagnosed as Migraines. Labs: BHCG negative Dx studies: Echo, CT Head and MRI. The listing indi


Page 4
Vaers Id: 385808-3 (S) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: AUGMENTIN; IBUPROFEN; Acetaminophen; Topamax; 15/Feb/2009: Computed axial tomography (CAT) scan was normal. 17/Feb/2009: Full blood work order: vitamin D, thyroid function, regular blood work. 20/Feb/2009: Magnetic resonance imaging (MRI) was normal; Labs: BHOG negative; Dx studies: Ec The patient has a history of conversion disorder and had an allergy of rash to red food dyes and a history of central auditory processing defect. The patient has a history of migraines. The patients concomitant medications was reported as unknown.


Page 5
Vaers Id: 396141-4 (S) Related reports: 396141-1; 396141-2; 396141-3 Age Gender Vaccine Date Onset Date Days Status Date State Received Date F 14-Aug-2010 14-Aug-2010 0 14-Feb-2011 US 14.0 11-Feb-2011 Type Manufacturer Lot Prev Doses Site VAX Detail: HPV4 MERCK & CO. INC. 1318Y Right arm TDAP UNKNOWN MANUFACTURER NULL Left arm VARCEL MERCK & CO. INC. 0093Z Left arm MNQ SANOFI PASTEUR NULL Right arm Seriousness: ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS
Mfr Report Id 201100458 Route Intramuscular Unknown Intramuscular Intramuscular
Last Edit Date 15-Feb-2011 Other Vaccine
MedDRA PT
Activities of daily living impaired, Anxiety, Chills, Convulsion, Demyelination, Dizziness, Dyskinesia, Encephalomyelitis, Fall, Feeling abnormal, Gastrooesophageal reflux disease, Headache, Hyperreflexia, Hypoaesthesia, Hypotonia, Injected limb mobility decreased, Injection site reaction, Malaise, Migraine without aura, Muscle contracture, Muscle spasms, Muscle twitching, Muscular weakness, Musculoskeletal stiffness, Myoclonus, Nausea, Pain, Pain in extremity, Paraesthesia, Personality change, Phonophobia, Photophobia, Pyrexia, Somnolence, Splint application, Stress, Tearfulness, Tension headache, Tetany, Tremor, Vision blurred
Symptom Text: Initial report received on 31 January 2011 via another manufacturer (reference number WAES 1009USA00016) who had received the original report from a physician. The following is verbatim from report: "Information has been received from a physician concerning a 15 year old female with no pertinent medical history who on 14-AUG-2010 was vaccinated intramuscularly with a dose of GARDASIL. (Lot Number is 665547/1318Y). It was part of the adolescent regime; she had gotten other shots that day. On 14-AUG-2010 the patient had a jerky reaction, headache and weakness in her arms after vaccination. The patient was rushed to the emergency room and was hospitalized. The patient had neurological testing done with normal results, she was on medicine but her mom did not know the name of it, she experienced tremors on 30-AUG-2010 and the family physician prescribed gabapentin. At the time of this report, the outcomes were unknown. Follow up information was received from the registered nurse (R.N.) who reported that the patient was 14 year old and had no known drug allergies (NKDA). On 14-AUG-2010, the patient was vaccinated with a dose of GARDASIL and a dose of MENACTRA in the right deltoid and a dose of VARIVAX (Merck) (MSD) (lot # 666761/0093Z) and a dose of Tdap in the left deltoid. There was no other concomitant medication. The nurse provided the name of the ER and indicated that there was "no admission". The nurse considered the events to be not disabling or life-threatening. She reported that she "had not seen the patient since the day the vaccines were given, but had heard that hand splints were needed two weeks after the event for flaccid arms, current status unknown". Additional information was reported by a medical assistant in the neurologist's office. It was reported that "the patient was seen twice - once on 16-AUG-2010 and then again on 31-AUG-2010. Follow up information was received from the Certified Medical Assistant (C.M.A.) who reported that the patient was seen on 16-AUG-2010 for jerking movement (described as tetany; not seizure). The patient was unable to straighten her right arm and she was prescribed SKELAXIN for muscle spasms. When she referred to Neurologist, neurology consult showed that Electroencephalography and other testing were normal, no seizure activity, and "etiology unknown". The patient was seen again on 30-AUG-2010, her exam presented normal and she was considered as recovered. She was prescribed Gabapentin 3 times daily as needed. The patient could go to school but to be abstained from sports for two weeks. Follow-up information was received from a physician and a medical record. The 14 year old, right-handed female with no allergies on 14-AUG-2010 was vaccinated with GARDASIL, VARIVAX (Merck), MENACTRA, "chickenpox", and Tdap in a car van. On the same date, the patient began jerking, uncontrollably. She went to ER and was given muscle relaxer which helped, but jerking unchanged when medicine wore off. The patient then saw neurology and MRI/EEG were normal. The patient also had right upper extremity jerking, tetany (for 3 weeks), weakness, headache (2 days), fever/chills (for 2 days), numbness (2 days), having vital space, now intermittent. On 16-AUG-2010, the patient was in the physician's office, presenting complaints of severe pain in her right arm and constant jerking that started on 14-AUG-2010 after she received shots. The mother stated that about three hours after vaccine the patient developed twitching in her right arm, intermittently. She was able to still use her arm but only with restrains. She described some tingling in both her hands. She denied any neck pain.


Page 6
Vaers Id: 396141-4 (S) She did have headaches that particular day, and then the headaches were mild. She did go to emergency room twice and once she was given ATIVAN. CT scan of her head and blood work were unremarkable. She was discharged. The patient was prescribed lorazepam which she tried but it made her sick so she was taking FLEXERIL 5 mg as needed. The Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: neurological testing (MRI / EEG) were normal. CT scan of head and blood work were unremarkable. Electroencephalography and other testing were normal. MRI of cervical spine and brain to evaluate for acute disseminated encephalomyelitis (ADEM Right handed with no known drug allergies (NKDA). No concomitant medications at time of vaccinations.


Page 7
Vaers Id: 400679-2 (S) Related reports: 400679-1 Age Gender Vaccine Date Onset Date F 25-Aug-2010 25-Aug-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Status Date State Received Date 12-Apr-2011 US 10-Mar-2011 Lot Prev Doses Site 0565Z 3 Left arm 0721Z 1 Left arm U3083CA Unknown U3511AA 0 Left arm
Mfr Report Id 201006408 Route Intramuscular Subcutaneously Unknown Intramuscular
Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: Initial report received from another manufacturer on 08 November 2010 (manufacturer report number WAES 1010USA03170) who received the report from the FDA (VAERS identification number 400679). The following is verbatim from report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female who on 25-Aug-2010 was vaccinated intramuscularly with the fourth dose of GARDASIL (Lot number 666162/0565z) in her left arm. Secondary suspect included the first dose of MENACTRA (Lot number U3511AA) given intramuscularly in to the left arm, and the second dose of Varicella (Merck) (MSD) (Lot number 668080/0721z) given subcutaneously into the left arm. Concomitant therapy included ADACEL (Lot number U3083CA). On 25-AUG-2010, the patient returned with left upper arm extremity (LUE) erythema, pain, and swelling from axilla to elbow. Rapidly enlarging. Admitted for intravenous antibiotics septic work-up. Monitored for possible abscess, compartment syndrome. Given intravenously BENADRYL no pain medications. Resolved after 2 days inpatient. All culture (CX) results were negative. Lab diagnostics included blood culture (CX): negative; serum C-reactive protein test (CRP): 41 to less than 29.8; complete blood cell count (CBC); within normal limit (WNL); ultrasound (LUE U/S); negative and erythrocyte sedimentation rate (ESR); 28. No further information is available. The original reporting source was not provided. The VAERS ID number is 400679." It was noted that the date of vaccination for the GARDASIL (Lot number 666162/0565z), and Varicella was also reported as being on 23 August 2010. Documents held by sender: None. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: All culture results were negative, Ultrasound (LUE) - negative, Serum C-reactive protein (CRP) 41 to less than 29.8, complete blood cell count within normal, erythrocyte sedimentation rate 28, blood culture negative. Unknown


Page 8
Vaers Id: 404482-2 (O) Related reports: 404482-1 Age Gender Vaccine Date Onset Date F 30-Apr-2010 01-May-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 24-Jan-2011 NJ 21-Jan-2011 Lot Prev Doses Site 1178Y 0 Left arm
Mfr Report Id Last Edit Date WAES1010USA02469 24-Jan-2011 Other Vaccine Route Intramuscular
Bone pain, Dizziness, Fatigue, Headache, Loss of consciousness, Menorrhagia, Polymenorrhoea, Presyncope, Tremor
Symptom Text: Information has been received from a consumer concerning her 15 year old daughter with spring-time allergies and no pertinent medical history who on 30-APR-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL. There was no concomitant medication. The consumer reported that "around the beginning of May 2010" on approximately 01-MAY-2010, her daughter had been experiencing heavy menstrual bleeding, headaches, quivering of the limbs, bone-crushing, fatigue and a series of black-outs since receiving a dose of GARDASIL. The consumer said that her daughter experienced these symptoms mainly on the second day of her period. The consumer said they had gone to see many specialists, including neurologist and cardiologist. On an unspecified date EEG, MRI and annual check-ups tests were performed (results not provided). At the time of the report, the patient had not recovered. Follow up information has been received from a physician. It was reported that the patient with acid reflux and congenital stridor was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 663559/1178Y) on 30-APR-2010 at 16:45. The physician reported that the patient was seen on 31AUG-2010 due to a second menstrual bleeding for 3 days (second time in that month). The patient experienced dizziness, shaking and near fainting. The physician reported that a similar episode had happened last month. Some dizziness was reported to take place daily and some was "present today." The patient was referred to the gynecologist, cardiologist, ear nose and throat (ENT) and neurology. At the time of the report the patient's outcome was unknown. Patient had a second menstrual bleeding for three days (second time in a month), dizziness, shaking and near fainting were considered to be other important medical events by the physician. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seasonal allergy; Congenital stridor; Oesophageal acid reflux None Unknown


Page 9
Vaers Id: 405873-2 (S) Related reports: 405873-1 Age Gender Vaccine Date Onset Date F 21-Mar-2008 23-Jul-2008 15.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 124
Status Date State Received Date 19-Jan-2011 US 14-Jan-2011 Lot Prev Doses Site NULL Unknown NULL 2 Unknown
Mfr Report Id Last Edit Date WAES1012USA01665 19-Jan-2011 Other Vaccine Route Unknown Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Abdominal distension, Abdominal pain, Abdominal tenderness, Asthenia, Diarrhoea, Excoriation, Fatigue, Headache, Hypoglycaemia, Infectious mononucleosis, Lymphadenopathy, Nausea, Rash, Rash pruritic, Rhinorrhoea, Spleen palpable, Syncope, Type 1 diabetes mellitus, Vomiting
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with mole of skin who on 22-JUN-2007 was intramuscularly vaccinated with the first dose of GARDASIL (lot # 654272/0319U) in right arm. Secondary suspect therapy included hepatitis A vaccine (manufacturer unknown) and varicella virus vaccine live (manufacturer unknown). Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient had strange itchy rash months before diagnosis, doctor recommended her taking CARITAN, did not diagnose. The patient also had DM (diabetes mellitus) Type 1 symptoms months before diagnosis. The following information was obtained through follow-up and/or provided by the government. On 29-OCT-2010 PCP (Primary Care Physician) records received for DOS (Date of Service) from 22-JUN-2007 to 12-AUG-2010. The patient returned on 12-SEP-2007 for additional vaccinations (reported to be second dose of GARDASIL, hepatitis A and varicella). PE (Physical exam) was WNL (Within Normal Limits). The third dose of GARDASIL and MENACTRA were administered on 21-MAR-2008. There was rash on feet and legs for 1 week which was noted on 23-JUL-2008. Food allergy was questioned and the patient was sent for RAST (radioallergosorbent test). On 13-FEB-2009 the patient went to OV (office visit), MD (Doctor of Medicine) noted DM Type 1 dx (Diagnosis) was made in OCT-2008. The patient complained of headache (H/A). Rash was noted again on 12AUG-2010. On 1-NOV-2010 ER (emergency room) records were received for DOS 10-SEP-2009. Final impression was as follow: Infectious Mononucleosis. Patient "c/c ST", running nose, vomiting, diarrhea, fatigue and HA for 1 week. Physical exam (PE) was positive for neck lymphadenopathy, abdominal tenderness, tender palpable spleen. D/c to f/u (Follow up) with PCP. On 8-NOV-2010 hospital records were received for DOS from 2-DEC-2009 to 6-SEP-2010 when patient presented at the ER after syncopal episode. Final impression was as follow: hypoglycemia, syncope. PE(+) was tenderness on upper extremities, abrasions on hands. On 6-SEP-2010 patient presented at ER with c/c abdominal pain, nausea, bloating, weakness. Patient left ER w/o (without) being discharged. A lot check has been initiated. One or more of the events required hospitalization, was considered to be disabling, was considered to be immediately life-threatening. This was originally reported by a consumer. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, and expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Mole of skin Diagnostic laboratory, diabetes type 1; Physical examination, 09/12/07, within normal limits; Physical examination, 11/01/10, positive for neck lymphadenopathy, abdominal tenderness, tender palpable spleen; Physical examination, 11/08/10, p


Page 10
Vaers Id: 406578-2 (S) Related reports: 406578-1 Age Gender Vaccine Date Onset Date F 12-May-2010 23-Sep-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR Seriousness: MedDRA PT
Days 134
Status Date State Received Date 31-Jan-2011 US 28-Jan-2011 Lot Prev Doses Site 0969Y 0 Right arm U3052AA 5 Left arm 1048S 1 Left arm AHAVB365CA 0 Right arm U3068AA 0 Right arm
Mfr Report Id Last Edit Date WAES1101USA00723 18-Apr-2011 Other Vaccine Route Intramuscular Intramuscular Subcutaneously Intramuscular Intramuscular
LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Alopecia, Arthralgia, Arthritis, Autoimmune disorder, Cognitive disorder, Decreased eye contact, Disturbance in attention, Dry eye, Educational problem, Epistaxis, Fatigue, Lethargy, Malaise, Memory impairment, Multiple sclerosis, Muscle spasms, Pain, Sjogrens syndrome, Systemic lupus erythematosus, Urinary tract infection
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 12 year old female patient. The patient's past medical history included: colic as infant (3 weeks old to 8 months old), ear infections, Upper Respiratory Tract Infection (URI), atopic dermatitis, eczema, Attention Deficit/Hyperactivity Disorder (ADHD), questionable Attention Deficit Disorder (ADD). On 12-MAY2010 the patient received the first dose of GARDASIL (lot # 663573/0969Y) IM in left arm and the second dose of VARIVAX (lot # reported as "1048S") SC in left arm. Concomitant vaccinations on the same included the first dose of MENACTRA (lot # U3068AA) IM in right arm, the first dose of HAVRIX (lot # AHAVB365CA) IM in right arm, and the fifth dose of ADACEL (lot # U3052AA) IM in left arm. On 23-SEP-2010 (134 days after vaccination) the patient experienced memory and cognitive deficit. In "May" to present - hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA (reported as antiphospholipid antibodies test) for an autoimmune diagnosis for either lupus, multiple sclerosis (MS), arthritis and Sjogren's. Patient went to neurology of hospital. Continued treatment. The following information was obtained through follow-up and/or provided by the government. On 19-NOV-2010, primary care physician (PCP) records was received for date of service (DOS) on 17-NOV-1997 - 18-NOV-2010 with assessment: multiple arthralgias of uncertain etiology. On 15-OCT-2010 patient complained of poor concentration, poor memory, body aches, falling grades. Past Medical History included (vitamin) B12 deficiency (per mom, no documentation), poor sleep, fatigue, and questionable Attention Deficit Disorder (ADD). The patient was provided flu vaccine and sent for labs. She was referred to rheumatologist. On 12-NOV-2010 the patient returned for labs results, complained of not feeling well. She was diagnosed with urinary tract infection (UTI). The patient returned on 18-NOV-2010 complained of feeling "like crap". She was scheduled for magnetic resonance imaging (MRI) and electroencephalography (EEG). She had poor eye contact during visit. Provided copy of lab results for rheumatology appointment. On 18-OCT-2010 more lupus 1:320, positive ANA testing TBD (to be determined). On 19-NOV-2010 lab/diagnostic reports received for DOS 10-NOV-2010 "IgG & IgM negative Anti-". Outcome of the events was not reported. The report indicated one or more of the reported AEs were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 406578. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met [Due to memory limitations, the remainder of this text could not be compared.] the requirements of the Research Center and was released. No further information is available. Other Meds: Lab Data: serum ANA, also reported as antiphospholipid antibodies test positive; lupus anticoagulant, 1:320; serum immunoglobulin G, negative; serum immunoglobulin M, negative.


Page 11
Vaers Id: 406578-2 (S) History: Prex Illness: Prex Vax Illns: Colic; Ear infection; upper respiratory tract infection; Dermatitis atopic; Eczema; Attention deficit/hyperactivity disorder; Attention deficit disorder; Vitamin B12 deficiency


Page 12
Vaers Id: 407172-2 (S) Related reports: 407172-1 Age Gender Vaccine Date Onset Date F 13-Jun-2007 22-Nov-2007 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 162
Status Date State Received Date 16-Feb-2011 US 15-Feb-2011 Lot Prev Doses Site 0637F 2 Right arm
Mfr Report Id Last Edit Date WAES1101USA00740 17-Feb-2011 Other Vaccine Route Intramuscular
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Affect lability, Aphasia, Apraxia, Arthropathy, Balance disorder, Cerebrovascular accident, Cognitive disorder, Coordination abnormal, Cranial nerve disorder, Demyelination, Disturbance in attention, Drooling, Dysarthria, Dyskinesia, Dysphagia, Dysphonia, Emotional disorder, Fatigue, Feeding disorder, Gait disturbance, Gastrointestinal tube insertion, Hyperreflexia, Leukoencephalopathy, Motor neurone disease, Movement disorder, Muscle spasticity, Muscular weakness, Nervous system disorder, Sensory loss, Speech disorder, Tongue paralysis, VIIth nerve paralysis, Vasculitis, Weight decreased
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female patient with a medical history of premature birth, cisterna magna, intracranial calcifications, periventricular hyperdensities and calcifications, hyoglycoracchia, and educational assistance since 2nd grade (verbal tasks were superior to ability to read), and no illness at time of vaccination, received a third dose of GARDASIL (Lot # 653937/0637F) IM, on the right arm, on 13-JUN-2007. First and second doses of GARDASIL were administered on 13DEC-2006 and 15-FEB-2007 respectively (Lot # not provided). The patient's speech was slurring. At this date patient could not talk, or move her muscles. Patient has eating through a feeding tube. The following information was obtained through follow-up and/or provided by the government. On 22-NOV-2010 hospital records were received for date of service 04 and 10-APR-2008 with a discharge diagnoses of leukoencephalopathy of unknown etiology. Secondary diagnoses: history of prematurity, question of neonatal Toxoplasma, Other viruses, Rubella, Cytomegalovirus, Herpes virus (TORCH) infection with residual ventriculomegaly, absent septum pellucidum, cerebellar hypoplasia and some gray matter heterotopia. The patient complained of progressively increasing dysarthria with word finding difficulties, loss of coordination, and more easily fatigued. Examination: slow hypophonic dysarthric speech, mild weakness in upper extremities deltoids and triceps, MRI consistent with vasculitic picture with multiple strokes or autoimmune demyelinating disorder, or possibly toxic or infectious cause. The patient was discharged home in stable condition with speech therapy. On 29-NOV-2010 Neurology consultant records received for date of service on 29-APR-2008 with diagnostic of 1) progressive neurological deficits marked predominantly by dysarthria, spasticity, and upper motor neuron findings; 2) apraxia; 3) cortical sensory deficits; 4) pseudobulbar affect; 5) cognitive deficits, predominantly attentional and learning; 6) abnormal MRI scan. The patient complained of slurred speech, midsentence hesitation, irregular rhythm and pitch - worse with fatigue, inability to straighten right knee and move right leg, balance difficulty, weight loss, difficulty concentrating, unable to close mouth on resulting in drooling, laughs and cries easily, leg weakness. Examination: cognitive deficits in attention and learning, apraxia, cortical sensory deficits, CN VII deficit with result on facial droop. Difficulty controlling tongue movements, hyperreflexia, spasticity, and difficulty heel walking. The patient was referred for testing. On 29-NOV-2010 speech pathology consultant records received for date of service on 30-APR-2008 with diagnostic of spastic/ataxic dysarthria. The patient seen for symptoms as noted. Additionally reported previous difficulty swallowing - [Due to memory limitations, the remainder of this text could not be compared.] lowing - controlled by eating slower and taking smaller bites. On 29-NOV-2010 neurology consultant records received for date of service 03-MAY-2008 and 25-JUN-2008 with diagnostic of progressive neurologic syndrome with imaging changes. Follow up visit revealed additional complaints of increasing difficulty swallowing. Other symptoms ongoing. Additional testing performed. The patient had performed several laboratories, MRIs, and brain biopsies without any results available. The patient presented to ER and was hospitalized. The reporter considered the adverse events to be life threatening, required hospitalization and permanent disabling. A lot check has been initiated. The original reporting source was not provided. The VAERS ID # is 407172. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expan Other Meds: Lab Data: Unknown Magnetic resonance, abnormal, see narrative; Brain biopsy, see narrative


Page 13
Vaers Id: 407172-2 (S) History: Prex Illness: Prex Vax Illns: Premature birth; cerebrospinal fluid retention; cerebral calcification; educational problem


Page 14
Vaers Id: 407699-1 (S) Age Gender Vaccine Date Onset Date F 01-Apr-2010 25-Aug-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Lyme disease, Papilloedema
Days 146
Status Date State Received Date 27-Jan-2011 FR 02-Nov-2010 Lot Prev Doses Site NULL 1 Unknown
Symptom Text: Information has been received from the Health Authorities on 25-OCT-2010 under the reference numbers TS20100410 and 10 408. Case medically confirmed. A 15-year-old female patient had received the first dose of GARDASIL (batch number not reported) in April 2010 and the second dose GARDASIL (batch number not reported( via intramuscular route on 01-JUN-2010. On 25-AUG-2010, a funduscopy was performed in the context of a systemic medical supervision of eye glasses wearer with accommodation disorder. It revealed an asymptomatic bilateral papilledema. The previous examination had been performed (without funduscopy) in June 2010 by an orthoptist. The results were normal. The patient was hospitalized for a workup. There was no ophthalmologic or neurologic or function sign. The cerebral angio scan performed in emergency showed no sign of intra-cranial blood pressure, no ventricles dilatation, nor thrombophlebitis. Lyme disease was suspected and treated with ROCEPHIN in spite of the absence of a notion of tick's bite, but with a serology initially positive although not confirmed on a subsequent check-up, nor on the PCR in the cerebrospinal fluid. No other etiology was found. There was no inflammatory, protein electrophoreses were normal, thyroidal work-up and lactic dehydrogenase were normal. The following serologies were negative or in favour of a former infection: toxoplasmosis, Cytomegalovirus, Epstein-Barr virus, Herpes simplex virus 1 and 2, VZV, rickettsial disease, leptospirosis, and toxocariasis. Immunologic work-up was negative (antinuclear antibodies SSA, SSB, SM, NRP, SL 70, Jo-1, centromere, rheumatoid factor, C3, C4 and CH 50 complements, angiotensin-converting enzyme, anticardiolipin antibodies, beta 2-GP1, antiphospholipid antibodies. Lumbar punction showed: cerebrospinal fluid protein level at 0.2 g/l, glycorrhachia at 3.34 1mol/l, chlorides at 121 mol/l, leukocytes at 1/mm3, erythrocytes at 25/mm3. MRI performed en 17-SEP-2010 was normal. In the beginning of October 2010, the patient went to an Ophthalmologic consultation which showed that the papilledema was regressing. The possible role of the GARDASIL vaccine was questioned as no other etiology was found. Outcome was considered as recovering. The Health authorities assessed the causal relationship between the reported reaction and vaccinations as "possible" (C2 S2 I2) according to the foreign method of assessment. Other business partner numbers include E2010-06366. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown ophthalmoscopy, 25Aug10, an asymptomatic bilateral papilledema; cerebral angiography, no sign of intra-cranial blood pressure, no ventricles dilatation, nor thrombophlebitis; Epstein-Barr virus antibodies, negative; HSV type 1 and/or 2 iden Unknown Accommodation disorder; eyeglasses wearer


Page 15
Vaers Id: 408723-2 (S) Related reports: 408723-1 Age Gender Vaccine Date Onset Date F 12-Oct-2010 21-Oct-2010 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 9
Status Date State Received Date 01-Feb-2011 US 31-Jan-2011 Lot Prev Doses Site 0096Z 1 Right arm
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Acne, Amnesia, Blood pressure abnormal, Chest pain, Conversion disorder, Convulsion, Disorientation, Dizziness, Emotional distress, Fatigue, Headache, Hyperventilation, Loss of consciousness, Migraine, Motor dysfunction, Movement disorder, Nausea, Presyncope, Rash, Respiratory rate increased, Staring, Syncope, Tremor, Unresponsive to stimuli, Vomiting
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with a history of dyslexia, amblyopia, vomiting and abdominal pain (after milk or ice cream) and penicillin allergy and no known pre-existing illness on 12-OCT-2010 was vaccinated with the second dose of GARDASIL (Lot # 666595/0096Z) IM into the right arm. Concomitant vaccine therapy included live intranasal (cold adapted Ann Arbor master strain) FLUMIST (Lot # 501051P), the first dose of ADACEL (Lot # U3486AA) IM into the left arm and the second dose of MENACTRA (Lot # U3511AA) IM into the left arm. On 21-OCT-2010 the patient experienced dizziness, syncope, disorientation. Seizures and syncope with loss of function on left side started on 28-OCT-2010 with hospitalization, headaches, migraines, nausea, vomiting, rash, acne, fatigue, abnormal blood pressure. The following information was obtained through follow-up and/or provided by the government. 16-NOV-2010 PCP office record and vaccination record received for DOS on 12-OCT-2010 and office visit rec received for DOS on 13-NOV-2010 to 15-NOV-2010. Assessment: Pseudoseizures. Patient was seen on 12-OCT-2010. Assessment: well child. Plan: screen for celiac disease. Visit on 03-NOV-2010 for follow up post hospitalization. Patient reported to have continued episodes involving loss of consciousness, convulsing, hyperventilating, and staring off into space and memory lapses. Patient also complaint of chest pain and headaches. Patient reported stressors (some picking on her at school, trouble with best friend). Neurological exam noted as normal. Assessment: Pseudoseizures, conversion disorder. Patient was seen on 15-NOV-2010 with continued complaint of episodes of seizure-like activity and "passing out". Neurological exam noted as normal. On 17-NOV-2010 discharge summary, in patient record and ER record received for DOS from 28-OCT-2010 to 29-OCT-2010. Diagnosis: Pseudoseizure/conversion disorder. Patient presented with complaint of near syncopal episode at school. Patient reported similar episode 2 weeks earlier. CT head ordered and IV started. In emergency room, patient had episode with eyes closed, non-responsive, entire body shaking side to side, hang grasping sheets, breathing quickly. Episode stopped when dad tickled her knee which made her smile. Record noted CT, blood and urine tests normal. Patient admitted and evaluated by neurology, psychology and physical therapy. Patient had continued periodic pseudoseizures and family educated as to origin (stressors). Patient discharged home and to follow up with PCP. Laboratory results included: CT scan, video EEG, EKG, blood tests, vitals, therapy. The following information was obtained through follow-up and/or provided by the government. On 17-NOV-2010 and 18-NOV-2010 records received. CT head/brain: normal, EEG: normal (normal awake). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. The events were serious. The original reporting source was not provided. The VAERS ID # is 408723. No further information is available. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. Other Meds: Lab Data: History: Prex Illness: Dyslexia; Amblyopia; Vomiting; Abdominal pain; Penicillin allergy Computed axial, head/brain: normal; Diagnostic laboratory, blood tests normal; Electrocardiogram, normal; urinalysis, normal


Page 16
Vaers Id: 408723-2 (S) Prex Vax Illns:


Page 17
Vaers Id: 411219-1 (O) Age Gender Vaccine Date Onset Date F 30-Sep-2010 28-Oct-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 28
Status Date State Received Date 03-Jan-2011 FR 02-Dec-2010 Lot Prev Doses Site NK10770 0 Unknown
Asthenia, Diarrhoea, Headache, Malaise, Somnolence
Symptom Text: This case was received from the Health Authority on 19-NOV-2010 under the reference number 2010-000588. This case is medically confirmed. A 12 year old female patient with unreported risk factors and concomitant medication received the first dose of GARDASIL, (batch number NM25090, lot number NK10770), intramuscularly, site not reported and experienced headache, asthenia, malaise, pain in head, somnolence and diarrhoea. One week post vaccination, the patient experienced a mild headache, followed by a violent headache two weeks post vaccination when the patient felt weak and sick. The site of the pain was at the back of the head. On 28-OCT-2010, 28 days post vaccination, the patient experienced the same again but also felt sleepy and had diarrhoea. The patient outcome has not been reported. Both the reporter and the agency considered the events to be serious for the other medically important condition requiring intervention. Other business partner numbers include E2010-07181. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 18
Vaers Id: 411220-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 03-Jan-2011 US 02-Dec-2010 Lot Prev Doses Site NULL 0 Unknown
Mfr Report Id Last Edit Date WAES1011USA03313 03-Jan-2011 Other Vaccine Route Unknown
Abdominal discomfort, Arthralgia, Dark circles under eyes, Fatigue, Headache, Herpes zoster, Influenza, Listless, Malaise, Muscle spasms, Myalgia, Pallor, Paralysis, Vaginal infection, Viral infection
Symptom Text: Information has been received from a consumer who posted her granddaughter's experience on internet on 13-NOV-2009. It was reported that the patient received one dose of GARDASIL (lot# not reported) and hadn't been right since. She had been in doctor's office 3 times since shot and diagnosed with flu, virus...-yet 6 weeks later she was still ill. She had stomach upset, headache, very tired (she even looked tired...dark circles under her eyes, pale, listless). She broke out in shingles 3 weeks after shot. Her joints/muscles ached. But, most alarming was the partial paralysis in fingers and toes (worse in toes). Her toes literally cramp up and curl under towards her foot. Most recently she has a vaginal infection and possible urinary tract infections (UTI) (going to get that checked tomorrow). At the time of this report, the patient's outcome was not reported for the patient's shingles. Upon internal review, partial paralysis in fingers and toes was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 19
Vaers Id: 411221-1 (O) Age Gender Vaccine Date Onset Date F 01-Mar-2007 Unknown 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Fall, Injury
Days
Symptom Text: Information has been received from a female consumer who posted her daughter's experience on internet. She reported that her healthy 13 year old daughter started having her first of several seizures after she had received her second dose of GARDASIL (lot# not reported) in March 2007. She was now 15 year old and still having random seizures. On 21-OCT-2010, the patient had a seizure and she fell to the ground and had minimal injuries. The outcome was not reported. Upon internal review, seizures was considered to be an other important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 20
Vaers Id: 411222-1 (O) Age Gender Vaccine Date Onset Date F 04-Nov-2010 04-Nov-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pain in extremity, Paraesthesia
Days 0
Status Date State Received Date 03-Jan-2011 FR 02-Dec-2010 Lot Prev Doses Site NULL Unknown
Symptom Text: Case received from the health authorities on 22-NOV-2010 (Reference number ES-AGEMED-022813441). Case medically confirmed. A 14 year old female patient with no relevant medical history reported on 04-NOV-2010 was vaccinated via intramuscular with a dose of GARDASIL (Lot and Batch# not reported). On the same date, 04-NOV-2010, the patient presented with paresthesia lower limb and leg pain. According to the narratives in the health authorities report, 2-3 hours after vaccine administration, the patient developed pain from knee to feet with intermittent paresthesia. The patient was sent to the hospital by her pediatrician, normal neurological examination was performed, the result was normal. In the health authorities report it was not reported whether the patient was hospital admitted or not. The outcome for these adverse events was unknown. Only paresthesia lower limb and leg pain was coded in the health authorities report. Case reported as serious by the health authorities with other medically important condition as criteria. Case was closed. Other business partner numbers include: E2010-07228. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown neurological examination, normal Unknown


Page 21
Vaers Id: 411654-1 (S) Age Gender Vaccine Date Onset Date F 05-Oct-2010 06-Oct-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 1
Abdominal pain, Condition aggravated, Eosinophilia, Leukocytosis, Lymphadenitis, Peritoneal disorder, Sleep disorder
Symptom Text: Serious case received from the health authorities on 22-NOV-2010. Case medically confirmed. case reported as serious by the health authorities. The primary reporter had reported the case as serious. A 13-year-old female patient with a medical history of mentioned "correct" general condition (sic) and no dependence. The patient had presented with nocturnal enuresis till 10 year because of overactive bladder. In March 2010, she had had constipation due to diet issue (no vegetables/fruit) and had presented with abdominal pain for which DICLOFENAC 2x25mg was given for 3 days. Eosinophilia which was minimally present about 7 months before. In September 2010, she had had serous otitis and congested nose treated with DAFALGAN with or without NUROFEN. The patient was frequently on holiday in another country. It was also mentioned that the patient's mother had a history of hay fever. On 05OCT-2010 she had received a dose of GARDASIL (Lot and batch# not reported). She experienced abdominal pain and increasing leukocytosis with clear eosinophilia and mesenteric lymph glands. On 06-OCT-2010, the patient developed progressive "++" abdominal pain and had mild peritoneal irritation. She did not have fever. Her night sleep was disturbed by pain. Menses were unclear. No medication was prescribed. Laboratory test were performed included: On 22-MAR-2010: white blood cells: 11.380 Eosinophiles 11%. On 11-OCT-2010: white blood cells: 29.8 (eosinophiles: 37%). On 13-OCT2010: white blood cells: 30.58 (eosinophiles: 53.2%). On 14-OCT-2010, the patient was in observation at the hospital. No toxemia, no neningism, no collapse was observed. Abdominal computed axial tomography showed increased mesenteric glands. Abdominal pain was found between navel and symphysis, not peritoneal. Rx thorax and Echo abdomen were normal. Dermatological, urogenital and ophthalmological examinations were normal. Lungs were normal. Dentist examination found one small hole. Ears, nose, and throat examination was normal. Bone marrow examination and coproculture. These tests were mentioned without results. It was specified that the adverse event was in evolution. Treatment: expectatio armata. The health care professional wondered about the influence of the vaccination on eosinophilia which was minimally present about 7 months before and escalated in October in such a way that hospital admission was needed. Other business partner numbers include: E2010-07211. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown hospital observation; 14Oct10; No toxemia, no meningism, no collapse; abdominal computed axial tomography; 14Oct10; normal; abdominal ultrasound; 14Oct10; Echo abdominal: normal; X-ray; 14Oct10;Rx Thorax: normal; urological examination; 14O Nocturnal enuresis; Constipation; Abdominal pain; glue ear; Nasal congestion; Eosinophilia; Overactive bladder


Page 22
Vaers Id: 411655-1 (O) Age Gender Vaccine Date Onset Date F 04-Nov-2010 04-Nov-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Formication, Myalgia, Tremor
Days 0
Symptom Text: Case received from the health authorities on 22-NOV-2010 (Reference number ES-AGEMED-922812341). Case medically confirmed. A 14 year old female patient with no relevant medical history reported on 04-NOV-2010 was vaccinated via intramuscular with a dose of GARDASIL (Lot and batch# not reported). On the same date, 04-NOV-2010, the patient presented with shakiness, formication and myalgia. The patient recovered from shakiness on an unspecified date. The outcome from formication and myalgia was unknown. Case reported as serious by the health authorities with other medically important condition as criteria. Case was closed. Other business partner numbers include: E2010-07218. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 23
Vaers Id: 411656-1 (O) Age Gender Vaccine Date Onset Date F 05-Nov-2010 05-Nov-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Loss of consciousness
Days 0
Symptom Text: Information has been received from the Health Authorities on 22-NOV-2010 under the reference number ES-AGEMED-622809341. Case medically confirmed. A 14 year old female patient received a dose of GARDASIL, batch number not reported, by intramuscular route on 05-NOV-2010 and on the same day, she experienced convulsions that lasted for 30 seconds with loss of consciousness. The patient recovered slowly, when she got up she experienced another loss of consciousness, this time without convulsions. Oxygen saturation readings at 99% (reported twice, with no dates reported), blood pressure levels (date not reported) 90/50mmHg and 120/70mmHg (date not reported). The patient completely recovered. Case reported as serious by the health authorities with other medically important condition as criteria. No further information reported. Case is closed. Other business partner numbers include: E2010-07247. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown blood pressure measurement, ??Nov10, 90/50 mmHg; blood pressure measurement, ??Nov10, 120/70 mmHg; arterial blood O2 saturation, ??Nov10, 99% Unknown


Page 24
Vaers Id: 411657-1 (O) Age Gender Vaccine Date Onset Date F 17-Nov-2010 17-Nov-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Muscle rigidity, Syncope
Days 0
Symptom Text: Information has been received from a Health Authority under the reference number ES-AGEMED-822846241 concerning a 14 year old female who on 17-NOV-2010 was vaccinated intramuscularly with a dose of GARDASIL (LOT# not reported). On 17-NOV-2010 the patient experienced convulsions, muscle rigidity and faint. The patient recovered from convulsions, muscle rigidity and faint on the same day. Case reported serious by the HA with other medically important condition as criteria. Other business partner numbers included: E2010-07434. No further information was reported. Case medically confirmed. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 25
Vaers Id: 411994-1 Age Gender Vaccine Date Onset Date F Unknown Unknown 11.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 04-Jan-2011 NJ 07-Dec-2010 Lot Prev Doses Site AHAVB462AA 1 Right arm C3476AA U3507AA 0766Z 0 0 0 Left arm Left arm Right arm
Mfr Report Id Route Unknown Unknown Unknown Unknown
Last Edit Date 20-May-2011 Other Vaccine
Injection site erythema, Injection site swelling
Symptom Text: 10 cm by 7 cm swollen redness on left upper arm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 26
Vaers Id: 412269-1 Age Gender Vaccine Date Onset Date F 29-Oct-2010 05-Nov-2010 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pain, Pain in extremity, Tenderness
Days 7
Status Date State Received Date 05-Jan-2011 OR 08-Dec-2010 Lot Prev Doses Site 1539Y 1 Left arm
Mfr Report Id Route Unknown
Symptom Text: 11/5 -> present sharp spreading pain when lifting arm; tender/painful to touch at specific point on arm/shoulder on day of vaccine & following 3-5 days spreading pain in arm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NUVARING; MVI; Probiotics None No No


Page 27
Vaers Id: 412303-1 Related reports: 412303-2 Age Gender Vaccine Date Onset Date F 05-Aug-2010 06-Aug-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Menorrhagia
Days 1
Status Date State Received Date 06-Jan-2011 OH 09-Dec-2010 Lot Prev Doses Site 0318Z 0 Left arm
Mfr Report Id Route Intramuscular
Symptom Text: First occurrence of heavy menses 24 hours post HPV. Patient normally not menstrual yet. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Hematuria; proteinuria; acne None - well visit


Page 28
Vaers Id: 412325-1 Age Gender Vaccine Date Onset Date F 02-Nov-2010 02-Nov-2010 13.0 Type Manufacturer VAX Detail: MEN SANOFI PASTEUR HPV4 MERCK & CO. INC. MMR MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 24-Feb-2011 GA 09-Dec-2010 Lot Prev Doses Site U3431AA 0 Right arm 0766Z 0 Right arm 0229Z 1 Left arm AHAVB427AA 0 Left arm 0244Z AC52B061CA 1 0 Right arm Left arm
Mfr Report Id GA10066 Route Intramuscular Intramuscular Subcutaneously Intramuscular Subcutaneously Intramuscular
Somnolence, Syncope, Unresponsive to stimuli
Symptom Text: Administer vaccines below, client became groggy, not responding and fainted. Client placed supine with feet elevated, compressed to face, stimuli, monitored VS. Called for assistance from MD & nurses when client fainted. Alert, oriented & talkative. Left with mom in good condition. Provided with cola. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Blood glucose, 10:20, 79 None None


Page 29
Vaers Id: 412428-1 (O) Age Gender Vaccine Date Onset Date F 11-Nov-2009 Unknown 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 05-Jan-2011 FR 10-Dec-2010 Lot Prev Doses Site NULL 0 Unknown
Abortion induced, Amenorrhoea, Drug exposure during pregnancy, Oral contraception, Primiparous
Symptom Text: Case received from a consumer in a foreign country through the Sanofi Pasteur GARDASIL Pregnancy Registry on 20-JAN-2010: Initial information has been received from a female consumer, for GARDASIL, a Pregnancy Registry product, concerning herself (age unspecified) who on 11-JAN-2010 was vaccinated with the second dose of GARDASIL (batch number not reported) as she was pregnant. On the day of reporting, she was in her 12th week of pregnancy. The pregnancy was spontaneous. The first dose of GARDASIL had been well tolerated. Additional information received from a health care professional on 21 and 25-JAN-2009: The patient was 16 years old. She had no relevant medical history. She was taking oral contraceptive, but had forgotten one pill. She was primipara and had no history of spontaneous abortion. The pregnancy was spontaneous. She had received the first dose of GARDASIL approximately two months before this report. There was no reaction after the first dose, nor after the second dose. The patient had been vaccinated at 7.5 weeks of amenorrhea. On 21-JAN-2010, the patient had told the reporter that she wanted to keep the baby. But on 25-JAN-2010, the reporter informed that finally the patient asked for a voluntary termination of pregnancy which was planned for the following Friday, i.e. on 29-JAN-2010. Follow up information received on 02-DEC-2010, according to the initial pregnancy questionnaire, the patient underwent an elective abortion on an unspecified date. The patient's outcome was unknown. Other business partner numbers included: E201000379. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 27Oct09) Unknown Unknown


Page 30
Vaers Id: 412597-1 Age Gender Vaccine Date Onset Date F 30-Apr-2010 30-Apr-2010 25.0 Type Manufacturer VAX Detail: HEPAB GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Immediate post-injection reaction
Days 0
Status Date State Received Date 06-Jan-2011 FL 23-Nov-2010 Lot Prev Doses Site AHABB174AA 0 Right arm 0672Y Left arm
Mfr Report Id A0871483A Route Unknown Unknown
Symptom Text: This case was reported by a healthcare professional and described the occurrence of increase in thyroid levels in a 25-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included hypothyroidism. Concurrent vaccination included GARDASIL (nongsk); Merck; unknown; unknown given on 30 April 2010. Concurrent medications included LOESTRIN. On 30 April 2010 the subject received 1st dose of TWINRIX (unknown route, right arm). On 30 April 2010, immediately after vaccination with TWINRIX, the subject experienced increase in thyroid levels. Relevant test results included thyroid levels over 100. At the time of reporting the outcome of the event was unspecified. The vaccination course with TWINRIX was discontinued. The subject was consulting with thyroid specialist. Follow-up information received on 03 August 2010 reported that following administration of TWINRIX and GARDASIL (given at the same time in the subject's left arm on 30 April 2010) the subject's thyroid levels immediately increased. GARDASIL was also reported to be suspect. It was noted that further vaccinations with TWINRIX were discontinued at the present time. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: LOESTRIN Thyroid function test abnormal, 30Apr2010, over 100 Hypothyroidism; It was unknown whether the subject had experienced adverse events following previous vaccinations. Follow-up reported that the subject does not use alcohol and uses a half pack of tobacco a day. Unknown


Page 31
Vaers Id: 412652-2 (S) Related reports: 412652-1 Age Gender Vaccine Date Onset Date Days M 10-Dec-2010 10-Dec-2010 0 18.0 Type Manufacturer VAX Detail: FLUN MEDIMMUNE VACCINES, INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT LIFE THREATENING, SERIOUS
Status Date State Received Date 22-Mar-2011 US 21-Mar-2011 Lot Prev Doses Site 501049P 1 Unknown 0768Z 2 Left arm
Mfr Report Id Last Edit Date WAES1103USA00580 22-Mar-2011 Other Vaccine Route Unknown Intramuscular
Anxiety, Cold sweat, Dizziness, Pallor, Peripheral coldness, Pulse abnormal, Skin discolouration
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 10-DEC-2010 an 18 year old male with no pre-existing illness was vaccinated IM into left arm with the third dose of GARDASIL (lot # 666597/0768Z). Concomitant medication included intranasal FLUMIST. The patient's physical examination was within normal limits before vaccination. The patient experienced dizziness, uneasiness within minutes of receiving shot. The patient was found to have pallor, cold clammy skin, thin thready pulse. After immunizations, patient's skin color changed and patient's hands became cold and clammy. He was given BENADRYL and epinephrine and free flow oxygen. It took 1520 minutes for recovery of good pulse volume and blood pressure. The patient recovered within a few minutes. On 11-DEC-2010 patient was feeling OK per patient's mother who was contacted by a follow-up call. The listing indicated that one or more of the events was considered to be immediately lifethreatening. The original reporting source was not provided. The VAERS ID # is 412652. A standard lot check investigation has been finalized. All inprocess quality checks for the lot number 666597/0768Z, were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 32
Vaers Id: 412755-1 (O) Age Gender Vaccine Date Onset Date F 28-Sep-2010 28-Sep-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Paraesthesia, Pyrexia
Days 0
Status Date State Received Date 04-Jan-2011 FR 14-Dec-2010 Lot Prev Doses Site NK25010 Unknown
Symptom Text: This case was initially received from a health authority on 02-DEC-"2012" ref 2010-000931. This is one of two linked cases concerning the same patient and different vaccines. This case is medically confirmed. A 12 year old female patient with no concomitant medication reported received an injection of GARDASIL (Batch number NM31130; lot number NK25010) on 28-SEP-2010. On 28-SEP-2010 approximately two hours post vaccination, the patient experienced paraesthesia of the arm and a swinging pyrexia. The patient had received MMR II (manufacturer and batch number not reported) aged five years and had patches with blisters in her arm. No risk factors were available. The patient missed three days of school and received NUROFEN as corrective treatment. The paraesthesia lasted three days. The patient recovered on an unreported date. The patient's mother withdrew consent for further doses of vaccine. The events were considered medically significant as they required intervention. Other business partner numbers include E2010-07575. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Immunisation; Blister


Page 33
Vaers Id: 412903-1 (S) Age Gender Vaccine Date Onset Date F 15-Nov-2007 Unknown 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days
Status Date State Received Date 11-Jan-2011 KY 15-Dec-2010 Lot Prev Doses Site 1063U 1 Unknown
Blindness, Optic nerve disorder, Optic neuritis
Symptom Text: Information has been received from a physician concerning a 11 year old female patient with no known drug reactions/allergies who in 2008 at 12 years old, was vaccinated IM with all three doses of GARDASIL (lot # not reported). The patient "had a normal eye exam before GARDASIL treatment and after starting GARDASIL treatment a later eye exam within the same year reported optic neuritis" in 2008. The patient sought unknown medical attention. Lab diagnostics test magnetic resonance imaging performed, no results provided. At the time of reporting the patient's optic neuritis did not improve. Followup information has been received from the physician concerning the 11 year old female student with exercise induced asthma who was vaccinated IM into the left arm with the first dose of GARDASIL (lot number 658558/1061U) on 25-AUG-2007, the second dose (lot number 658563/1063U) on 15-NOV2007, and the third dose (lot number 660387/1967U) on 27-MAY-2008. In spring 2008, the patient wanted to opthamologist as could not see at school, bilat, dead spots seen on each optic nerve. Patient had had a normal eye exam in 2005. In 2008, the 11 year old patient experienced optic neuritis after GARDASIL 1 to 3 dose. At the time of this report, the patient's adverse events did not recover. The patient's "could not see at school" and bilat, dead spots seen on each optic nerve were considered to be disabling and other important medical events by the physician. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma exercise induced Unknown ophthalmological exam, ?/?05, normal; ophthalmological exam, ?/?08, optic neuritis


Page 34
Vaers Id: 412904-1 (O) Age Gender Vaccine Date Onset Date F 29-Oct-2010 29-Oct-2010 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Angioedema, Urticaria
Days 0
Symptom Text: Information has been received from the Health Authorities (HA) under the reference number DK-DKMA-20103489. Case medically confirmed. A 21 year old female patient had received an injection of GARDASIL (batch number not reported, IM) on 29-OCT-2010. HA coded urticaria and angioedema with onset on 29-OCT-2010. The patient received corrective treatment with antihistamines and prednisolone, she was not hospitalized. The patient visited the emergency ward and afterwards her own doctor. The HA considered angioedema as serious. Upon medical review the company upgraded the case to serious due to other medically important condition. At the time of reporting, the outcome was recovering. Other business partner numbers include: E2010-07472. No further information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 35
Vaers Id: 412905-1 (S) Age Gender Vaccine Date Onset Date F 01-Jun-2007 01-Jun-2007 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 0
Back disorder, Back pain, Convulsion, Extraocular muscle paresis, Headache, Hypoaesthesia facial, Tremor
Symptom Text: Information has been received via the internet from a 24 year old female consumer with no history of seizures who was vaccinated with the third dose of GARDASIL in June 2007. In August 2007 the patient was hospitalized due to back problems. It was reported that "the following day", the patient experienced seizures (it was also reported that the onset date of back pain and seizures was in June 2007). The patient stated she experienced the following "preliminary symptoms: left eye weakens, strong pain in left side of the head, tremors and no feeling in face etc." After several days of seizures they disappear for several months and then reoccur. The patient stated that she had referred to a neurologist who did not know how to help her. The patient visited an epilepsy clinic where she was told that it was all in her mind because all the tests came positive. The outcome of the back pain was unknown and at the time of this report the patient had not recovered from the seizures. The reporter felt that the seizures were related to therapy with GARDASIL. Upon internal review seizures were considered to be an Other Medical Event. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown diagnostic laboratory, positive Unknown


Page 36
Vaers Id: 413043-1 (O) Age Gender Vaccine Date Onset Date F 21-Sep-2010 22-Sep-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pruritus generalised, Urticaria
Days 1
Symptom Text: This case was received from health authority on 09-DEC-2010 under the reference number 2010-001195. This case was medically confirmed. A 13 year old female patient with an unreported medical history and non concomitant medication received the first dose of GARDASIL (batch number NM11420, lot number NK25010) on 21-SEP-2010 and on 22-SEP-2010, 24 hours later, the patient experienced an urticarial rash and severe whole body itch. The patient received corrective treatment with ZIRTEK 10 mg. The event lasted for two days. At the time of reporting, the patient has recovered. The agency considered the events were serious due to other medically important condition which required intervention. Other business partner numbers include E2010-07723. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown Unknown


Page 37
Vaers Id: 413045-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cyanosis
Days
Symptom Text: This case was reported by a Health Care Professional on 09-DEC-2010. This case is linked to E2010-07789, same reporter and similar events, different batch numbers. This case is medically confirmed. A female patient of unreported age who had received dose 1 of GARDASIL, batch not reported, on an unreported date, received dose 2 of GARDASIL, batch not reported on an unreported date. One hour post vaccination the patient developed cyanosis of both hands. The patient's outcome was not reported. Other business partner numbers include E2010-07762. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown Unknown


Page 38
Vaers Id: 413046-1 (O) Age Gender Vaccine Date Onset Date F 17-Sep-2010 17-Sep-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cyanosis, Peripheral coldness
Days 0
Symptom Text: This case was received from the Health Authority on 09-DEC-2010 under the reference number 2010-001131. This case is medically confirmed. A 14 year old female patient with no medical history and no concomitant medications received a dose of GARDASIL (lot# NK25010, batch# NM31130) 0.5 ml intramuscularly, site not reported on 17-SEP-2010 and on 17-SEP-2010, following the vaccination, the patient experienced peripheral cyanosis of both hands and the hands felt very cold. The events lasted for two days. There was no central cyanosis and the patient's feet were evidently not affected. The patient had no previous similar episodes. The patient received no corrective treatment. At the time of reporting, the patient was recovered. The reporter considered the events to be serious due to other medically important condition which required intervention. Other business partner numbers include E2010-07786. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 39
Vaers Id: 413047-1 (O) Age Gender Vaccine Date Onset Date F 24-Nov-2010 24-Nov-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness, Syncope
Days 0
Status Date State Received Date 12-Jan-2011 FR 17-Dec-2010 Lot Prev Doses Site 1334X 0 Unknown
Symptom Text: Case received from a Health Authority on 09-DEC-2010 under the reference number 2010-03560. Case medically confirmed. A 15 year old female patient received a dose of GARDASIL (lot# 1334X, batch# NL20290, site of administration not reported), 0.5 ml, via intramuscular route on 24-NOV2010. About 10 minutes after the administration of the vaccination, the patient developed syncope with loss of consciousness lasting several seconds. The patient then got up, but suffered another episode of syncope with loss of consciousness lasting several seconds 5 minutes later. During the episode of syncopes her blood pressure could not be measured, but it returned to normal in the course of 5 minutes. She was put in the shock position. The patient was not given any medication. The patient was hospitalized. The patient completely recovered. The attending doctor considered the cause of the syncope to be vasovagal. In the present case there was a chronological relationship between GARDASIL injection and the onset of two successive episodes of syncope at an interval of 5 minutes. The patient was admitted to hospital, and the cause of syncopes was given as vasovagal. The information for Health Care Professional mentions the onset of syncopes after vaccination with GARDASIL. No non-drug cause for the syncope was identified. In the overall view of the findings, therefore, the causality of GARDASIL for the suspected undesirable effects according to the guidelines is classified as probable. Syncope with loss of consciousness was considered to be an other important medical event. Other business partner numbers include E2010-07745. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 40
Vaers Id: 413259-1 (O) Age Gender Vaccine Date Onset Date F 01-Sep-2009 19-Apr-2010 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 230
Status Date State Received Date 06-Jan-2011 NY 20-Dec-2010 Lot Prev Doses Site NULL 0 Unknown
Abortion induced, Drug exposure during pregnancy
Symptom Text: Information has been received from a 25 year old female with no known drug reactions/allergies and with a history of caesarean section for first pregnancy who in approximately September 2009, "about six months ago" was vaccinated with the first dose of GARDASIL. Concomitant therapy included SUBOXONE. The patient reported that she received the third dose of GARDASIL the same day she had a positive pregnancy test. The patient reported to be about 1 month pregnant. The last menstrual period was estimated happened in January 2010 and the estimated delivery date is 08-OCT2010. The patient sought medical attention visiting the physician. Follow up information has been received from a physician from a pregnancy questionnaire who reported that the patient had an elective termination of pregnancy on 19-APR-2010, 11 weeks from last menstrual period. It was unknown if the products of conception were examined. It was unknown if the fetus was normal. The patient's last menstrual period was on 01-JAN-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: SUBOXONE beta-human chorionic, positive Caesarean section


Page 41
Vaers Id: 413260-1 (S) Age Gender Vaccine Date Onset Date M 17-Nov-2010 04-Dec-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 17
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Arrhythmia, Bacterial infection, Cardiac enzymes, Cardiac monitoring, Condition aggravated, Genital lesion, Lip blister, Oropharyngeal blistering, Pyrexia, Stevens-Johnson syndrome
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old male patient with Stevens-Johnson syndrome and no drug reaction/allergies, who on approximately on 17-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) (4 days ago, reported date as 08-DEC-2010). The nurse reported that on 04-DEC-2010 about three weeks after vaccination, the patient had a flare up of Stevens-Johnson syndrome. The patient had a fever, high white cell count, blisters on his mouth, lips and genitals and was diagnosed with a bacterial infection. He also had cardiac arrhythmias and required a cardiac monitor and evaluation of his cardiac enzymes. He was hospitalized on 05-DEC-2010 and released on 07DEC-2010. He was prescribed with antibiotics and steroids for 6 months. At the time of the report, the patient was recovering. Flare up of StevensJohnson syndrome, cardiac arrhythmia and bacterial infection were considered to be immediately life-threatening by the reporter. Upon internal review flare up of Stevens-Johnson syndrome and hospitalization were considered to be an other important medical events. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Stevens-Johnson syndrome Unknown WBC count, high


Page 42
Vaers Id: 413440-1 (S) Age Gender Vaccine Date Onset Date F 08-Nov-2010 08-Nov-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 0
Status Date State Received Date 12-Jan-2011 TX 22-Dec-2010 Lot Prev Doses Site 0768Z 0 Unknown
ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Asthenia, Complex regional pain syndrome, Dysphagia, Dyspnoea, Joint effusion, Muscle atrophy, Pain in extremity, Streptococcal infection, Walking aid user
Symptom Text: Information has been received from a physician and from a licensed practical nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-NOV-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination at that time. The nurse stated that on 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained of difficulty breathing and was unable to swallow. The patient was seen in the emergency room. It was reported that the patient was positive for a strep infection (not specified). The patient's white blood cell (WBC) count was elevated. The patient was treated with a penicillin shot and was sent home and was not admitted to the hospital. Approximately twelve hours later on 09-NOV-2010, the patient experienced left leg pain (also reported as bilateral lower extremity pain) and weakness on. The patient was seen in the hospital and was admitted. The patient was hospitalized on 09-NOV-2010. The patient had a magnetic resonance imaging (MRI), computed axial tomography (CT) scan and a bone scan. The tests revealed fluid on the patient's hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged on 14-NOV-2010 on NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required a walker for ambulate due to muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require a walker to ambulate due to muscular was considered by a physician to be disabling. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NECON magnetic resonance, 11/09?/10, Fluid on the patient's hip; computed axial, 11/09?/10, Fluid on the patient's hip; bone scan, 11/09?/10, Fluid on the patient's hip; diagnostic laboratory, 11/08?/10, Positive for a strep infection; WBC count, Unknown


Page 43
Vaers Id: 413441-1 (O) Age Gender Vaccine Date Onset Date F 28-Sep-2010 29-Sep-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dermatitis allergic, Pruritus, Urticaria
Days 1
Symptom Text: This case was received by the Health Authority on 09-DEC-2010 under the reference number 2010-001211. This case is medically confirmed. A 13 year old female patient with no medical history and no concomitant received the first dose of GARDASIL (batch # NM31130, lot # NK25010) intramuscularly, site not reported on 28-SEP-2010. 24 hour later on 29-SEP-2010, the patient experienced an allergic type skin reaction with urticaria and was itchy. The patient received corrective treatment with cortrophin 1% cream. The events persisted for six days. At the time of reporting, the patient has recovered on 06-OCT-2010. The agency considered the events to be serious for other medically important condition which required intervention. The patient was due for second dose on 30-NOV-2010 when the reaction was reported. The second dose was deferred whilst the reporter was awaiting guidelines. Other business partner numbers include E2010-07720. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 44
Vaers Id: 413442-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cyanosis
Days
Symptom Text: This case was reported by a Health Care Professional (HCP) on 09-DEC-2010, and is linked to E2010-07762 (WAES# 1012USA02250), same reporter and similar events. This case is medically confirmed. A female patient of unreported age with unreported history received the first dose of GARDASIL (batch not reported, route and site not reported) on an unreported date. An unreported date, 2 days post vaccination, the patient experienced cyanosis of both hands plus the leg below the knee but not the foot. The events spontaneously resolved on an unreported date. Upon internal review this case was determined to be medically significant and serious. Other business partner numbers include E2010-07789. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown Unknown


Page 45
Vaers Id: 413443-1 (O) Age Gender Vaccine Date Onset Date F 23-Nov-2010 24-Nov-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash pruritic, Urticaria
Days 1
Symptom Text: Information has been received from the Health Authority (2010-001132). This case is medically confirmed. A 14 year old female patient with no risk factors available and history being prone to tonsillitis, she was a premature baby and had a rash on her neck at age three months which the GP thought was due to the washing powder "Persil", received the third dose of GARDASIL (Lot # NK10770 and Batch # NM25090), expiry in January 2012 on 23NOV-2010. On 24-NOV-2010, 12 hours post vaccination; the patient experienced an urticarial rash on legs, back and neck, an itchy rash. On 15-NOV2010 (prior vaccination) the patient saw the doctor with a sore throat, runny nose, etc. The doctor who saw her indicated that her cervical glands were enlarged and that she had a cough and sore throat. The patient was prescribed CLONAMOX. The course finished on 21-NOV-2010. The patient had also experienced conjunctivitis one week earlier. The GP indicated a possible association with streptococcal. The patient was given PIRITON as corrective treatment. At the time of reporting the rash was persisting but was less obvious. The events were considered serious as they were medically important and required intervention. Other business partner numbers include: E2010-07806. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Premature baby; Rash; Sore throat; Runny nose; Tonsillitis; Cough Conjunctivitis


Page 46
Vaers Id: 413655-1 Age Gender Vaccine Date Onset Date F 29-May-2008 02-Aug-2008 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 65
Status Date State Received Date 03-Jan-2011 NH 28-Dec-2010 Lot Prev Doses Site 1062U 1 Left arm
Abdominal pain, Abdominal tenderness, Chills, Decreased appetite, Diplopia, Dizziness, Dyspnoea, Eyeglasses therapy, Eyelid ptosis, Fatigue, Headache, Myasthenia gravis, Nausea, Ophthalmoplegia, Pain, Palpitations, Paraesthesia, Pelvic pain, Strabismus, Syncope, Tinnitus, Vertigo
Symptom Text: Vertigo constant head pressure till this day. Tingling fingers, ringing ears, aches, shortness of breath, fainting, EKG, MRI etc. Many school days missed. The following information was obtained through follow-up and/or provided by the government. 1/6/2011 neuro/ophthamoloy consultant record received for DOS 12/20/2010 w/ impression likely myasthenia gravis. Pt presented w/ 6 month hx of rt upper lid ptosis, ophthalmoplegia, vertical diplopia, headaches, dizziness. PE by other MD's: large vertical deviation, ptosis, rt large hypertropia, fatigable ptosis lt upper lid. PE at this visit normal. Suspect ocular myasthenia gravis. Sent pt for additional labs and will f/u in 2 months. 1/14/2011 PCP records received for DOS 3/26-11/12/2008 w/ assessment: vertigo, palpitations. 11/12 pt presented w/ 3 day hx of dizziness, palpitations, shortness of breath. Dizziness improved by shaking her leg or moving around, spells caused her to fall asleep in class, pt afraid to go to school. Pt able to run cross country track w/o difficulties. Got new glasses 2 weeks prior, but not wearing consistently. 1/20/2011 ER record received for DOS 12/3/2008 w/ impression: dizziness. Pt to ER c/o 3 weeks dizziness. Pt previousley seen by PCP & referred to ENT. Pt also c/o racing heartbeat. Pt released w/ instructions to call ENT to move up appointment. 1/20/2011 ER records received for DOS 12/20/2009 w/ impression: pelvic pain. Pt to ER c/o abdominal pain (cramping), chills, loss of appetite, nausea, dizziness, light headaches. Abdomen tender to palpation. Pt d/c'd home in stable condition. Other Meds: Lab Data: 2 years of labs 2008-2010 The following information was obtained through follow-up and/or provided by the government. 1/6/2011 lab/diagnostic results per neuro consultant: Acetylcholine receptor binding antibodies (-). MRI brain and orbits: unremarkable. 1/20/2011 lab/diagnostic records received for DOS 11/4/2008-1/3/2011. ANA, Hep C antibody, RPR, herpes virus, EBV negative. CPK, ESR WNL. Blood: Fe 266 mcg/dL (H), CMV <4 (H). Pelvic US normal. EKG unremarkable. The following information was obtained through follow-up and/or provided by the government. PMH: VSD (resolved), varicella, enlarged lymph node below lt ear. None
History: Prex Illness:
Prex Vax Illns: ~HPV (no brand name)~2~14.00~Patient


Page 47
Vaers Id: 413677-1 Age Gender Vaccine Date Onset Date F 17-Sep-2010 18-Sep-2010 9.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 03-Jan-2011 TN 28-Dec-2010 Lot Prev Doses Site AHAVB427BA 0 Left arm 1539Y 0610Z 0 1 Right arm Left arm
Mfr Report Id TN10014 Route Intramuscular Intramuscular Subcutaneously
Injected limb mobility decreased, Myalgia, Pain in extremity
Symptom Text: Pt states awoke next morning after 1st HPV injection and could not abduct (R) arm. States area sore & had trouble lifting it x 1-1 1/2 wks then symptoms subsided. Pain & difficulty lifting (R) arm recurred 10/27/10. Pt states muscle soreness prevents full function. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None Penicillin URI


Page 48
Vaers Id: 413744-1 (O) Age Gender Vaccine Date Onset Date F 23-Sep-2009 23-Sep-2009 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 03-Jan-2011 NJ 30-Dec-2010 Lot Prev Doses Site 0100Y 0 Unknown
Abortion missed, Drug exposure during pregnancy, Uterine dilation and evacuation
Symptom Text: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with depression, obesity, hypertension and no known drug allergies who on 23-SEP-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # 662300/0100Y). Concomitant therapy included labetalol HCl. On 12-OCT-2009 the patient had a positive urine pregnancy test. The patient sought medical attention through an office visit. Last menstrual period and gestational age were unknown at the time of the report. Follow up information had been received from a registered nurse and was reported that the patient had a "missed abortion", and a Dilation and evacuation (D & E) on 13-NOV2009. Upon internal review, the missed abortion was determined to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown); Hypertension; Depression; Obesity labetalol hydrochloride urine beta-human, 10/12/09, positive


Page 49
Vaers Id: 413745-1 (O) Age Gender Vaccine Date Onset Date F 06-Dec-2010 06-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Oropharyngeal pain, Swollen tongue
Days 0
Symptom Text: Information has been received from the Health Authority (HA), reference 2010-001362. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medications and no available data or risk factors, received GARDASIL batch number NN01990, lot number NK44350, 0.5 ml intramuscularly on 06-DEC-2010. Fifteen to thirteen minutes post vaccination, the patient experienced a sore throat and a swollen tongue that persisted for two to three hours. Corrective treatment included chlorphenamine (G). The patient went home with her parents after three hours and went back to school the next day, the patient was recovered at the time of reporting. The IMB considered the case to be serious and an other important medically important condition because the event required intervention. Other business partner numbers include: E2010-07854. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 50
Vaers Id: 413746-1 (O) Age Gender Vaccine Date Onset Date F 13-Oct-2010 14-Oct-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Somnolence, Syncope
Days 1
Status Date State Received Date 03-Jan-2011 FR 30-Dec-2010 Lot Prev Doses Site MN39510 2 Unknown
Symptom Text: Case received from Health Authority on 17-DEC-2010, reference number C201012-479. Case medically confirmed. A 13 year old female patient had experienced two episodes of faint and excessive somnolence after the administration of the third dose of GARDASIL (batch n. MN39510, site of administration not reported) 0.5mL, 1 unit, indicated against papillomavirus, via intramuscular route on 13-OCT-2010. The two episodes had occurred 16 hours after vaccination and the patient had quickly recovered consciousness. One hour after the faint episodes, the patient was observed in the primary care unit and the regular clinical observation showed a normal result. During the day after the vaccination, the patient experienced excessive somnolence. The patient had completely recovered from the adverse event on the second day. Unknown previous adverse reactions to the suspected drug or to any other drugs. Case is closed. No further information is available. Other business partner numbers include E2010-07950. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 51
Vaers Id: 413747-1 (O) Age Gender Vaccine Date Onset Date F 21-Dec-2010 21-Dec-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 03-Jan-2011 FR 30-Dec-2010 Lot Prev Doses Site 0411Y 0 Unknown
Condition aggravated, Convulsion, Cyanosis, Gaze palsy, Lip disorder
Symptom Text: Information has been received from a physician concerning a female with egg allergy and medication (unspecified) hypersensitivity and a history of convulsion, hospitalization due to pneumonia who on 21-DEC-2010 was vaccinated with the first dose of GARDASIL 0.5 ml IM (Lot # 0411Y/Batch# NM35450) (therapy site unknown). There were no concomitant medications. On 21-DEC-2010, about 5 minutes after receiving the vaccination, the patient developed convulsion. Her eyes moved in any direction, and her lips were curled up and turned in blue color. While taking her blood pressure, she became normal. The duration of convulsion was less than 5 minutes. She went back home with no treatment given. The physician mentioned that he tried to keep the patient from being vaccinated because of her history of convulsion, but the patient wanted to. The reporter considered that convulsion was related to therapy with GARDASIL. Upon internal review, convulsion was determined to be an other important medical event. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Convulsion; Pneumonia; Hospitalisation Egg allergy; Drug hypersensitivity


Page 52
Days
Status Date State Received Date 03-Jan-2011 FR 30-Dec-2010 Lot Prev Doses Site NM31130 1 Unknown
Erythema, Injection site induration, Injection site reaction, Local reaction, Pain in extremity, Urticaria
Symptom Text: This case was received from the health authority on 21-DEC-2010. Company ref 2010-001391. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication and no risk factors available, received the second dose of GARDASIL (batch number: NM31130) IM 0.5 ml on 16-NOV-2010. On an unreported date post vaccination, the patient experienced local reaction, muscle at site got hard, painful arm, red spots and urticaria/wheals on upper arm. Corrective treatment included ibuprofen and acetaminophen. At the time of reporting the patient's outcome was unknown. The event was considered serious as it was medically important. Other business partner numbers include E2010-07979. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 53
Vaers Id: 413756-1 Age Gender Vaccine Date Onset Date F 28-Dec-2010 Unknown 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Unevaluable event
Days
Status Date State Received Date 03-Jan-2011 KS 29-Dec-2010 Lot Prev Doses Site 0565Z 2 Right arm
Symptom Text: None stated. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 54
Vaers Id: 413757-1 Age Gender Vaccine Date Onset Date F 27-Dec-2010 Unknown 1.0 Type Manufacturer VAX Detail: MMR MERCK & CO. INC. HPV4 MERCK & CO. INC. HEPA MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Wrong drug administered
Days
Status Date State Received Date 03-Jan-2011 NC 29-Dec-2010 Lot Prev Doses Site 0743Z 0 Right leg 0337Z 0 Right leg 1215Z 0 Left leg
Mfr Report Id Route Unknown Unknown Unknown
Symptom Text: Mother was notified by NP and was advised of vaccine given, reactions and need for Hib vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 55
Vaers Id: 413785-1 (S) Related reports: 413785-2; 413785-3 Age Gender Vaccine Date Onset Date Days F 25-May-2010 25-May-2010 0 12.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness:
Status Date State Received Date 04-Jan-2011 GA 30-Dec-2010 Lot Prev Doses Site 1412Y Unknown AC52B046DA 1 Left arm AHAV3349BA 0075Y U3018AA 1 1 1 Unknown Unknown Unknown
Mfr Report Id Route Subcutaneously Intramuscular Unknown Intramuscular Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS Abdominal pain, Abdominal pain upper, Anaphylactic reaction, Anxiety, Asthenia, Blindness, Cellulitis, Chest pain, Conversion disorder, Convulsion, Cough, Dehydration, Diarrhoea, Dizziness, Dyskinesia, Dysphagia, Dyspnoea, Dysuria, Emotional disorder, Emotional distress, Erythema, Excessive eye blinking, Fight in school, Foaming at mouth, Gaze palsy, Headache, Hypersensitivity, Hyperventilation, Hypoglycaemia, Hypotonia, Joint injury, Lip oedema, Lip swelling, Loss of consciousness, Malaise, Nausea, Oropharyngeal pain, Paraesthesia oral, Pharyngitis, Presyncope, Pyrexia, Rash, Rhabdomyolysis, Syncope, Tonic clonic movements, Tremor, Upper respiratory tract infection, Vision blurred, Visual impairment, Weight decreased, Wrist fracture
MedDRA PT
Symptom Text: The same day she broke out in rash with headaches and dizzy spells. A couple of months later she started having seizures, severe headaches, stomach pains, anaphylaxis and several other problems. The following information was obtained through follow-up and/or provided by the government. 01/10/2011 ER record received for DOS 08/21/2010. Impression: Syncope, Dehydration, Headache and early rhabdomyolysis. Patient presented with c/o clonic tonic type movements, eyes rolled back in head and foaming at the mouth. Episode lasted 20 seconds. Patient had been playing in softball tournament all day in the heat. Patient reported having a headache since last night. The patient received IV fluids and was discharged home. 01/05/2011 vaccine record for DOS 05/25/2010 and PCP office records received for DOS 08/23/2010 to 12/28/2010. Assessment: Dehydration, Seizure. Patient seen on 08/23/10 for ER follow-up. Patient reported to have played 4 ball games back to back on Saturday. Patient passed out, had seizure, in& out of consciousness and went to ER, dehydrated. Patient seen the next day for c/o fever at school, bad headache and hard time urinating. Patient noted to have abdominal pain. Patient's temperature was 97.7 F and U/A normal. Assessment: Abdominal pain, left side. Patient seen 10/01/10 for c/o sore throat, cough and chest pains. Assessment: URI/early pharyngitis. Patient seen 10/21/10 for c/o right wrist hurt during soft ball game. X-ray revealed non-displaced Fracture of wrist. Plan: splint. Patient seen for ER follow-up. Patient reported that on Saturday, she felt nauseated and felt unwell. Patient passed out and checked blood sugar "40". Assessment: Syncopal episode, Hypoglycemia. Patient seen 12/01/10 for Right wrist. Redness noted at base of old FX. Assessment: Cellulitis. Patient seen 12/28/2010. Patient reported passing out eating nuts and also passed out again the next day. Also lip swelled up. Patient noted has had problems since HPV in May. Assessment: Anaphylaxis reaction nuts. 01/10/2011 ER records received for DOS 10/30/2010 and 11/06/2010. Assessment: Near fainting episode, hypoglycemia. Patient presented to ER with c/o feeling weak, lightheaded and nauseated while on a hayride. Patient reportedly told friend that she thought she was going to have a seizure. Patient was witnessed to go limp, then shaking. Friend's mother reported that patient seemed anxious, apprehensive and was hyperventilating. Patient was given a couple of cokes. Blood sugar was reported to be the 40s. Upon ER presentation, pt. alert without sensory or motor deficits. Patient was discharged home. Patient presented to ER on 11/06/2010 for c/o seizure-like event. Patient was in car with parents and started jerking and kicking. The parents did not visualize the movements directly. Upon presentation, patient alert and smiling. Patient discharged home and to F/U with pediatrician. 01/10/2011 In-pt. hospital records H&P, progress notes and diagnostics received for DOS 11/10/10 to 11/12/10. DX: Pseudoseizure. Patient received per transfer with c/o fainting spells which have intensified over past 10 days. First episode


Page 56
Vaers Id: 413785-1 (S) reported 31 Oct., 2010 while on hayride. Patient noted to have episodes with tonic clonic movement of arms and legs with eyelids blinking rapidly and a headache since 31 Oct., 2010. Patient reported to have complete vision loss yesterday and today vision is blurry. Patient's parents noted patient has lost 21 lbs. and has had nonbloody diarrhea 3 xs per day. Record noted patient anxiety and patient was suspended from school due to fights with softball teammates. Patient neurology and general physical exam were normal. Assessment: Headache and abnormal involuntary movement NEC. Plan: take patient off Trileptal and bedside long-term EEG. During night patient had 2 episodes of seizure-like activity and patient's EEG did not show epileptiform activity. Patient discharged home and to follow up with psychology. 01/14/2011 ER notes received f Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: They cannot figure it out but trust me I will. I know this is what caused it and I will make sure everyone knows what it did to my daughter. The following information was obtained through follow-up and/or provided by the government. 01/10/2 She was healthy before the vaccine. The following information was obtained through follow-up and/or provided by the government. 01/10/2011 records received. History: Anxiety attacks. No, but there was after the vaccine. She broke out into a rash with bad headaches. Soon after she started having seizures, visio


Page 57
Vaers Id: 413785-2 (S) Related reports: 413785-1; 413785-3 Age Gender Vaccine Date Onset Date Days F 01-May-2010 01-May-2010 0 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Status Date State Received Date 10-Jan-2011 GA 07-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Mfr Report Id Last Edit Date WAES1012USA03794 22-Mar-2011 Other Vaccine Route Intramuscular
Convulsion, Headache, Intensive care, Swelling, Urticaria, Visual impairment
Symptom Text: Information has been received from a consumer concerning her 12 year old daughter with no allergies and no medical history, who in May 2010, was vaccinated with a first "120mcg/3 part series" dose of GARDASIL (Lot # not reported), IM. There was no concomitant medication. The caller stated that in May 2010, "the day my daughter received her first dose of GARDASIL, she experienced swelling, hives, and a headache. BENADRYL helped with the swelling and hives. The next day she began having seizures. She had about 60 seizures in three days and was admitted to medical center. She was placed in Pediatric Intensive Care Unit (PICU) and Intense Care Unit (ICU). She was hospitalized and was losing her sight. Therapy with GARDASIL was discontinued "same day as first injection". The caller also stated that her daughter never had any health problems before and at the time of the report was not looking any better. It was reported that the mother was worried she may die. "Blood work, magnetic resonance imaging (MRI), computed axial tomography (CAT) scan and many other tests in the hospital" (results not reported). The health care professional contacted during telephone follow-up could not supply the following information: Lot number. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 58
Vaers Id: 413785-3 (S) Related reports: 413785-1; 413785-2 Age Gender Vaccine Date Onset Date Days F 25-May-2010 Unknown 12.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness:
Status Date State Received Date 23-Mar-2011 US 22-Mar-2011 Lot Prev Doses Site AHAV3349BA 1 Unknown AC52B048DA 1 Unknown U3018AA 0075Y 1412Y 1 1 Unknown Unknown Unknown
Mfr Report Id Last Edit Date WAES1103USA00523 23-Mar-2011 Other Vaccine Route Unknown Intramuscular Unknown Intramuscular Subcutaneously
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS Abdominal pain, Abdominal pain upper, Anaphylactic reaction, Anxiety, Arthralgia, Asthenia, Blindness, Cellulitis, Chest pain, Consciousness fluctuating, Conversion disorder, Convulsion, Cough, Dehydration, Diarrhoea, Dizziness, Dyskinesia, Dysuria, Erythema, Excessive eye blinking, Fight in school, Foaming at mouth, Gaze palsy, Headache, Hyperventilation, Hypoglycaemia, Hypotonia, Lip swelling, Loss of consciousness, Malaise, Movement disorder, Nausea, Oropharyngeal pain, Pharyngitis, Presyncope, Pyrexia, Rash, Rhabdomyolysis, Syncope, Tonic clonic movements, Tremor, Upper respiratory tract infection, Vision blurred, Weight decreased, Wrist fracture
MedDRA PT
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 25-MAY-2010, a 12 year old female was intramuscularly vaccinated with second dose of GARDASIL (lot # 661954/0075Y). Secondary suspect therapy included VARIVAX (lot # 665810/1412Y). Concomitant therapy included HAVRIX (lot # AHAV3349BA), BOOSTRIX (lot # AC52B046DA) and MENACTRA (lot # U3018AA). The reporter stated that on the same day patient broke out in rash with headaches and dizzy spells. A couple of month later she started having seizures, severe headaches, stomach pains, anaphylaxis and several other problems. The following information was obtained through follow-up and /or provided by the government. On 10-JAN-2011 ER record was received for date of service (DOS) 21-AUG-2010. The impression was as bellow: syncope, dehydration, headache and early rhabdomyolysis. Patient presented with complaint of (c/o) clonic tonic type movement, eyes rolled back in head and foaming at the mouth. Episode lasted 20 seconds. Patient had been playing in softball tournament all day in the heat. Patient reported having a headache since last night. The patient received IV fluids and was discharged home. On 05-JAN-2011 vaccine report was received for DOS 25-MAR2010 and primary care physician (PCP) office records received for DOS from 23-AUG-2010 to 28-DEC-2010. Assessment was as below: dehydration, seizure. Patient had seen on 23-AUG-2010 for ER follow-up. Patient reported to have played 4 ball games back to back on Saturday. Patient passed out, had seizure, in & out of consciousness and went to ER, dehydrated. Patient had seen the next day for c/o fever at school, bad headache and hard time urinating. Patient noted to have abdominal pain. Patient's temperature was 97.7 F and urine analysis (U/A) was normal. Assessment was as bellow: abdominal pain, left side. Patient was seen 01-OCT-2010 for c/o sore throat, cough and chest pains. Assessment was upper respiratory tract infection (URI) early pharyngitis. Patient had seen on 21-OCT-2010 for c/o right wrist hurt during soft ball game. X-ray revealed non-displaced fracture of wrist. Plan was splint. Patient had seen for ER follow-up. Patient reported that on Saturday she nauseated and felt unwell. Patient passed out and checked blood sugar "40". Assessment was as bellow: syncopal episode, hypoglycemia. Patient has seen on 01-DEC-2010 for right wrist. Redness noted at the base of old fracture (FX). Assessment was cellulitis. Patient had seen on 28-DEC-2010. Patient reported passing out eating nuts and also passed out again the next day. Also lip swelled up. Patient noted having problems since receiving GARDASIL in May. Assessment was anaphylaxis reaction nuts. On 10-JAN-2011 ER records were received for DOS 30-OCT-2010 and 06-NOV-2010. Assessment was as bellow: near fainting episode, hypoglycemia. Patient presented to ER with c/o feeling weak, lightheaded [Due to memory limitations, the remainder of this text could not be compared.] htheaded and nauseated while on a hayride. Patient reported told friend that she thought she was going to have a seizure. Patient was witnessed to go limp, then


Page 59
Vaers Id: 413785-3 (S) shaking. Friend's mother reported that patient seemed anxious, apprehensive and was hyperventilating. Patient was given a couple of coles. Blood sugar was reported to be the 40s. Upon ER presentation, patient alerted without sensory or motor deficits. Patient was discharged home. Patient presented to ER on 06-NOV-2010 for c/o seizure-like event. Patient was in car with parents and started jerking and kicking. The parents did not visualize the movement directly. Upon presentation, patient alerted and smiled. Patient discharged home and to follow up (F/U) with pediatrician. On 10-JAN-2011 patient's hospital records, progress notes and diagnostics were received for DOS from 10-NOV-2010 to 12-NOV-2010. Diagnosis (DX) was pseudoseizure. Patient received her transfer with c/o Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: X-ray, 10/21/10, nin-displaced fracture of wrist; Blood glucose, 40 Unknown


Page 60
Vaers Id: 413795-1 (S) Age Gender Vaccine Date Onset Date F 01-Feb-2007 01-Feb-2010 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 1096
Status Date State Received Date 03-Jan-2011 VA 31-Dec-2010 Lot Prev Doses Site NULL 2 Unknown
Last Edit Date 03-Jan-2011 Other Vaccine
Abdominal pain, Dysstasia, Pain, Painful respiration, Renal pain
Symptom Text: terrible pain in abdomen, kidneys, hurt to eat, go to the bathroom, breathe, pain to stand up straight Other Meds: Lab Data: History: Prex Illness: NO NO
Prex Vax Illns: 02/01/2010~HPV (Gardasil)~2~0.00~Patient


Page 61
Vaers Id: 413802-1 Age Gender Vaccine Date Onset Date F 18-Jun-2009 01-Aug-2009 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Cyanosis, Erythema, Skin discolouration
Days 44
Status Date State Received Date 03-Jan-2011 US 01-Jan-2011 Lot Prev Doses Site 1312X Unknown
Symptom Text: My daughter's hands and feet are red, purple, blue and white. We took her to the clinic, they said she should go to the ER. After running many tests and ruling out anything life threatening they said to follow up in the clinic. She is thought to have Raynaud's. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ER ran various lab tests None No


Page 62
Vaers Id: 413872-1 (O) Age Gender Vaccine Date Onset Date Days F 11-May-2010 11-May-2010 0 14.0 Type Manufacturer VAX Detail: HEPA UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Status Date State Received Date 04-Jan-2011 US 03-Jan-2011 Lot Prev Doses Site NULL Unknown 1311X 1 Unknown
Abortion spontaneous, Drug exposure during pregnancy
Symptom Text: Information has been received from a register nurse, for GARDASIL a Pregnancy Registry product, concerning a 14 year old smoker female with depression, who on 12-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot # unknown) and on 11-MAY-2010 with the second dose of GARDASIL (lot # 661531/1311Y). Suspect vaccine therapy included a dose of HEPATITIS A (manufacturer unknown). Other concomitant therapy included "depression medication". The nurse reported that the patient, requested an in-office pregnancy test afterwards which determined she was pregnant. The patient was reported to be 10 weeks pregnant. LMP approximately 28-FEB-2010, EDD approximately 06-DEC-2010). The patient sought unspecified medical attention. Follow-up information has been received from a completed questionnaire, concerning the 14 years old patient with anxiety. Patient's LMP was reported as 20-MAR-2010 and the EDD on 26-DEC-2010 (previously reported as 28-FEB-2010 and 06-DEC-2010 respectively). It was reported that that patient was taken LEXAPRO as concomitant therapy during the pregnancy. On 27-MAY-2010 the patient experienced a spontaneous abortion (<20 weeks). It was unknown if the product of conception was examined or if the fetus was normal. At the time of this report, the patient's outcome was unknown. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP= 3/20/2010); Smoker; Depression; Anxiety LEXAPRO; mg beta-human chorionic. 05/11/10, determined she was pregnant


Page 63
Vaers Id: 413873-1 (O) Age Gender Vaccine Date Onset Date F 29-Jan-2009 01-May-2010 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 457
Status Date State Received Date 04-Jan-2011 PA 03-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Caesarean section, Drug exposure before pregnancy, Foetal disorder, Twin pregnancy
Symptom Text: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient who on 29-JAN2009 was vaccinated with the first dose of GARDASIL (No lot number provided). Subsequently the patient became pregnant after receiving GARDASIL. The patient's date of last menstrual period was approximately on 03-AUG-2009 and estimated delivery date is 20-MAY-2010. Series of GARDASIL was discontinued. Unspecified medical attention had been sought. Follow up information has been received from an obstetrical (OB) coordinator who reported that the patient's last GARDASIL was given to this patient on 29-JAN-2009 and her LMP prior to this pregnancy was in July 2009 (previously reported as "approximately on 03-AUG-2009"). This patient delivered twins in May 2010 via a scheduled cesarean section, due to Baby A being in breech position. The OB coordinator didn't know the exact gestational age, but stated the twins were at term, "so at least 38 weeks." She said the mother was doing well, but she could not tell me what the health of the babies was; she did not have any information related to the status of the twins. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 7/1/2009) Unknown Unknown


Page 64
Vaers Id: 413891-1 (O) Age Gender Vaccine Date Onset Date F 16-Nov-2010 16-Nov-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 04-Jan-2011 FR 03-Jan-2011 Lot Prev Doses Site NK25010 1 Unknown
Hypoaesthesia, Lethargy, Malaise, Pyrexia, Vomiting
Symptom Text: This case was reported by the Health Authority on 22-DEC-2010, reference number 2010-001532. This case is medically confirmed. A 13 year old female patient with unknown medical history and no concomitant medication, received GARDASIL (lot number NK25010, batch number NM31130) intramuscularly, dose 2 on 16-NOV-2010. On the same day post vaccination, the patient experienced feeling sick and that evening lost feeling in her left arm and developed a high temperature and vomiting and lethargy. The patient was seen in the evening by the doctor, no corrective treatment was given by the general practitioner. The duration of the reaction was approximately 12 hours. At the time of reporting, the patient outcome was unknown. The company considered the case to be serious as an other medically important condition with required intervention. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown Unknown


Page 65
Vaers Id: 413892-1 (O) Age Gender Vaccine Date Onset Date F 17-Nov-2010 17-Nov-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chest pain
Days 0
Status Date State Received Date 04-Jan-2011 FR 03-Jan-2011 Lot Prev Doses Site NK44350 Unknown
Symptom Text: This case was received from the Health Authority on 22-DEC-2010. Reference number: 2010-001435. This case is medically confirmed. A female of unknown age with no medical history or concomitant medication and no risk factors available received an IM injection of GARDASIL (lot number NK44350, batch number NN01990) on 17-NOV-2010. On 17-NOV-2010, one hour post vaccination, the patient complained of central chest pain. The patient's vital signs were recorded and she was seen by the doctor. Reassurance was given and she was monitored in recovery for 45 minutes. The patient recovered on an unspecified date. The events were considered medically important as they required intervention. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 66
Vaers Id: 413893-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Pallor, Vision blurred
Days
Symptom Text: Information has been received from the health authority on 22-DEC-2010, reference 2010-01436. This case is medically confirmed. A 13 year old female patient with unknown medical history and risk factors not available and no concomitant medication received an injection of IM GARDASIL (batch # NM31130, lot # NK25010) on an unreported date. On an unreported date, post vaccination, the patient complained of feeling faint associated with blurred vision and poor colour. The patient was placed lying down and allowed to recover slowly. Her observations were stable and she was observed in recovery for one hour. The patient was discharged with her friends. The final patient outcome was not reported. The events were considered medically important as they required intervention. Other business partner numbers include E2010-7997. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown Unknown


Page 67
Vaers Id: 413894-1 (O) Age Gender Vaccine Date Onset Date F 29-Sep-2010 29-Sep-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 05-Jan-2011 FR 03-Jan-2011 Lot Prev Doses Site NK25010 Left arm
Depressed level of consciousness, Presyncope
Symptom Text: The case was received from the health authority on 21-DEC-2010. Agency ref 2010-001514. This case is medically confirmed. A 13 year old female patient with no medical history had no risk factors available and no concomitant medication received an injection of GARDASIL (batch number: NM11420; lot number: NK25010) 0.5mL IM in the left deltoid on 29-SEP-2010. On 29-SEP-2010, ten minutes post vaccination, the patient experienced a vasovagal reaction and a momentary consciousness decreased. The patient was observed sliding from the chair and was assisted to the floor. Her feet were elevated. The patient's blood pressure was 94/65 and pulse 68 bpm at 11:30 am. The patient recovered within 20 seconds. The event was considered serious as it was medically important and required intervention. Other business partner numbers include E2010-07975. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Blood pressure measurement, 29Sep10, 94/65, at 11:30 am; Total heartbeat count, 29Sep10, 68 bpm, at 11:30 am None


Page 68
Vaers Id: 413902-1 (O) Age Gender Vaccine Date Onset Date F 29-Nov-2010 03-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Grand mal convulsion
Days 4
Symptom Text: Information has been received from the health authority on 22-DEC-2010, reference 2010-001525. This case is medically confirmed. A 13 year old female who had no underlying conditions and was a healthy young girl with no concomitant medications received the second dose of GARDASIL (batch # NN01990, lot # NK44350), intramuscularly on 29-NOV-2010. On 03-DEC-2010 4 days post vaccination, the patient experienced a grand mal seizure lasting 3 minutes. The patient was given first aid and admitted to hospital overnight, at the time of reporting to the health authority the patient was recovered. The health authority considered the case to be serious as an other medically important condition that required intervention. Other business partner numbers include E2010-08006. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 69
Vaers Id: 413903-1 (S) Age Gender Vaccine Date Onset Date F 01-Aug-2010 01-Sep-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 31
Status Date State Received Date 05-Jan-2011 FR 03-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Anxiety, Fear, Hallucination, Middle insomnia, Panic attack, Sensory disturbance
Symptom Text: Information has been received from a pharmacist concerning a 16 year old female patient who received the first dose of GARDASIL (batch number not reported) in August 2010. One month after vaccination, she experienced a panic attack associated with nocturnal awakening, fear and "sensation of splitting". She went to the emergency unit care where she was given a quarter of a dose of LEXOMIL. She was not hospitalized. To be noted that according to the patient's mother, there had been "no change in the patient's life". She had no relevant medical history; she had not taken any drug nor alcohol. The patient went to see a psychiatrist, who was still "investigating" and was considering placing her in a place "with people like her". At the time of reporting, the patient had not recovered. Follow-up information received on 16-DEC-2010. The case initially reported as non-serious was upgraded to serious due to seriousness criterion "hospitalization". The vaccine was administered via the intramuscular route. No concomitant medication had been taken. One month post-vaccination the patient experienced severe anxiety and hallucinations. Panics attack, nocturnal awakening, fear and sensation of "splitting" were no longer reported. The patient was admitted to hospital one night for monitoring in the emergency unit and she received corrective treatment with anxiolytics. Since then the patient was receiving psychological support. At the time of report the outcome was on-going. Case medically confirmed. Other business partner numbers include: E2010-07332. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 70
Vaers Id: 413904-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Headache, Hyperhidrosis
Days
Symptom Text: This case was received from the health authority on 22-DEC-2010. Agency ref 2010-001437. This case is medically confirmed. A 14 year old female patient with unknown medical history and concomitant medication and no risk factors available received an IM injection of GARDASIL (batch number: NM11420; lot number: NK25010) on an unreported date. On an unreported date, post vaccination, the patient complained of headache ++ and sweating ++. Corrective treatment included paracetamol (generic). She was monitored in recovery and seen by the doctor. She was discharged with her granny. At the time of reporting the patient had not yet recovered. The events were considered medically important as they required intervention. Other business partner numbers include E2010-08001. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 71
Vaers Id: 413920-1 Related reports: 413920-2 Age Gender Vaccine Date Onset Date F 27-Dec-2010 30-Dec-2010 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash, Skin warm
Days 3
Status Date State Received Date 03-Jan-2011 NY 03-Jan-2011 Lot Prev Doses Site NULL 0 Left arm
Symptom Text: Rash between fingers, inside arms, behind legs, around arm pit region and around hip bones. Rash hot to touch. Still spreading to other regions as of 1/3/2011. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 72
Vaers Id: 413920-2 Related reports: 413920-1 Age Gender Vaccine Date Onset Date F 27-Dec-2010 30-Dec-2010 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Urticaria
Days 3
Status Date State Received Date 02-Feb-2011 NY 26-Jan-2011 Lot Prev Doses Site 1333Y 0 Left arm
Symptom Text: Urticarial rash. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 73
Vaers Id: 413950-1 Age Gender Vaccine Date Onset Date M 13-Oct-2010 14-Oct-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dyspnoea, Palpitations
Days 1
Status Date State Received Date 05-Jan-2011 MO 03-Jan-2011 Lot Prev Doses Site 0565Z 0 Left arm
Symptom Text: Mother reports approx. 24 hours after receiving vaccine child reported having SOB, and heart palpitations. Mother picked up child from school then took him to a walk in urgent care clinic and that clinic referred them to the ER due to child c/o SOB. Mother states child was only there approx. 1 hour with 30 minutes of oxygen no other testing was done and child felt fine & was d/c'd. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No testing was done. None None


Page 74
Vaers Id: 413955-1 Related reports: 413955-2 Age Gender Vaccine Date Onset Date F 04-Nov-2010 Unknown 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure before pregnancy
Days
Status Date State Received Date 05-Jan-2011 GA 04-Jan-2011 Lot Prev Doses Site 1778Y 0 Right arm U3281BA 0 Left arm 0714Z 1 Left arm
Mfr Report Id GA10085 Route Intramuscular Intramuscular Subcutaneously
Symptom Text: Patient was seen on 11-4-10 at the Health Center at that time patient had urine preg test done which was negative. Gave last LMP as 10-15-10 - Pt then received VZV, TDAP, HVP return to clinic on 11-23-10 with positive pregnancy test report to Merck/Pregnancy Registry. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No Hx kidney stone; allergic PNC - CECLOR - Erythromycin; Codeine None


Page 75
Vaers Id: 413958-1 Age Gender Vaccine Date Onset Date F 23-Dec-2010 24-Dec-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 12-Jan-2011 CA 04-Jan-2011 Lot Prev Doses Site 0768Z 0 Left arm U3710MA 0 Right arm 1027Z 1 Left arm
Last Edit Date 29-Jun-2011 Other Vaccine
Asthenia, Cough, Oropharyngeal pain, Pyrexia, Upper respiratory tract infection
Symptom Text: Approx 12 hrs after imm she developed fever/cough -> 104 -> continue x 4 days, has decreased energy, no achy, URI & sore throat now with persistent cough. Other Meds: Lab Data: History: Prex Illness: None Prex Vax Illns: Sz.~DTaP (no brand name)~1~0.20~Patient ADDERALL XR 5 mg Strep; CXR; Breathing tx


Page 76
Vaers Id: 414009-1 Age Gender Vaccine Date Onset Date F 02-Dec-2010 03-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 05-Jan-2011 CO 04-Jan-2011 Lot Prev Doses Site 0886Z 0 Unknown
Dizziness, Headache, Loss of consciousness, Nausea, Neck pain, Photophobia, Pruritus generalised, Rash, Tinnitus, Vertigo, Vision blurred
Symptom Text: Extreme dizziness, severe headache, blackout in pe class, ringing in ears, itchiness all over her body, blurred vision. The rash symptoms lasted about 6 hours. The dizziness, headache and ringing continued without relief. In the span of 5 days patient was in two different ER's and was seen by her primary care Dr. twice. The following information was obtained through follow-up and/or provided by the government. 01/21/11. ER report for DOS 12/04/10. Clinical impression: HA, vertigo. CC: HA. Also, Pt had blurred vision, photophobia, nausea, rash. Pt had nausea and dizziness. Tx: Benadryl, Ibuprofen, caffeine. ER visit on 12/06/10: Clinical impression: HA, dizziness, possible migraine HA. P/w HA, vertigo, ringing in ears, neck pain. Discharged in stable condition. 01/24/11. PCP visit for 12/02/10. DX: dysmenorrhea. C/o painful and heavy menses. Pt received HPV vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CT scan done on Dec. 4th. MRI done on Dec. 6th. Blood tests run at each visit The following information was obtained through follow-up and/or provided by the government. 01/21/11. Labs and DX studies: CT of head normal: MRI study of brain limited, but normal. no pre existing conditions - allergy to penicillin The following information was obtained through follow-up and/or provided by the government. PMH: dysmenorrhea, painful and heavy menses. Allergies: PCN. none


Page 77
Vaers Id: 414014-1 Age Gender Vaccine Date Onset Date F 28-Oct-2010 14-Nov-2010 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 17
Status Date State Received Date 05-Jan-2011 CA 04-Jan-2011 Lot Prev Doses Site 0664Z 2 Left leg
Last Edit Date 25-May-2011 Other Vaccine FLU
Deep vein thrombosis, Limb discomfort, Oedema peripheral, Pain in extremity, Thrombosis, Ultrasound Doppler normal
Symptom Text: Blood clot in left leg The following information was obtained through follow-up and/or provided by the government. 01/07/2011 vaccination record received. HPV vaccination given 10/28/2010. 01/07/2011 Family practice office note received for DOS 12/28/2010. Left calf pain. Patient was seen on 12/28/2010 for c/o left calf pain. Examination noted calf pain and trace lower extremity swelling. Record noted patient had history of recent DVT of left lower extremity. Patient had been previously seen on 11/29/10 and was symptom free at that time. Plan: Ultrasound of extremity. Subsequently, the findings of ultrasound of lower extremity were negative for DVT. 01/19/2011 Chest/critical care clinic consult record received for DOS 11/29/2010. Patient seen in consultation for evaluation of recent diagnosis of below-the-knee deep venous thrombosis, while on oral contraceptive. Patient had no previous history of venous thromboembolism. Patient was not treated with anticoagulation therapy. Patient has noted improvement of her leg symptoms (swelling of left calf and mild discomfort). Patient has been walking on her legs without problems. Examination noted no extremity edema. Consult noted DVT stable over 3 venous Doppler studies and pt. improved off estrogen therapy and no longer immobile. Recommendation: no further Doppler studies, no initiation of anticoagulation. F/U in one month. Other Meds: Lab Data: Cozaar Numerous ultra sounds of leg. Many doctor's visit. Much stress. The following information was obtained through follow-up and/or provided by the government. 01/07/2011: Ultrasound lower extremity: negative for DVT, ALB: 3.2 (L), Sed rate: 25 (H), CHOL: 246 (H). 01/26/2011 records received: Venous blood flow study 12/28/10: negative for DVT in left lower extremity. VSD closure The following information was obtained through follow-up and/or provided by the government. 01/07/2011 Nephrology consult note received for DOS 10/14/10. Patient was seen due to a recent increase in proteinuria and also left abdominal pain. History: proteinuria (since age 5), ankle edema, idiopathic pericarditis, ventricular septal defect repair in 1991, scoliosis, tympanostomy, asthma, left hydronephrosis, pulmonary hypertension, arthralgias, shortness of breath, chest pain, chronic headaches, general muscle weakness, allergic rhinitis, and allergy to Lisinopril. 01/07/2011 Family practice office note received for DOS 10/20/2010. Assessment: Tachycardia, nonspecific subjective. Patient presented with c/o tachycardia x 3 to 4 None
History:
Prex Illness: Prex Vax Illns:


Page 78
Vaers Id: 414025-1 Age Gender Vaccine Date Onset Date F 29-Dec-2010 29-Dec-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cyanosis, Hypoaesthesia
Days 0
Status Date State Received Date 05-Jan-2011 FL 04-Jan-2011 Lot Prev Doses Site 0096Z 0 Left arm
Symptom Text: Arm became numb and fingernails became cyanotic (bluish in color) for 18 hours. Used heating pad. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 79
Vaers Id: 414026-1 Age Gender Vaccine Date Onset Date F Unknown Unknown 14.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Migraine
Days
Status Date State Received Date 07-Jan-2011 MS 04-Jan-2011 Lot Prev Doses Site AHAVB143AA 0 Left arm 0188U 1 Right arm
Mfr Report Id Route Intramuscular Intramuscular
Symptom Text: Migraines, dizzy spells. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 80
Vaers Id: 414028-1 Related reports: 414028-2 Age Gender Vaccine Date Onset Date F 03-Jan-2011 03-Jan-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 06-Jan-2011 NJ 04-Jan-2011 Lot Prev Doses Site 1178Y 1 Left arm
Abdominal pain upper, Arthralgia, Chest discomfort, Dizziness, Fatigue, Headache, Musculoskeletal chest pain, Myalgia, Nausea, Neck pain, Pain, Pain in extremity, Pallor, Vaccination complication
Symptom Text: Leg/knee/ankle/arm/neck pain started 1/03/11 headache dizzy stomach ache fatigue nausea pallor per 1/4/11. The following information was obtained through follow-up and/or provided by the government. 3/2/2011 ER record received for DOS 1/4/2011 w/ Dx's: 1) myalgia; 2) toe fracture, closed; 3) vaccination, Gardacil, side effects; 4) headache. Pt c/o thigh pain, headache (6/10) - rt frontal throbbing, chest tightness, pain under ribs, shooting pains from hips down legs, myalgia, dizziness since 40 min after vaccination. Pt d/c'd home w/ instructions. Other Meds: Lab Data: History: Prex Illness: None None The following information was obtained through follow-up and/or provided by the government. 3/2/2011 lab/diagnostic records received for DOS 1/4/2011. UA: unremarkable. X-ray rt foot: abnormal. None The following information was obtained through follow-up and/or provided by the government. PMH: rt 2nd toe fx. None The following information was obtained through follow-up and/or provided by the government. Rt 2nd toe fx.
Prex Vax Illns: Dizzy and headache.~HPV (Gardasil)~1~12.00~Patient


Page 81
Vaers Id: 414037-1 (O) Age Gender Vaccine Date Onset Date F Unknown 01-Dec-2009 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 06-Jan-2011 DC 05-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Carcinoma in situ, Loop electrosurgical excision procedure
Symptom Text: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no drug reaction and allergies who on an unspecified day was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number not provided). Concomitant therapy included oral contraceptive. In December 2009, some time after the first dose of GARDASIL, the patient had an abnormal Papanicolaou (pap) smear. The smear revealed a "CIM-3 abnormality with carcinoma in situ." On 12-FEB-2010 the physician performed a LEAP procedure on the patient. On 08-SEP-2010 this patient's follow-up smear revealed that no HPV was present. The physician also mentioned that the patient received a second dose of GARDASIL (lot number not provided) late on 10-NOV-2010. At time of the report the patient was recovered. Upon internal review, a "CIM-3 abnormality with carcinoma in situ". was determined to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: hormonal contraceptives Pap test, 12/??/09, CIM-3 abnormality with carcinoma in situ; Pap test, 09/08/10, no HPV was present None


Page 82
Vaers Id: 414039-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 06-Jan-2011 FR 05-Jan-2011 Lot Prev Doses Site NULL Unknown
Condition aggravated, Epilepsy, Grand mal convulsion, Thoracic vertebral fracture
Symptom Text: Initial information was reported in a published article. The aim of the study was to analyze detailed clinical information of SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community) cases of syncope and seizure after GARDASIL vaccination. One of the patients mentioned in the article experienced a generalized tonic-clonic seizure 2 days after receiving GARDASIL. This resulted in a wedge fracture of spinal vertebrae (T5/T6), which was treated conservatively. A generalized epilepsy disorder was confirmed and anticonvulsant medication commenced. At the time of the report, the outcome of the patient was unknown. the article also discussed the experience of other patients vaccinated with GARDASIL (WAES #s 100USA04506, 1012USA04211, 1012USA04212 and 1012USA04214). Upon internal review, generalized tonic-clonic seizure was considered to be an other important medical event. No further information is available. A copy of the published article is attached as further documentation of the patient's experience. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Epilepsy Unknown Unknown


Page 83
Vaers Id: 414040-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Unevaluable event
Days
Symptom Text: The following was reported in a published abstract. The GARDASIL vaccination program commenced in May 2007 for females aged 12-26 years. Syncope and syncopal seizures can occur with any painful stimulus. High rates of both have been documented post GARDASIL vaccination. Alm: To describe cases of 'syncope' and 'seizures' post GARDASIL vaccination notified to SAEFVIC. Methods: All reports of adverse events following immunization (AEFI) received by SAEFVIC between May 2007 - April 2009 were selected for analysis. AEFI following GARDASIL vaccine coded as seizure or syncope were reviewed. Results: During the study period, 6% (9711653) of all SAEFVIC reports met the criteria: afebrile seizures (3), syncopal seizures (31) and syncope alone (63). Median age at vaccination was 15 yrs (range 8-30 years). 23% (7131) of syncopal seizures had associated urinary incontinence. An injury was sustained in seven cases, including one vertebral (TSTT6) fracture. After clinical review, further GARDASIL vaccine doses were given under supervision whilst lying down for 20 minutes to 21 women with no recurrences. The rate of syncopal seizures was 2.6 per 100,000 doses of GARDASIL vaccine distributed. Conclusion: A high rate of syncope and syncopal seizures was seen post GARDASIL vaccination. Clinical follow-up allows for clarification of the diagnosis, a physical examination and investigations as appropriate. Effective strategies to minimize the risk recurrent syncope post vaccination include lying down before and 20 minute post vaccination. Additional information was reported in a published article. The aim of the study was to analyze detailed clinical information on SAEFVIC cases of syncope and seizures after GARDASIL vaccination. In the 2 year study period, 29% (485/1653) of SAEFVIC reports included GARDASIL vaccine. A total of 192 reports involved seizures and/or syncope. Of these, 51% (97/192) of patients had received GARDASIL. All patients were female, and the median age was 15 years (range, 8-26 years). The authors discussed that the fact that syncope occurred after GARDASIL vaccine administration was not unexpected, as vaccination was a painful stimulation and a young, female population was targeted in this catch-up program. Upon internal review, seizure was considered to be an other important medical event. The article also discussed the experience of other patients vaccinated with GARDASIL (WAES #s 1012USA04211, 1012USA04212, 1012USA04213 and 1012USA04214). No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Epilepsy Unknown Unknown


Page 84
Vaers Id: 414041-1 (O) Age Gender Vaccine Date Onset Date F 07-Oct-2009 Unknown 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 06-Jan-2011 MI 05-Jan-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with no relevant drug reactions/allergies and with no pertinent medical history who on 07-OCT-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number reported). Concomitant therapy included influenza virus vaccine (unspecified). It was reported that the patient received her first dose of the vaccine and she was pregnant with a last menstrual period of 04-SEP-2009 (EDD: 11-JUN-2010). Urine pregnancy test was performed and was positive (unspecified date). The patient sought medical attention by an office visit. Follow up information has been received from a nurse. It was reported that the patient terminated the pregnancy early on, in her first trimester. The nurse reported that the patient and her family decided for multiple reasons, not as a result of her having had the GARDASIL during pregnancy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review termination of the pregnancy was considered to be an other important medical event. No further information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 9/4/2009) urine beta-human, positive


Page 85
Vaers Id: 414043-1 (O) Age Gender Vaccine Date Onset Date F 22-Sep-2009 22-Sep-2009 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 06-Jan-2011 US 05-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Caesarean section, Drug exposure during pregnancy, Labour induction, Prolonged pregnancy
Symptom Text: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no pertinent medical history and no known drug allergies who on 22-SEP-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot number reported as 662664/0981X, invalid for GARDASIL, but is a valid lot number for PNEUMOVAX 23. There was no concomitant medication. At the time of this report, the patient was pregnant. Physician assistant believed the day of conception was the day of the first dose of GARDASIL. A pregnancy test was performed on 22-SEP-2009 and the result was negative. The patient sought medical attention through a prenatal office visit. The patient's last menstrual period was 08-SEP-2009. Expected date of delivery was 15-JUN-2010. Follow up information has been received via telephone call from an obstetric nurse indicating that the patient's pregnancy was "relatively uncomplicated". She had a choroid plexus cyst noted on her mid-trimester fetal ultrasound but everything was normal at the follow-up ultrasound. The patient was scheduled for an induction on 24-JUN-2010, the nurse suspected it was because she would have been 41 weeks gestation, and she could not find any other indication when asked. The induction resulted in a primary cesarean section on 24-JUN-2010, and the patient delivered a baby in good health. She stated there was no congenital anomalies. The nurse confirmed that both the baby and the mother were in good health at her post-partum visit, and the mother recovered from her cesarean without complications. The infant's experience has been captured in WAES 0911USA02673B1. Upon internal review the induction that resulted in a primary cesarean section was considered to be another important medical event. No further information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 9/8/2009) None ultrasound, 01?/??/10, Choroid plexus cyst noted on her mid-trimester; ultrasound, ?/?/10, follow up ultrasound: normal; beta-human chorionic, 09/22/09, negative


Page 86
Vaers Id: 414044-1 (O) Age Gender Vaccine Date Onset Date U Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Mfr Report Id Last Edit Date WAES0911USA02673B 01-Feb-2011 1 Other Vaccine Route Intramuscular
Congenital choroid plexus cyst, Drug exposure during pregnancy
Symptom Text: Information has been received from an OB nurse concerning a baby whose 23 year old mother, with no medical history or preexisting allergies, was vaccinated IM on 22-SEP-2010 with a 0.5 ml first dose of GARDASIL, (Lot no. not reported). Her LMP was on 08-SEP-2010. No concomitant therapies were mentioned. Nurse reported that an ultrasound performed on the mother's mid-trimester showed a choroid plexus cyst. The nurse stated that "everything was normal at the follow-up ultrasound". On 24-JUN-2010, the mother delivered a baby in good health. Nurse reported that there were no congenital anomalies. Nurse confirmed that baby and the mother were in good health at her post-partum visit. The mother's experience has been captured in WAES 0911USA02673. Upon internal review choroid plexus cyst was considered to be a congenital anomaly. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown ultrasound, 01/??/10, choroid plexus cyst noted on mid trimester; ultrasound, 01/??/10, follow up ultrasound: normal Unknown


Page 87
Vaers Id: 414045-1 (O) Age Gender Vaccine Date Onset Date F 01-Nov-2010 04-Nov-2010 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chemotherapy, Hodgkins disease
Days 3
Symptom Text: Initial and follow up information has been received from a Registered Nurse concerning a 21 year old female patient who in November 2010, was vaccinated with a first dose of GARDASIL (lot # unknown). The nurse reported that the patient was scheduled to start chemotherapy, some time in January 2011. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. A telephone call was made to the registered nurse and she also stated the patient has a medical history of methamphetamine addiction, smoking cigarettes and HPV. Her mother and her mother's uncle both had lymphoma. The patient was vaccinated with a first dose of GARDASIL in November 2010 on an unknown date and the nurse stated that the patient said she due for her second dose in January 2011. Subsequently, the patient had a lymph node biopsy on 04-NOV2010 that confirmed a diagnosis of Hodgkin's lymphoma. She started chemo on 18-NOV-2010. She was not admitted and is being treated as an outpatient. Upon internal review Hodgkin's lymphoma was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown lymphatic structure, 11/04/10, Hodgkin's lymphoma Papilloma viral infection; Dependence on amphetamines; Smoker


Page 88
Vaers Id: 414046-1 (O) Age Gender Vaccine Date Onset Date F 01-Nov-2008 07-Oct-2009 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Drug exposure during pregnancy
Days 340
Status Date State Received Date 06-Jan-2011 IL 05-Jan-2011 Lot Prev Doses Site 0947X 0 Unknown
Symptom Text: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient, with no pertinent medical history and no drug reactions or allergies, who in November 2008, was vaccinated with a first dose of GARDASIL (lot # 0947X, expire date 05-JUL-2010), 0.5 ml, intramuscularly. Concomitant therapy included vitamins. Subsequently, the patient realized she was pregnant. On an unspecified date, blood test and ultrasound (also reported as: ultrasound) were performed for routine prenatal care. The patient delivered a healthy male on 07-OCT-2009. During delivery, on 07-OCT-2009, the patient required IV and oxygen. In January 2010, the patient was vaccinated with the second dose of GARDASIL (lot # 1423X, expire date 20-JUN-2011), 0.5 ml, intramuscularly. "No adverse symptoms noted". On 11-NOV-2010, she was vaccinated with the third dose of GARDASIL (lot #, expire date not reported), 0.5 ml, intramuscularly. The registered nurse considered IV and oxygen requirements during delivery to be other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 2/1/2009) Vitamins (unspecified) Unknown


Page 89
Vaers Id: 414047-1 (S) Age Gender Vaccine Date Onset Date F 23-Nov-2010 23-Nov-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Asthenia, Headache, Pyrexia, Vision blurred
Days 0
Status Date State Received Date 13-Jan-2011 FR 05-Jan-2011 Lot Prev Doses Site 1353X Unknown
Symptom Text: Information has been received from Health Authority (case n. 130521) through (local case n. IT666/10). Initial report received on 22-DEC-2010. Case medically confirmed. A 12 year old female was vaccinated with a dose of GARDASIL (lot # 1353X, batch # NL44120, site of administration not reported) via intramuscular route on 23-NOV-2010. On the same day, the patient experienced headache, blurred vision of short duration, fever at 38-39 degrees C and asthenia. The patient had received a third dose of meningococcal vaccine on 31-OCT-2010 with no adverse reaction. At her discharge: laboratory tests, consultation in neurology and infectious diseases were prescribed. The patient had fully recovered on 30-NOV-2010. Case was closed. No further information is available. Other business partner numbers include E2010-08010. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 90
Vaers Id: 414051-1 (S) Age Gender Vaccine Date Onset Date F 29-Jul-2010 Unknown 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days
Status Date State Received Date 06-Jan-2011 CA 05-Jan-2011 Lot Prev Doses Site NULL Unknown
Convulsion, Head injury, Loss of consciousness, Syncope
Symptom Text: Information has been received from a physician concerning an 18 year old female patient who on 29-JUL-2010 was vaccinated with a dose of GARDASIL (Lot #, expire date and route not reported). The physician stated that on 29-JUL-2010 after receiving the dose of GARDASIL the patient experienced fainting, banging her head on a counter, having a seizure and blacking out for about a minute. Physician also said that patient was taken via ambulance to a nearby unspecified hospital where she received unspecified treatment and was released later the same day. Fainting, banging her head on a counter, having a seizure and blacking out were considered to be an other important medical event by the physician. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 91
Vaers Id: 414067-1 (S) Age Gender Vaccine Date Onset Date F 05-Oct-2010 19-Oct-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Cellulitis, Injection site mass, Pyrexia
Days 14
Symptom Text: This case was received from the Health Authority on 21-DEC-2010 under the reference number 2010-001389. This case is medically confirmed. A 14 year old female patient with no medical history and no concomitant medication received a first dose of GARDASIL (Lot No. NK25010, Batch No. NM31130) intramuscularly, site not reported on 05-OCT-2010 and on 19-OCT-2010, two weeks post vaccination developed and lump at the injections site, pyrexia and severe cellulitis leading to hospitalisation (for approximately ten days). The patient had not had a previous problem with vaccines. The patient's mother reported that shortly after the vaccination on 05-OCT-2010 that the boys and girls had been hitting each others arms. The duration of the events was two weeks and the patient made a complete recovery. This information came to light as the patient's mother refused consent for the second dose. Additional information is not expected. Other business partner numbers include E2010-07954. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 92
Vaers Id: 414069-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion
Days
Symptom Text: Initial information was reported in a published article. The aim of the study was to analyze detailed clinical information on cases of syncope and seizures after GARDASIL. One of the patients mentioned in the article had a generalized seizure 4 hours after the GARDASIL (dose 2). At the time of the report, the outcome of the patient was unknown. The article also discussed the experience of other patients vaccinated with GARDASIL (WAES #s 1005USA04506, 1012USA04212, 1012USA04213 and 1012USA04214). Upon internal review, generalized seizure was considered to be an other important medical event. No further information is available. A copy of the published article is attached as further documentation of the patient's experience. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 93
Vaers Id: 414070-1 Age Gender Vaccine Date Onset Date Days F 28-Dec-2010 28-Dec-2010 0 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TTOX UNKNOWN MANUFACTURER MEN UNKNOWN MANUFACTURER Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Status Date State Received Date 06-Jan-2011 OK 05-Jan-2011 Lot Prev Doses Site 1318Y 0 Left arm NULL 1 Right arm NULL Left arm
Asthenia, Convulsion, Dizziness, Loss of consciousness
Symptom Text: My daughter received tetanus, meningitis, and a new vaccine called HPV (GARDASIL). Within 5 min. she passed out and had a seizure lasting approx. 10 seconds. She was extremely weak - dizzy for a few days after vaccinations. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: FLONASE - nasal spray None - no test were taken None - Dr. said ears, nose, throat, etc was fine. None


Page 94
Days
Complex partial seizures, Condition aggravated
Symptom Text: Initial information was reported in a published article. The aim of the study was to analyze detailed clinical information on cases of syncope and seizures after GARDASIL. One of the patients mentioned in the article had a exacerbation of complex partial seizures 4 hours after the GARDASIL (dose 2). At the time of the report, the outcome of the patient was unknown. The article also discussed the experience of other patients vaccinated with GARDASIL (WAES #s 1005USA04506, 1012USA04211, 1012USA04213 and 1012USA04214). Upon internal review, exacerbation of complex partial seizure was considered to be an other important medical event. No further information is available. A copy of the published article is attached as further documentation of the patient's experience. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 95
Vaers Id: 414114-1 Age Gender Vaccine Date Onset Date Days F 05-Jan-2011 05-Jan-2011 0 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS FLUN MEDIMMUNE VACCINES, INC. HEP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Status Date State Received Date 06-Jan-2011 FL 05-Jan-2011 Lot Prev Doses Site 0786Z 2 Left arm U3433AA 0 Right arm AHAVB444BA 0 Left arm 501049B AHBV846AA 0 2 Unknown Right arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Unknown Intramuscular
Symptom Text: 5 minutes after vaccines administration, patient passed out. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 96
Days 0
Mfr Report Id Last Edit Date WAES1011POL00008 13-Jan-2011 Other Vaccine Route Intramuscular
Hypoaesthesia, Influenza like illness, Oedema peripheral, Paresis
Symptom Text: Information has been received from a physician concerning a 32 year old female who on 09-NOV-2010 was vaccinated with first dose of GARDASIL. On 09-NOV-2010 the patient experienced hand edema, hand numbness and hand paresis. On 12-NOV-2010 the patient experienced flu-like symptoms. On 12-NOV-2010 the patient was examinated by a physician and the hydrocortisone was prescribed. The patient's hand edema and hand numbness and hand paresis and flu-like symptoms persisted. Upon internal review, hand paresis was determined to be an other important medical event. The reporter was not sure that hand edema, hand numbness, hand paresis and flu-like symptoms were related to therapy with GARDASIL. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 97
Vaers Id: 414129-1 (S) Age Gender Vaccine Date Onset Date F 21-Aug-2010 21-Oct-2010 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 61
Status Date State Received Date 13-Jan-2011 FR 05-Jan-2011 Lot Prev Doses Site NJ28270 0 Unknown
Abdominal pain, Insomnia, Syncope, Ventricular extrasystoles
Symptom Text: Case received from the Health Authorities on 10-NOV-2010 under the reference number ES-AGEMED-205193349. Case medically confirmed. A 19 year old female patient received a dose of GARDASIL (batch number not reported, route of administration unknown) on 21-OCT-2010 and on the same day, 21-OCT-2010 she experienced extrasystole ventricular, syncope and abdominal pain. Test performed, and ECG (date not reported) showed isolated ventricular extrasystoles. The patient was hospital admitted (hospital admission and discharged date not provided). The patient recovered from extrasystole ventricular and syncope on the 21-OCT-2010, at the time of this reporting the outcome for abdominal pain was not recovered. Two days after a dose of GARDASIL administered on 23-AUG-2010 the patient presented with non specific abdominal pain and insomnia. In the HAs report, it was written that the batch number of the first dose (it was no reported the dose that this case concerns) was NK18760 and also it was reported that the batch number of the second dose was unknown. Other business partner numbers include E2010-06861. No further information was reported. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown electrocardiogram, Isolated ventricular extrasystoles Unknown


Page 98
Vaers Id: 414133-1 Age Gender Vaccine Date Onset Date M 05-Jan-2011 05-Jan-2011 18.0 Type Manufacturer VAX Detail: IPV SANOFI PASTEUR MMR MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. HEP GLAXOSMITHKLINE BIOLOGICALS HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Fall, Hypoventilation, Pallor
Days 0
Status Date State Received Date 06-Jan-2011 TX 06-Jan-2011 Lot Prev Doses Site D0674 Right arm 0578Z Right arm U3562AA Right arm U3281BA Left arm 1038Z Left arm 0768Z Left arm AHBVB833CA Right arm AHAVB441AA Left arm
Mfr Report Id Route Subcutaneously Subcutaneously Intramuscular Intramuscular Subcutaneously Intramuscular Intramuscular Intramuscular
Symptom Text: Client was sitting in chair-fell out of chair. Pale, shallow respirations. Lasted about 15 sec. Client had not eaten since breakfast. Was feeling better at 5:10pm. No longer pale respirations were normal. Other Meds: Lab Data: History: Prex Illness: none Not known Not known
Prex Vax Illns: light headedness~ ()~~0.00~Patient


Page 99
Days 0
Status Date State Received Date 13-Jan-2011 FR 06-Jan-2011 Lot Prev Doses Site NM31190 0 Unknown
Fatigue, Hypersensitivity, Lethargy, Pruritus, Rash vesicular, Skin lesion, Somnolence, Urticaria
Symptom Text: Information has been received from a physician concerning a female patient (age not reported) with an unreported medical history and concomitant medication, who on an unspecified date received the first dose of GARDASIL (batch, route and site not reported). Within hours post vaccination, the patient experienced a severe urticarial vesicular rash on both her upper limbs and also experienced an associated drowsiness and lethargy. The patient was examined eleven weeks post vaccination and the vesicle remnants were still visible. The reporter diagnosed a true allergic reaction and was not happy to give the patient the second dose in an isolated clinic and would seek advice before vaccination. The patient's twin sister received the GARDASIL vaccine vaccination and had no problems and was administered the second dose at the clinic. At the time of reporting the patient had not recovered from the vesicular rash and the outcome of the remainder of the events had not been reported. Follow up information had been received from the agency on 22-DEC-2010 (ref. 2010-001486): The patient was a 12 year old female with no medical history, no risk factors available, a healthy child taking no concomitant medications. The patient received GARDASIL (batch number NM31190) 0.5 ml, IM, on 27-SEP-2010. On 27-SEP-2010, 2-3 hours post vaccination, the patient developed vesicular urticarial rash on both upper limbs, lethargy, tiredness, and vesicular eruptions on upper limbs and forearms which continued to develop overnight with an itch. Lesions were confined to upper limbs only and did not occur in any other part of the body. The duration of the reaction was 12-18 hours. Corrective treatment included ibuprophen (generic), paracetamol (generic) and anti-inflammatory products (generic). At the time of reporting the patient was not yet recovered. Medical advice was not sought at the lesions still present almost 15 weeks after the initial reaction. The patient presented for her second dose of GARDASIL on 09-DEC-2010 but the reporter was reluctant to administer this given the nature of her reaction to the first dose. Case E2010-07765 (WAES#1012USA02390) has been identified as a duplicate of E2010-06110 (WAES#1010USA01428). E2010-07765 (WAES#1012USA02390) will be deleted and all information transferred to master case E2010-06110 (WAES#1010USA01428). This case is now a cluster of three cases linked with E2010-06110 (WAES#1010USA01428) and E2010-07766 (WAES#1012USA02391). This case is medically confirmed. This is one of three cases reported by the same reporter, concerning the same vaccine. Allergic reaction was considered to be an other important medical event. The agency considered urticarial rash, tiredness, lethargy, vesicular eruption and itch to be serious for the following reason: medically significant. Other business number included E2010-07764. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 100
Vaers Id: 414194-1 Age Gender Vaccine Date Onset Date F 03-Jan-2011 03-Jan-2011 11.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 07-Jan-2011 TN 06-Jan-2011 Lot Prev Doses Site 0926Z 1 Right arm AHAVB469AA 0 Left arm 0087Y 0 Left arm
Mfr Report Id Route Subcutaneously Intramuscular Intramuscular
Head injury, Loss of consciousness, Syncope
Symptom Text: Child received HEP A #1, HPV #1, and VARIVAX #2 then had syncopal episode seconds later. She did hit her head on exam table and floor but regained consciousness quickly. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 101
Vaers Id: 414242-1 Age Gender Vaccine Date Onset Date F 04-Jan-2011 05-Jan-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 07-Jan-2011 DE 06-Jan-2011 Lot Prev Doses Site 0992Z 2 Left arm
Asthenia, Fatigue, Headache, Injection site pain, Photophobia, Vomiting
Symptom Text: The patient's mother reported the following. Pt experienced severe head pain located across her forehead and at her temples. This pain woke pt from her sleep at 0230AM on 01/05/11. Exposure to light intensified the pain. Pt took two over the counter Ibuprofen and "vomited them back up". Patient was given an "Imitrex shot" at 0500 by her mother. Pt's pain resolved after the "shot" but she was "weak and very tired" for the remainder of the day. The patient also reported that she experienced more pain at the injection site than she had with the previous GARDASIL vaccines. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 102
Vaers Id: 414243-1 Age Gender Vaccine Date Onset Date F 16-Dec-2010 17-Dec-2010 17.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 07-Jan-2011 MT 06-Jan-2011 Lot Prev Doses Site U3440AA 0 Left arm C786Z 0 Left arm
Dizziness, Headache, Nausea, Paraesthesia, Pyrexia, Tenderness, Tremor
Symptom Text: Rec'd MENACTRA & GARDASIL #1 on 12/16/10 in afternoon. At approx 5:00 am next morning she awoke with dizziness, nausea, shaky, headache "slight" fever, (L) arm tender & "tingly" to fingers. Symptoms lasted 3 days, progressively better. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None stated None None stated None stated


Page 103
Vaers Id: 414249-1 Age Gender Vaccine Date Onset Date F 05-Jan-2011 05-Jan-2011 22.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. FLU GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dizziness, Fall, Tremor
Days 0
Status Date State Received Date 07-Jan-2011 MA 07-Jan-2011 Lot Prev Doses Site AHAVB456AA Left arm 0337Z AFLLA603AA Unknown Left arm
Symptom Text: On 1/5/11, AM RN gave influenza, Hepatitis A and HPV vaccines. She also received PPD on L arm. Pt stood up after receiving last vaccine (HPV) felt dizzy and fell. RN heard noise and found her on the floor. Pt was noticed to have slight movement & was alert, responding to commands HR 48, B/P 96/60. Pt was unconscious briefly, awoke quickly. Not confused afterwards. Pt reports blacking out after phlebotomy in the past. She was examined by PCP. EK done - sinus bradycardia. Discharged home in stable condition. Pt was advised to alert future vaccine administrators or phlebotomists to her history of syncopal episode. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PPD EKG- Sinus bradycardia sinus arrhythmia, otherwise normal EKG. Pt was examined by PCP after fall, LOC. She was DCD to home. No No


Page 104
Vaers Id: 414266-1 Age Gender Vaccine Date Onset Date F 27-Dec-2010 29-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash erythematous, Rash pruritic
Days 2
Status Date State Received Date 07-Jan-2011 CO 07-Jan-2011 Lot Prev Doses Site NULL 1 Unknown
Symptom Text: Rash-itchy red spots on arms, fingers. She didn't report the rash appeared on her rear end after the first dose, until the rash appeared on her arms after second dose. Treating with Benadryl. Rash continuning to spread to legs, hips and stomach. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 105
Vaers Id: 414288-1 (O) Age Gender Vaccine Date Onset Date F 03-Jan-2011 03-Jan-2011 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 13-Jan-2011 FR 07-Jan-2011 Lot Prev Doses Site 0411Y 0 Unknown
Bed rest, Dyspnoea, Hypotension, Pallor, Shock
Symptom Text: Information has been received from a physician concerning an approximately 24 year old female who on 03-JAN-2011 was vaccinated with the first dose of GARDASIL 0.5 ml pre-filled syringe IM (Lot# 0411Y, Batch# NM35450) (therapy site unknown). On 03-JAN-2011, about 5 minutes after receiving the vaccination, the patient experienced shock. Her symptoms included pale face, trouble breathing, and low blood pressure of 80/50 mmHg. She took a bed rest at the clinic. 17 minutes after the vaccination, her blood pressure measured as 90/50 mmHg. 40 minutes after the vaccination, she was able to sit up. 45 minutes after the vaccination, she went back home with no specific treatment given. Subsequently, the patient recovered from shock. The reporter felt that shock was medically important and was related to therapy with GARDASIL. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown blood pressure measurement, 03Jan11, 80/50 mmHg, 5 minutes after vaccination; blood pressure measurement, 03Jan11, 90/50 mmHg, 17 minutes after vaccination Unknown


Page 106
Vaers Id: 414289-1 Age Gender Vaccine Date Onset Date F 08-Oct-2010 08-Oct-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Headache, Nausea
Days 0
Status Date State Received Date 07-Jan-2011 US 07-Jan-2011 Lot Prev Doses Site 0786Z 1 Unknown
Symptom Text: Pt came into office this morning for second GARDASIL injection. Pt now c/o HA, nausea, and dizziness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pt did well without any reaction to the first injection.


Page 107
Vaers Id: 414307-1 Age Gender Vaccine Date Onset Date F 07-Jan-2011 07-Jan-2011 13.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR MEN SANOFI PASTEUR HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dyskinesia, Syncope
Days 0
Status Date State Received Date 10-Jan-2011 FL 07-Jan-2011 Lot Prev Doses Site C3475AA 0 Right arm U3463AA 0 Left arm 0096Z 0 Left arm AHAVB4538BA 0 Right arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Intramuscular
Symptom Text: FAINTED, UPPER BODY JERKED, LASTED 10 SECONDS Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NO


Page 108
Vaers Id: 414337-1 Age Gender Vaccine Date Onset Date F 05-Nov-2010 Unknown 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 10-Jan-2011 WI 07-Jan-2011 Lot Prev Doses Site 0331Z 1 Left arm
Pruritus, Rash erythematous, Rash macular, Tenderness
Symptom Text: Generalized erythematous, macular eruption & tenderness with itching soon after #2 dose of 3-4 week duration. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Skin tests to HPV vaccine negative. None None


Page 109
Vaers Id: 414373-1 (S) Age Gender Vaccine Date Onset Date F 12-Apr-2010 25-Aug-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 135
Status Date State Received Date 10-Jan-2011 FL 10-Jan-2011 Lot Prev Doses Site 0075Y 3 Left arm
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Anxiety, Back pain, Bone pain, Chest discomfort, Chest pain, Diarrhoea, Dizziness, Dyspnoea, Flank pain, Headache, Heart rate irregular, Insomnia, Irritability, Mood swings, Nausea, Pain, Pain in extremity, Palpitations, Panic attack, Rash, Stress, Syncope, Tachycardia, Vision blurred
Symptom Text: SEVERE HEADACHES, FAINTING, NAUSEA, IRREGULAR HEART BEATS, BLURRED VISION, BONES ACHING, TACHYCARDIA, SHORTNESS OF BREATH, RASHES, CHEST PAIN, IRRITABILITY, MOOD SWINGS, HOSPITALIZED NUMEROUS TIMES. The following information was obtained through follow-up and/or provided by the government. 01/10/11. ER 08/27/10. CC: HA, syncopal episode, R flank pain (throbbing), diarrhea. Clinical impression: HA, syncopal episode, back pain. Discharged home in stable condition. 2-nd ER, H&P for DOS 12/04/10. Clinical impression: chest pain. CC: chest pain substernal started 2 wks ago and racing heart. P/w lightheadedness, syncope, stabbing pressure like chest pain, SO. Tx: Atenolol, Zofran. Psychiatric consult on 12/06/10, Impression: stress, anxiety and sx consistent with panic attacks. C/o trouble sleeping, leg pain, Affect normal, euthymic mood, displayed normal logical thought processes. 01/11/11. ER report for 11/21/10. Clinical impression: migraine HA, Ha. Discharged home in stable condition. On 12/03/10. ER visit on 12/03/10. Impression and CC: palpitations, chest discomfort. Referred for behavior psychology evaluation. 02/02/11. Progress notes for DOS 12/05/10. A: palpitations, syncope. C/o chest pain, SOB, palpitations. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE The following information was obtained through follow-up and/or provided by the government. Labs and DX studies: ECG normal, echocardiogram normal; negative preg test; CT of head normal. NONE The following information was obtained through follow-up and/or provided by the government. PMH: syncope for 2 yrs; vasovagal reaction, asthma, migraines, HA, syncope, asthma exercise induced, family h/o anxiety. Allergies: Zofran. NO


Page 110
Vaers Id: 414402-1 (O) Age Gender Vaccine Date Onset Date F 03-Feb-2009 19-Mar-2009 22.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 44
Status Date State Received Date 12-Jan-2011 PA 10-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Abortion spontaneous, Dizziness, Drug exposure during pregnancy, Haemorrhage, Muscle spasms
Symptom Text: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no drug allergies and irregular menses and a history of abnormal "low grade squamous" pap in February 2008, who on 03-FEB-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not provided). There was no concomitant medication. On 16-FEB-2009 the patient sought medical attention for prenatal care at physician's office for a confirmed pregnancy. On 19-MAR-2009 the patient phoned physician's office and complained of bleeding. Therefore a quantitative Human Chorionic Gonadotropin (HCG) was drawn with a result was "61, 811". On 21-MAR-2009 the patient had a repeat quantitative Human Chorionic Gonadotropin (HCG) level drawn with a result of "46, 393". On 23-MAR-2009 the patient went to her primary care physician's office and had a "cytotech" procedure performed there for a miscarriage. On 04-APR-2009 the patient visited an emergency room for complaints of cramping and bleeding following the "cytotech" procedure. On 14-APR-2009 the patient came to physician's office and complained of dizziness. On 21-APR-2009 the patient met with the nurse practitioner at physician's office when her second dose of GARDASIL was due, but it was not given at that time. On 28-DEC-2010 the patient came to physician's office and received the second dose of GARDASIL (therapy route and lot # not provided) late. At the time of reporting, the patient's status was recovered. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Serum prostatic acid, 02/??/08, abnormal "low grade squamous" pap; Serum beta-human, 03/19/09, 61, 81; Serum beta-human, 03/21/09, 46,39 Cervical low grade squamous intraepithelial lesion Pregnancy NOS (LMP = Unknown); Menstruation irregular


Page 111
Vaers Id: 414421-1 Age Gender Vaccine Date Onset Date F 22-Dec-2010 07-Jan-2011 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 16
Status Date State Received Date 11-Jan-2011 TX 10-Jan-2011 Lot Prev Doses Site NULL 2 Unknown
Injection site mass, Injection site pain, Injection site swelling
Symptom Text: There was some swelling at site of injection after this HPV vaccine and it went away in days. There is now a bump at injection site that appeared weeks later and its tender. Other Meds: Lab Data: History: Prex Illness: NONE NONE
Prex Vax Illns: soreness at infection site~HPV (Gardasil)~2~0.00~Patient


Page 112
Vaers Id: 414435-1 Age Gender Vaccine Date Onset Date F 07-Jan-2011 07-Jan-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Loss of consciousness
Days 0
Status Date State Received Date 11-Jan-2011 IN 10-Jan-2011 Lot Prev Doses Site 0766Z 1 Right arm AC52B056AA 0 Left arm
Symptom Text: Pt given 2nd HPV - within 5 minutes - pt. complained of dizziness, lightheadedness - "blacking out". Pt helped to a chair in hallway of office; elevated feet - gave pt water, orange juice, crackers - wet washcloth- pt "felt fine" after 15 minutes. BP checked - pt released with mother. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BENZACLIN 15% gel; PROAIR HFA None None - well child visit


Page 113
Vaers Id: 414448-1 Age Gender Vaccine Date Onset Date F 10-Jan-2011 10-Jan-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Injection site rash, Rash
Days 0
Status Date State Received Date 12-Jan-2011 WV 11-Jan-2011 Lot Prev Doses Site 0337Z 1 Left arm
Symptom Text: 1 hour post injection - pt returns to clinic presenting with rash on chest & neck & around injection site. Sent to ER. Follow up - pt doing well. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: TRILEPTAL Pt received SOLU-MEDROL IM at ER & d/c'd. Dx - Mood D.O; Allergies: BENADRYL; Ibuprofen; NSAIDS None


Page 114
Vaers Id: 414450-1 Age Gender Vaccine Date Onset Date M 04-Jan-2011 04-Jan-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA MERCK & CO. INC. FLU SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dry mouth, Pallor
Days 0
Status Date State Received Date 11-Jan-2011 PA 11-Jan-2011 Lot Prev Doses Site 1016Z 0 Right arm 1215Z 1 Left arm UT3656AA 0 Left arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular
Symptom Text: Very anxious about receiving immunizations. Five min after shots became pallor, dry mouth, H2O given, cool compresses to neck and head. Lie down on exam table. Reassurance offered. Mom present. Full recovery. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 115
Vaers Id: 414453-1 (O) Age Gender Vaccine Date Onset Date F 20-Oct-2009 01-Nov-2009 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 12
Status Date State Received Date 12-Jan-2011 MD 11-Jan-2011 Lot Prev Doses Site 0819Y 0 Unknown
Abdominal pain, Autoimmune disorder, Diarrhoea, Fibromyalgia, Headache, Premature menopause
Symptom Text: Information has been received from a mother concerning her 16 year old daughter (17 years old now) who in October 2009, was vaccinated with the first dose of GARDASIL (lot # not reported). There was no concomitant medication. Subsequently, the patient had no period in November 2009, or after that. In December 2009, the patient was vaccinated with the second dose of GARDASIL (lot # not reported) and her ovaries failed due to auto immune disease. The patient now (in 2010) had fibromyalgia and was taking ELAVIL and estrogen. The patient had reached menopause. The patient did not recover at the time of report. The patient sought unspecified medical attention. Follow up information has been received from the physician who reported that the now 17 year old female patient with trivial mitral valve regurgitation and back pain at the time of vaccination, on 20-OCT-2009 at 3:30 pm was vaccinated intramuscularly with the first dose of GARDASIL (lot # 663558/0819Y). The physician reported that in November 2009 the patient experienced premature ovarian failure, loose stools, abdominal pain and headache. At the time of the report, the patient had not recovered. The physician considered premature ovarian failure, loose stools, abdominal pain and headache to be another important medical event. Routine laboratory test were performed which showed result within the normal ranges. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Back pain; Mitral regurgitation None Unknown


Page 116
Vaers Id: 414454-1 (O) Age Gender Vaccine Date Onset Date F 29-Sep-2010 18-Dec-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Lichen planus, Rash
Days 80
Status Date State Received Date 13-Jan-2011 FR 11-Jan-2011 Lot Prev Doses Site NM00070 1 Unknown
Mfr Report Id Last Edit Date WAES1101BRA00009 13-Jan-2011 Other Vaccine Route Intramuscular
Symptom Text: Information has been received from a nurse concerning a female who on 29-SEP-2010 was vaccinated with the first dose of GARDASIL with no adverse event. On 18-NOV-2010 the patient received the second dose of GARDASIL (Local Lot#: NM00070) intramuscular. On approximately 18-DEC-2010, after 20 or 30 day of the vaccination the patient experienced skin rash on body and extremities and lichen planus. At the moment of the reporter the patient was recovering from skin rash on body and extremities and lichen planus. The patient's physician felt that the causality is indeterminate to the therapy with GARDASIL. The patient's physician considered the events as an important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None Unknown


Page 117
Vaers Id: 414480-1 (S) Age Gender Vaccine Date Onset Date F Unknown 01-Dec-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days
Mfr Report Id B0691910A Route Unknown
Cervix carcinoma stage I, Uterine dilation and curettage
Symptom Text: This case was reported by a sales representative and described the occurrence of cervical cancer stage 1 in a female subject of unspecified age who was vaccinated with CERVARIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of CERVARIX (unknown route of administration, lot number not provided). In last December 2010, at an unspecified time after vaccination with CERVARIX, the subject underwent dilatation and curretage of uterine cervix which showed cervical cancer stage I. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. No further details were given by the reporter. Additional information was requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown UNK


Page 118
Days 9
Mfr Report Id B0692168A Route Intramuscular
Drug exposure before pregnancy, Drug exposure during pregnancy, Twin pregnancy, Vaginal haemorrhage
Symptom Text: This prospective pregnancy case was reported by a physician and described the occurrence of vaginal bleeding in a 32-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) during pregnancy. On 19 November 2010, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, unknown lot number). An ultrasound was performed and showed dominant follicule which insured that she was not ovulating. On 28 November 2010, 7 days after vaccination with 1st dose of CERVARIX, the subject experienced vaginal bleeding. She thought she got her periods and felt safe. On 23 December 2010, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site, unknown lot number). Her last menstrual period was on 8 November 2010. The subject was exposed to the vaccine before conception and at 7 weeks gestation. On 2 January 2011, the ultra-sound showed that the patient was pregnant with 8 weeks and that she has a twin. Her estimated date of delivery was on 15 August 2011. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Ultrasound fetal, 02Jan2011, see text; Ultrasound ovary, 19Nov2010, see text


Page 119
Vaers Id: 414486-1 (S) Related reports: 414486-2 Age Gender Vaccine Date Onset Date F 18-Feb-2008 28-Jun-2008 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MEN SANOFI PASTEUR Seriousness: MedDRA PT
Days 131
Status Date State Received Date 12-Jan-2011 CA 11-Jan-2011 Lot Prev Doses Site 0928U 1 Unknown AC52B019AA Unknown U2382BA Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Abasia, Arthralgia, Body temperature increased, Joint swelling, Juvenile arthritis, Myalgia, Pain, Pyrexia, Rash, Rash macular, Rheumatoid arthritis
Symptom Text: Patient's body temperature went up to 104 and she couldn't walk. She was is a lot of pain and was admitted to the hospital. The following information was obtained through follow-up and/or provided by the government. 01/19/2011 Hospital discharge summary, H&P, consults & diagnostics for DOS 06/28/2008 to 07/02/2008 and ER record for DOS 09/13/2008. Final Dx: Juvenile Rheumatoid Arthritis. Patient presented with c/o high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4F and patient had severe joint & muscle pain and would not move her limbs, unless asked. Symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone & Benadryl. One day after the rash resolved, the patient then developed fever and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on Rocephin. Rheumatology was consulted. Consult exam noted salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home. Plan: refer to med. Center for further diagnostic evaluation .ER record of 09/13/08, noted patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). Patient was seen and received leucovorin. Impression: Juvenile rheumatoid arthritis. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ANA confirming systemic Juvenile Rheumatoid Arthritis The following information was obtained through follow-up and/or provided by the government. 01/19/2011: Segmented neutrophils: 83.2 (H), C-reactive protein: 2.16 (H), WBC: 21.9 (H), ANA none The following information was obtained through follow-up and/or provided by the government. 01/19/2011 records received. History: Tonsillectomy, NKA. no


Page 120
Vaers Id: 414486-2 (S) Related reports: 414486-1 Age Gender Vaccine Date Onset Date F 18-Feb-2008 28-Jun-2008 12.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 131
Status Date State Received Date 31-Mar-2011 US 30-Mar-2011 Lot Prev Doses Site AC52B019AA Unknown U2382BA 0928U Unknown Unknown
Mfr Report Id Last Edit Date WAES1103USA00669 31-Mar-2011 Other Vaccine Route Unknown Unknown Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Abasia, Arthralgia, Hypokinesia, Joint swelling, Juvenile arthritis, Myalgia, Pain, Pyrexia, Rash, Rash erythematous, Rash macular, Tenderness
Symptom Text: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Serum ANA, ?/?/08, confirming systemic juvenile rheumatoid arthritis; Segmented neutrophil, ?/?/08, 83.2 H; Serum C-reactive, ?/?/08, 2.16 H; WBC count, ?/?/08, 21.9 H; Body temp, 06/28/08, 104, went up; Body temp, ?/?/08, 100.4 F Tonsillectomy


Page 121
Days 0
Status Date State Received Date 12-Jan-2011 CO 11-Jan-2011 Lot Prev Doses Site 0653X 0 Right arm
Chills, Headache, Injection site pain, Nausea, Vision blurred
Symptom Text: Pt called clinic with c/o headache, nausea, chills, blurred vision & pain at injection site. Pt denies fever, difficulty breathing, & redness/swelling/drainage from injection site. Pt reports no other symptoms. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: LO OVRAL None None per patient None


Page 122
Vaers Id: 414519-1 Related reports: 414519-2 Age Gender Vaccine Date Onset Date F 10-Jan-2011 10-Jan-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 13-Jan-2011 WV 11-Jan-2011 Lot Prev Doses Site 0337Z 0 Right arm
Symptom Text: Pt had syncope episode x1 - no treatment necessary other than monitored in office x 30 minutes. F/u pt doing well today. 1-11-11 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DEPO None Migraines None


Page 123
Vaers Id: 414550-1 (S) Related reports: 414550-2 Age Gender Vaccine Date Onset Date F 25-Sep-2009 26-Sep-2009 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, LIFE THREATENING, SERIOUS
Days 1
Status Date State Received Date 13-Jan-2011 SC 12-Jan-2011 Lot Prev Doses Site 1497X 0 Left arm U2932AA Left arm 9C52B033BA Right arm
Mfr Report Id Route Intramuscular Unknown Intramuscular
Acne, Affect lability, Asthenia, Biopsy lung, Chest pain, Cough, Crying, Decreased activity, Depression, Dyspnoea, Fatigue, Haematemesis, Nodule, Obliterative bronchiolitis, Organising pneumonia, Pallor, Pneumonia, Pulmonary vasculitis, Pyrexia, Rhinorrhoea, Skin laceration, Sleep disorder, Upper respiratory tract infection, Vasculitis, Vomiting, Weight fluctuation
Symptom Text: On 9/26/10, the patient developed midsternal chest pain. Evaluation within a short time showed a "black shadow" on chest xray which was diagnosed as pneumonia and treated with Azithromycin. She then started with vomiting which has continued about 1-2 times per week. She left school feeling weak and pale at the beginning of the vomiting episodes. Fever has been intermittent about once a week. This is not documented rather tactile fever. Her weight has also waxed and waned up and down. She has only once experienced any dyspnea at PE class. She had one bout of hematemesis. She was seen in the ED (July 2010) and was evaluated for pulmonary embolus and the results excluded the embolus but revealed multiple pulmonary nodules. The biopsy (performed in August 2010) showed a vasculitis of the small and medium vessels and a bronchiolitis obliterans. She started taking prednisone and methotrexate in August 2010. She is currently being followed in Pediatric Rheumatology at hospital. The following information was obtained through follow-up and/or provided by the government. 01/13/2011 PCP family medicine office record received for DOS 09/25/2009. Assessment: URI, finger laceration and acne. Patient presented with c/o finger laceration (cut 3 days ago on braces), acne on face and cough/runny nose for 2-3 days. Patient examined and small laceration noted on right 2nd finger, which had no drainage and was healing well. Lungs were clear to auscultation. Acne noted on bilateral cheeks and forehead. Plan: acne-Duac Gel applied to face BID, Finger laceration (no signs of infection) - continue cleaning and Neosporin, URI symptomatic treatment. F/U PRN. 01/13/2011 Pediatric Pulmonary Clinic, Ped. Surgery clinic and Ped. Rheumatology clinic records received for DOS 08/02/2010 to 10/21/2010. Impression: Pulmonary vasculitis of unclear etiology. Patient seen in pulmonary clinic for initial visit on 08/02/10 for c/o pulmonary nodules. Patient & parent reported history of chest pain since September 2009 after first Gardasil dose. Yesterday, chest pain awoke patient from sleep and she was taken to ER. The sharp pain was on the left side of chest and increased with breathing. Chest CT showed multiple interpulmonary nodules and patient was referred for further evaluation. The patient also reported that in the last year, she has had decreased activity, has been tired more often, has had fevers, vomiting every few days and one episode of bloody emesis. Patient was previously diagnosed with pneumonia and was treated. Present examination noted normal air exchange. DX: Pulmonary nodules. Plan: refer to surgery clinic for tissue evaluation. Patient seen on 08/04/10 in surgery clinic and scheduled for left thoracoscopic pulmonary biopsy. Patient was seen on follow-up at rheumatology clinic on 08/11/10 for evaluation of pulmonary vasculitis & bronchiolitis obliterans revealed by biopsy. Patient noted to be recovering uneventfully from biopsy. Evaluation of lung biopsy noted granulomatous changes really not present and not felt typical of Wegener granulomatosis. Not suggestive of sarcoidosis. No evidence of infection. The possibly of Gardasil being a putative trigger was discussed and albeit impossible to prove. ANA is nonspecific and the patient is a single organ vasculitis at present time. Assessment: Pulmonary vasculitis; cannot classify based on laboratory testing. Patient seen on 10/21/10 with c/o cries at the drop of a hat and not sleeping good. Assessment: emotional lability, probable depression and sleep disorder. Plan: start on Amitriptyline, increase methotrexate and taper Orapred. Other Meds: Lab Data: See attached The following information was obtained through follow-up and/or provided by the government. 01/13/2011: CT paranasal sinuses: Normal,


Page 124
Vaers Id: 414550-1 (S) CT chest: abnormal (interpulmonary nodules). Lung wedge biopsy: abnormal (DX: vessel vasculit History: Prex Illness: Prex Vax Illns: Asthma The following information was obtained through follow-up and/or provided by the government. 01/13/2011 records received. History: seasonal allergies, asthma.


Page 125
Vaers Id: 414550-2 (S) Related reports: 414550-1 Age Gender Vaccine Date Onset Date F 25-Sep-2009 Unknown 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, LIFE THREATENING, SERIOUS
Days
Status Date State Received Date 23-Mar-2011 US 22-Mar-2011 Lot Prev Doses Site 1497X 0 Left arm U2932AA Left arm 9C52B033BA Right arm
Mfr Report Id Last Edit Date WAES1103USA00672 23-Mar-2011 Other Vaccine Route Intramuscular Unknown Intramuscular
Acne, Affect lability, Asthenia, Chest pain, Condition aggravated, Cough, Crying, Decreased activity, Depression, Dyspnoea, Fatigue, Haematemesis, Laceration, Lung neoplasm, Obliterative bronchiolitis, Painful respiration, Pallor, Pneumonia, Poor quality sleep, Pulmonary vasculitis, Pyrexia, Rhinorrhoea, Sleep disorder, Upper respiratory tract infection, Vomiting, Weight fluctuation
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 12 year old female with a history of asthma and seasonal allergies, who on 25-SEP-2009 was vaccinated with a first dose of GARDASIL (lot # 662229/1497X) intramuscularly in the left arm. Concomitant therapy included doses of MENACTRA (lot # U2932AA) in the left arm and BOOSTRIX (lot # 9C52B033BA) intramuscularly in the right arm. On 26-SEP-2010 the patient developed midsternal chest pain. Evaluation within a short time showed a "black shadow" on chest x ray which was diagnosed as pneumonia and treated with azithromycin. The patient started with vomiting which was continued about 1-2 times per week. She left school feeling weak and pale at the beginning of the vomiting episodes. Fever was intermittent about once a week. This was not documented rather than tactile fever. Her weight was also waxed and waned up and down. She had only once experienced any dyspnoea at PE class. She had one bout of hematemesis. She was seen in the emergency department (July 2010) and was evaluated for pulmonary embolus and the results excluded the embolus but revealed multiple pulmonary nodules. The biopsy (performed in August 2010) showed a vasculitis of the small and medium vessels and a bronchiolitis obliterans. She started taking prednisone and methotrexate in August 2010. She was currently being followed in Pediatric Rheumatology at hospital. The following information was obtained through follow-up and/or provided by the government. On 13-JAN-2011: PCP family medicine office record received for DOS 25-SEP-2009: Assessment: Upper respiratory infection, finger laceration and acne. The patient presented with complaining of finger laceration (cut 3 days ago on branches), acne on face and cough/runny nose for 2-3 days the patient was examined and a small laceration was noted on right 2nd finger, which had no drainage and was healing well. Lungs were clear to auscultation. Acne noted on bilateral cheeks and forehead. Plan was: acne: DUAC GEL applied to face BID; finger laceration: (no signs of infection): continue cleaning and NEOSPORIN, URI: symptomatic treatment. Follow up PRN. On 13-JAN-2011 pediatric pulmonary clinic, ped surgery clinic and ped rheumatology clinic records received for dates from 02-AUG-2010 to 21-OCT-2010. Impression: pulmonary vasculitis of unclear etiology. The patient was seen in pulmonary clinic for initial visit on 02-AUG-2010 complaining of pulmonary nodules. The patient and her parent reported a history of chest pain since September 2009 after GARDASIL first dose. On 01-AUG-2010, chest pain awoke patient from sleep and she was taken to emergency department. The sharp pain was on the left side of chest and increased with breathing. Chest CT showed multiple interpulmonary nodules and the patient was referred for further information. The patient also reported that in the last year, she has had decreased activity, had been tired more often, has had fevers, vomiting every few days and one episode of bloody emesis. The patient was previously diagnosed with pneumonia and was treated. Present examination noted normal air exchange. Diagnosis: Pulmonary nodules; plan: refer to surgery clinic for tissue evaluation. The patient was seen on 04-AUG-2010 in surgery clinic and scheduled for left thoracoscopic pulmonary biopsy. The patient was seen on follow up at rheumatology clinic on 11-AUG-2010 for evaluation of pulmonary vasculitis and bronchitis obliterans revealed at biopsy. The patient noted to be recovering uneventfully from biopsy. Evaluation of lung biopsy noted granulomatous changes really not present and no felt typical of Wegener granulomatosis. Not suggestive of sarcoidosis. No evidence of infection. The possibility of GARDASIL being a putative trigger was discussed and albeit impossible to prove. ANA was nonspecific and the patient was a single organ vasculitis at present time. Asses


Page 126
Vaers Id: 414550-2 (S) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:
Pulmonary biopsy, 08/??/10, vasculitis of the small and medium vessels and a bronchiolitis obliterans; chest computed axial, 08/02?/10, multiple interpulmonary nodules; computed axial, paranasal sinuses: normal Asthma; Seasonal allergy


Page 127
Vaers Id: 414571-1 Related reports: 414571-2 Age Gender Vaccine Date Onset Date F 17-Sep-2010 Unknown 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 14-Jan-2011 NY 12-Jan-2011 Lot Prev Doses Site 1081Z Left arm
Contraception, Drug exposure before pregnancy
Symptom Text: Received GARDASIL # 2 9-17-10. LMP 10/4/10. Pt was using NUVARING. Pregnant now. 1/11/11 Pt terminating pregnancy. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 128
Vaers Id: 414571-2 (O) Related reports: 414571-1 Age Gender Vaccine Date Onset Date F 17-Sep-2010 Unknown 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 09-Feb-2011 US 08-Feb-2011 Lot Prev Doses Site NULL 1 Unknown
Mfr Report Id Last Edit Date WAES1101USA03532 09-Feb-2011 Other Vaccine Route Unknown
Symptom Text: Information has been received from a Registered Nurse concerning a 25 year old female who was vaccinated with the first and second 0.5ml dose of GARDASIL (route unspecified) on 28-OCT-2009 (Lot number was unknown) and on 17-SEP-2010 respectively. Concomitant therapy included ethinyl estradiol (+) etonogestrel (MSD) (duration, dose and indication not reported). The patient did not receive any concomitant vaccination at that time. The nurse stated that patient found out she was pregnant after receiving the second dose of GARDASIL on 17-SEP-2010 and while on ethinyl estradiol (+) etonogestrel (MSD). Last menstrual period (LMP) and the estimated delivery date (EDD) were unspecified. On 19-NOV-2010, the patient had a visit with the physician. On 10-JAN-2011, the patient reported via a phone conversation with the physician that she had terminated the pregnancy, and it was reported that this was not due to vaccination with GARDASIL. The patient did not have a follow up visit with the physician. It was reported that, the patient had cancelled the appointment to receive the third dose. Action taken with ethinyl estradiol (+) etonogestrel (MSD) was not reported. At the time of the report the patient's outcome was unknown. Upon internal review, patient had terminated the pregnancy was determined to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) NUVARING Unknown


Page 129
Vaers Id: 414573-1 Age Gender Vaccine Date Onset Date F 11-Jan-2011 11-Jan-2011 12.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 13-Jan-2011 PA 12-Jan-2011 Lot Prev Doses Site UH224AC 1 Unknown 0549Z 1 Unknown C3382AA 0 Unknown U3334AA 0 Unknown 1333Y 0 Unknown
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Intramuscular Intramuscular
Symptom Text: Fainting spell 10 minutes after vaccine. Had received catch up vaccines at same time sxs cleared within 10 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None ADHD URI


Page 130
Days 1
Status Date State Received Date 28-Jan-2011 FR 13-Jan-2011 Lot Prev Doses Site NN04410 0 Unknown
Gilberts syndrome, Hyperbilirubinaemia, Jaundice, Ocular icterus
Symptom Text: This is a spontaneous case report received from agency concerning an 11 years old female patient who was vaccinated with first dose of GARDASIL (Batch#NN04410) on 18 November 2010. On 19 November 2010, laboratory control revealed indirect hyperbilirubinemia (total bilirubin was 71, direct bilirubin 7), all other parameters were in normal range. Five days after vaccine administration the patient visited physician again due to "yellow eyes". During clinical examination only subicterus was identified. The patient was sent to specialist who repeated her laboratory test. Again only indirect hyperbilirubinemia was seen, GILBERT'S syndrome was suspected. The patient was not taking any other medication and otherwise was a healthy child. At the time of the report, the patient was recovering. This information included initial and follow up report. The agency considered these adverse events to be an other important medical event. This was originally reported by a physician. If additional information arrived, follow up report will be sent. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None serum direct bilirubin, 19Nov10, 7; total serum bilirubin, 19Nov10, 71 Unknown


Page 131
Vaers Id: 414609-1 Age Gender Vaccine Date Onset Date F 06-Jan-2011 06-Jan-2011 10.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 13-Jan-2011 CA 13-Jan-2011 Lot Prev Doses Site U3520AA 0 Right arm 0768Z 0 Left arm
Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: Injection site began to swell and turn red. Pt began to feel pain and discomfort. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PCN None


Page 132
Vaers Id: 414720-1 (O) Age Gender Vaccine Date Onset Date F 15-Dec-2010 15-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Dermatitis allergic, Pruritus, Rash, Rash erythematous
Symptom Text: Information has been received from health authority on 04-JAN-2011, reference 2010-001610. This case is medically confirmed. A 13 year old female patient with no medical history and no concomitant medication received GARDASIL (batch # NN01990, lot # NK44350) intramuscularly on 15-DEC2010. On the same date the patient experienced an allergic red rash and pruritis in both arm for 6 hours. Corrective treatment included PIRITON orally. At the same time of reporting the patient had recovered. The health authority considered the case to be serious and for other medically significant reasons. Other business partner numbers include E2010-00050. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 133
Vaers Id: 414721-1 (O) Age Gender Vaccine Date Onset Date F 15-Dec-2010 15-Dec-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Condition aggravated, Epilepsy
Days 0
Symptom Text: This case was received from the health authority on 04-JAN-2011 under the reference number 2010-001607. This case was medically confirmed. A 14 year old female patient with a history of epilepsy received a second dose of GARDASIL (batch number NN01990, lot number NK44350), route and site not reported on 15-DEC-2010. On 15-DEC-2010, one hour post vaccination the patient experienced an epileptic episode which required medical intervention. The patient had a history of epilepsy for which she was receiving treatment with LAMICTAL (started date not reported) 50 mg twice a day. The patient did not receive any corrective treatment but the patient was put in the recovery position. At the time of reporting the patient had recovered. According to the agency, the event was considered serious due to other medically important condition which required intervention. Other business partner numbers include E2011-00043. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: LAMICTAL Unknown Epilepsy


Page 134
Vaers Id: 414722-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Cervical conisation, Cervical dysplasia
Days
Symptom Text: Case received from a gynecologist on 04-JAN-2011: A 20 year old female patient developed a cervical intraepithelial neoplasia III lesion after receiving the three doses of GARDASIL (batch number not reported) on unspecified dates. She was hospitalized in order to be treated by cervical conisation. Further inquiries were ongoing concerning the vaccinations dates, results of the previous cervical uterine smears, date of the exam revealing CIN III and whether search for human papillomavirus had been performed on previous smears or not. At the time of reporting, the outcome was not provided. Other business partner numbers include E2011-00038. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown diagnostic laboratory test, cervical intraepithelial neoplasia III Unknown


Page 135
Vaers Id: 414723-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days
Status Date State Received Date 18-Jan-2011 US 14-Jan-2011 Lot Prev Doses Site NULL Unknown
Activities of daily living impaired, Autonomic nervous system imbalance, Fatigue, Gastric disorder, Orthostatic hypotension, Syncope, Tachycardia
Symptom Text: Information has been received from a physical therapist concerning three female patients who on an unspecified date were vaccinated with a dose of GARDASIL (lot# not reported). It was reported that on an unspecified date, the patients were suffering from dysautonomia. At the time of the report, the patients' outcomes were unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the physical therapist concerning a current 13 year old female patient who developed orthostatic hypotension, tachycardia, "tummy trouble", fainting, and chronic fatigue after she received GARDASIL (lot and date unknown). She did not go to school for long periods of time because of these symptoms. The physical therapist stated that this condition has been "life altering". At the time of this report, the patient's outcome was unknown. Orthostatic hypotension, tachycardia, "tummy trouble", fainting and chronic fatigue were considered to be disabling. This is one of several reports received from the same source. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 136
Vaers Id: 414724-1 (O) Age Gender Vaccine Date Onset Date F 18-Nov-2009 24-Feb-2010 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 98
Status Date State Received Date 18-Jan-2011 NY 14-Jan-2011 Lot Prev Doses Site NULL 0 Unknown
Symptom Text: Information has been received from a 25 year old female consumer with allergy to penicillin and a history of leukemia, for the Pregnancy Registry for GARDASIL, who on 18-NOV-2009 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. not reported). There was no concomitant medication. The consumer became pregnant after receiving her first dose of GARDASIL. Pregnancy was confirmed through a "home pregnancy test". Her LMP was on 11-NOV-2009 and her EDD was estimated to be on 18-AUG-2010. There was no adverse event reported. Follow up information has been received from a receptionist in the physician's office concerning the female patient. It was reported that the patient was pregnant and miscarried on 24-FEB-2010 at 11 weeks of gestation. Upon internal review the patient's miscarriage was considered to be another important medical event. The patient subsequently became pregnant again after vaccination with GARDASIL (MSD, WAES# 1101USA00792). Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None beta-human chorionic, "home pregnancy test" positive Leukemia Pregnancy NOS (LMP = 11/11/2009); Allergic reaction to antibiotics


Page 137
Vaers Id: 414751-1 Age Gender Vaccine Date Onset Date F 15-Jan-2011 15-Jan-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Erythema, Skin striae, Syncope
Days 0
Status Date State Received Date 18-Jan-2011 WI 15-Jan-2011 Lot Prev Doses Site 0573X 2 Left arm
Last Edit Date 18-Jan-2011 Other Vaccine HEPA
Symptom Text: Fainted, seizure (10 seconds), red stripe from palm to elbow joint on the anterior left forearm. (same side as immunization was administered.) EMT called and did an assessment. She declined further assessment at the ER. Instructed to go to ER if any symptoms reoccur and to follow up with an appointment with her primary care physician. Observed for 15 minutes upon recovery and instructed to continue on light duty with continued observation by coworker. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to Amoxicillin and Penicillin None noted


Page 138
Vaers Id: 414754-1 (S) Related reports: 414754-2 Age Gender Vaccine Date Onset Date F 20-May-2010 24-May-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: ER VISIT, LIFE THREATENING, SERIOUS
Days 4
Status Date State Received Date 18-Jan-2011 NY 15-Jan-2011 Lot Prev Doses Site 0969Y 2 Unknown
Last Edit Date 24-Jan-2011 Other Vaccine HPV4
MedDRA PT
Abdominal distension, Abdominal pain, Abdominal pain upper, Abdominal symptom, Abdominal tenderness, Alopecia, Asthenia, Autoimmune disorder, Chest discomfort, Chest pain, Chills, Diarrhoea, Disturbance in attention, Dizziness, Dysmenorrhoea, Dyspnoea, Ear pain, Fatigue, Flatulence, Food craving, Headache, Hypoaesthesia, Insomnia, Lactose intolerance, Lymphadenopathy, Medial tibial stress syndrome, Memory impairment, Muscular weakness, Myalgia, Nausea, Oedema peripheral, Oropharyngeal blistering, Oropharyngeal pain, Pain, Pain in extremity, Peripheral coldness, Pharyngitis, Polydipsia, Postural orthostatic tachycardia syndrome, Similar reaction on previous exposure to drug, Sleep disorder, Somnolence, Temperature intolerance, Thirst, Tinnitus, Vaginal discharge, Vaginal infection, Vulvovaginitis, Weight increased
Symptom Text: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS. THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT. The following information was obtained through follow-up and/or provided by the government. 01/19/2011 Pediatric rheumatology consult and diagnostics received for DOS 01/04/11 to 01/07/11. Impression: Unlikely rheumatologic disease Patient seen for evaluation of c/o fatigue, multiple aches/pains (no specific arthralgias), SOB and dizziness. Patient has multiple symptoms since spring. Parent reported patient's symptoms started after receiving Gardasil. After initial Gardasil shot in March of 2010, patient was reported to have experienced sore throat & stomach pain. After second Gardasil shot, patient experienced blisters in throat, extreme tiredness, leg swelling, numb feet, stomach pains, nausea, enlarged notes on neck, forgetfulness, hot & cold intolerance and chest pain. After third Gardasil shot, patient sleeps more, has mid-day headaches, food cravings, extreme thirstiness, has gained 40 lbs, and has vaginal discharge. Patient was noted to be falling asleep in school and energy level has decreased significantly. Upon presentation, patient was well-appearing. Examination noted abdominal R. & L. upper quadrant tenderness with palpation. Assessment: Exam findings not consistent w/ rheumatologic disease in that pt. having wt. gain and no joint pain, swelling or stiffness and no history of photosensitive rash. Plan: unlikely rheumatologic disease but will obtain blood work. 01/20/2011 PCP office records received for DOS 03/11/10 to 12/28/10. Assessment: Autoimmune disease. Patient presented on 03/11/10 for scheduled adolescent well child visit. Patient had concern of acne on her back. Parent had no specific concern. Assessment: normal growth & development. Gardasil administered. Patient next seen on 05/24/10 for c/o sore throat. Assessment: Pharyngitis Acute. Plan: throat culture. Patient seen 09/29/10 for c/o sore throat and left ear pain. Patient also reported bloated feeling in upper abdomen and pain associated with her period. Assessment: Abdomen & pelvis symptoms other (likely lactic intolerance), Pharyngitis acute. Patient presented on 10/19/10 with c/o vaginal discharge worse than usual x 2wks. Patient also reported belly pain and bloating, which she felt was due to her lactose intolerance. Assessment: Vaginitis & Vulvovaginitis unspecified. Patient seen on follow up on 11/05/10 for c/o continued bloating and vaginal discharge. Patient also received Gardasil vaccine. Plan: cultures sent. Patient seen 12/28/10. Subjective note: Pt. c/o stomach bloating, gassy, looser stools. Patient tested for celiac and inflammatory bowel disease in November and all nl. Patient noted shin pain since September and patient had nuclear med scan that showed shin splints. Patient c/o headaches and ringing in ear and being tired. Reviewed labs revealed ANA positive: Plan: needs rheumatologist evaluation. Assessment: Autoimmune disease. 01/20/2011 PT evaluation for DOS 12/08/2010.DX: B. shin pain. Plan: cont. PT. 01/20/2011 Orthopedic consult and notes for DOS 10/05/10 to 11/04/10. Patient seen for evaluation of bilateral leg severe pain. Patient runs cross-country and first experienced pain after activity in August. Assessment: Possible chronic exertional compartment syndrome. Plan: First step-resolve shin splint component: orthotics, anti-inflammatories, schedule noninvasive treadmill test. Other Meds: CONCERTA ADD


Page 139
Vaers Id: 414754-1 (S) Lab Data: History: Prex Illness: Prex Vax Illns: PATIENT IS CURRENTLY BEING TESTED FOR POTS SYNDROME BY NEUROLOGIST. ANA SCREEN POSITIVE/ DIFF MANUAL BANDS HIGH/ REACTIVE LYMPHS 1/ + CRENATED CELLS/ ANA TITER 1:1280/ ANA PATTERN HOMOGENOUS. The following information was obtained through f NO The following information was obtained through follow-up and/or provided by the government. 01/19/2011 records received. History: NKDA, ADHD, anorexia, binge eating. 01/20/2011 records received. History: Sleep walker. NO


Page 140
Vaers Id: 414754-2 (S) Related reports: 414754-1 Age Gender Vaccine Date Onset Date F 20-May-2010 24-May-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: ER VISIT, LIFE THREATENING, SERIOUS
Days 4
Status Date State Received Date 22-Mar-2011 US 21-Mar-2011 Lot Prev Doses Site 0969Y 2 Unknown
Mfr Report Id Last Edit Date WAES1103USA00676 22-Mar-2011 Other Vaccine Route Unknown
MedDRA PT
Abdominal distension, Abdominal pain, Abdominal pain upper, Acne, Alopecia, Asthenia, Autoimmune disorder, Blister, Chest discomfort, Chest pain, Chills, Condition aggravated, Diarrhoea, Discomfort, Disturbance in attention, Dizziness, Dysmenorrhoea, Dyspnoea, Ear pain, Fatigue, Flatulence, Food craving, Headache, Hypersomnia, Hypoaesthesia, Lactose intolerance, Lymphadenopathy, Medial tibial stress syndrome, Memory impairment, Myalgia, Nausea, Oedema peripheral, Oropharyngeal pain, Pain, Pain in extremity, Peripheral coldness, Pharyngitis, Polydipsia, Temperature intolerance, Thirst, Tinnitus, Vaccine positive rechallenge, Vaginal discharge, Vaginal infection, Vulvovaginitis, Weight increased
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no known drug allergies, Attention deficit/hyperactivity disorder, anorexia, binge eating and who was reported to be sleep walker who after the second injection of GARDASIL experienced fatigue, polydipsia, cold extremities, chest discomfort, tinnitus, headache, muscle pain and weakness, severe abdominal pain, bloating, sleep trouble, impaired concentration, chills, hair falling out in clumps was vaccinated with the third dose of GARDASIL (Lot # 663573/0969Y) (route and site not reported). Concomitant therapy included CONCERTA. It was reported that the patient experienced the same symptoms with increase in intensity and discomfort. The information was obtained by the government on 19-JAN-2011. The pediatric rheumatology consult and diagnostics were received for DOS on 04-JAN-2011 to 07-JAN-2011. Impression: unlikely rheumatology disease. The patient was seen for evaluation of complained of fatigue, multiple aches/pains (no specific arthralgias), SOB and dizziness. The patient had multiple symptoms since spring. The parent reported the patient's symptoms started after receiving GARDASIL. After initial GARDASIL shot in March of 2010, the patient was reported to have experienced sore throat and stomach pain. After the second GARDASIL shot experienced blisters in throat, extreme tiredness, leg swelling, numb feet, stomach pain, nausea, enlarged notes on neck, forgetfulness, hot and cold intolerance and chest pain. After the third GARDASIL shot, the patient slept more, had mid day headache, food cravings, extreme thirstiness, had gained 40 pounds and had vaginal discharge. The patient was noted to be falling asleep in school and energy level had decreased significantly. Upon presentation, the patient was well appearing. Assessment exam: findings not consistent with rheumatology disease in that patient having weight gain and no joint pain, swelling or stiffness and no history of photosensitive rash. Plan: unlikely rheumatology disease but would obtain blood work. On 20-JAN-2011, PCP office records were received for DOS (11MAR-2010 to 28-DEC-2010). Assessment: autoimmune disease. The patient presented on 11-MAR-2010 for scheduled adolescent well child visit. The patient had concern of acne on her back. The parent had no specific concern. Assessment was normal growth and development. The GARDASIL vaccine was administered. The patient was seen on 24-MAY-2010 for complained of sore throat. Assessment was pharyngitis acute; the plan was throat culture. The patient was seen on 29-SEP-2010 for complained of sore throat and left ear pain. The patient also reported bloated feeling in upper abdomen and pain associated with her period. Assessment: abdomen and pelvis symptoms other (likely lactic intolerance), pharyngitis acute. The patient presented on 19-OCT-2010 with [Due to memory limitations, the remainder of this text could not be compared.] 0 with complained of vaginal discharge worse than usual for 2 weeks. The patient also reported belly pain and bloating, which she felt was due to her lactose intolerance. Assessment was vaginitis and vulvovaginitis unspecified. The patient was seen on follow up on 05-NOV-2010, for complained of continued bloating and vaginal discharge. The patient also received GARDASIL. The plan: cultures were sent. The patient was seen on 28-DEC-2010. The patient complained of stomach bloating, gassy and looser stools. The patient was tested for celiac and inflammation bowel disease in November and all was normal. The patient noted shin pain since September and the patient had nuclear med scan that showed shin splints. The patient complained of headaches and ringing in ear also the patient was being tired. The review labs revealed: ANA positive; needed rheumatologist evaluation. Assessment was autoimmune disease. On 20-JAN-2011, the PT evaluatio


Page 141
Vaers Id: 414754-2 (S) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCERTA abdominal exploration, right and left upper quadrant tenderness with palpation; diagnostic laboratory, 11/??/10, celiac and inflammation bowel disease; all normal; serum ANA, positive; atypical lymphocyte, 1; serum ANA quantitative, 1:128 sleep problem; fatigue; cold extremities; polydipsia; chest discomfort; headache; weakness; bloating; concentration impaired; hair loss; chills; sleep difficult; abdominal pain; myalgia; tinnitus Attention deficit/hyperactivity disorder; anorexia; binge eating


Page 142
Vaers Id: 414773-1 Age Gender Vaccine Date Onset Date M 10-Dec-2010 10-Dec-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Asthenia, Hypotension, Nausea, Pallor
Days 0
Status Date State Received Date 18-Jan-2011 PR 18-Jan-2011 Lot Prev Doses Site 07862 1 Left arm AHAVB441BA 0 Right arm
Mfr Report Id PR1101 Route Intramuscular Intramuscular
Symptom Text: FIVE MINUTES AFTER RECEIVING THE VACCINE THE PATIENT BEGAN HAVING NAUSEA, LOOKED PALE AND WEAK. WAS TAKEN IN A WHEELCHAIR TO ER. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BP 79/39 PULSE 55 DX- HYPOTENSION ASTHMA


Page 143
Vaers Id: 414775-1 Age Gender Vaccine Date Onset Date F 11-Jan-2011 14-Jan-2011 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Abdominal pain upper, Pain
Days 3
Status Date State Received Date 20-Jan-2011 NY 17-Jan-2011 Lot Prev Doses Site 0565Z 0 Left arm
Symptom Text: C/o severe RUQ pain since receiving immunization on 1-11-11 - much more intense today 1-14-11 temp 98.6 degrees F BP 138/86. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CELEXA 40mg CBC; CMP; U/A C & S; Abd survey U/S Amoxicillin - rash; depression/anxiety; Migraine H/A None


Page 144
Vaers Id: 414816-1 Age Gender Vaccine Date Onset Date M 13-Jan-2011 13-Jan-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Lip swelling, Oedema peripheral, Urticaria
Days 0
Status Date State Received Date 19-Jan-2011 NH 14-Jan-2011 Lot Prev Doses Site 0768Z 1 Left arm
Symptom Text: Rash, urticarial maternal report of lip and extremity swelling. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 145
Vaers Id: 414822-1 Age Gender Vaccine Date Onset Date F 13-Jan-2011 14-Jan-2011 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 20-Jan-2011 NC 17-Jan-2011 Lot Prev Doses Site U3541AA 0 Right arm 0786Z 1 Left arm
Cellulitis, Injection site erythema, Injection site swelling
Symptom Text: 1/14/11 swelling & redness at injection site (right deltoid). Approx. 8 cm in diameter of redness & swelling. Child treated for cellulitis 1/15/11 with BACTRIM. Symptoms resolved by 1/17/11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to OMNICEF None


Page 146
Vaers Id: 414830-1 Age Gender Vaccine Date Onset Date F 10-Jan-2011 10-Jan-2011 16.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy
Days 0
Status Date State Received Date 19-Jan-2011 OK 18-Jan-2011 Lot Prev Doses Site AHAVB441AA 0 Right arm 0786Z U3358BA U3491AA 1039Z 0 0 0 0 Left arm Right arm Left arm Left arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Intramuscular Subcutaneously
Symptom Text: Pregnant client received live virus vaccine, Varivax. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Positive Preganancy test at physicians office. Pregnancy confirmed at private Dr's office Pregnant client received immunization against Varicella with administration of Live Virus vaccine - Varivax.


Page 147
Vaers Id: 414860-1 Age Gender Vaccine Date Onset Date Days F 23-Dec-2010 04-Jan-2011 12 11.0 Type Manufacturer VAX Detail: FLUN MEDIMMUNE VACCINES, INC. HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Status Date State Received Date 19-Jan-2011 WV 18-Jan-2011 Lot Prev Doses Site 501051P 0 Unknown 1333Y 0 Unknown U3432AA 0 Unknown
Mfr Report Id Route Unknown Intramuscular Intramuscular
Facial asymmetry, Facial paresis, Headache, Hypoaesthesia facial, Nasal congestion, Paraesthesia, Tension headache, VIIth nerve paralysis
Symptom Text: Patient presented to our office with left facial weakness noted with diminished left nasolabial fold and weak upper lid. I diagnosed her with Bell's palsy. The following information was obtained through follow-up and/or provided by the government. 1/20/11. Consultant records DOS 1/6/11. DX: 1) Bell's palsy. 2) Tension-type headache. CC: numbness, tingling L side of face, HA, L ear pain, stuffy nose, facial asymmetry. PE: L facial weakness c diminished L nasolabial fold, weak upper lid. Rxed c artificial tears et oral steroids. DOS 1/12/11: RTC for f/u. Symptoms improving - less facial weakness, HA now intermittent. Steroid rx continued, OTC analgesic added to regimen. Condition improving, but ongoing. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Vesicoureteral reflux The following information was obtained through follow-up and/or provided by the government. 1/20/11. Consultant records. PMH: vesicoureteral reflux in infancy. Allergy: PCN No


Page 148
Vaers Id: 414893-1 (S) Related reports: 414893-2; 414893-3 Age Gender Vaccine Date Onset Date Days F 13-Oct-2010 15-Oct-2010 2 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Status Date State Received Date 19-Jan-2011 AR 18-Jan-2011 Lot Prev Doses Site U3443BA 0 Unknown AHAVB446AA 1 Unknown C3438AA 0786Z 0 0 Unknown Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Abdominal distension, Abdominal pain, Cough, Diplegia, Dysuria, Fall, Hypoaesthesia, Ileus, Immunoglobulin therapy, Inflammation, Muscular weakness, Myelitis transverse, Neurogenic bladder, Neurogenic bowel, Paraesthesia, Paraplegia, Plasmapheresis, Rhinorrhoea, Sensory loss
Symptom Text: Onset of lower extremity weakness progressing to complete paralysis of both legs within one week of HPV vaccine. Diagnosed with transverse myelitis. Treated with steroids. The following information was obtained through follow-up and/or provided by the government. 1/31/2011 hospital records received for DOS 10/17-11/23/2010 w/ d/c Dx: LE paraplegia w/ neurogenic bowel & bladder. Pt presented w/ acute onset paraplegia: tingling in rt leg, fell when tried to stand. Pt taken to outside facility - on arrival both legs were numb, pt could only move toes of rt foot, unable to urinate. Pt transferred for higher level care. On arrival, both legs w/o sensation, unable to move either leg, unable to urinate, c/o abdominal pain & distension. 4 day hx cough & runny nose. Ileus noted on abdominal X-rays. Tx: IVIG & plasmapheresis w/o improvement. Pt transferred to rehab after ileus resolved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: spine MRI showed inflammation at T8-9 level of spinal cord consistent with transverse myelitis. The following information was obtained through follow-up and/or provided by the government. 1/31/2011 lab/diagnostic records received for DOS 10 none The following information was obtained through follow-up and/or provided by the government. PMH: 2 weeks in NICU for meconium aspiration, recurrent sinus infections. none The following information was obtained through follow-up and/or provided by the government. Cough, runny nose, sinus infect


Page 149
Vaers Id: 414893-2 (O) Related reports: 414893-1; 414893-3 Age Gender Vaccine Date Onset Date Days F 13-Oct-2010 17-Oct-2010 4 11.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Status Date State Received Date 23-Feb-2011 US 22-Feb-2011 Lot Prev Doses Site AHAVB446AA Unknown 0786Z C3438AA 0 Unknown Unknown
Mfr Report Id Last Edit Date WAES1102USA01593 23-Feb-2011 Other Vaccine Route Unknown Unknown Unknown
Dysstasia, Fall, Hypoaesthesia, Monoplegia, Paraesthesia
Symptom Text: Information has been received from a person concerning an 11 year old female patient who on 13-OCT-2010 was vaccinated with the first dose of GARDASIL (Lot # 666598/0786Z, expire date and route not reported). Concomitant therapy included HAVRIX (Lot # AHAVB446AA and ADACEL (lot # C3438AA) both vaccines administered on the same day on 13-OCT-2010. The patient "experienced paralysis of her legs" after administration of first dose of GARDASIL. On 17-OCT-2010, the patient experienced tingling in her legs. The patient was then unable to stand up and if the patient tried to stand up she would fall to her knees. Her legs then became numb. She could only move her toes on her right leg. Her left leg had full motion. It was unknown if the patient sought medical attention. Upon internal review, paralysis was considered to be an other important medical event. At the time of the report, patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 150
Vaers Id: 414893-3 (S) Related reports: 414893-1; 414893-2 Age Gender Vaccine Date Onset Date Days F 13-Oct-2010 15-Oct-2010 2 11.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. HEPAB GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT
Status Date State Received Date 23-Mar-2011 US 22-Mar-2011 Lot Prev Doses Site C3438AA 0 Unknown U3443BA 0 Unknown 0786Z 0 Unknown AHAVB446AA 1 Unknown
Mfr Report Id Last Edit Date WAES1103USA00688 23-Mar-2011 Other Vaccine Route Intramuscular Intramuscular Intramuscular Intramuscular
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Diplegia, Inflammation, Muscular weakness, Myelitis transverse
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female with no pertinent medical history and no previous illness who on 13-OCT-2010 was intramuscularly vaccinated with the first dose of GARDASIL (lot# 666598/0786Z, dose not reported). Concomitant therapy included intramuscular the first dose of MENACTRA (lot# U3443BA, dose not reported), intramuscular the second dose of TWINRIX (lot# AHAVB446AA, dose not reported) and intramuscular the first dose of ADACEL (lot# C3438AA, dose not reported). On 15-OCT-2010, the patient had an onset of lower extremity weakness progressing to complete paralysis of both legs within one week of GARDASIL. Spine MRI showed inflammation at T8-9 level of spinal cord consistent with transverse myelitis. The patient was diagnosed with myelitis transverse and treated with steroids. At the time of report, the outcomes were unknown. It was reported that an ER visit was required. The listing indicated that one or more of the events required hospitalization and extended hospital stay, was considered to be permanent disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID# is 414893. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: magnetic resonance, spine MRI showed inflammation at T8-9 level of spinal cord consistent with transverse myelitis None


Page 151
Vaers Id: 414929-1 (O) Age Gender Vaccine Date Onset Date F 01-Oct-2010 01-Oct-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Headache, Rash, Urticaria
Days 0
Symptom Text: This case was reported by the health authority on 01-JAN-2011, reference 2010-001617. This case was medically confirmed. A 13 year old female patient with no medical history received the first dose of GARDASIL (batch number not reported) intramuscularly 0.5 ml in October 2010, exact date not reported. 1 week post vaccination the patient experienced a rash, headache and urticaria lasting for 10 days and the patient then recovered. Corrective treatment included generic steroids. The IMB considered the case to be serious for other medically significant reasons. Other business partner numbers include E2011-00051. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 152
Vaers Id: 414930-1 (O) Age Gender Vaccine Date Onset Date F 20-Oct-2010 24-Oct-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Insomnia, Rash generalised, Rash pruritic
Days 4
Status Date State Received Date 28-Jan-2011 FR 18-Jan-2011 Lot Prev Doses Site NK25010 0 Left arm
Symptom Text: Information received from a HCP on 06-Jan-2010, the HCP had also informed the IMB of the same report and this case was also received from the IMB on 07-Jan-2011 under the reference 2010-001675. This case is medically confirmed. A 14 year old female patient received the first dose of GARDASIL (lot number NK25010, batch number NM11420, expiry Apr-2012) in the left deltoid on 20-OCT-2010. Four to five days post vaccination the patient experienced a very itchy rash everywhere. The patient attended the casualty department and staff said the rash looked like a meningitis type rash. The patient was followed up a week later and the rash was still present. The rash was described as like a nettle rash with very itchy "wee spots" and the patient could not sleep with the itch which was mainly on arms, legs, back and belly. The patient was referred to a paediatric paediatrician by the consultant neurologist. The rash had flared up "on and off" since. The patient was given a prescription for steroids and antihistamines in casualty and told to take prednisolone 10mgs daily for one week. No one else in the patient's home had a rash. The second dose of GARDASIL was deferred and no further vaccines were to be offered to the patient pending investigation and doctors recommendation. At the time of reporting the patient was well. The patient had a medical history of diagnosed of myasthenia gravis for which she was receiving steroids on alternate days and 2 immunosuppressants tablets per day. The patient was not allergic to any of the constituents of GARDASIL. The patient was not pregnant and had no previous severe reaction to GARDASIL and had not experienced this type of rash in the past. The reporter informed the IMB of the events. Other business partner numbers include E2011-00094. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Myasthenia gravis corticosteroids (unspecified) Unknown


Page 153
Vaers Id: 414944-1 (O) Age Gender Vaccine Date Onset Date F 22-Nov-2008 01-Nov-2009 27.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Alopecia areata
Days 344
Symptom Text: Information has been received from a physician via CSL (manufacturer control # 20101119GC1) concerning a 27 year old female who on an unspecified date was vaccinated with GARDASIL (therapy dose, route and site unknown). Subsequently the patient experienced alopecia areata after the vaccination. Dexamethasone-Cyclophoshamide pulse (DCP) immunotherapy and extra injectable corticosteroids were given for the treatment of alopecia. The patient had a family history. Her aunt and cousin had alopecia areata. At the time of this report, the patient was getting worse. This is one of several reports received from the same source. Follow up information has been received from the physician. The physician reported that the patient's hair started falling out in mid September 2009. In November 2009, widespread alopecia areata was noted. The full blood exam, electrolytes, liver function tests, androgen, prolactin, thyroid function tests and lipids were all normal. The patient had required treatment with oral steroids for 6 weeks and multiple intralesional steroid injection with slow but incomplete improvement. At the time of this report, the patient had not recovered. The physician considered that widespread alopecia areata was related to therapy with GARDASIL. The reporting physician considered this adverse event to be an other important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Familial risk factor Unknown Diagnostic laboratory test, full blood exam (FBE: normal; diagnostic laboratory test, proluchin: normal; serum electrolytes test, normal; hepatic function tests, normal; serum prolactin test, normal; serum free androgen index, normal; thyro


Page 154
Vaers Id: 414945-1 (O) Age Gender Vaccine Date Onset Date F 19-Nov-2007 24-Jul-2008 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 248
Status Date State Received Date 21-Jan-2011 NY 19-Jan-2011 Lot Prev Doses Site 1266U 2 Unknown
Arthralgia, Arthritis, Immobile, Joint swelling, Rheumatoid arthritis
Symptom Text: Information has been received from a physician concerning a 21 year old female who in November 2007, was intramuscularly vaccinated with the first dose of GARDASIL (dose and lot# not reported). The physician reported that the patient received the three dose series of GARDASIL "between November 2007 and June 2008." The patient was diagnosed with joint pain/arthritis in August 2008 and was currently being treated with methotrexate and prednisone. Physician noted the patient "went on a field camping trip two months after completing the GARDASIL series." Patient had no family history of arthritis. The patient sought unspecified medical attention. The patient had not recovered. Follow up information has been received from a medical assistant reported that the 21 year old female with on pertinent medical history and no known drug allergies on 15-MAR-2007 was vaccinated with the first dose of GARDASIL (lot# 657006/0188U), the second dose of GARDASIL (lot# 657736/0389U) on 17-MAY-2007, the third dose of GARDASIL (lot# 659437/1266U) on 19-NOV-2007 (dose not reported). No other vaccines received concomitantly and no concomitant therapies. The patient told doctor that symptoms began in August 2008 and she was subsequently diagnosed with rheumatoid arthritis. Information received from medical records reported that the 21 year old female (68", 123 lbs.) student experienced left wrist pain in July 2008. On 31-JUL-08, rheumatoid factor (RF) was 63 IU/ml. On 24JUL-08, the patient was diagnosed with rheumatoid arthritis; diagnosed within 1 year of GARDASIL. It was noted that the patient has no family hx of rheumatoid arthritis or autoimmune disease. On 20-AUG-2008, RF was 70 IU/ml. Lyme Ab was 1.59 and the patient was prescribed antibiotics. The patient had pains in knuckles and shoulder. The patient had brief relief of pain from November 2008 to March 2009. In March 2009, pain recurred with sporadic bilateral knuckles and proximal interphalangeal (PIP) joint. In May 2009 pain was increasing. On 20-MAY-09, RF was 235 IU/ml. In Fall 2009, the patient had daily foot and hand pain. In Spring 2010, the patient had inflammation of left PIP and left elbow; immobile for 6 weeks. In May 2010, the patient attended physical therapy with steroid injection for left elbow. Rheumatologist started the patient on MOBIC. The patient had pain in jaw and clavicles. Foot pain was improved with MOBIC. In June 2010, the patient experienced immobility due to right knee swelling and inflammation related to jogging. The patient was treated with occasional methylprednisolone packs. In July 2010, Rheumatologist gave the patient cortisone injection in the knee. In July 2010, the patient required emergency room/ doctor visit for knee evaluation. It was noted that the patient had not recovered as this was considered a chronic illness. In August 2010, rheumatology evaluation; the patient started disease modifying meds (methylprednisolone 4mg BID, methotrexate [Due to memory limitations, the remainder of this text could not be compared.] trexate 2.5mg weekly, and folic acid 1mg). Rheumatoid arthritis was noted to require medical/ surgical intervention by the physician. Additional information is not expected. All available medical will be provided upon request. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Sserum rheumatoid factor, 07/31/08, 63 IU/m; serum rheumatoid factor, 08/20/08, 70 IU/m; serum B.burgdorferi, 08/20/08, 1.59; serum rheumatoid factor, 05/20/09, 235 IU/m; serum cyclic citrulline, 08/20/08, 110.4; serum cyclic citrulline, 05 None


Page 155
Vaers Id: 414946-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days
Status Date State Received Date 20-Jan-2011 US 19-Jan-2011 Lot Prev Doses Site NULL Unknown
Arthralgia, Autoimmune disorder, Hypersensitivity, Myalgia, Nervous system disorder, Pancreatitis, Systemic lupus erythematosus
Symptom Text: This report was received from a person and was assigned manufacturer report number US201011004024. An unknown number of young girls on an unspecified date were vaccinated with a dose of GARDASIL (Lot # not provided) on an unspecified date. It was reported that the patients experienced bad reactions to GARDASIL. The reporter stated that they had had bad reactions that were like autoimmune disorders as a result of treatment with GARDASIL. Some of the patients had experienced pancreatitis. "It was like the body turned around and attacked itself, almost like an allergic reaction." The reporter said that the physician thought that the patients may have lupus or other autoimmune disorder. She also stated that the patient's were also complaining of joint-muscle pain and neurological system problems. At the time of this report, the patient's outcome was unknown. This was originally reported by a lawyer. This is one of several reports received from the same source. Upon internal review, pancreatitis was considered to be an other important medical event. Attempts to obtain additional identifying information to distinguish the individual patients mentioned in this report has been unsuccessful. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 156
Vaers Id: 414972-1 Age Gender Vaccine Date Onset Date F 18-Jan-2011 18-Jan-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Nausea
Days 0
Status Date State Received Date 20-Jan-2011 AZ 19-Jan-2011 Lot Prev Doses Site 0664Z 2 Right arm
Symptom Text: CLIENT BECAME NAUSEATED AFTER VACCINATION AND COMPLAINED OF BEING DIZZY. SHE WAS INSTRUCTED TO REMAIN SEATED 15 MIN. BP WAS CHECKED 3 TIMES. TWICE SITTING, 1 STANDING. SENT HOME WITH MOM AFTER STATING "I FEEL BETTER'. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: cough N/A


Page 157
Vaers Id: 415000-1 Age Gender Vaccine Date Onset Date Days M 18-Jan-2011 Unknown 18.0 Type Manufacturer VAX Detail: FLU NOVARTIS VACCINES AND DIAGNOSTICS HPV4 MERCK & CO. INC. FLUN MEDIMMUNE VACCINES, INC. HEPA MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Expired drug administered
Status Date State Received Date 20-Jan-2011 ND 19-Jan-2011 Lot Prev Doses Site 111794P1 1 Right arm 0565Z 501047P 0568Z 1215Y 0 0 1 0 Left arm Unknown Right arm Left arm
Mfr Report Id Route Intramuscular Intramuscular Unknown Intramuscular Subcutaneously
Symptom Text: Influenza vaccine that was administered was expired. (FLUMIST) IM influenza repeated. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 158
Vaers Id: 415013-1 (S) Age Gender Vaccine Date Onset Date F 27-Aug-2009 27-Aug-2009 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Status Date State Received Date 26-Jan-2011 FR 20-Jan-2011 Lot Prev Doses Site 1612X 2 Unknown
Cyst aspiration, Cyst drainage, Dermal cyst, Hypersensitivity, Injection site reaction, No reaction on previous exposure to drug, Oedema peripheral, Periarthritis, Radiculitis brachial
Symptom Text: Information was obtained on a request by the Company from the agency concerning a 12 year old female who on 27-AUG-2009 was vaccinated with the third dose of GARDASIL (lot #: 662963/1612X, batch # N0280). The patient had received first two doses of GARDASIL with no problems. On 27-AUG2009 the patient was diagnosed frozen shoulder, deep subcutaneous cyst lesion that required aspiration in April and August 2010 and injection site reaction, excessive limb swelling, brachial neuritis, allergic reaction. The AEs caused or prolonged inpatient hospitalization on unspecified date. Therapy, drainage and pain relief were required. At the time of this report, the patient had not recovered. The agency considered that the AEs were possibly related to therapy with GARDASIL. The original reporting source was not reported. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 159
Vaers Id: 415016-1 Age Gender Vaccine Date Onset Date F 13-Jan-2011 13-Jan-2011 12.0 Type Manufacturer VAX Detail: IPV SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pain in extremity
Days 0
Status Date State Received Date 20-Jan-2011 PA 20-Jan-2011 Lot Prev Doses Site D04132 3 Left arm U3439AA 0 Left arm 0766Z 0 Right arm AHAVB461BA 0 Right arm
Symptom Text: Client reports on 1/20/11 pain in right forearm that is present from elbow to wrist denies numbness or tingling. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No No


Page 160
Vaers Id: 415018-1 (S) Age Gender Vaccine Date Onset Date F 26-Sep-2007 22-Jul-2008 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT LIFE THREATENING, SERIOUS Cervix carcinoma, Laser therapy
Days 300
Symptom Text: Information was obtained on a request by the Company from the agency, via a Public Case Detail, concerning a 26 year old female who on 26-SEP2007 was vaccinated IM with the first dose of GARDASIL. On 05-MAY-2010, the patient was vaccinated IM with the third dose of GARDASIL. Normal recommended dosage regime (0, 2, 6 months) not followed. On 22-JUL-2008, two month later, the patient was diagnosed with cervical cancer. The patient was treated with laser. At time of this report, the patient had not recovered. The agency considered cervix cancer was possibly related to therapy with GARDASIL. The cervical cancer was considered to be immediately life-threatening. The original reporting source was not reported. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 161
Vaers Id: 415032-1 Age Gender Vaccine Date Onset Date F 19-Jan-2011 19-Jan-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 20-Jan-2011 CT 20-Jan-2011 Lot Prev Doses Site 14372 1 Unknown
Concussion, Confusional state, Fall, Head injury, Retrograde amnesia, Syncope
Symptom Text: Patient fainted while standing, hit head on chair and/or floor. No LOC, but patient confused, retrograde amnesia of event. Concussion from fall. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CT done in ER, negative, sent homne for rest, concussion precautions no no


Page 162
Vaers Id: 415033-1 Related reports: 415033-2 Age Gender Vaccine Date Onset Date F 15-Dec-2010 17-Dec-2010 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 2
Status Date State Received Date 20-Jan-2011 IL 20-Jan-2011 Lot Prev Doses Site NULL 1 Unknown
Abdominal pain upper, Asthenia, Dehydration, Diarrhoea, Dizziness, Duodenitis, Dyspnoea, Fluid replacement, Gastritis, Oesophagitis, Pallor, Peripheral coldness
Symptom Text: Dizziness,pain in her stomach and diarrhea started that day. As she continued with these symptoms she became weak and ended up at the hospital 2 times, put on an IV for dehydration and low potassium.She was also short of breath and have spells where she would become pale and then complain of her feet being cold. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: previous 2 shots of gardasil left her tired and had stomach problems too. She was referred to a GI Dr, whom performed an esophagogastroduodenoscopy and colonoscopy.Test results showed mild esophagitis in lower 3rd of esophagus, mild chronic gastritis found in antrum. Duodenitis in the duodenal bulb and firs porti Allergies-food,animals, air born None that we were aware of


Page 163
Vaers Id: 415067-1 Age Gender Vaccine Date Onset Date F 03-Jan-2011 03-Jan-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Skin discolouration
Days 0
Status Date State Received Date 26-Jan-2011 FL 20-Jan-2011 Lot Prev Doses Site 09992Z 2 Right arm
Symptom Text: Hands & feet looked bluish within a few hours after 3rd Gardasil vaccine. Was seen at ER and Hosp. Labs normal. Prescibed steroids but took only 1 dose. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Normal arterial blood gas, CBC, ESR, D-DIMER, CXR BMP NONE None


Page 164
Days 0
Status Date State Received Date 25-Jan-2011 CA 20-Jan-2011 Lot Prev Doses Site 1377Y 2 Left arm
Chest discomfort, Headache, Myalgia, Palpitations, Vision blurred
Symptom Text: Headache, muscle aches, chest tightness, unable to focus and palpitations. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: YAZ; Calcium & Iron supplements; VENTOLIN Elevated CPK = 205 u/L None None


Page 165
Vaers Id: 415108-1 (S) Age Gender Vaccine Date Onset Date Days F 01-Dec-2009 01-Dec-2009 0 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. FLU(H1N1) UNKNOWN MANUFACTURER Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Status Date State Received Date 25-Jan-2011 FR 21-Jan-2011 Lot Prev Doses Site NULL 0 Unknown NULL Unknown
Headache, Hemicephalalgia, Migraine, Nausea, Phonophobia, Photophobia
Symptom Text: Case received from the Health Authorities on 07-JAN-2011 under the reference number LL20100607. Case medically confirmed. A 15 year old female patient developed chronic migraine and was hospitalized one month after she had received the first injection of GARDASIL (lot # and batch # nor reported) in December 2009 and two days after receiving an injection of H5N1 (local trade name and batch number not reported, other manufacturer) on an unspecified date. She had a family history of migraine, kinetosis and somniloquence during childhood. Cephalgia was permanent and was initially mild in nature and then, quite promptly onset of typical and real episodes of migraine was noted in addition to permanent cephalgia and was described as alternate and pulsatile hemicrania, with nausea but no vomiting and with phonophobia and photophobia. The patient was also taking JASMINENELLE, coded as suspect drug by the Health Authorities. Magnetic resonance imaging (MRI) was normal. The patient received corrective treatment with ibuprofen 4/month and IMIGRAN 1/month. According to the Health Authorities she had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccination and other suspect drugs as doubtful (C1 S1 I1) according to the foreign method of assessment. Other business partner numbers include E2011-00177. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Migraine; motion sickness; somniloquism Unknown magnetic resonance imaging, normal


Page 166
Vaers Id: 415165-1 Age Gender Vaccine Date Onset Date F 18-Jul-2007 31-Jul-2007 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 13
Status Date State Received Date 27-Jan-2011 MI 21-Jan-2011 Lot Prev Doses Site 02110 0 Right arm
Anxiety, Contusion, Disturbance in attention, Dysmenorrhoea, Fatigue, Immunodeficiency, Infection, Insomnia, Lymphadenopathy, Menstruation irregular, Migraine, Myalgia, Paraesthesia, Personality change, Rash, Respiratory tract infection, Syncope, Tremor, Urinary tract infection
Symptom Text: Developed paresthesias of the R great toe within a few days of the 1st Gardasil vaccine. She now experiences intermittent paresthesias of the toes and hands. Developed irregular menses and severe dysmenorrhea 4 months after 1st Gardasil vaccine which is ongoing. Received 2nd Gardasil 11/5/07 and the 3rd 8/14/09. Developed migraines 9/08 and continues to have frequently migraine headaches, some of which are intractable for days. Has had syncopal events, hand tremors, personality changes, easy bruising, myalgias, chronic fatigue, problems with concentration, rashes, anxiety, insomnia and poor immunity with very frequent infections (mostly respiratory, but has swollen lymph nodes and urinary tract infections as well). All of these did not start until after the 1st Gardasil vaccine 4 years ago. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: tried and failed Levoxyl and Yasmin 11/07 CBC, iron levels, vitamin B12 level, blood lead level, blood mercury level, ESR, CPK, HgbA1C, ANA, TSH, FT4, FT3, CMP, EBV IgG & IgM. All normal except iron levels and vitamin B12 level at low end of normal. Consulted with a pediatric neuro molluscum contagiosum nocturnal enuresis until age 12 allergy to sulfa, penicillin, zithromax, keflex no


Page 167
Vaers Id: 415199-1 Age Gender Vaccine Date Onset Date F 21-Jan-2011 21-Jan-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness, Rash, Syncope
Days 0
Status Date State Received Date 31-Jan-2011 TX 23-Jan-2011 Lot Prev Doses Site NULL 0 Left arm
Symptom Text: Fainting passed out for 5 minutes. Following day rash on legs after receiving Gardasil Vaccine dose number 1. Other Meds: Lab Data: History: Prex Illness: none none none
Prex Vax Illns: none~Influenza (Seasonal) (no brand name)~1~14.17~Patient


Page 168
Vaers Id: 415217-1 Age Gender Vaccine Date Onset Date F 20-Jan-2011 Unknown 13.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 27-Jan-2011 NE 21-Jan-2011 Lot Prev Doses Site AHABV401BA 1 Left arm 1495Y 0 Right leg
Mfr Report Id Route Unknown Unknown
Inappropriate schedule of drug administration
Symptom Text: Misadministration of Hep A vaccine 8 days early. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 169
Vaers Id: 415252-1 (S) Age Gender Vaccine Date Onset Date F 19-Oct-2010 22-Nov-2010 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 34
Status Date State Received Date 25-Jan-2011 MO 24-Jan-2011 Lot Prev Doses Site NULL 2 Unknown
Drug exposure during pregnancy, Ectopic pregnancy, Salpingectomy
Symptom Text: Information has been received from a 26 year old female registered nurse, for GARDASIL, a Pregnancy Registry product, concerning herself with a family history of cervical cancer and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot number not provided) in 2009, and the final dose (lot number not provided) on 19-OCT-2010. Concomitant therapy included methotrexate. On 22-NOV-2010 the patient later discovered she was 1 week pregnant with an ectopic pregnancy. She required surgery to remove her right fallopian tube. The patient sought medical attention by calling physician. Diagnostic laboratory test sonogram performed, no results provided. Pregnancy test was positive (unspecified for which time of pregnancy). On an unspecified date, the patient was hospitalized. At the time of this report, the patient's outcome was unknown. On 10-DEC-2010 the patient discovered she was pregnant again with another ectopic pregnancy, this time on the left side and had been on methotrexate, (WAES #1101USA01251). Follow-up information has been received from a licensed practical nurse reporting that GARDASIL were not administered by their office; vaccine dates and lot #s not known. No information available regarding any concurrent conditions or personal medical history. No LMP data available. The patient was seen from January 2009 to March 2010 for abnormal Papanicolaou (PAP) smears (pre cancerous cells). On 22-NOV-2010, the patient admitted to hospital; and emergency surgery performed. The patient was last seen on 03-JAN-2011. Methotrexate started with doses given on 07-JAN-2011 and 14-JAN-2011. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot numbers. Follow-up information has been received from the patient reporting that she got her GARDASIL vaccines through a planned parenthood center. The patient's last normal period was on 23-SEP-2010. The first dose of methotrexate was "not successful in dissolving the ectopic pregnancy" on the left side. She was to see doctor for more blood work on 21-JAN-2011 to see if the second dose of methotrexate was successful. The patient's status was not recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: beta-human chorionic, positive; Pap test, abnormal-pre cancerous cells Family history of cancer


Page 170
Vaers Id: 415253-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days
Status Date State Received Date 25-Jan-2011 TX 24-Jan-2011 Lot Prev Doses Site NULL Unknown
Mfr Report Id Last Edit Date WAES1101USA01378 18-Apr-2011 Other Vaccine Route Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Convulsion
Symptom Text: Information has been received from a physician concerning a 15 year old female patient he heard about (it was unknown if this was a patient of a clinical colleague or an acquaintance of him), that "was healthy as a horse" who on an unspecified date was vaccinated with GARDASIL (it is unknown which dose this was in the series). The physician reported that "within two weeks of administration of the vaccine she is in the hospital with seizures and is a picture of death". At the time of the report, the patient had not recovered. The patient's symptoms were considered to be disabling and immediately lifethreatening by the physician. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 171
Days
Emotional distress, Local reaction, Nausea, Pallor, Similar reaction on previous exposure to drug, Syncope, Vertigo
Symptom Text: This case was received from a physician on 12-JAN-2011. This case was medically confirmed. A female patient of unknown age received the second dose of GARDASIL (batch number not reported) on an unreported date. On an unreported date post vaccination, the patient experienced severe vertigo. The patient had a history of severe vertigo following the first dose of GARDASIL (batch number not reported) on an unreported date. The patient had no previous episodes of vertigo prior to this. The vertigo was worse following the second dose with 3-4 episodes per day each lasting 30-40 (units not reported) and occurred continuously for 2-3 weeks with gradual resolution. These episodes were associated with pallor and nausea and on one occasion the patient fainted. The patient was very distressed by the episodes. The patient also developed a significant local reaction. The patient's outcome was not reported. Upon internal medical reviews the events were considered medically significant. The reporter had also reported these events to the IMB. Other business partner numbers included E2011-00199. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Vertigo


Page 172
Vaers Id: 415263-1 Age Gender Vaccine Date Onset Date F 22-Sep-2010 22-Sep-2010 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Urticaria
Days 0
Status Date State Received Date 28-Jan-2011 IL 24-Jan-2011 Lot Prev Doses Site 0644Z 1 Left arm
Symptom Text: On 09-23-10 Patient reported had a few hives the night of 09-22-10, awoke to find "covered with hives" the morning of 09-23-10. Pt stated in call that she had taken Benadryl and was instructed to continue to do so, and was instructed not to get final shot of series. Patient denied any airway swelling. Patient was instructed to call office if no relief or other concerns, and patient did not call office again for this event. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Junel FE 1.5/30 Pt stated blueberries, cranberries, penicillin Pt indicated did not know


Page 173
Vaers Id: 415284-1 Age Gender Vaccine Date Onset Date F 20-Jan-2011 20-Jan-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 27-Jan-2011 VA 24-Jan-2011 Lot Prev Doses Site 0664Z Left arm U3440AA Right arm 0679Z Left arm
Mfr Report Id Route Intramuscular Intramuscular Subcutaneously
Immediate post-injection reaction, No reaction on previous exposure to drug, Syncope
Symptom Text: Brief fainting spell after vaccination occurred immediately after 3rd vaccine. Was fine with #1, #2 vaccines. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Tension type headaches None


Page 174
Days 6
Status Date State Received Date 02-Feb-2011 IA 24-Jan-2011 Lot Prev Doses Site 1377Y 0 Left arm
Decreased appetite, Fatigue, Nausea, Pain, Pruritus, Rash, Tanning, Tremor
Symptom Text: Patient received 1st GARDASIL imm. on Jan. 5, 2011. On Jan. 11 developed a rash on both arms & chest. Took BENADRYL to alleviate itching. Jan. 13, noticed spots had appeared in rash area. Other symptoms Jan. 11-14 included shaky hands, hands were achy, fatigue, loss of appetite & nausea. Rash disappeared Jan. 15 but fatigue & nausea continue. Patient had used tanning bed during the time rash appeared. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CLARITIN Patient saw Dr. on 1/17/11. He did C-reactive protein, CBC w/auto diff & sed rate. No None


Page 175
Vaers Id: 415380-1 Age Gender Vaccine Date Onset Date F 17-Jan-2011 17-Jan-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Hyperhidrosis, Nausea, Pallor, Presyncope
Days 0
Status Date State Received Date 28-Jan-2011 CA 25-Jan-2011 Lot Prev Doses Site 0768Z 1 Left arm
Symptom Text: HPV #2 vax given. 10" later pt displays pallor & c/o nausea, diaphoresis & feeling like she "may pass out" pt given 6oz water to drink, a sweet cereal snack & a peppermint hard candy. Phys exam was WNL. Pt laid down supine & felt better in 15" & went home. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None needed None None


Page 176
Vaers Id: 415382-1 Age Gender Vaccine Date Onset Date M Unknown Unknown 12.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 01-Feb-2011 PA 25-Jan-2011 Lot Prev Doses Site 1042Z 1 Right arm AC52B051BB 0 Left arm U3434AA 0768Z 0 0 Right arm Left arm
Injection site erythema, Injection site induration, Injection site warmth, Vaccination site reaction
Symptom Text: 2 inch area erythema @ site of VARIVAX injection. 1 inch area induration warm to touch. Dx: Local vaccine reaction. Treated with BENADRYL po & ice. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 177
Vaers Id: 415385-1 Age Gender Vaccine Date Onset Date F 11-Jan-2011 11-Jan-2011 12.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 01-Feb-2011 MN 25-Jan-2011 Lot Prev Doses Site AHAVB446AA 0 Left arm U336AA 0992Z 0 0 Right arm Left arm
Last Edit Date 02-Feb-2011 Other Vaccine MMR TDAP VARCEL
Injection site induration, Injection site pruritus, Injection site swelling, Scratch
Symptom Text: About 8 hours after receiving vaccines, (R) upper arm "started itching real bad". Started scratching it - continued itching for the next 24 hours or so. Pt denied trouble breathing, fever or any other rash. Pt reported this 1/12/11 - on exam mid right deltoid mild swelling (firm) & non-tender to palpation. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Loratadine as needed None History of seasonal allergies None


Page 178
Vaers Id: 415389-1 Age Gender Vaccine Date Onset Date F 07-Jan-2011 08-Jan-2011 18.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Injection site erythema, Injection site pain
Days 1
Status Date State Received Date 31-Jan-2011 MN 25-Jan-2011 Lot Prev Doses Site U3468AA 0 Left arm C3490AA Right arm 0716Z Right arm 0337Z 0 Left arm
Mfr Report Id Route Intramuscular Intramuscular Subcutaneously Intramuscular
Symptom Text: Redness, tenderness, painful at injection site. KEFLEX 500mg QID x 10 days, BENADRYL, Ibuprofen. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DEPO PROVERA NKDA; Chlamydia; Hep. C No


Page 179
Vaers Id: 415397-1 Age Gender Vaccine Date Onset Date F 07-Jan-2011 07-Jan-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Days 0
Status Date State Received Date 31-Jan-2011 WA 25-Jan-2011 Lot Prev Doses Site 0597Z 2 Left arm
Symptom Text: Pass out right after injection approximately 5-7 seconds and recovers by herself. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 180
Vaers Id: 415405-1 Age Gender Vaccine Date Onset Date F 20-Dec-2010 20-Dec-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness, Pallor
Days 0
Status Date State Received Date 01-Feb-2011 IA 25-Jan-2011 Lot Prev Doses Site 0768Z 0 Left arm
Symptom Text: Pt passed out in check out area approx. 10 min after adm. of GARDASIL. Pale but conscious. Vitals stable 110/60 P 58, sat up without lightheadedness & stood within few minutes. Pt drank fluids in waiting area, felt better. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None URI


Page 181
Vaers Id: 415458-1 Age Gender Vaccine Date Onset Date Days F 24-Jan-2011 24-Jan-2011 0 9.0 Type Manufacturer VAX Detail: VARCEL UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Wrong drug administered
Status Date State Received Date 02-Feb-2011 CA 25-Jan-2011 Lot Prev Doses Site NULL 1 Left arm NULL 0 Left arm
Symptom Text: On 24-Jan-2011, pt. was brought into her PCP office for a routine/annual check-up by her mother. It was determined by Dr., that a chicken pox and tetanus/diphtheria booster was needed on this visit. RN performed injections (2) on pt.'s left deltoid. After vaccination, Dr. reentered room to explain the wrong vaccination was given; GARDASIL instead of tetanus/diphtheria. No education or informed consent had been provided to mother prior to vaccination. Medication error due to (per MD) similar generic trade names. "ADACEL" vs. HPV vaccine (GARDASIL). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 182
Vaers Id: 415590-1 Related reports: 415590-2 Age Gender Vaccine Date Onset Date F 19-Jan-2011 19-Jan-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Unevaluable event
Days 0
Status Date State Received Date 02-Feb-2011 PA 27-Jan-2011 Lot Prev Doses Site 0337Z 0 Left arm
Symptom Text: None stated. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 183
Vaers Id: 415590-2 Related reports: 415590-1 Age Gender Vaccine Date Onset Date F 19-Jan-2011 19-Jan-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Unevaluable event
Days 0
Status Date State Received Date 02-Feb-2011 PA 31-Jan-2011 Lot Prev Doses Site 0337Z 0 Left arm
Symptom Text: None stated. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 184
Days 0
Status Date State Received Date 28-Jan-2011 FR 26-Jan-2011 Lot Prev Doses Site 1648U 0 Right arm
Convulsion, Immediate post-injection reaction, Loss of consciousness, Presyncope, Stupor, Syncope, Tonic clonic movements
Symptom Text: Information has been received from a physician concerning a 15 year old female with no relevant medical history who was vaccinated with the first or second dose of GARDASIL (batch number not reported) one month before this report (on approximately 04-OCT-2010). Immediately after receiving the vaccine, the patient experienced a convulsive syncope associated with tonic clonic movements, loss of consciousness and a state of torpor. The events lasted 30 seconds at most. The clinical exam performed in the medical cabinet after the events was normal. There was no motor deficiency and the blood pressure was normal. At time of reporting, the patient had recovered. Upon medical review, the company considered the case as serious. Convulsion was considered to be an other important medical event. Follow up information had been received on 11-JAN-2011: The vaccine was administered IM in the right arm on 14-SEP-2010. Batch # was NH43700, (lot #1648U). Ten seconds post vaccination the patient experienced a short loss of consciousness with convulsion, which spontaneously resolved in 2 minutes. Of note, tonic-clonic movements and torpor were no more reported. The patient diagnosed with lipothymia followed by a short convulsion. The adverse events were considered moderate. The case is medically confirmed. Other business partner numbers included E2010-06735. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown physical examination, clinical exam normal Unknown


Page 185
Vaers Id: 415601-1 (O) Age Gender Vaccine Date Onset Date F 30-Sep-2010 01-Dec-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 62
Arthropathy, Polyarthritis, Rheumatoid arthritis
Symptom Text: Case received from a physician on 14-JAN-2010. Case medically confirmed. A 15 year old female patient had received the third dose of GARDASIL (batch number not reported) at the end of September 2010. At the beginning of December, i.e approximately 2 months after vaccination, the patient developed first symptoms of inflammatory polyarthritis. The origin was undeterminate at the time of reporting. A heavy treatment would be soon introduced. Rheumatoid arthritis was evoked. Additional information received on 20-JAN-2010 and 21-JAN-2010. The patient was seen by a rheumatologist. Diagnosis of rheumatoid arthritis was confirmed. A symmetric proximal metacarpophalangeal disorder was observed on both hands. There was no other information on the elements of the diagnosis. At the time of reporting, the patient had not recovered. To be noted that the patient had received the two first doses of GARDASIL without adverse effects. The reporting physician considered Rheumatoid arthritis to be another important medical event. Other business partner numbers included E2011-00293. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 186
Days 2
Apparent death, Implantable defibrillator insertion, Intensive care, Movement disorder, Resuscitation, Ventricular fibrillation
Symptom Text: Information has been received from a physician concerning a 14 year old female patient who on 07-OCT-2010 was vaccinated with the first dose of GARDASIL (lot number unspecified). On 09-OCT-2010 while the patient was at home, she had a sudden death and it was her father who resuscitated her. She had ventricular fibrillation. She spent one month and a half in intensive care, and as a consequence of what happened to her, she had some motivity problems. They could not find a medical reason for what happened to her. She now had an automatic implantable defibrillator. She was now at home and taking beta-blocker treatment. The patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 187
Vaers Id: 415646-1 (O) Age Gender Vaccine Date Onset Date F 01-Aug-2008 01-Feb-2009 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Tremor
Days 184
Symptom Text: Information has been received concerning a female who in August 2008, was vaccinated with the first dose of GARDASIL. Medical history, drug reactions and allergies were all unspecified by reporter. In approximately February 2009, "6 months after receiving GARDASIL vaccination", the patient's hands were trembling and shaking. On 10-OCT-2010 the patient experienced seizure. The patient sought unspecified medical attention, her present status was unknown. Upon internal review, seizure was considered to be on other important medical event. No further information was available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 188
Vaers Id: 415667-1 Age Gender Vaccine Date Onset Date F 18-Jan-2011 20-Jan-2011 18.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS VARCEL MERCK & CO. INC. FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 2
Status Date State Received Date 31-Jan-2011 MI 28-Jan-2011 Lot Prev Doses Site AC52B044CA Left arm 1006Z U3737AA 0565Z U3515AA Left arm Right arm Left arm Right arm
Mfr Report Id Route Unknown Unknown Unknown Unknown Unknown
0 0 0
Pyrexia, Vaginal haemorrhage, Vulvovaginal pain
Symptom Text: (1) Vaginal bleeding (like a period) (2) Vaginal wall tenderness (3) Fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 189
Vaers Id: 415710-1 Age Gender Vaccine Date Onset Date Days F 21-Jan-2011 21-Jan-2011 0 11.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR MNQ NOVARTIS VACCINES AND DIAGNOSTICS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Status Date State Received Date 02-Feb-2011 VA 28-Jan-2011 Lot Prev Doses Site U3298CA 0 Left arm 029011 0 Left arm 0337Z 0 Right arm
Symptom Text: On 1/21/2011 - administered TDAP, MENACTRA & GARDASIL (first of 3) & pt fainted approximately 2 minutes after shots - lasted 30 seconds. Pt with dizziness & lightheaded right before event. Had pt lay down with legs elevated x 20 minutes BP normal. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 190
Vaers Id: 415775-1 (S) Related reports: 415775-2 Age Gender Vaccine Date Onset Date F 07-May-2007 01-Dec-2007 34.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, LIFE THREATENING, SERIOUS
Days 208
Status Date State Received Date 03-Feb-2011 MA 30-Jan-2011 Lot Prev Doses Site 0314U 0 Right arm
Mfr Report Id Route Subcutaneously
Chest pain, Cough, Drug exposure before pregnancy, Ear discomfort, Facial pain, Gastrooesophageal reflux disease, Hodgkins disease, Hodgkins disease nodular sclerosis stage II supradiaphragmatic, Lymphadenopathy, Migraine, Nasopharyngitis, Nausea, Rhinitis allergic, Sinus headache
Symptom Text: Approximately one year later, I developed a terrible cough that would not go away. I thought it was allergies. I also noticed that my lymph nodes were swollen. As I became pregnant, I could not have any tests done to see what was going on. I gave birth to my son in November 2008, and immediately had a chest x-ray, which led to a PET scan, and biopsy. These results confirmed the diagnosis of Hodgkin's Lymphoma. The following information was obtained through follow-up and/or provided by the government. 2/7/11. PCP records DOS 5/7/07. Received vax at OV. Several OV for unrelated complaints. On 6/12/07 c/o cold s/s X 5 weeks, chest pain c palpation, sinus pressure, sinus HA, cough. Repeat CT done. On OV 7/30/07 pt dx c migraine, nausea, GERD, UTI, possible endometriosis. 2/11/11. PCP records DOS 6/12/07; 7/30/07. DX: allergic rhinitis, cough. CC: ears stuffed, face pain; f/u on incidental CT finding to LLL. On 2nd visit pt c/o acid reflux. 3/1/11. Consultant records. DOS 12/23/08 - 12/1/09. DX: Hodgkin's disease nodular sclerosis thorax, stage IIB. Records reveal that pt presented c symptoms at 3-weeks postpartum: fevers, night sweats, swollen cervical lymph nodes. Diagnosed c Hodgkin's lymphoma at 7-weeks postpartum; received chemotherapy X6. Most recent radiological tests indicate pt is currently free from disease reoccurrence. Other Meds: Lab Data: History: CT, PET, biopsy, blood work The following information was obtained through follow-up and/or provided by the government. 2/7/11. Labs diagnostics. H/H: 11.1/33 (L). 3/1/11. Consultant records. CXR: superior mediastinal mass. Chest CT: para n/a The following information was obtained through follow-up and/or provided by the government. 2/7/11. 3/1/11. PMH: R ovarian cyst, fibrocystic breast disease, hyperlipidaemia, Bartholin's cyst, recurrent pyelonephritis, UTI. On 4/23/07 notation of incidental finding of 3mm lung nodule noted on CT, mass in chest. Ex-smoker. NKDA none The following information was obtained through follow-up and/or provided by the government. 2/7/11. PCP records. Rhinorrhoe


Page 191
Vaers Id: 415775-2 (S) Related reports: 415775-1 Age Gender Vaccine Date Onset Date F 07-May-2007 12-Jun-2007 34.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT LIFE THREATENING, SERIOUS
Days 36
Status Date State Received Date 04-Apr-2011 US 01-Apr-2011 Lot Prev Doses Site 0314U 0 Right arm
Mfr Report Id Last Edit Date WAES1103USA00794 04-Apr-2011 Other Vaccine Route Subcutaneously
Chest pain, Condition aggravated, Cough, Drug exposure before pregnancy, Ear congestion, Facial pain, Gastrooesophageal reflux disease, Hodgkins disease, Lymphadenopathy, Migraine, Nasopharyngitis, Nausea, Palpitations, Rhinitis allergic, Sinus headache, Urinary tract infection
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done. On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Chest X-ray, 11/??/08, confirmed the diagnosis of Hodkin's lymphoma; positron emission, 11/??/08, confirmed the diagnosis of Hodkin's lymphoma; biopsy, 11/??/08, confirmed the diagnosis of Hodkin's lymphoma; diagnostic laboratory, H/H; 11.1 Ovarian cyst; fibrocystic breast disease; Bartholin's cyst; chest mass NOS; urinary tract infection Pregnancy NOS (LMP=Unknown); Hyperlipidaemia; Pyelonephritis; Lung nodule; Rhinorrhoea


Page 192
Vaers Id: 415781-1 Age Gender Vaccine Date Onset Date F 24-Nov-2008 01-Dec-2008 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Fatigue, Menstruation irregular, Pain
Days 7
Status Date State Received Date 02-Feb-2011 CA 30-Jan-2011 Lot Prev Doses Site NULL 2 Unknown
Symptom Text: After having all three HPV shots, my daughter starting having irregular periods, every two - three weeks. This went on for over a year before we decided to put her on birth control pills. She was very regular before this. She was also achy and tired more often after the three rounds of shots. That still has not gone away. Doctor says neither of these symptoms can be linked to shots for sure. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none performed because doctors don't think her symptoms are side effects. no no


Page 193
Vaers Id: 415783-1 Age Gender Vaccine Date Onset Date F 10-Jan-2011 13-Jan-2011 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Back pain, Hypomenorrhoea, Menorrhagia
Days 3
Status Date State Received Date 02-Feb-2011 TN 30-Jan-2011 Lot Prev Doses Site NULL 1 Left arm
Mfr Report Id HPV Route Unknown
Symptom Text: I experience back pain and light bleeding period. The symptom has been presented from 01/13/11 until today 01/30/11. Which I think, it should not be my period schedule. My period is pretty normal and never last long. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No No


Page 194
Vaers Id: 415790-1 Age Gender Vaccine Date Onset Date F 06-Jan-2011 06-Jan-2011 26.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Pallor, Skin warm
Days 0
Status Date State Received Date 02-Feb-2011 MI 29-Jan-2011 Lot Prev Doses Site AHAVB443BA 0 Right arm 0096Z C3475AA 0 0 Left arm Left arm
Symptom Text: 1045 - c/o dizziness. Laid on floor with feet elevated. Pale, skin warm, dry. BP 78/50, p-72. A & O, speaking banana/coffee this am. 1048 - 84/58 - sitting up 1050 - BP 90/64, P-60. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DEPO PROVERA None None


Page 195
Vaers Id: 415795-1 Age Gender Vaccine Date Onset Date M 28-Jan-2011 28-Jan-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Days 0
Status Date State Received Date 02-Feb-2011 OH 31-Jan-2011 Lot Prev Doses Site 0786Z 0 Right arm U3486AA 0 Left arm U3442BA 0 Left arm
Symptom Text: Patient passed out ater shots given for a short time (Less than 30 sec). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None known. patient did have 5 doses of DTaP prior to the Tdap. Patient also stated didn't eat much lunch prior to getting shots. None None Known


Page 196
Vaers Id: 415809-1 Age Gender Vaccine Date Onset Date M 28-Jan-2011 28-Jan-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 02-Feb-2011 WA 31-Jan-2011 Lot Prev Doses Site NULL 2 Left arm
Asthenia, Chills, Dizziness, Nausea, Pallor, Pyrexia
Symptom Text: He developed a fever, chills, nausea and weakness. We gave him Advil and put him to bed. The next morning the fever was at 102.6. It went down to 99.8 after more Advil, but then spiked up to 103.6 at around 5:00Pm on 1/29/2011. He continued to have nausea, chills, weakness and dizziness in addition to fever. The fever was gone by 1/30/2011 and he was pale and weak, but recovering. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No No


Page 197
Vaers Id: 415834-1 (O) Age Gender Vaccine Date Onset Date F 17-Oct-2007 01-Nov-2010 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1111
Status Date State Received Date 01-Feb-2011 US 31-Jan-2011 Lot Prev Doses Site 0930U 2 Unknown
Neoplasm, Papilloma viral infection, Precancerous cells present
Symptom Text: Information has been received from a registered nurse concerning a 22 year old female patient with asthma in 2007 and no allergies, who on 02-MAR2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 654510/0962F), IM. On 24-MAY-2007 was vaccinated with a second 0.5 ml dose of GARDASIL (lot# 654510/0962F), IM, and on 17-OCT-2007 was vaccinated with a third 0.5ml dose of GARDASIL (Lot# 658488/0930U), IM. Concomitant therapy included DEPO-PROVERA which was reported that she re-started on 04-JAN-2011 and it was not taken in 2010. On 17-OCT-2007 and in 2009 Papanicolaou test were performed and both were negative. The nurse reported that on 16-NOV-2010 a human papilloma virus test was performed that was positive and the patient was sent to a gynecologist. The patient on unspecified date had a colposcopy that was positive for HPV neoplasia. The nurse also stated that this was not present prior to receiving GARDASIL. The nurse reported that these events were related to "pre cancer". The nurse reported that the patient would have a loop electrosurgical excision procedure (LEEP) at the gynecologist's (date not reported). At the time of the report the patient had not recovered from these events. Upon internal review "pre-cancer" was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DEPO-PROVERA Colposcopy, positive; Pap test, 11/16/10, positive; Pap test, 10/17/07, negative; Pap test, ?/?/09, negative Asthma


Page 198
Vaers Id: 415835-1 (S) Age Gender Vaccine Date Onset Date F 01-Sep-2010 17-Dec-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 107
Status Date State Received Date 01-Feb-2011 FR 31-Jan-2011 Lot Prev Doses Site 1334X 0 Left arm
HOSPITALIZED, LIFE THREATENING, SERIOUS Convulsion
Symptom Text: Information has been received from the Health Authorities (HA) (reference number PEI2011000537). Case medically confirmed. A 15 year old female patient had received the second dose of GARDASIL (batch number NM15940, lot number NJ51180) IM into the left upper arm on an unspecified date in November 2010. On 17-DEC-2010 she developed a cerebral seizure (status epilepticus) leading to hospitalization for an unspecified time. On 18-DEC2010, cerebrospinal fluid (CSF) revealed protein with 739 mg/L. The patient was found to have a moderately blood-brain barrier disturbance. Serology and CSF testing were negative for herpes simplex virus (HSV), varicella, enterovirus, borrelia antibodies and herpes polymerase chain reaction (PCR). At the time of reporting to HA the patient had not recovered. The event was considered as life threatening by the reporter. Dose 1 of GARDASIL (batch number NL31810, lot number 1334X) was given on an unspecified date on September 2010, toleration was not reported. A lot check has been requested. Other business partner numbers include: E2011-00311. The case is closed. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Diagnostic laboratory test, 18Dec10, moderately blood-brain barrier disturbance; CSF HSV Ab, 18Dec10, negative; cerebrospinal fluid total protein test, 18Dec10, 739 mg/L; cerebrospinal fluid culture, 18Dec10, negative for varicella, ,entero Unknown


Page 199
Vaers Id: 415836-1 (O) Age Gender Vaccine Date Onset Date F 27-Sep-2010 27-Sep-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Asthenia, Headache, Influenza like illness
Days 0
Status Date State Received Date 01-Feb-2011 FR 31-Jan-2011 Lot Prev Doses Site NK25010 Unknown
Symptom Text: This case was reported by a Health Authority on 19-JAN-2011, reference 2011-001714, this case is medically confirmed. A 13 year old female patient who was not taking any concomitant medications received GARDASIL (lot # NK25010, batch # NM31130, 0.5ml intramuscularly on 27-SEP-2010. A few hours post vaccination on 27-SEP-2010 the patient experienced a headache, flu like symptoms and weakness. The patient received corrective treatment with paracetamol. At the time of reporting to the Medicine Board (IMB) the patient had not yet recovered. The IMB considered the case to be serious and other medically significant due to required intervention. Other business partner numbers included: E2011-00400. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown Unknown


Page 200
Vaers Id: 415837-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Blindness unilateral
Days
Status Date State Received Date 01-Feb-2011 WI 31-Jan-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a physician concerning a 20 year old female patient who was vaccinated with GARDASIL (dose and route unknown) on an unspecified date. Subsequently the patient experienced blindness in her one eye. The patient went to the optomologist and was given unspecified treatment for blindness. The optomologist was blaming GARDASIL for blindness in her one eye. At the time of the report, the patient's outcome was unknown. Upon internal review, blindness in one eye was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 201
Vaers Id: 415854-1 Age Gender Vaccine Date Onset Date Days F 04-Dec-2010 04-Dec-2010 0 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MEN UNKNOWN MANUFACTURER Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Status Date State Received Date 02-Feb-2011 GA 31-Jan-2011 Lot Prev Doses Site NULL 2 Right arm NULL 0 Gluteous maxima
Asthenia, Dyspnoea, Fatigue, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site rash
Symptom Text: Right after vaccine experienced pain and itching at injection site with a raised bump, severe numbness in hands and feet, difficulty breathing, shortness of breath, fatigue, loss of energy, etc. Other Meds: Lab Data: History: Prex Illness: Asthma, diagnosed with Endometriosis in May of 2010. No, but right after vaccine experienced pain and itching at injection site with a raised bump, severe numbness in hands and feet
Prex Vax Illns: Tingling in legs and arms, shortness of breath, no energy, etc.~HPV (Gardasil)~3~20.50~Patient


Page 202
Vaers Id: 415880-1 Age Gender Vaccine Date Onset Date M Unknown Unknown 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 02-Feb-2011 WV 31-Jan-2011 Lot Prev Doses Site U3465AA Left arm 0992Z Right arm 1412Y 1 Right arm AC52B061BA Left arm
Injection site erythema, Injection site induration, Injection site pain, Local reaction
Symptom Text: Extended local reaction with erythema, induration & pain 10 x 4 cm on (L) upper arm down from inj site of DTAP. Other Meds: Lab Data: History: Prex Illness: None None None
Prex Vax Illns: Local.~Influenza (Seasonal) (no brand name)~UN~9.00~Patient


Page 203
Vaers Id: 415883-1 Age Gender Vaccine Date Onset Date F 25-Jan-2011 25-Jan-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Fall, Head injury, Syncope
Days 0
Status Date State Received Date 02-Feb-2011 NH 31-Jan-2011 Lot Prev Doses Site 0766Z 2 Right arm U3517AA 0 Left arm
Mfr Report Id NH01312011 Route Intramuscular Intramuscular
Symptom Text: Patient fainted following physical - had received #3 HPV vaccine - (Pt fell to floor - hit her head and required treatment in ER). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NUVARING; ACCOLATE 20mg bid "Environmental" None


Page 204
Vaers Id: 415906-1 Age Gender Vaccine Date Onset Date F 27-May-2010 30-Jun-2010 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 34
Status Date State Received Date 02-Feb-2011 IL 01-Feb-2011 Lot Prev Doses Site 0312Y 0 Right arm
Arthralgia, Hypoaesthesia, Myalgia, Oedema peripheral, Paraesthesia, Venous insufficiency
Symptom Text: Tingling, hand numbness, venous insufficiency with lower ext swelling. Muscle aches, joint pains. Most improved except leg swelling, VI. Mild joint pain. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Doxycycline 20 mg; YAZ; Nicotinamide; Vit. C; BIOTIN; flaxseed; iron Chem; blood cts; thyroid nl.; high ANA 1:640; Rest AI w/u (-) Iron deficiency; Acne; alopecia None


Page 205
Vaers Id: 415921-1 Age Gender Vaccine Date Onset Date F 03-Jan-2011 04-Jan-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Migraine
Days 1
Status Date State Received Date 02-Feb-2011 CA 01-Feb-2011 Lot Prev Doses Site 1016Z 2 Right arm
Symptom Text: 24 hrs after 3rd GARDASIL, pt. developed severe migraine that persisted for 5 days despite multiple medications (triptan, narcotics, ibuprofen, acetaminophen, then valproate). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: (None) None None


Page 206
Vaers Id: 415925-1 Age Gender Vaccine Date Onset Date F 17-Nov-2010 19-Nov-2010 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 2
Status Date State Received Date 02-Feb-2011 CA 01-Feb-2011 Lot Prev Doses Site U3478AA 0 Left leg 0992Z 0 Left leg
Rash generalised, Rash papular, Rash pruritic, Skin exfoliation
Symptom Text: Fine papular widespread rash, very pruritic - onset 2 days after HPV & MENACTRA. Fingers & hands peeled 2 months afterwards. (-) fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Asthma; Keratosis Pilaris URI - Cold


Page 207
Vaers Id: 415945-1 Age Gender Vaccine Date Onset Date F 19-Jan-2011 19-Jan-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness, Syncope
Days 0
Status Date State Received Date 02-Feb-2011 PA 01-Feb-2011 Lot Prev Doses Site 0565Z 0 Left arm U33Y1AA 0 Right arm C3353AA 0 Left arm
Symptom Text: Pt. with syncopal episode 5 min after vaccinations. LOC less than 5 seconds then awake, drinking juice & left office ambulatory with mom. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 208
Vaers Id: 415993-1 Age Gender Vaccine Date Onset Date M 31-Jan-2011 31-Jan-2011 13.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness
Days 0
Status Date State Received Date 02-Feb-2011 PA 01-Feb-2011 Lot Prev Doses Site UH182AD 1 Right arm 1016Z 0 Left arm
Symptom Text: A few minutes after received vaccines, he felt a little dizzy ("woozy") but did not faint or lose consciousness. Asked for a glass of water & felt fine afterward. Observed in office for several minutes & reported no further symptoms. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None known None


Page 209
Vaers Id: 416004-1 (O) Age Gender Vaccine Date Onset Date F Unknown 01-Sep-2010 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 02-Feb-2011 CA 01-Feb-2011 Lot Prev Doses Site NULL Unknown
Loop electrosurgical excision procedure, Neoplasm malignant, Nervousness, Papilloma viral infection
Symptom Text: Information has been received from a consumer's mother concerning her 18 year old female daughter who in approximately 2008 was vaccinated with a dose of GARDASIL (dose, route and Lot# not reported). The consumer's mother stated that in November 2010, her daughter was diagnosed with cancer after receiving GARDASIL and could no specify what type of cancer it was. A colposcopy was performed (no results reported). At the time of the report the patient's outcome was unknown. Upon internal review cancer was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information was received from the consumer concerning her daughter had the GARDASIL shot's from her pediatrician when she was 15 1/2 to 16 years of age. She became sexually active at the age of 17 1/4 years old. She did not use a condom with this particular partner. She had been with her same boyfriend since 25-MAY-2010. In September her and the consumer went to their family doctor to get her birth control pills so, she had her first pap smear. It came back abnormal, so she went back again and had a second and it came back human papilloma virus test (HPV) positive high risk. They were told to see an obstetrics and Gynecologist (OBGYN) which they did, and the patient did a colposcopy (also reported as colonscopy) which confirmed she had three infected areas. She was under a loop electrosurgical excision procedure (LEEP) procedure on 24-JAN2011 (no results reported). She was 5' 8" and 111 Ibs. She started at 117 but she could not eat from nerves as she felt like her life was ruined forever now. At the time of the report the patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown colonoscopy, confirmed she had three infected areas; serum prostatic acid, positive, high risk Unknown


Page 210
Vaers Id: 416005-1 (O) Age Gender Vaccine Date Onset Date F 08-Nov-2010 08-Dec-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 30
Status Date State Received Date 02-Feb-2011 US 01-Feb-2011 Lot Prev Doses Site 0969Y 0 Unknown
Convulsion, Fall, Headache, Hypertonia, Migraine without aura, Movement disorder, Postictal state, Tension headache, Vaccine positive rechallenge, Vascular headache
Symptom Text: Information has been received from a nurse practitioner (N.P.) and follow up information has been received from a registered nurse (R.N.) concerning a 12 year old female with no concurrent conditions, no known drug reaction and no pertinent medical history who on 08-NOV-2010 was intramuscularly vaccinated with the first 0.5ml dose of GARDASIL (lot# 663573/0969Y). There was no concomitant medication. On 08-DEC-2010 the patient experienced a seizure and was sent to ER. EEG and CT scan of head were performed with negative results reported. The patient was not admitted to hospital. On 21-JAN-2011, the patient was intramuscularly vaccinated with the second 0.5ml dose of GARDASIL (lot# 663573/0969Y). There was no concomitant medication. On 24-JAN-2011 the patient experienced a seizure again. The patient was sent to ER and not admitted. On an unknown date, the patient recovered from seizure and came back to school but being followed by neurology (no contact information available). No other vaccines was given at the time of the two GARDASIL doses. Seizure was determined to be an other important medical event. No further information is available. The following information was obtained through follow-up and/or provided by the government. 2/8/11. ER records DOS 12/8/10. DX: New onset seizures. CC: seizure at home lasting 45 secs, postictal X 5 mins.; headache X few weeks. PE: L tongue bitten. Assessed et observed in ER; DC home to f/u c PCP. 2/9/11. ER records DOS 1/24/11. DX: Seizure. CC: seizure; generalized shaking all over, lasting ~ 2 mins, witnessed by health professional; followed by HA postictally. Declined anticonvulsants; DC in stable condition to f/u c PCP et neurologist. 2/17/11. Consultant records DOS 2/14/11. DX: Other convulsions; mixed headache (tension et vascular HA); migraine without aura, intractable. CC: On 1st event fell out of chair, stiffened up et started shaking for 1-2 minutes. Taken to ER, postictally was tired, disoriented et had HA. HA is bifrontal associated c nausea, occurs QOD. PE: NAD. Prescription given for antimigraine meds, recommended to keep seizure diary et maintain HA diet. Brain MRI et EEG scheduled. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Electroencephalography, 12/08/10, negative; head computed axial, 12/08/10, negative The following information was obtained through follow-up and/or provided by the government. 2/8/11. Labs/diagnostics. WBC 5 K/mm3 (N), lymphs 18% (L), monos None The following information was obtained through follow-up and/or provided by the government. 2/17/11. Consultant records. PMH: shingles. NKDA.


Page 211
Vaers Id: 416006-1 (S) Age Gender Vaccine Date Onset Date F 22-Nov-2010 25-Dec-2010 22.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 33
Status Date State Received Date 02-Feb-2011 FR 01-Feb-2011 Lot Prev Doses Site NULL 0 Unknown
Asthenia, Blood pressure increased, Dizziness, Encephalitis, Feeling abnormal, Headache, Heart rate increased, Malaise, Movement disorder, Pain in extremity, Paraesthesia, Pyrexia, Stupor, Tremor, Vomiting
Symptom Text: Information has been received from a mother concerning her daughter, a 22 year old female whose cervical wound that developed due to HPV infection was treated by freezing in September 2010. The patient had been taking immunomodulator for 4 months (most likely it was ISOPRINOSINE), taken for 2 weeks, then 2 weeks off-drug. On 22-NOV-2010 the patient was vaccinated with the first dose of GARDASIL. Approximately one month later, around 25-DEC-2010, the patient experienced dizziness and headache that appeared more than once a day. This series repeated every 2-3 days. "Two weeks ago", in January 2011, the patient vomited at night and by morning she had fever (on a Sunday) and experienced pain in extremities, shaking and torpidity (pins and needles). When these symptoms disappeared, the patient had 2-3 symptom-free days, then on a Thursday the symptoms returned (vomiting, headache, shaking and torpidity). Her pulse was measured many times, recently it was above 90 even without other symptoms. When she felt bad, the pulse rate was 120 and her blood pressure was also elevated. An increase in frequency and intensity of headache had been experienced since 20-JAN-2011, the patient had 3-4 courses of sickening a day. On the night of 24-JAN-2011 she felt very bad, vomiting and due to the symptoms and weakness she felt unable to move. As of 25-JAN-2011, she was hospitalized, being hydrated and examined. The patient's events persisted. The treating physician suspected the possibility that the vaccination might have caused encephalitis (according to the narrative of the patient's relative). The reporter felt that unable to move, dizziness, headache, vomiting, fever, pain in extremities, shaking, pins and needles, elevated heart rate, elevated blood pressure and weakness were related to therapy with GARDASIL. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown blood pressure measurement, ??Jan11, elevated; total heartbeat count, ??Jan11, 90; total heartbeat count, ??Jan11, 120 Papilloma viral infection; Cervix lesion


Page 212
Vaers Id: 416007-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 02-Feb-2011 FR 01-Feb-2011 Lot Prev Doses Site NULL 1 Left arm
Activities of daily living impaired, Allergy to vaccine, Arthralgia, Burning sensation, Joint swelling, Juvenile arthritis, Local swelling, Malaise, Mobility decreased, Oedema peripheral, Pain in extremity, Rash erythematous, Rash generalised, Skin warm, Wheelchair user
Symptom Text: This case was identified in a magazine article in a foreign country on 21-JAN-2011. This case is linked to E1011-00455 (WAES # 1101USA03100 (same vaccine identified in the same magazine). This case was not medically confirmed. A 15 year old female patient received the second dose of GARDASIL (manufacturer unspecified) (batch # not reported) in the top of her left arm on an unreported date. On the same day, three hours post vaccination, the patient developed systemic juvenile rheumatoid arthritis (or Still's disease). The patient received the first dose of GARDASIL (manufacturer unspecified) on an unreported date with no adverse effect. Three hours post vaccination the patient had a sore and swollen thumb on the right hand. The GP prescribed ibuprofen but she did not improve. A few days later the patient's knee and foot were hurting and swollen. The patient also had a red rash on her arms which spread over her body and was burning hot to touch. She was soon getting sick and couldn't go to school and her whole body was swollen. Over the next two weeks her joints became so swollen that she could not bend any of her limbs and all she could do was lie on the couch, sleep and wake up only to drink water. If she tried to eat she was sick. A doctor at the hospital stated she had had an allergic reaction to the vaccine and prescribed antihistamines but her condition didn't improve. The patient was referred to a paediatrician and had x-rays and scans and she was diagnosed with systemic juvenile rheumatoid arthritis. The paediatrician stated that this could have been something that she would have developed later in life but that the, vaccine could have triggered it. The patient was prescribed steroids, painkillers and antiinflammatories. The patient's condition started to improve after a few weeks and she could get off the sofa and take some steps but could not climb the stairs. The patient still had painkilling injections three times a week and one year after the vaccination, could potter about the house but needed a wheelchair if she went out and could only go to school for one hour a week. At the time of the reporting the patient had not yet recovered. The event of juvenile rheumatoid arthritis was considered to be another important medical event. Other business partner numbers include E2011-00449. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 213
Vaers Id: 416008-1 (S) Age Gender Vaccine Date Onset Date F 01-Jun-2009 08-Feb-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days 252
Status Date State Received Date 03-Feb-2011 FR 01-Feb-2011 Lot Prev Doses Site 0772X 2 Unknown
Diplopia, Eyelid ptosis, Neurological examination abnormal, Ocular myasthenia
Symptom Text: Information has been received from a Health Authority (case n. 132695). The case was medically confirmed. A 12 year old female patient was vaccinated IM on 01-JUN-2009 with the third dose of GARDASIL (Lot # 0772x, batch # NK15900). On 08-FEB-2010, she presented with sudden right eyelid ptosis associated with diplopia. These symptoms occurred inconsistently during the day, worsening in the evening. She was admitted to the hospital. A brain MRI with contrast had been taken 1 week before and was negative. Lab work performed included: WBC 6150; N: 56.9; L: 36.6; M: 5.5; E: 0.7; B:0.3; RBC: 4.370.000; Hb: 12.7; Htc: 38.0; MCV:97.0; Plt: 326.000; C-reactive protein: 0.2; sedimentation rate: 2; glycemia: 90: LDH: 179: CK: 143. Chest Xray was within normal limits; Anti-EBV antibodies: Ab VCA IgA and EBNA IgG present (past infection); Anti CMV antibodies: absent; Antibodies antiDNA, ANA: absent; Anti-reoglobulin antibodies: negative; Anti-peroxidase antibodies: negative; C3: 99; C4: 9; Anti-TSA receptor antibodies: negative; Total protein: 7.5; IgG: 1259; IgA: 227; IgM: 211; Anti-MUSK antibodies: negative and Anti-RAB antibodies: negative. A neurological consultation performed on 18-FEB-2010, noted moderate eyelid ptosis in the right eye with slight elevation deficit and upward diplopia. An Electranyography showed motor conduction of the facial and right ulnar nerves within normal limits. Mediastinic sonogram: excluded the presence of timoma, normal mediastinum. Venous-MRI of the right intracranial district did not show any aneurisms. The patient was treated with MESTINON. During admission the eyelid ptosis improved in the morning hours to progressively worsen during the day and in the evening. The final diagnosis: possible myasthenia. The patient was referred to a Neurological Institute. The patient was re-evaluated on 25-FEB-2010, she appeared to be responding to the therapy with MESTINON. Ptosis was noted also in the left eye, she complained diplopia in all directions except downwards. Possible ocular myasthenia was confirmed, to be reevaluated when antibodies results for MUSK, ENA and ANCA were available. Neurological evaluation on June 2010: ptosis of the right eye still present with mild ptosis of the left eye as well. Diplopia still present. The diagnosis of ocular myasthenia with negative anti-AAB and anti-MJSK antibodies was confirmed. The patient was initiated on steroid therapy with DELTACORTENE. At the tine of reporting the patient had not yet recovered. HA coded diplopia, ptosis and ocular myasthenia. The events of diplopia, ptosis and ocular myasthenia were considered to be disabling events. The case was closed. Other business partner numbers include: E2011-00405. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Magnetic resonance imaging, 01?Feb10, with contrast: negative. Diagnostic laboratory test, ??Feb10, Anti-tireoglobulin antibodies: negative; Diagnostic laboratory test, ??Feb10, Anti-peroxidase antibodies: negative; Diagnostic laboratory te Viral infection; Purpuric rash


Page 214
Days
Status Date State Received Date 03-Feb-2011 FR 01-Feb-2011 Lot Prev Doses Site NULL Unknown
Colitis ulcerative, Dizziness, General physical health deterioration, Pain, Pancreatitis relapsing, Paralysis
Symptom Text: This case was identified in a magazine article in a foreign country on 21-JAN-2011. This case is linked to E1011-00449 (WAES # 1101USA03098) (same vaccine identified in the same magazine). This case was not medically confirmed. This case concerns an unknown number of unknown female patients who received GARDASIL (manufacturer unspecified) (batch # not reported) on unreported dates. Post vaccination, the patients mothers described severe ill-health that their daughters had suffered from including paralysis, constant pain, recurring pancreatitis, ulcerative colitis, dizziness and other physical problems. The patients outcomes were not reported. The events of paralysis, constant pain, recurring pancreatitis, ulcerative colitis, dizziness and other physical problems were considered to be other important medical events. Other business partner numbers include E2011-00455. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 215
Vaers Id: 416033-1 (S) Age Gender Vaccine Date Onset Date F 27-Oct-2010 21-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 55
Abdominal pain, Similar reaction on previous exposure to drug, Vomiting
Symptom Text: This case was received from the health authority on 20-JAN-2011. IMB ref. 2011-001729 and 2011-001755. This case is medically confirmed. A 13 year old female patient received the second dose of GARDASIL (Batch # not reported) on 17-DEC-2010. On 21-DEC-2010, four days post vaccination, the patient experienced abdominal pain and vomiting. The patient had no significant medical history as well. There were no risk factors available. The patient received the first dose of GARDASIL (batch # not reported) on 27-Oct-2010 and three days post vaccination experienced abdominal pain and vomiting requiring hospital admission. Any corrective treatment and the patient outcome were unknown. The patient was hospitalized and treated with IV fluids ZOFRAN, morphine for pain (PRN) and BUSCOPAN PRN. At the time of the reporting, the patient had not recovered. Other business partner numbers include E2011-00432. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Vomiting; Abdominal pain; Hospitalisation


Page 216
Vaers Id: 416038-1 Age Gender Vaccine Date Onset Date F 25-Jan-2011 26-Jan-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash
Days 1
Status Date State Received Date 02-Feb-2011 KY 02-Feb-2011 Lot Prev Doses Site 0650X 1 Left arm
Symptom Text: Rash on Face, pt came to Student Health Clinic @ 11:30 am to be evaluated. Pt prescribed Benadryl 25mg one every 6 hours prn. Return to clinic or ER if symptoms worsen. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seroquel 300mg 2 @ hs Elavil 25mg @ hs Bentyl 20mg 1 @ am, lunch supper & hs Lamictil 200mg 1 1/2 @ hs Wellbutrin 150mg every am OCP None Severe depression, Allergy to Cefzil None


Page 217
Vaers Id: 416077-1 Age Gender Vaccine Date Onset Date F 21-Sep-2010 30-Oct-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Grand mal convulsion
Days 39
Status Date State Received Date 11-Feb-2011 WI 02-Feb-2011 Lot Prev Doses Site 0819Y 1 Unknown AC52B045BA Unknown
Symptom Text: Witnessed tonic clonic seizure. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None EEG & MRI head & labs confirm seizure None Post strep infection


Page 218
Vaers Id: 416078-1 Age Gender Vaccine Date Onset Date F 30-Nov-2010 06-Jan-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Condition aggravated, Convulsion
Days 37
Status Date State Received Date 11-Feb-2011 WI 02-Feb-2011 Lot Prev Doses Site 0819Y 0 Unknown
Symptom Text: (1) Unwitnessed seizure. Found down on bedroom floor by parents. (2) Second seizure since 1st on 10.30.2010. Pt now began on LAMICTAL. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Had 1st seizure 10.30.10 Post non group strep


Page 219
Vaers Id: 416090-1 (O) Age Gender Vaccine Date Onset Date F 04-Oct-2010 08-Oct-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 4
Status Date State Received Date 04-Feb-2011 FR 03-Feb-2011 Lot Prev Doses Site NULL 0 Left arm
Hypersensitivity, Pruritus, Skin reaction, Urticaria
Symptom Text: This case was received from a physician. This case is medically confirmed. A 14 year old female patient born in 1996 with an unreported medical history and concomitant medications, received the first dose of GARDASIL (Batch# not reported), route and site not reported, three weeks prior to reporting in October 2010 and four days later experienced an allergic reaction with wheals and hives. The patient went to the hospital and received corrective treatment with PIRITON tablets and CHLORPHENAMINE injections. The patient recovered and there was no overnight stay. The physician arranged for an allergy test one week later and the results showed that the patient was allergic to nothing and the physician thought that the patient had a reaction to GARDASIL. The patient was not to continue with the course of GARDASIL. Follow up information received from the initial reporter on 02-DEC-2010. The patient was 13 year old (not 14 as initially reported). The patient had no history of note, no reaction to previous vaccines or drugs and was not taking any concomitant medication. The patient received the GARDASIL IM in the left arm on 04-OCT-2010. 08-OCT-2010, four days post vaccination, the patient experienced a skin reaction and allergy. The patient had hives and was itching ++. The patient was given antihistamines and steroids for five days and recovered on 12-OCT-2010. On 20-OCT-2010 the patient had IgE and radioallergosorbent (RAST) test both of which were nothing abnormal detected (NAD). The reporter stated that the events were moderate in severity, non-serious and probably caused by vaccination. Upon internal medical review the events were considered serious. Relevant Test/Laboratory Data on 20-OCT-2010: IgE - NAD, RAST - NAD. Other business partner numbers included: E2010-06543. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Serum multiallergen radioallergosorbent, 20Oct10, nothing abnormal detected; serum immunoglobulin E test, 20Oct10, nothing abnormal detected Unknown


Page 220
Vaers Id: 416091-1 (S) Age Gender Vaccine Date Onset Date Days F 28-Sep-2010 25-Oct-2010 27 12.0 Type Manufacturer VAX Detail: FLU UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS Pain, Pain in extremity
Status Date State Received Date 04-Feb-2011 CA 03-Feb-2011 Lot Prev Doses Site NULL Unknown NULL 0 Unknown
Mfr Report Id Last Edit Date WAES1011USA03651 04-Feb-2011 Other Vaccine Route Unknown Intramuscular
Symptom Text: Information has been received from a physician concerning a 12 year old female patient with asthma who on 28-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported). Concomitant therapy given on the same day included a INFLUENZA vaccine (unspecified). The physician stated that the patient came to his office on 25-OCT-2010 with systemic right side pain down to her legs and was admitted to an unspecified hospital for three days, where upon discharge symptoms resided. It was also reported that on 28-OCT-2010 the patient recovered from all these symptoms and the sequence of GARDASIL was discontinued, after the first dose was administered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma Unknown Unknown


Page 221
Vaers Id: 416092-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 04-Feb-2011 US 03-Feb-2011 Lot Prev Doses Site NULL Unknown
Central venous catheterisation, Chemotherapy, Hodgkins disease, Lymphadenopathy, Oophorectomy
Symptom Text: Information has been received from the Aunt of an 18 year old female consumer who on an unspecified date was vaccinated, IM with a dose of GARDASIL (dosage not provided) for the prevention of cervical cancer. It was reported that, on an unspecified date, the patient "developed an enlarged lymph node on the left side, supra clavicular, which was diagnosed as infected lymph node at first. She was given an antibiotic. But later went to the ER and found out she had cancer stage 3 Hodgkins lymphoma type D. It was a 3cm lymph node from the right axilla", requiring chemo, portacath and bone marrow biopsy. It was reported the patient also had a chest x-ray, cat scan w/ contrast, a PETscan, blood work and had an ovary removed to harvest an egg. At the time of the report, the patient had not recovered. Upon internal review, cancer stage 3 Hodgkins lymphoma type D was determined to be an other important medical event. Additional information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 222
Vaers Id: 416102-1 Age Gender Vaccine Date Onset Date F 19-Jan-2011 19-Jan-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Crying, Pain in extremity
Days 0
Status Date State Received Date 14-Feb-2011 TX 03-Feb-2011 Lot Prev Doses Site 10181207862 1 Left arm
Symptom Text: Severe pain on left arm. Patient was crying uncontrollably that mother had to call 911 and take her by EMS. However, records from the hospital ER where she was treated did not reflect the magnitute of symptoms mother was describing. She was discharged on Motrin for pain only. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Patient was seen twice after the incident. Because of persistent symptoms and conflicting reports of areas of pain, she was referred to neurologist on 01/31/2011. MRI of her left arm is pending at this time. Migraine headaches No


Page 223
Vaers Id: 416104-1 Age Gender Vaccine Date Onset Date F 18-Jan-2011 19-Jan-2011 11.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 14-Feb-2011 AZ 03-Feb-2011 Lot Prev Doses Site C3448AA 0 Left arm 0786Z 0 Right arm U3430AA 0 Right arm
Symptom Text: (R) local deltoid swelling with erythema onset yesterday 1/19/11 vax given 1/18/11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic rhinitis Allergic rhinitis


Page 224
Vaers Id: 416116-1 (O) Age Gender Vaccine Date Onset Date F 27-Jul-2009 28-Feb-2010 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 216
Status Date State Received Date 04-Feb-2011 NY 03-Feb-2011 Lot Prev Doses Site 1312X 2 Unknown
Drug exposure before pregnancy, Live birth, Pre-eclampsia, Premature labour
Symptom Text: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning an 20 year old female with 1 previous pregnancy including 1 spontaneous abortion (miscarriage) and no medical history or concurrent condition who was vaccinated with the third dose of GARDASIL (lot # 661846/1312X) on 27-JUL-2009 then became pregnant. Concomitant medication included PLAN B. Her estimated conception date was 10-AUG-2009 (LMP: 27-JUL-2009, EDD: 03-MAY-2010). Method of confirmation was unknown. Follow up information was received which reported that on 18-NOV-2009, 17-DEC-2009 and 05-JAN-2010, the patient underwent routine ultrasound and results revealed normal. On 28-FEB2010, at 28 weeks from LMP, the patient delivered a liveborn infant with unspecified congenital anomaly (also reported normal). During labor/delivery, the patient experienced pre-eclampsia. It was also reported that the patient received PROCARDIA during this pregnancy for an unspecified indication. Upon internal review, infant born at 28 weeks from LMP was considered to be an other important medical event. Unspecified congenital anomaly was reported for the baby. The baby's experience has been captured in WAES 0909USA02628B1. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PLAN B 0.75 mg ultrasound, 11/18/09, routine-normal; ultrasound, 12/17/09, routine-normal; ultrasound, 01/05/10, routine-normal Miscarriage


Page 225
Vaers Id: 416117-1 (O) Age Gender Vaccine Date Onset Date F 27-Jul-2009 Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Congenital anomaly, Premature baby
Days
Status Date State Received Date 04-Feb-2011 NY 03-Feb-2011 Lot Prev Doses Site 1312X 2 Unknown
Mfr Report Id Last Edit Date WAES0909USA02628B 06-May-2011 1 Other Vaccine Route Unknown
Symptom Text: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a baby whose mother was an 20 year old female with 1 previous pregnancy including 1 spontaneous abortion (miscarriage) and no medical history or concurrent condition who was vaccinated with the third dose of GARDASIL (lot# 661846/1312X) on 27-JUL-2009 then became pregnant. Concomitant medication included PLAN B. The mother's estimated conception date was 10-AUG-2009 (LMP: 27-JUL-2009, EDD: 03-MAY-2010). Method of confirmation was unknown. On 18-NOV-2009, 17-DEC-2009 and 05-JAN-2010, the mother underwent routine ultrasound and results revealed normal. On 28-FEB-2010, at 28 weeks from LMP, the mother delivered a liveborn infant with unspecified congenital anomaly (also reported normal). Upon internal review, infant born at 28 weeks from LMP was considered to be an other important medical event. The mother's experience has been captured in WAES 0909USA02628. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Miscarriage


Page 226
Vaers Id: 416118-1 (S) Age Gender Vaccine Date Onset Date F Unknown 01-Jan-2009 10.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT LIFE THREATENING, SERIOUS Adverse reaction
Days
Symptom Text: Information has been received from a nurse practitioner concerning a 10-12 years old female patient who on an unspecified date was vaccinated with GARDASIL (lot # not reported). In January 2009 ("2 years ago"), the patient experienced systemic reaction. The vaccination with GARDASIL was discontinued and not reintroduced. Subsequently, the patient recovered from systemic reaction. Systemic reaction was considered to be immediately lifethreatening by the reporter. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 227
Vaers Id: 416119-1 (O) Age Gender Vaccine Date Onset Date F 17-May-2010 01-Aug-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Anogenital warts, Wart excision
Days 76
Status Date State Received Date 04-Feb-2011 FR 03-Feb-2011 Lot Prev Doses Site NJ39100 0 Unknown
Symptom Text: Information has been received from the agency via a Case Line Listing and regulatory form via CSL, concerning a 14 year old female patient with known allergy and other medical conditions and a history of being immunocompromised due to chemotherapy and radiotherapy for Ewing's sarcoma (unknown status of this condition), who on 17-MAY-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # NJ39100, batch # NK44150). In August 2010, the patient developed perianal genital warts requiring excision after receiving a GARDASIL. At the time of reporting, the patient's outcome was unknown. The agency felt that the causality between genital warts and the therapy with GARDASIL was unknown. The event was considered requiring medical intervention to prevent harm by the agency. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Ewing's sarcoma; Chemotherapy; Radiotherapy


Page 228
Vaers Id: 416120-1 (S) Age Gender Vaccine Date Onset Date F 25-Aug-2010 01-Sep-2010 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Angioedema, Arthralgia, Urticaria
Days 7
Status Date State Received Date 04-Feb-2011 FR 03-Feb-2011 Lot Prev Doses Site 1521X Unknown
Symptom Text: Information has been received from an agency via CSL concerning a 19 year old female patient with known allergy listed (no details provided) who developed serum-sickness-like disorder (severe) after vaccination with a 0.5 ml dose of GARDASIL (Batch# NM07130; Lot# 1521X), IM on 25-AUG2010. Secondary suspect therapy included fluoxetine used for an unknown indication (continuing). "The patient reportedly presented to department of emergency and was admitted with sudden onset of urticaria angioedema and arthralgia about 22 days after GARDASIL vaccination. On careful immunology service review, no more temporally immediate participating agents were identified and, with the presence of arthralgia and duration to onset, was considered to be a possible serum sickness-like event (severe) following the GARDASIL exposure." The patient was reported to have been hospitalized on an unknown date. The event reportedly commenced on an unknown date in September 2010 and had subsequently resolved without sequelae. The agency considered that the event Serum sickness-like disorder was possibly related to therapy with GARDASIL. No further information is available. No follow-up is possible. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Hypersensitivity Unknown Unknown


Page 229
Vaers Id: 416121-1 (S) Age Gender Vaccine Date Onset Date F 04-Sep-2010 04-Sep-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Angioedema, Clonus, Coordination abnormal, Dizziness, Dyspnoea, Erythema, Neurological symptom, Rash erythematous, Reaction to previous exposure to any vaccine, Visual impairment
Symptom Text: Information has been received from a physician specialist concerning a 15 year old female patient with history of myalgia and fatigue after receiving the first dose of GARDASIL (Lot # NJ49350 and Batch # NL35360) and microcystic ovarian dystrophia who on 04-SEP-2010 was vaccinated with the second dose of GARDASIL (Lot # NJ49370 and Batch # NL53400). One hour after vaccination, the patient experienced neurological syndrome associated with coordination disorders, dizziness, clonism and visual trouble. The symptoms spontaneously resolved within a few hours, consequently the physician did not report the events. The general practitioner did not want to administer the third dose. On 07-OCT-2010, the patient developed dermatologic troubles characterized by erythematous rash at the level of the neck, chin and low neck (2 red stripes of "V" shape), and respiration labored. Sclerodema was suspected then ruled out after cutaneous biopsy and immunitary work-up. The event was reported to a Centre. On 19-JAN-2010, she was found to have a Quincke's oedema after eating paella. She was led to the Emergency Unit Care and was hospitalized for a few hours. She was seen again on 20-JAN-2011 by the physician. She was all right except for a redness which persisted between the neck and low-neck. Complementary allergological investigations were planned. This is one of several cases concerning the same patient (WAES # 1101USA03561). No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Skin biopsy, sclerodema was suspected then ruled out after cutaneous biopsy and immunitary work-up Myalgia; Fatigue Ovarian disorder


Page 230
Vaers Id: 416151-1 Age Gender Vaccine Date Onset Date F 02-Feb-2011 02-Feb-2011 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Flushing, Rash
Days 0
Status Date State Received Date 14-Feb-2011 KY 03-Feb-2011 Lot Prev Doses Site 0786Z 1 Right arm
Symptom Text: Rash to upper chest, flushed cheeks, lightheaded BENADRYL 50mg PO pt received DEPO PROVERA injection just prior to vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ROBITUSSIN DM; HYDROXYCUT; Water pills with caffeine


Page 231
Vaers Id: 416156-1 Age Gender Vaccine Date Onset Date F 01-Feb-2011 01-Feb-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEP MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Cyanosis, Loss of consciousness
Days 0
Status Date State Received Date 14-Feb-2011 GA 03-Feb-2011 Lot Prev Doses Site 0664Z 1 Left arm 1024Y 3 Right arm
Symptom Text: Client was given DEPO by RN then seen by LPN to complete assessment for other vaccines. Approximately 10 minutes after DEPO, client received Hepatitis B and GARDASIL. Client was in immunization room approx 30 minutes and left clinic without incident. Mom called at 2:30 pm to state daughter had reaction after leaving clinic and was transported by ambulance to hospital. Mom stated client "turned blue & passed out". Mom stated ER gave her "nausea medication" & follow up with M.D. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None; Medroxy progesterone Unknown


Page 232
Vaers Id: 416193-1 Age Gender Vaccine Date Onset Date F 02-Feb-2011 02-Feb-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Days 0
Status Date State Received Date 14-Feb-2011 OH 04-Feb-2011 Lot Prev Doses Site NULL 0 Left arm
Symptom Text: About 5 minutes after receiving the Gardasil vaccine, I passed out. I was given water and I stayed seated for about 15 minutes afterwards. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Mitral valve prolapse as a child None


Page 233
Vaers Id: 416209-1 Age Gender Vaccine Date Onset Date U 25-Jan-2011 26-Jan-2011 10.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Local reaction, Swelling
Days 1
Status Date State Received Date 14-Feb-2011 CA 04-Feb-2011 Lot Prev Doses Site 0768Z Left arm U3676AA Right arm AC52B057CA Right arm
Symptom Text: Local redness & swelling onset 48 hr after vaccine (largely reversed in clinic 1/27 single EPI 0.3ml SQ). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None No


Page 234
Vaers Id: 416246-1 Age Gender Vaccine Date Onset Date F 31-Jan-2011 03-Feb-2011 11.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 3
Status Date State Received Date 04-Feb-2011 NY 04-Feb-2011 Lot Prev Doses Site U3639CA Left arm 0768Z Right arm U3476AA Right arm C3475AA Left arm
Erythema, Oedema peripheral, Pruritus, Skin lesion, Urticaria
Symptom Text: CHILD DEVELOPED AN URTICARIAL RASH AND COMPLAINED OF SWOLLEN HANDS AND FEET, NURSE FROM SCHOOL SUGGESTED MAY BE VACCINES. WHEN EXAMINED FEW RED ITCHY ELEVATED LESION, NO SWOLEN FEET OR HANDS. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BENADRYL GIVEN AT SCHOOL AND BY MOTHER TOTAL TWO DOSES. TODAY STARTED IN CLARITIN NONE BY HISTORY CHILD HAD URTICARIAL RASH AFTER EATING CHEESE LAST SUMMER CONGESTED NOSE


Page 235
Vaers Id: 416247-1 Age Gender Vaccine Date Onset Date M 04-Feb-2011 04-Feb-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS HEP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 14-Feb-2011 CO 04-Feb-2011 Lot Prev Doses Site 0768Z 0 Left arm AHAVB469AA 0 Right arm AHBVB836AA 0 Right arm
Convulsion, Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor
Symptom Text: Client received 3 vaccines, immediately following vaccine #3, client lost consciousness and began to seize. Reaction lasted approximately 30 seconds. Client then regained consciousness and began feeling nauseated and appeared pale. Client provided with juice, and nausea dissipated and client regained normal coloring. Client instructed to wait in waiting room for 15 minutes before leaving clinic. Instructed to call with recurring side effects or questions. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None aware of None


Page 236
Vaers Id: 416251-1 Age Gender Vaccine Date Onset Date M 02-Feb-2011 03-Feb-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 14-Feb-2011 IA 04-Feb-2011 Lot Prev Doses Site 0786Z 2 Left arm
Injection site erythema, Injection site induration
Symptom Text: Patient and his mother complain that muscle where arm was injected is "hard". School nurse examined pt on 02/04/11 and said the upper arm was slightly "pink" in an area of 1-1/4" x 1-1/2 " and firmer than his other arm in an area of 2-1/2 x 2". Nurse assessing the complaint says it is a minor reaction. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none no


Page 237
Vaers Id: 416288-1 (O) Age Gender Vaccine Date Onset Date F 28-Dec-2010 Unknown 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 08-Feb-2011 AZ 07-Feb-2011 Lot Prev Doses Site 0922Z 2 Unknown
Symptom Text: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient who on 28-DEC2010 was vaccinated with a third dose of GARDASIL (Lot # reported as 0922Z; Exp date in October 2012 (valid for VARIVAX (Merck)). The physician stated that the patient received GARDASIL and was discovered that the patient might be pregnant by urine test. The patient had been taking oral contraceptives and wanted to switch to an intrauterine device (IUD). The pregnancy test was run twice and both times was positive. No adverse effects were reported. Follow up information has been received from the physician concerning the female patient. Concomitant medication used during the patient's pregnancy included CYTOTEC, "200 microgram, every 8 hours, 3 times a day for aid in termination". It was reported that on an unspecified date, the patient underwent elective termination. The products of conception were not examined. It was unknown if the fetus was normal. Upon internal review elective termination was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) hormonal contraceptives; CYTOTEC 200 microgm urine beta-human, 12/28?/10, positive twice time


Page 238
Vaers Id: 416319-1 Age Gender Vaccine Date Onset Date F 16-Dec-2010 16-Dec-2010 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Vision blurred
Days 0
Status Date State Received Date 15-Feb-2011 AZ 07-Feb-2011 Lot Prev Doses Site 1016Z 0 Left arm
Symptom Text: Pt called 2/7/11 to state she has had blurred vision in (R) eye since shot administered on 12/16/10. Advised today to see optometrist for vision check. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 239
Vaers Id: 416348-1 Age Gender Vaccine Date Onset Date F 23-Nov-2010 Unknown 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MMR MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy
Days
Status Date State Received Date 15-Feb-2011 GA 07-Feb-2011 Lot Prev Doses Site 0597Z 0 Right arm 0406Z 1 Left arm
Mfr Report Id GA11003 Route Intramuscular Subcutaneously
Symptom Text: None - Phone from client 1 1/2 wks later stating she had a blood test & is early pregnant. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 240
Vaers Id: 416355-1 (O) Age Gender Vaccine Date Onset Date F 07-Dec-2010 07-Dec-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Asthenia, Nausea, Pain in extremity
Days 0
Status Date State Received Date 09-Feb-2011 FR 08-Feb-2011 Lot Prev Doses Site NK44350 1 Unknown
Symptom Text: This cluster case was received from a physician on 01-FEB-2011. This is one of a cluster of five cases (same reporter, same batch) and was linked with E2011-00643, E2011-00646, E2011-00650, E2011-006995. This case was medically confirmed. A 15 year old female patient with a history of controlled asthma and being nervous pre-vaccination, and no concomitant medication, received dose two of GARDASIL (Batch # NN01990, Lot # NK44350, expiry in May 2012) IM, 0.5 mL, on 07-DEC-2010 in the morning. On 07-DEC-2010, post vaccination, the patient felt weak, and nauseated and had a sore arm. The patient's vital signs were monitored and were BP 120/71 and pulse 106. The patient was placed flat with her legs elevated. The patient was reassured. The patient took her own NUROFEN for the sore arm. The patient recovered completely on 07-DEC-2010 in the afternoon after a few hours. The events were described as mild. The events were also reported to the IMB. Upon internal medical review the event were considered to be medically significant. Other business partner numbers included E2011-00648. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma Unknown Blood pressure measurement, 07Dec10, 120/71; Total heartbeat count, 07Dec10, 106


Page 241
Vaers Id: 416356-1 (O) Age Gender Vaccine Date Onset Date F 15-Nov-2010 15-Nov-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Anxiety, Dizziness, Dyspnoea
Days 0
Status Date State Received Date 10-Feb-2011 FR 08-Feb-2011 Lot Prev Doses Site NK44350 Unknown
Symptom Text: Information has been received from the Health authority under the reference number: 2011-001792. This case is medically confirmed. A 12 year old female patient with a history of asthma received a dose of GARDASIL (Batch # NN01990, Lot # NK44350) intramuscularly, site not reported, on 15NOV-2010. On 15-NOV-2010, the same day as the vaccination, the patient experienced light headedness, breathlessness and was anxious. The patient's medical history included asthma and received treatment with VENTOLIN as required at home. On 15-NOV-2010, post vaccination, the patient returned to the recovery area in school complaining of a light headedness, breathlessness and was anxious. The patient received corrective treatment with VENTOLIN, which was administered with good effect. The patient improved greatly and with further reassurance and discharged back to class. At the time of reporting, the patient had recovered. The IMB considered the events to be serious due to other medically important condition which required intervention. Other business partner numbers included E2011-00560. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma VENTOLIN Unknown


Page 242
Days 0
Eye pruritus, Ocular hyperaemia, Pruritus, Rash
Symptom Text: This case was received from the health authority on 27-JAN-2011. Ref 2011-001793. This case is medically confirmed. A 12 year old female patient with an unknown medical history and concomitant medication received the second dose of GARDASIL (batch# NM46680, Lot# NK44350) IM 0.5 ml on 09-DEC-2010. On 09-DEC-2010, three hours post vaccination, the patient experienced itchy red eyes, rash inside elbows and itchy wrists and a rash under the skin on her face and arms. Corrective treatment included PIRITON 4 mg tablets and prednisolone 30 mg. The patient recovered on an unreported date. The events were considered medically significant as they required intervention. Other business partner numbers included: E201100556. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 243
Vaers Id: 416358-1 (O) Age Gender Vaccine Date Onset Date F 22-Nov-2010 22-Nov-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chest discomfort, Dizziness, Nausea
Days 0
Status Date State Received Date 09-Feb-2011 FR 08-Feb-2011 Lot Prev Doses Site NK44350 Left arm
Symptom Text: This case was received from a health authority on 27-JAN-2011. Agency ref 2011-001791. This case is medically confirmed. A 13 year old female patient with a medical history of being asthmatic and no risk factors available and with no concomitant medication received an IM 0.5 ml injection of GARDASIL (batch# NN01990; lot# NK44350) in the left deltoid on 22-NOV-2010, post vaccination, the patient experienced slight chest tightness, dizziness and nausea. No inhaler was used to treat the patient's slight chest tightness. The patient was given a glucose drink and biscuit and was put lying on the mat with her legs elevated. The patient was seen by assistant medical officer (AMO) for the slight chest tightness. The patient's color was normal, there was no distress, respiratory rate was normal, chest was clear and there was no wheeze. The patient's pulse was 80 regular and strong. The patient was reassured and returned to class well. At the time of reporting the patient had recovered. The events were considered medically significant as they required intervention. Other business partner numbers included: E2011-00553. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma None Pulse oximetry, 22Nov10, 80, regular and strong.


Page 244
Vaers Id: 416359-1 (O) Age Gender Vaccine Date Onset Date F 14-Jul-2010 14-Jul-2010 36.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Gait disturbance, Muscular weakness, Syncope
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # and route not reported). After the vaccine administration the patient moderate faint. At the time of the report, the outcome of the patient was not reported. Follow up information has been received from a physician. It was reported that the approximately 36 year old patient was vaccinated with the second dose of GARDASIL (lot number not provided) on 14-JUL-2010. On 10-JAN-2011 the patient was vaccinated with the third dose of GARDASIL (lot number not provided). Concomitant therapy included magnesium (unspecified) and BRUFEN. It was reported that after the second and third administration of GARDASIL (on 14-JUL-2010 and 10-JAN-2011) the patient experienced moderate faint, muscle weakness and problems with walking. On 12-JAN-2011 the patient recovered. It was unspecified if the patient sought medical attention. The physician considered that moderate faint, muscle weakness and problems with walking were related to therapy with GARDASIL. The physician considered moderate faint, muscle weakness and problems with walking to be medically significant. No further information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BRUFEN; Magnesium (unspecified) Unknown Unknown


Page 245
Vaers Id: 416360-1 (S) Age Gender Vaccine Date Onset Date F 03-May-2010 25-May-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 22
Abdominal pain, Arthralgia, Haematuria, Henoch-Schonlein purpura, Vasculitic rash
Symptom Text: Information was obtained on a request by the company from the agency via a Case Line listing and regulatory form via CSL, concerning 14 year old female patient who on 03-MAY-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (batch #NK20450, lot # NJ29430). On 25-MAY-2010 the patient experienced Henoch-Shonlein purpura. The patient was presented to ED about 3 weeks after the first dose of GARDASIL with vasculitic rash, abdominal pain, arthralgia and microscopic haematuria and was hospitalized overnight. She went on to receive the second dose of GARDASIL -no subsequent AE report submitted and therefore presumed to be without event. On an unspecified date the patient recovered without sequelae from henoch-shonlein purpura. The causality assessment had been reported as "possible" by agency. The event was considered serious due to hospitalisation and was reported as severe in nature. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 246
Vaers Id: 416361-1 (S) Age Gender Vaccine Date Onset Date F 07-May-2009 Unknown 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days
Status Date State Received Date 09-Feb-2011 FR 08-Feb-2011 Lot Prev Doses Site 1283U 2 Unknown
Condition aggravated, Fall, Injury, Loss of consciousness, Syncope, Temperature intolerance
Symptom Text: Information has been received from the agency via a Case Line Listing and regulatory form via CSL concerning an 18 year old female with known allergies (no details provided) and "other medical conditions" (no details provided) who on 07-May-2009 was vaccinated IM with the third 0.5 mL dose of GARDASIL (lot # 1283U, batch # NJ11440), and on an unspecified date placed on therapy of budesonide (+) formoterol fumarate daily by inhalation and albuterol as needed by inhalation. The patient was reported to be taking nutritional supplements (unknown details). On an unspecified date the patient had had frequent sudden loss of consciousness of up to 3-4 minutes at times also with heat indolence especially over the summer months which began about a month after the first dose of GARDASIL. The patient had the second and the third dose of GARDASIL. The episodes had persisted, becoming more frequent as months progressed. The patient had had cardiac and neurological investigation including MRI and ECG/Holter monitor, but neither had identified any pathology. Neurological report notes that the syncopal episodes did not have associated seizure-like activity and there was no incontinence. The syncopal spells were also of sudden nature with no warning to take precautionary measures to mitigate falls and had resulted in injury. The event had not yet resolved at the time of reporting. The patient's mother and uncle were reported to have similar sudden syncopal episodes (especially the uncle), when they were young. No information as to whether familial QT prolongation had been considered or investigated for. The severity of the event was reported as "severe" and causality had been unclassified. The agency felt that that frequent sudden loss of consciousness of up to 3-4 minutes at times also with heat indolence and syncopal episodes were related to therapy with GARDASIL. The event is considered serious due to persistent disability criteria. This was originally reported by a GP (general practitioner). No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Magnetic resonance imaging, no pathology; Holter monitoring, no pathology; Electrocardiogram, no pathology Familial risk factor; Syncope; Depressed level of consciousness Hypersensitivity


Page 247
Vaers Id: 416362-1 (O) Age Gender Vaccine Date Onset Date F 16-Nov-2010 17-Jan-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 62
Hypersensitivity, Injection site erythema, Injection site reaction, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician via phone concerning a female patient who on unspecified dates, was vaccinated with the first and the second dose of GARDASIL (lot# not reported) respectively. The patient got GARDASIL twice. After the administration of first vaccinate, the patient had allergic reaction in site of administration. After second vaccine administration the again moderate allergic reaction occurred, antihistamine therapy by orally was required. At the time of reporting, the outcome of the event was unknown. Follow-up information has been received from the physician via email concerning the 13 year old female patient who on 17-JAN-2011 the patient was vaccinated with the second dose of GARDASIL (batch# NN4410). Concomitant therapy included DITHIADEN. After the administration of first vaccinate of GARDASIL (batch# NM10370), the patient had allergic reaction in site of administration - erythema of the skin in the administration site, after second vaccine administration - erythema of the skin (diameter about 10 cm) on 17-JAN-2011. No systemic allergic reaction occurred. On 20-JAN-2011, the patient was placed on therapy with ZODAC 10 mg once a day and triamcinolone cream for treatment of the local allergic reaction. All described symptoms disappeared in approximately 5 days on 22-JAN-2011. It was unspecified if the patient sought medical attention. The reporter considered that allergic reactions in site of administration were related to therapy with GARDASIL. The allergic reaction in site of administration was considered to be an other important medical event by the physician. No further information expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DITHIADEN Unknown Unknown


Page 248
Vaers Id: 416363-1 (O) Age Gender Vaccine Date Onset Date F 15-Oct-2009 29-Apr-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 196
Status Date State Received Date 09-Feb-2011 US 08-Feb-2011 Lot Prev Doses Site 1350Y Unknown
Mfr Report Id Last Edit Date WAES0912USA01991B 22-Feb-2011 1 Other Vaccine Route Unknown
Drug exposure during pregnancy, Foetal disorder
Symptom Text: Information has been received from a registered nurse concerning a 1 day old male patient whose mother was exposed to GARDASIL during pregnancy. It was reported that the patient was born, weight 6 lb 5.9 oz, APGAR (Appearance, Pulse, Grimace, Activity, Respiration.) score 8/9. The baby experienced intrauterine growth retardation and umbilical mass (also reported infant normal). At the time of the report, the patient's outcome was unknown. Upon internal review, umbilical mass was considered to be a congenital anomaly. The mothers experience has been reported in WAES # 0912USA01991. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Heartburn; Ringworm NOS Lotrisone; PRILOSEC; ZANTAC Unknown


Page 249
Days 1
Status Date State Received Date 17-Feb-2011 NJ 08-Feb-2011 Lot Prev Doses Site NULL 1 Left arm
Abdominal pain upper, Arthralgia, Lymphadenopathy
Symptom Text: severe stomach ache, gland swelling, joint pain after receiving Gardasil vaccine Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none blood work, appointments with ophthalmologist and pediatrician none no


Page 250
Vaers Id: 416426-1 Age Gender Vaccine Date Onset Date F 20-Dec-2010 20-Dec-2010 14.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 09-Feb-2011 CA 08-Feb-2011 Lot Prev Doses Site U3644CA Right arm 0768Z 0 Right arm U3441BA 1 Left arm 1106Z 1 Right arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Subcutaneously
Anxiety, Complication of pregnancy, Drug exposure during pregnancy
Symptom Text: Pt came to clinic 1 m prior to pregnancy test. The following information was obtained through follow-up and/or provided by the government. 02/14/2011 PCP office records received for DOS 12/20/10, 01/20/2011 and 01/24/2011. Patient seen on 12/20/10 for c/o back pain x2wks. Patient noted that she stretches a lot with exercise and thinks pain may be due to the exercise. Examination noted paraspinal spasm to lower back. Motor, sensory and reflexes were normal. Urinalysis was normal. Assessment: Back pain and spasm of muscle. Given vaccinations on 12/20/10. Patient seen on 01/20/2011 to obtain referral to OB/GYN and patient worried that shots received while pregnant could affect baby. Patient reported that last period was Nov 29, 2010 and home pregnancy test was positive. Examination was normal. Patient seen 01/24/2011. Office record noted patient found out she is two months pregnant and received shots one month ago. Brief normal exam. Assessment: Pregnancy complications, NEC-unspecified (646.80). Plan: patient to pick up lab slip in front office to check urine for pregnancy. F/U PRN. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Per patient took 3 home pregnancy tests. NK The following information was obtained through follow-up and/or provided by the government. 02/14/2011 records received. History: Pregnant, Back pain. NK The following information was obtained through follow-up and/or provided by the government. Back pain.


Page 251
Vaers Id: 416434-1 (S) Age Gender Vaccine Date Onset Date F 03-Nov-2010 11-Nov-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Condition aggravated, Convulsion
Days 8
Symptom Text: Information has been received from a pharmacist on 28-JAN-2011. Case medically confirmed. A 15 year old female patient had received the first dose of GARDASIL (Batch # not reported) on 03-Nov-2010 and a few days later, on 11-NOV-2010, she developed convulsive seizures. The seizures recurred and she was admitted to hospital for investigations. A diagnosis of grand mal or petit mal was suspected. She was put on antiepileptics. Since the treatment was stopped in December 2010, the patient had still experienced convulsive seizures. The patient had a medical history of convulsion during childhood with no treatment. At the time of reporting, the patient had not recovered. Other business partner numbers included E2011-00551. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Convulsion


Page 252
Vaers Id: 416435-1 (O) Age Gender Vaccine Date Onset Date F 01-Nov-2009 01-Nov-2009 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Epilepsy, Haemorrhage, Tongue biting
Days 0
Symptom Text: Information has been received from a lawyer concerning a female patient who had received the first dose of GARDASIL (batch number not reported) in November 2009 and the following day, she was found on the floor being covered with blood and with the bitten tongue. She received the second dose of GARDASIL (batch number not reported) in January 2010. At the time of reporting her epileptic symptom seemed to persist. The patient's outcome was not provided. Epilepsy was considered to be an other important medical event by the reporter. Case non medically confirmed. Other business partner numbers include: E2011-00582. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 253
Vaers Id: 416436-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cervical conisation
Days
Symptom Text: Information has been received from a physician on 27-JAN-2011. Case medically confirmed. A 20 year old female patient underwent a conisation after she had received the third dose of GARDASIL, (batch number not reported) on an unspecified date. She had received the three doses of GARDASIL (batch number not reported) at the age of 17. She had had no sexual activity before or during the vaccination protocol. The patient's outcome was not reported. Other business partner numbers included E2011-00572. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 254
Vaers Id: 416437-1 (O) Age Gender Vaccine Date Onset Date F 01-Aug-2010 01-Dec-2010 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 122
Status Date State Received Date 10-Feb-2011 HI 09-Feb-2011 Lot Prev Doses Site NULL 1 Unknown
Abortion spontaneous, Drug exposure before pregnancy
Symptom Text: Information has been received from a consumer for GARDASIL a Pregnancy Registry product, who in approximately August 2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# not reported) and in approximately November 2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot# not reported). The consumer stated that she became pregnant around September 2010. LMP (last menstrual period) was approximately in September 2010. EDD (estimated date of delivery) was on 08-JUN-2011 and then she experienced a miscarriage around December 2010. She also stated that she felt fine. Therapy with GARDASIL was discontinued. At the time of the report, the consumer recovered. The consumer did not seek medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 9/1/2010) Unknown Unknown


Page 255
Vaers Id: 416438-1 (O) Age Gender Vaccine Date Onset Date F 01-Apr-2009 Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 10-Feb-2011 TN 09-Feb-2011 Lot Prev Doses Site 1496X Unknown
Acrochordon, Congenital naevus, Drug exposure during pregnancy
Symptom Text: Information has been received from a nurse concerning a 21- year-old female patient with a medical history of papanicolaou smear abnormal who on 01-APR-2009 was vaccinated with GARDASIL (Lot # 661954/1496X). There were no concomitant medications. The patient had recently become pregnant. She found out she was pregnant on 01-JUN-2009. This information was previously reported in WAES 0906USA00715. Follow up information was received from the licensed practical nurse, via medical record reported that on 13-JAN-2010 the 22 year old female patient delivered a normal female infant without any congenital anomaly. The abnormal lab data for the mother is Chlamydia positive. The lab data for the baby is apgar score 9 for 1', 9 for 5', birth weight 3391 gms, length 52.1 cm, OFC 33.17 cm, Hgb 12.9/37.2 to 11.8/39.0, skin exam showed mongoliem on buttracks, head fontanets exam showed molding, eyes showed b/c kk, chest lungs exam showed small left nipple skin tag, GU exam showed large labra, spine/back exam showed closed sacral dimple. The baby was vaccinated with a dose of hepatitis vaccine on 13-JAN-2010 and was discharged on 14-JAN-2010, discharged weight was 3222 gms. Upon internal review, mongoliem on buttrack was considered to be a congenital anomaly. The mother's information was captured in WAES 0906USA00715. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Apgar score, 01/13/10, 9, 1'; Apgar score, 01/13/10, 9, 5'; Hemoglobin, 12.9/37.2; Hemoglobin, 11.8/39.0 Unknown


Page 256
Vaers Id: 416441-1 (S) Age Gender Vaccine Date Onset Date M 01-Feb-2011 01-Feb-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 0
Status Date State Received Date 14-Feb-2011 MD 09-Feb-2011 Lot Prev Doses Site 1167Z 2 Unknown
Abdominal pain lower, Abdominal pain upper, Appendicectomy, Appendicitis, Back injury, Endotracheal intubation, Endotracheal intubation complication, Extubation, Joint injury, Laparoscopic surgery, Laryngospasm, Obstructive airways disorder, Pulmonary arterial pressure, Pulmonary oedema
Symptom Text: Our son (13) began to complain of stomach pains the evening of Feb. 2, 2011. He had a very difficult night the night of 2/1-2/2/11. On Wed., Feb. 2, he was diagnosed with acute appendicitis at 4pm and had surgery at 9pm at Hospital. The surgery was laporoscopic and successful. The appendix had not ruptured. However, when his breathing tube was removed (late Wed. night, Feb. 2, 2011), his larynx spasmed, collapsed, blocked the airway, causing pressure to build up and fluid to be pushed into his lungs. He was released from the hospital on Friday, Feb. 4, 2011 and is now recovering at home. The following information was obtained through follow-up and/or provided by the government. 02/10/11. DC summary for DOS 02/02/11-02/04/11. DX: acute appendicitis. CC: abdominal pain radiating down to RLQ. U/S confirmed acute appendicitis (nonperforated). Intubated. After extubation, Pt went to laryngeal spasm and flash pulmonary edema. Oxygen applied. Treated with pain meds. Pt improved and discharged home. 02/10/11. ER report for DOS 02/07/11. DX: shoulder strain, back injury. S/p appendectomy. C/o pain in L shoulder, SOB, chest pain. Discharged home. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The following information was obtained through follow-up and/or provided by the government. Labs and DX studies: laparoscopic appendectomy; CXR normal, blood culture growth negative. Augmentin, Amoxycillin The following information was obtained through follow-up and/or provided by the government. PMH: adenoidectomy, tonsillectomy, pneumonia in Jan `11. Allergies: PCN. No.


Page 257
Vaers Id: 416472-1 Age Gender Vaccine Date Onset Date F 24-Jan-2011 24-Jan-2011 11.0 Type Manufacturer VAX Detail: IPV SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. HEP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dyskinesia, Loss of consciousness
Days 0
Status Date State Received Date 16-Feb-2011 IL 09-Feb-2011 Lot Prev Doses Site D10861 Left arm U3517AA 0 Left arm 1333Y 0 Left arm AHBVB836AA Left arm
Symptom Text: Had jerking movements and passed out about one minute after receiving HPV, MCV, Hep B & IPV. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 258
Vaers Id: 416491-1 Age Gender Vaccine Date Onset Date F 03-Jan-2011 05-Jan-2011 12.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS DTAP GLAXOSMITHKLINE BIOLOGICALS VARCEL MERCK & CO. INC. MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 2
Status Date State Received Date 14-Feb-2011 MS 09-Feb-2011 Lot Prev Doses Site AHAVB444BA 0 Left arm AC14B118AA 1181Z U3517AA 1377Y 5 1 0 0 Left arm Right arm Right arm Left arm
Activities of daily living impaired, Arthralgia, Body tinea, Condition aggravated, Fall, Gait disturbance, Guillain-Barre syndrome, Liver function test abnormal, Muscle strain, Muscular weakness, Myositis, Pain in extremity, Sensory loss, Vaccination complication, Wrong drug administered
Symptom Text: Guillain Barre complex after vaccines of Tdap, Hep A, GARDASIL, Varicella, MENACTRA on 1/3/11; falls started on 1/5/11 - total of seven to date. The following information was obtained through follow-up and/or provided by the government. 2/10/11. Consultant records DOS 1/31/11. CC: pain in legs, knees, feet. PE: full ROM, good muscular tone, strength 5/5. Referred to neurology et psychiatry. 2/18/11. PCP records DOS 1/3/11. Received vax. RTC 1/24/11. DX: Falls. CC: keeps falling, legs go out; pain to both legs from knee to foot, S/S started 1/5/11. Referred to neurologist. Returned for F/U on 2/7/11. DX: 1) myositis SP vax. 2) Elevated LFTs. 3) Tinea corporis. CC: falls continue. PE: weak BLEs, cannot lift against gravity. Referred to PT. 2/18/11. Consultant records DOS 2/1/11. DX: Lower extremity weakness. CC: progressive physical weakness noted in school, falling frequently, difficulty walking, difficulty getting up p fall; pain to bottom of feet. PE: minimally ambulatory, shuffling gait, subtle weakness to UEs, LE weakness L>R, unable to dorsiflex L foot. 3/3/11. ER records DOS 1/13/11. DX: Strain B knee. PE: NAD. DC home in stable condition. 3/3/11. ER records DOS 1/26/11. DX: none written. CC: no feeling in legs progressively worsened in past few months; episodes of legs going out when ambulating. PE: NAD. DC in stable condition to f/u c PCP, neurology. Other Meds: Lab Data: None W/u by neurologist ongoing & MRI of brain, CBC with diff, CMP, ESR, RF, ANA to be done 2/7/11 @ 0900. The following information was obtained through follow-up and/or provided by the government. 2/10/11. Consultant records. Xray knees: sunrise view of patella reveal skeletally immature pt. No abnormalities. 2/18/11. Labs/diagnostics. Albumin 3.6 g/dL (L), ALT 169 u/L (H), AST 186 u/L (H), CK 10,680 u/L (H). WBC 6.4 K/mm3 (N), neutr 54% (L), monos 10 (H). MRI brain WNL. 3/3/11. Labs/diagnostics. Nil new. 3/3/11. ER records. Xray bilateral knee: WNL. 5/17/11. Labs/diagnostics. NCV: nerve conduction study was WNL in all nerves tested. EMG: Fibrillation potentials & positive sharp waves present in all LLE muscles examined. Rapid recruitmen The following information was obtained through follow-up and/or provided by the government. 2/10/11. Consultant records DOS 1/31/11. Falling when walking, knees give and unable to get up, falls occur 1-2X/week; legs go flaccid et have no strength in lower extremities. Pt states falls occurring for ~ 2 months. NKDA. Atopic Dermatitis The following information was obtained through follow-up and/or provided by the government. 2/18/11. PCP records. Atopic dermatitis.
History:


Page 259
Vaers Id: 416499-1 (O) Age Gender Vaccine Date Onset Date F 23-Feb-2010 Unknown 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 11-Feb-2011 US 10-Feb-2011 Lot Prev Doses Site 0819Y Unknown
Symptom Text: Information has been received from a Licensed Visiting Nurse (L.V.N.) for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no medical history or drug allergies who on 23-FEB-2010 was vaccinated intramuscularly with a dose of GARDASIL (lot# 663558/0819Y). Concomitant therapy included TYLENOL. On 23-FEB-2010 the patient came into the office to get some lab exams and a pregnancy test. GARDASIL was ordered and given before the pregnancy result returned positive (about 7 weeks pregnancy). No adverse event occurred. It was unspecified if the patient sought medical attention. Follow-up information has been received from the L.V.N. via a voice mail reporting the patient had an "elective termination" on an unspecified date. Upon internal review, an "elective termination" was determined to be an other important medical event. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) TYLENOL beta-human chorionic, 02/23/10, positive


Page 260
Days
Neurogenic shock, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with two doses of GARDASIL (Lot # not reported). The physician reported that after each dose of GARDASIL the patient had a reaction with a vagal shock and different symptoms. It was unknown if the patient sought medical attention. At the time of the report the relationship between GARDASIL and vagal shock was unknown and, the patient's outcome was unknown. Upon internal review vagal shock was considered to be other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 261
Vaers Id: 416549-1 Age Gender Vaccine Date Onset Date F 31-Jan-2011 31-Jan-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site swelling, Pruritus, Urticaria
Days 0
Status Date State Received Date 16-Feb-2011 IL 10-Feb-2011 Lot Prev Doses Site 1539Y 2 Left arm
Symptom Text: Injection site slightly swollen, c/o hives on lower arms and legs "felt itchy inside". Symptoms persisted for 3 days. Treated with Benadryl. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: History of asthma Allergic to: Sulfa, Singulair, Pulmocort, Ciprodex None


Page 262
Vaers Id: 416554-1 Age Gender Vaccine Date Onset Date F 24-Jan-2011 02-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 9
Status Date State Received Date 16-Feb-2011 MI 10-Feb-2011 Lot Prev Doses Site 15602 1 Left arm
Rash, Urticaria, Vaccine positive rechallenge
Symptom Text: rash and hives Other Meds: Lab Data: History: Prex Illness: Also had rash after fist Gardasil given on 11/16/10 10 days later no no
Prex Vax Illns: rash~HPV (Gardasil)~1~12.08~Patient


Page 263
Vaers Id: 416571-1 Age Gender Vaccine Date Onset Date F 07-Feb-2011 08-Feb-2011 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Headache, Injection site pain
Days 1
Status Date State Received Date 16-Feb-2011 GA 10-Feb-2011 Lot Prev Doses Site U3474AA 0 Right arm AC52B049BA Left arm 08194 0 Right arm
Symptom Text: first noted headache ~24 hours after shots, along with left deltoid tenderness, acetaminophen no help. Worse during the night and the next m,orning so brought to my office at 8:00 AM Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: complete physical normal none none


Page 264
Vaers Id: 416592-1 Age Gender Vaccine Date Onset Date Days F 10-Feb-2011 10-Feb-2011 0 14.0 Type Manufacturer VAX Detail: FLUN MEDIMMUNE VACCINES, INC. PNC13 PFIZER\WYETH HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Injection site erythema, Scratch
Status Date State Received Date 14-Feb-2011 OR 10-Feb-2011 Lot Prev Doses Site 501059P Unknown 914517 0 Right arm 0597Z 0 Left arm U3439AA 0 Left arm 1140Z Right arm
Mfr Report Id Route Unknown Intramuscular Unknown Unknown Subcutaneously
Symptom Text: 3 Im, 1 sq given, pt went to front desk and mother noticed red area from right arm, MCV 4 given and on other arm, left, SQ where Varicella was given. Both area's looked like child had scratched them child denied any scratching. Vital taken, normal when left. Left with BENADRYL instruct. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 265
Vaers Id: 416597-1 Age Gender Vaccine Date Onset Date M 08-Feb-2011 09-Feb-2011 12.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 16-Feb-2011 TX 11-Feb-2011 Lot Prev Doses Site U3486AA 0 Right arm U3512AA 0 Left arm 0331Z 0 Right arm
Injection site erythema, Injection site rash, Injection site swelling
Symptom Text: Patient with rash/erythema/swelling at injection site - erythema appeared approximately 12 hours after administration. No treatment given. Reaction to MENACTRA injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 266
Vaers Id: 416603-1 (O) Age Gender Vaccine Date Onset Date F 17-Dec-2009 14-Apr-2010 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 118
Symptom Text: This is a case of pregnancy follow up. This case was initially reported by a health care professional on 08-APR-2010. Medinfosys 91947. This case concerns an 18 year old female patient. The patient received a pregnancy registry product, the first dose of GARDASIL (batch number not reported) on 17-DEC-2009. The patient received dose two of GARDASIL (batch number not reported) on 10-FEB-2010. The patient was subsequently found to be pregnant and saw the GP on 26-MAR-2010. Her LMP was 18-JAN-2010. No information regarding any adverse effect was provided. Upon internal review a corrective version was created on 18-MAY-2010 to amend the LMP in narrative from 18-JAN-2010 to 28-JAN-2010. Follow up information received on 03-FEB-2011. This case had been upgraded to serious. No previous pregnancies, the patient did not receive any treatment for infertility and the patient did not use any method of contraception. On 14-APR-2010 at ten weeks gestation the patient experienced a complete miscarriage confirmed by ultrasound scan. The reporter confirmed that the patient had not experienced any complications during pregnancy. Relevant Test/Laboratory Data: Ultrasound scan on 14-APR-2010 confirmed a complete miscarriage at 10 weeks gestation. Miscarriage was considered to be an other important medical event by the reporter. Other business partner numbers included: E2010-02358. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 28Jan10) Unknown Ultrasound, 14Apr10, confirmed a complete miscarriage at 10 weeks gestation


Page 267
Days 0
Asthenia, Body temperature increased, Decreased appetite, Lymphadenopathy, Pain
Symptom Text: Information has been received from a physician concerning a 15 year old female patient with no medical history or concomitant medication who received the first dose of GARDASIL (batch number NN01990, lot number NK44350, expiry May 2012) IM, 0.5ml, on 16-NOV-2010. On 16-NOV-2010 in the afternoon, post vaccination, the patient experienced an elevated temperature, extreme pain from neck to toes, swollen throat glands, no appetite and no energy. The patient was at home when she reacted. Her mother gave her paracetamol and possibly some other painkillers. The patient was seen by her general practitioner (GP). At the time of the report the events were continuing. The patient was still improving but was not 100%. The events were also reported to the IMB. Upon internal medical review the events were considered medically significant. This is one of a cluster of five cases (same reporter, same batch) and was linked with E2011-00643, E2011-00646, E2011-00648, E2011-006995. This case is medically confirmed. Other business partner numbers include: E2011-00650. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 268
Days 10
Status Date State Received Date 14-Feb-2011 FR 11-Feb-2011 Lot Prev Doses Site NN05770 0 Unknown
Dyspnoea, Hypersensitivity, Oedema peripheral, Rash, Swelling face, Urticaria
Symptom Text: Case received from a physician on 26-JAN-2011 via the local site. Case medically confirmed. A 16-years-old female patient had received the first dose of GARDASIL (lot number, batch number NN05770, site of administration not reported) via intramuscular route on 06-JAN-2011. On 16-JAN-2011, approximately, the patient experienced an allergic crisis characterized by urticarial rash in trunk and limbs, swelling of the face and hands, and breathlessness sensation, about 11 days after the administration of the vaccine. The patient was treated with TAVIST 1 dose via intramuscular route and SOLU-DACORTIN 100 mg via intravenous route, and has improved. At the time of reporting, the patient has recovered. Cessation date was indicated as 19-JAN-2011 approximately. The patient had medical history of childhood asthma. Upon medical review, the company upgraded the case to serious (other medically important condition). Case is closed. Other business partner numbers include E2011-00565. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Asthma


Page 269
Vaers Id: 416638-1 Age Gender Vaccine Date Onset Date F 05-Nov-2010 11-Feb-2011 16.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 98
Status Date State Received Date 14-Feb-2011 OH 11-Feb-2011 Lot Prev Doses Site U37143AD Left arm 1332Y 1 Left arm
Amenorrhoea, Breast enlargement, Breast tenderness, Drug exposure during pregnancy, Nausea, Pregnancy, Pregnancy test positive, Vomiting
Symptom Text: Positive pregnancy test in pediatric office. Date of conception unknown, possibly prior to vaccine adminstration The following information was obtained through follow-up and/or provided by the government. 03/03/2011 Clinic office records received for DOS 11/05/10 and 02/11/11. Impression: pregnant. Patient seen for concerns of cough, right ganglion cyst which has grown back and Depo last given last May (patient in a relationship and has not had anything since). Contraception method: Patient using condoms. Office urine pregnancy test noted as negative. Patient given Depo, and vaccinations (Flu, HPV). Follow-up visit: Patient seen 02/11/11 due to concern of pregnancy. Patient c/o breast tenderness, breast enlargement, no period since October and nausea & vomiting since November. Patient reported home pregnancy test was positive. Examination noted patient in no distress and abdomen nontender. Urine pregnancy tested was positive for pregnancy and date of conception unknown. Assessment: On 11/05/10, Depo was given and negative pregnancy test documented at time of Depo. Possible patient was pregnant at time of Depo but too early to give positive test. Plan: prenatal vitamins, refer to OB. Other Meds: Lab Data: Depo-Provera 150mg to right arm on 11/5/10 Lot#:X03012 Postive urine pregnancy test. The following information was obtained through follow-up and/or provided by the government. 03/03/11 records received. [unknown date] home pregnancy test: positive, [02/11/11] urine pregnancy test: positive. 03/08/2011 records received. Urine pregnancy screen results 11/05/10 & 02/11/11. No additional information. None The following information was obtained through follow-up and/or provided by the government. 03/03/11 records received. History: Abortion (in May), R. ganglion cyst, cough, Allergy to Motrin, Bactrim. None The following information was obtained through follow-up and/or provided by the government. [11/05/10] urine pregnancy test: negative.
History: Prex Illness: Prex Vax Illns:


Page 270
Vaers Id: 416669-1 Age Gender Vaccine Date Onset Date M 05-Dec-2010 20-Dec-2010 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Anogenital warts, Cryotherapy
Days 15
Status Date State Received Date 22-Feb-2011 CO 13-Feb-2011 Lot Prev Doses Site UNSHURE 0 Left arm
Symptom Text: Diagnosed with genital warts aproximatley 15 days after receiving Gardisil vaccine. Chryotherapy treatment by physician. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Shelfish None


Page 271
Vaers Id: 416710-1 (O) Age Gender Vaccine Date Onset Date U Unknown 23-Feb-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Drug exposure during pregnancy, Premature baby
Symptom Text: Information has been received from a medical assistant concerning a premature baby who was born at 22 weeks gestation. The mother was a 26 year old female patient with no pertinent medical history, who on unspecified dates were vaccinated with two doses of GARDASIL (lot# not reported). The mother's Last Menstrual Period was 17-SEP-2009 and expected date of delivery was 24-JUN-2010 (also reported as 23-FEB-2010). The mother was referred to a "high risk physician" because she received GARDASIL during pregnancy. The medical assistant informed that the mother had a "normal healthy delivery" on 23-FEB-2010 (22 weeks from LMP). The medical assistant reported that their office had no information on the health of the baby. It was unspecified if the patient sought medical assistant. Upon internal review, the baby was born by 22 weeks from LMP was determined to be an other important medical event. The mother's experience has been captured in WAES 0911USA02681. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 272
Vaers Id: 416712-1 (O) Age Gender Vaccine Date Onset Date F Unknown 23-Feb-2010 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 15-Feb-2011 FL 14-Feb-2011 Lot Prev Doses Site NULL 1 Unknown
Drug exposure during pregnancy, Premature labour
Symptom Text: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female patient with no pertinent medical history who on unspecified dates were vaccinated with two doses of GARDASIL (lot# not reported) at another office but does not recall when. There was no concomitant medication. Her Last Menstrual Period was 17-SEP-2009. Her expected date of delivery was 24-JUN-2010 (also reported as 23-FEB-2010). On 16-NOV-2009, the patient was seen in the office for pregnancy. The result of ultrasound was pregnancy. She was being referred to "a high risk physician" because she received GARDASIL during pregnancy. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from a medical assistant informing that the patient had a "normal healthy delivery" on 23-FEB-2010 (22 weeks from LMP). The medical assistant reported that their office had no information on the health of the baby. Upon internal review, a "normal healthy delivery" on 23FEB-2010 (22 weeks from LMP) was determined to be an other important medical event. The baby's experience has been captured in WAES 0911USA02681B1. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 9/17/2009) None ultrasound, 11/16/09, pregnancy


Page 273
Days
Blindness, Papilloma viral infection, Sudden visual loss
Symptom Text: Case received on 03-FEB-2011 from a nurse regarding a 14 year old female patient with no relevant history reported who presented an adverse event. Case medically confirmed. The patient received the first dose of a GARDASIL (batch#, site and route were not reported) in November 2010. A week ago (exact date not reported), the patient while the patient was at the school, she presented a complete and sudden and total loss of vision, and she was blind since then. Multiple test performed by ophthalmologist revealed that she had human papillomavirus in her maculas. At the time of reporting, the patient had not recovered. Upon medical review the company considered this case as serious with other medically important condition as criteria. Other business partner numbers included: E2011-00719. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown diagnostic laboratory test, Human papillomavirus in her maculas Unknown


Page 274
Vaers Id: 416718-1 (S) Age Gender Vaccine Date Onset Date F 25-Aug-2010 25-Aug-2010 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 0
Epilepsy, Loss of consciousness, Salivary hypersecretion, Trismus
Symptom Text: Case received from Health Authority (case 133627) through (local case# IT045/11). Initial report received on 02-FEB-2011. Case medically confirmed. An 11 year old female patient with no relevant history reported was vaccinated on 25-AUG-2010, with the second dose of GARDASIL (batch# NK44500; lot# NJ49370) IM. On the same day, 5 hours post-vaccination, she presented with loss of consciousness with mandibular deviation and loss of saliva; 2 months post vaccination the same episode reoccurred (like recidivation of epileptic seizure). The patient was taken twice to the emergency room (ER) and underwent several neurological consultations. No other information reported. The outcome of the event was not reported. The case is closed. Other business partner numbers included: E2011-00682. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 275
Days 0
Arthralgia, Dizziness, Dyspnoea, Myalgia, Syncope, Vomiting
Symptom Text: Case received from Health Authorities on 01-FEB-2011 under the reference number L201101-693 via the local site Sanofi Pasteur MSD. Case medically confirmed. A 32 year old female patient had received the third dose of GARDASIL (lot n. NJ37720, batch n. NL04170, site of administration not reported) via intramuscular route on 13-JAN-2011. On the same day, a few minutes p-v, the patient experienced fainting during a few seconds, vomiting, dizziness, shortness of breath during 30 minutes and muscle pain about 1 day. The suspect drug was administered by a pharmacist qualified by a training of administration of injections given by the Pharmaceutical, in a specific room, equipped with the material legally required. On 14-JAN-2011, the patient still had some muscle pain and joint pain. On 17-JAN-2011, the patient had no complaints and had considered that she was in her normal state. Unknown adverse reactions to the suspected drug or to other drugs. The patient received specific treatment of the AE with oxygen. The AE had improved with the treatment. At the time of report, the patient had fully recovered. The patient received concomitant treatment with oral contraceptive: ethinylestradiol / levonorgestrel. The patient had received the first dose of GARDASIL on 13-JUL-2011 via intramuscular route and the second dose in September 2010 via intramuscular route. The patient had no known clinical history. Upon medical review, the company judged relevant to coded "joint pain" which was mentioned in the narrative by HA but not coded. Serious criteria: other important medical event. Case is closed. Other business partner numbers include: E2011-00709. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Contraception ethinyl estradiol (+) levonorgestrel; 2009 - Unk Unknown


Page 276
Vaers Id: 416739-1 Age Gender Vaccine Date Onset Date F 01-Feb-2011 03-Feb-2011 16.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 2
Status Date State Received Date 14-Feb-2011 MA 14-Feb-2011 Lot Prev Doses Site UH180AA 2 Left arm 0927Z 1 Right arm 1539Y 2 Right arm
Dizziness, Muscular weakness, Nausea, Pallor
Symptom Text: 36-48 hr after flu, VARIVAX and HPV #3, pallor/dizzy to conscious. ? worse signs??? Dx vac -reaction ? HPV was nauseous after #3 HPV. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CBC/Diff; 6000 WBC ? viral illness


Page 277
Vaers Id: 416747-1 Age Gender Vaccine Date Onset Date F 01-Dec-2010 01-Dec-2010 15.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Headache, Infectious mononucleosis
Days 0
Status Date State Received Date 14-Feb-2011 OR 14-Feb-2011 Lot Prev Doses Site 0968Z 1 Left leg U3567CA 3 Left leg 0768Z 0 Right leg
Symptom Text: 12/1/10 HPV - really bad headache x 4 days starting the day of the vaccine went to school, took TYLENOL later developed EBV mono approximately 1/1/11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None but had occasional headache None


Page 278
Vaers Id: 416778-1 Age Gender Vaccine Date Onset Date F 07-Feb-2011 07-Feb-2011 16.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MMRV MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 21-Feb-2011 WA 14-Feb-2011 Lot Prev Doses Site AHAVB441BA 1 Right arm 0786Z 0313Z 2 0 Left arm Right arm
Injection site erythema, Injection site urticaria, Injection site warmth
Symptom Text: Large urticarial reaction with area (central) of erythema & heat at SC site of MMRV. Patient given ROCEPHIN 1gm IM & BENADRYL 50 mg IM. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Albuterol No No


Page 279
Vaers Id: 416802-1 Age Gender Vaccine Date Onset Date M 28-Jan-2011 28-Jan-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chromatopsia, Dizziness
Days 0
Status Date State Received Date 21-Feb-2011 CA 14-Feb-2011 Lot Prev Doses Site 0768Z 0 Left arm
Symptom Text: Pt got dizzy. Said things turned green. Had pt. lay down and took B/P, O2. Had him wait until he was OK. Mom in a hurry. Had to use wheelchair took him to the car. Pt is now fine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None ADHD None


Page 280
Vaers Id: 416814-1 Related reports: 416814-2 Age Gender Vaccine Date Onset Date F 26-Jan-2011 Unknown 14.0 Type Manufacturer VAX Detail: FLU GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 14-Feb-2011 NY 14-Feb-2011 Lot Prev Doses Site AFLUA567BA 0 Right arm 1167Z 0 Left arm
Axillary pain, Pain in extremity, Sensation of heaviness
Symptom Text: C/O left side of axillary and spreading to the left arm and leg pain and heavy feeling 1 wk after HPV vaccine. The sx lasted for couple weeks. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None EKG - Normal; Spirometry - Normal None None


Page 281
Vaers Id: 416821-1 Age Gender Vaccine Date Onset Date F 13-Sep-2010 13-Sep-2010 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chest discomfort, Dyspnoea, Syncope
Days 0
Status Date State Received Date 21-Feb-2011 PA 14-Feb-2011 Lot Prev Doses Site 0096Z 0 Right arm
Symptom Text: shortness of breath followed by syncope lasting several minutes, when patient awoke she has chest pressure and soight shortness of breath. She went to sleep and it resolved Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none no


Page 282
Vaers Id: 416836-1 Related reports: 416836-2 Age Gender Vaccine Date Onset Date F 10-Feb-2011 10-Feb-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 21-Feb-2011 PA 14-Feb-2011 Lot Prev Doses Site 0075Y 0 Left arm
Dizziness, Face oedema, Headache, Nausea
Symptom Text: (L) facial edema x 30 min, 30 min after injection 40 after injection -> HA, dizzy, nausea. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Neg CT of head Bee sting allergy requiring EPIPEN; asthma No


Page 283
Vaers Id: 416844-1 Age Gender Vaccine Date Onset Date F 10-Feb-2011 11-Feb-2011 15.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site swelling, Local swelling
Days 1
Status Date State Received Date 15-Feb-2011 GA 15-Feb-2011 Lot Prev Doses Site U3744AA 0 Left arm AHAVB461CA 1 Right arm 0887Z 1345Z 0 1 Left arm Right arm
Symptom Text: Localized swelling at varicella vaccine inj site measured by physician today as 7 x 5cm. Tx with Hydroxyzine HCL tablet 25 mg 3 times daily. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None No


Page 284
Vaers Id: 416866-1 (O) Age Gender Vaccine Date Onset Date F Unknown 16-Aug-2010 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Abortion missed, Abortion spontaneous, Drug exposure during pregnancy, Intra-uterine death, Menstruation irregular, Papilloma viral infection
Symptom Text: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with high risk papilloma viral infection diagnosed on 16-AUG-2010 and no drug reactions or allergies who was vaccinated IM with the first, second and third 0.5ml dose of GARDASIL (lot# not reported) on 29-MAR-2010, 02-JUN-2010 and 23-SEP-2010 respectively. Concomitant therapy included prenatal vitamins (unspecified). It was reported that the patient was administered her third dose of GARDASIL on 23-SEP-2010 and was subsequently determined to be pregnant on 13-OCT-2010. A pregnancy test in the office on 23-SEP-2010 was negative but a urine pregnancy test in the office on 13-OCT-2010 was positive. Her last menstrual period was 31-AUG-2010 and her estimated delivery date was 07-JUN-2011. A prenatal ultrasound would be scheduled for next week. No problems reported. The patient sought medical attention. Follow up information received indicating the patient had ultrasound on 09-NOV-2010 which showed 8 weeks and 2 days pregnancy, early dating. The patient had irregular menses. The patient's last menstrual period was 31-AUG-2010, estimated delivery date was 19-JUN-2011. The patient had no previous pregnancies. Follow-up information was received from a outcome pregnancy questionnaire which reported that the patient had prenatal vitamins daily from 21-OCT-2010 to 01-DEC-2010 for pregnancy. The patient had IUFD (intra uterine fetal demise) and on 01-DEC-2010 sonogram showed missed abortion at approximately 9.5 weeks (also reported on 06-DEC-2010, at 12 weeks and 1 day). Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 8/31/2010) Vitamins (unspecified) Ultrasound, 11/09/10, 8 weeks and 2 days pregnancy, early dating, irregular menses; Ultrasound, 12/01/10, missed abortion at 9.5 weeks; Beta-human chorionic, 09/23/10, negative; Urine beta-human, 10/13/10, positive


Page 285
Days 0
Condition aggravated, Dizziness, Headache, Immediate post-injection reaction, Muscle twitching, Syncope
Symptom Text: This case was received from a physician. This is one of a cluster of five cases (same reporter, same batch) and was linked with E2011-00646, E201100648, E2011-00650, E2010-06995. This case is medically confirmed. A 16 year old female patient with a history of faints with twitching with needles (which is continuing) and no other medical problems or concomitant medications, received the first dose of GARDASIL (batch number NN01990, lot number NK44350, expiry May 2012) IM, reported as 0.5 mg, on 13-DEC-2010. On 13-DEC-2010, at 10:43 am, immediately post vaccination, the patient fainted and experienced twitching of the lower limbs during fainting. The patient was also dizzy and had a headache. The patient's BP was monitored and was 115/60 and then 118/62 at 11:07. The patient took her own NUROFEN for the headache. The patient recovered completely from the events at 11:07 (13-DEC-2010) but still went home from school. The events were also reported to the company and the corresponding report was received on 09-FEB-2011 under reference company ref 2011-005015. The company considered the events to be medically significant as they required intervention. Other business partner numbers include: E2011-00643. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown blood pressure measurement, 13Dec10, 115/60; blood pressure measurement, 13Dec10, 118/62 Syncope; Twitching


Page 286
Vaers Id: 416885-1 (S) Related reports: 416885-2; 416885-3 Age Gender Vaccine Date Onset Date Days F 14-Feb-2011 14-Feb-2011 0 22.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. DTAP SANOFI PASTEUR Seriousness: MedDRA PT
Status Date State Received Date 16-Feb-2011 PA 15-Feb-2011 Lot Prev Doses Site 0992Z 0 Left arm U3487AA 0 Left arm
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Bladder catheterisation, Brain midline shift, Bruxism, Confusional state, Convulsion, Endotracheal intubation, Eye movement disorder, Fall, Head injury, Hypokalaemia, Intensive care, Loss of consciousness, Mental status changes, Muscle rigidity, Skull fracture, Status epilepticus, Subdural haematoma, Subdural haemorrhage, Syncope, Tonic clonic movements, Unresponsive to stimuli, Vision blurred, White blood cell count increased
Symptom Text: Syncopal episode, 5-10 minutes after vaccine administration. Fell to ground from standing position, hit head. Skull fracture, subdural hematoma. Required intubation, ICU admission. The following information was obtained through follow-up and/or provided by the government. 02/16/2011 ER record received for DOS 02/14/11 to 02/15/11. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, the patient was unresponsive and actively seizing. The patient was intubated, an IV was started and a foley catheter placed. The patient underwent head CT scan and was treated with Ativan, mannitol, dilantin and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC. The patient was admitted to neurosurgical ICU in critical condition. 03/18/2011 Hospital discharge summary, H&P, ophthalmology consult, speech consult received for DOS 2/14/11 to 2/18/11. DX: Right frontal subdural hematoma. Patient experienced what was likely a vasovagal syncopal event (syncopated during finger stick in past) while at primary care appointment for blood work. The patient fell, hit her head with loss of consciousness for a few minutes and then had a seizure. The patient was transferred to the med. center due to status epilepticus secondary to subdural hematoma. On the night of admission, the patient was extubated successfully. The patient had depressed mental status the next day, but followed commands and could move all extremities. On 2/16/11, physical therapy ambulated the patient and speech pathology recommended full liquid diet. On 2/17/11, the patient advanced to regular diet and was alert to name. On 2/18/11, the patient was transferred to the floor. The patient was seen by ophthalmology for blurry vision. At discharge to rehabilitation, the patient was oriented x3 with occasional mild confusion. Discharge medications included Dilantin, heparin, levothyroxine, ranitidine, and Tylenol. 03/21/2011 PCP office records received for DOS 02/14/11. Patient presented to office as new patient to establish care on 02/14/11. No complaints and requested script for levothyroxine (diagnosed hypothyroid at age 12). Exam unremarkable. Blood pressure was 117/78 mm Hg. Patient given Tetanus booster and HPV. Plan: TSH ordered. While waiting to go to lab, patient fell to the ground, hit head and was not responsive with left side rigid. After 1 to 2 minutes, patient walked with assistance to exam room and lay on table. After five minutes, patient again became unresponsive and left side became rigid. Rapid response team started IV, gave supplemental oxygen and inserted nasal-pharyngeal airway. The patient was transported on to the ER. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Synthroid 0.1 mg/day Head CT scans, ICU admission, ongoing neurosurgery care The following information was obtained through follow-up and/or provided by the government. 02/16/2011 records received. CT head/brain WO cont.: abnormal (nondisplaced FX of left occip None The following information was obtained through follow-up and/or provided by the government. 02/16/2011 records received. History: Hypothyroid, anxiety (on Lexapro). None


Page 287
Vaers Id: 416885-3 (S) Related reports: 416885-1; 416885-2 Age Gender Vaccine Date Onset Date Days F 14-Feb-2011 15-Feb-2011 1 22.0 Type Manufacturer VAX Detail: DTAP SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Status Date State Received Date 29-Apr-2011 US 28-Apr-2011 Lot Prev Doses Site U3487AA 0 Left arm 0992Z 0 Left arm
Mfr Report Id Last Edit Date WAES1104USA01807 29-Apr-2011 Other Vaccine Route Intramuscular Intramuscular
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Bladder catheterisation, Brain midline shift, Bruxism, Convulsion, Endotracheal intubation, Fall, Gaze palsy, Head injury, Hypokalaemia, Intensive care, Skull fracture, Subdural haematoma, Subdural haemorrhage, Syncope, Tonic clonic movements, Unresponsive to stimuli
Symptom Text: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonicclonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1. This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Hypothyroidism SYNTHROID head computed axial, CT head/brain WO cont.: abnormal (nondisplaced FX of left occip); serum potassium, mild hypokalemia; WBC count, mild elevated WBC


Page 288
Vaers Id: 416898-1 Age Gender Vaccine Date Onset Date F 18-Jan-2011 18-Jan-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR FLU SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Abdominal pain upper, Headache
Days 0
Status Date State Received Date 16-Feb-2011 VA 15-Feb-2011 Lot Prev Doses Site 1437Z 0 Right arm U3676AA 0 Left arm U3741AA Unknown
Symptom Text: Headache & stomach ache starting within hours of immunizations. Not sure exact start time Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Rapid Strep test & culture (negative) Headsche stopped 1/28/2011. Returned to normal activity 1/28/2011. No None known. Given at well visit.


Page 289
Vaers Id: 416921-1 Age Gender Vaccine Date Onset Date F 24-Jan-2011 25-Jan-2011 25.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR PPV MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site haematoma
Days 1
Status Date State Received Date 16-Feb-2011 CO 16-Feb-2011 Lot Prev Doses Site U3740AA 0 Left arm 0703Z 0 Left arm C3719AA 0 Right arm 1158Z 0 Right arm
Symptom Text: Pt with large tender raised area around injection site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 290
Vaers Id: 416931-1 (O) Age Gender Vaccine Date Onset Date F 04-Mar-2010 Unknown 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy, Erbs palsy
Days
Status Date State Received Date 17-Feb-2011 CA 16-Feb-2011 Lot Prev Doses Site 1013Y 2 Left arm
Symptom Text: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female who on 04-JAN-2010 was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 04-MAR-2010. Third dose of GARDASIL (Lot# 662304/1013Y) was given on 06-JUL-2010. On 22-DEC-2010 the patient delivered a female infant. The infant was diagnosed with "brachial palsy (Erb-Duschenne palsy), left upper arm". At the time of the report, the outcome of the event was unknown. Upon internal review, "brachial palsy (Erb-Duschenne palsy), left upper arm" was considered to be an other important medical event. The mother's experience was captured in WAES# 1008USA01305. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 291
Vaers Id: 416932-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Juvenile arthritis
Days
Symptom Text: Information has been received from a health care professional (mother's patient who was an ophthalmologist) on 04-FEB-2011. Case medically confirmed. A 19 year old patient had received the first dose of GARDASIL (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date and 40 days later, the patient was found to have Still's disease. Any other disease was ruled out. According to the mother's patient, they did not know whether this disease was related with the vaccination or not. Upon medical review the company considered this case as serious with "other medically important condition as criteria". At the time of reporting the outcome was not reported. Other business partner numbers included E2011-00736. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 292
Vaers Id: 416937-1 Age Gender Vaccine Date Onset Date F 07-Feb-2011 08-Feb-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 22-Feb-2011 TX 16-Feb-2011 Lot Prev Doses Site 0097Z 2 Left arm
Abdominal pain, Appendicectomy, Appendicitis, Headache, Pyrexia, Vomiting
Symptom Text: Fever 99.8 - 101.2, headache, abdominal cramping. Pt instructed to take MOTRIN. Vomiting. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Pt was diagnosed with appendicitis - treated with appendectomy


Page 293
Vaers Id: 416938-1 Age Gender Vaccine Date Onset Date F 11-Feb-2011 11-Feb-2011 28.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pruritus, Rash
Days 0
Status Date State Received Date 22-Feb-2011 MN 16-Feb-2011 Lot Prev Doses Site 1539Y 0 Left arm
Symptom Text: Rash, itching started 2/11/11 & continued to get worse no relief with BENADRYL OTC called & presented to clinic 2/15/11 Methylpred sodium su 125 mg IM & Prednisone taper 2/16/11 I left a message for pt to call if symptoms no improved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ATIVAN; PERCOCET; WELLBUTRIN; LASIX; ADDERALL None Allergies: MS CONTIN; Latex; ASA; VICODIN; Endometriosis; Depression with anxiety; ADHD; Carpal tunnel syndrome


Page 294
Vaers Id: 416972-1 Age Gender Vaccine Date Onset Date F 14-Feb-2011 15-Feb-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Tenderness
Days 1
Status Date State Received Date 22-Feb-2011 AZ 16-Feb-2011 Lot Prev Doses Site 0786Z 2 Left arm AHAVB441AA 1 Right arm
Symptom Text: (L) arm (GARDASIL #3) w/ redness, swelling, tenderness starting day after vaccine admin. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 295
Vaers Id: 416983-1 Age Gender Vaccine Date Onset Date M 14-Feb-2011 15-Feb-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 23-Feb-2011 FL 16-Feb-2011 Lot Prev Doses Site 0337Z 0 Left arm 0225Z Right arm C3490AA Right arm U3355BA 0 Left arm
Mfr Report Id Route Intramuscular Subcutaneously Intramuscular Intramuscular
Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: 3 injection sites red and swollen sore. 2-15-11 started went to ER-given VISTARIL po TID cool compresses. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: AUGMENTIN Allergy; Asthma


Page 296
Vaers Id: 416998-1 Age Gender Vaccine Date Onset Date F 20-Nov-2010 20-Nov-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HPV2 GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 23-Feb-2011 NJ 10-Feb-2011 Lot Prev Doses Site NULL 0 Unknown NULL 0 Unknown
Mfr Report Id A0894703A Route Unknown Unknown
Accidental overdose, Dizziness, Wrong drug administered
Symptom Text: This case was reported by a healthcare professional and described the occurrence of dizziness in a 12-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline), (non-gsk) GARDASIL. On 20 November 2010 the subject received 1st dose of CERVARIX (0.5 ml, unknown, unknown arm) and 1st dose of GARDASIL (unknown). On 20 November 2010, less than one day after vaccination with CERVARIX and GARDASIL, the subject experienced dizziness and unintentional overdose. The subject accidentally received CERVARIX and GARDASIL at the same time instead of CERVARIX and MENACTRA. She felt dizzy for 15 minutes but was fine after that. At the time of reporting the dizziness was resolved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Concomitant medications and relevant medical history were unknown. It was unknown if adverse events occurred with previous vaccinations. Unknown


Page 297
Vaers Id: 417053-1 Age Gender Vaccine Date Onset Date M 01-Feb-2011 02-Feb-2011 26.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 22-Feb-2011 NY 17-Feb-2011 Lot Prev Doses Site AHAVB375AA 0 Left arm 1333Y AC52B045BA 0 0 Left arm Left arm
Erythema, Hypoaesthesia, Local swelling, Musculoskeletal stiffness, Nerve injury, Paraesthesia, Pruritus, Rash
Symptom Text: 1 AM 2/2/11 - R Thumb red, swollen, numb, hard to move and itchy. 3 PM 2/2/11 - middle fingers R and L hand numb, itchy neck, sl. rash and itchy belly. Took benadryl on own. 2/3/11 AM - R thumb sl. swollen and electricy feeling in hands bilaterally. 2/4/11 tingling starting to subside and MD seen on 2/3 feels not vaccines but a "pulled" nerve Per pt. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Nuvo Ring None None None


Page 298
Vaers Id: 417063-1 Age Gender Vaccine Date Onset Date F Unknown 01-Jul-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Chills, Pyrexia, Tachycardia, Tremor, Vomiting
Symptom Text: 12 yo female in ER with sx: shaking, shivering, tachycardia (HR150), vomiting, fever after GARDASIL vaccination. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 299
Vaers Id: 417137-1 (D) Related reports: 417137-2 Age Gender Vaccine Date Onset Date F 04-Jan-2011 02-Feb-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT DIED, SERIOUS
Days 29
Status Date State Received Date 21-Feb-2011 TN 18-Feb-2011 Lot Prev Doses Site 0096Z 1 Right arm U3432AA 0 Left arm
Mfr Report Id TN1101 Route Intramuscular Intramuscular
Cardiac arrest, Death, Endotracheal intubation, Fall, Haematemesis, Joint stiffness, Loss of consciousness, Peripheral coldness, Presyncope, Pulse absent, Resuscitation, Viral infection, Vomiting
Symptom Text: Patient deceased within 30 days of vaccine administration. The following information was obtained through follow-up and/or provided by the government. 5/11/11 ER records received. Service date 2/2/11 Diagnosis: Cardiac Arrest. Patient and family members had recent viral illness and vomiting. Had taken nonsteroidals. Near syncope at clinic, vomited blood and fell down. EMS found unconscious and pulseless. Arrived at ER in cardiac arrest/asystole. Hands cool, ankle stiffness. CPR/ALS continued, intubation. Chest compressions, femoral central venous catheter placed for ongoing resuscitation. Patient expired. 5/25/11 Received Autopsy Report which states COD as: group A streptococcal toxic shock syndrome. Report also indicates pt had 3 day hx of sore throat, nausea, vomiting & diarrhea. Findings at autopsy included: DIC; (+) throat, lung, csf & blood cultures; pulmonary hemorrhage; pleural effusions; dehydration; obesity; superficial abrasion of left thigh. Original focus of infection unclear but strep throat could not be ruled out since postmortem c/s (+) & illness began w/sore throat. Other Meds: Lab Data: NORINYL The following information was obtained through follow-up and/or provided by the government. 5/11/11 Labs and Diagnostics: Glucose 150 mg/dL (H). CBC - RDW 14.3% (H) Platelets 80 K/uL (L) Segs 7% (L) Lymph 67% (H) Mono 21% (H) Myelo 3% (H) Segs# 0.6 K/uL (L) Lymph# 5.4 KuL (H) Mono# 1.7 K/uL (H) NRBC 2 /100WBC (H), Burr Cells mild, Schistocytes Mild, Many Bacteria Noted - Compatible with Septicemia. PT >90.0 sec (H), INR >9.80 (H) PTT >200 sec (H). ECG - Abnormal. Chest X-ray - Abnormal. 5/25/11 Autopsy report labs: throat c/s (+), lung c/s (+), csf c/s (+), blood c/s (+) all with heavy growth group A streptococcus Hay fever; Animal fur none


Page 300
Vaers Id: 417157-1 Age Gender Vaccine Date Onset Date M 16-Dec-2010 16-Dec-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dizziness, Fall, Syncope
Days 0
Status Date State Received Date 28-Feb-2011 CA 18-Feb-2011 Lot Prev Doses Site 0766Z 0 Left arm
Symptom Text: 1st dose of HPV was given & pat. was told he needs to remain seated for 10 min. He did not follow command & started walking. MA asked him to sit, he cont. & felt dizzy & fell onto the back of his head (fainted). EMR was called & pat. was taken to ER. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood glucose checked; BP WNL None None


Page 301
Vaers Id: 417231-1 Age Gender Vaccine Date Onset Date M 14-Feb-2011 15-Feb-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 28-Feb-2011 WA 18-Feb-2011 Lot Prev Doses Site 0768Z 1 Left arm U3442BA 0 Right arm AC52B054BA Left arm
Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Symptom Text: At area of HPV injection redness, increased warmth, pain developed with fever. Treated with KEFLEX. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 302
Vaers Id: 417299-1 Age Gender Vaccine Date Onset Date F 15-Feb-2011 15-Feb-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dizziness, Headache, Nausea
Days 0
Status Date State Received Date 02-Mar-2011 TX 21-Feb-2011 Lot Prev Doses Site 0337Z 2 Left arm
Symptom Text: After receiving her third booster for HPV in her left upper arm she began feeling dizzy, nauseated and c/o of a headache at 9:46 am & seen by physician. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Glucose (finger stick) 289 Type 1 Diabetes; Seizure disorder


Page 303
Vaers Id: 417315-1 (O) Age Gender Vaccine Date Onset Date F 16-Mar-2010 16-Mar-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEP MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 23-Feb-2011 FR 22-Feb-2011 Lot Prev Doses Site NJ470120 0 Unknown 1597Y Unknown
Mfr Report Id Last Edit Date WAES1102USA01539 23-Feb-2011 Other Vaccine Route Intramuscular Intramuscular
Convulsion, Eyelid oedema, Lip swelling, Swollen tongue
Symptom Text: Information was obtained on a request by the Company from the agency via a Public Case Details form, concerning a female who on 16-MAR-2010 was vaccinated with RECOMBIVAX HB (intramuscular, Lot# 666571/1597Y, Batch#N3850). On the same day the patient was given GARDASIL (manufacturer unknown) (Lot# , Batch #NJ470120), which was the secondary suspected therapy. On 16-MAR-2010, the patient experienced puffiness of eyes, lip, tongue and convulsions. She recovered on the same day. The agency considered that puffiness of eyes, lip, tongue and convulsions were possibly related to therapy with RECOMBIVAX HB and GARDASIL (manufacturer unspecified). Puffiness of eyes, lip, tongue and convulsions were considered to be other important medical events by the agency. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 304
Vaers Id: 417317-1 (S) Age Gender Vaccine Date Onset Date F 28-Dec-2010 28-Dec-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MMR GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Peripheral nerve palsy, VIIth nerve paralysis
Days 0
Status Date State Received Date 23-Feb-2011 FR 22-Feb-2011 Lot Prev Doses Site NK25030 1 Unknown A69FC318A 1 Unknown
Mfr Report Id Last Edit Date WAES1102USA01553 23-Feb-2011 Other Vaccine Route Intramuscular Subcutaneously
Symptom Text: Information has been received from an health authority under the reference number DK-DKMA-ADR-20915158 concerning a 12 year old female who on 28-DEC-2010 was vaccinated with GARDASIL (dose 1, batch# NM16750, lot# NK25030). Concomitant therapy included PRIORIX (dose 2, mfr other, batch number A69FC318A, SC) administrated on 28-DEC-2010. Case medically confirmed. The patient experienced varicella infection in early December 2010. She had received one dose of PRIORIX (mfr other) on an unspecified date. The night following the vaccinations, the patient experienced peripheral facial nerve palsy. Blood test and lumbar-puncture were performed for the detection of any infection, including borrelia, herpes simplex and varicella. General objective investigations carried out including neurological examination showed: Except for the peripheral facial nerve palsy all tests (on unspecified dates) were normal. HA coded facial paresis with onset on 28-DEC-2010. The patient was hospitalized on an unspecified date. The palsy decreased over the following weeks and was completely gone when the patient was seen in the outpatient on 21-JAN-2011. The patient recovered on 21-JAN-2011. Other business partner number included: E2011-00910. No further information expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Spinal tap, normal; Diagnostic laboratory test, blood test normal Varicella


Page 305
Vaers Id: 417329-1 Age Gender Vaccine Date Onset Date M 19-Feb-2010 26-Feb-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 7
Status Date State Received Date 02-Mar-2011 RI 22-Feb-2011 Lot Prev Doses Site 1099Y 1 Unknown
Activities of daily living impaired, Arthralgia, Asthenia, Fatigue, Headache, Pain
Symptom Text: Fatigue, headaches, body aches, multiple joint pains, debilitating to the point that student misses school days, music school, fencing, etc. Doctors visits including Rheumatology, Physical Medicine, PCP, Urgent Cares. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Available if requested


Page 306
Vaers Id: 417340-1 (O) Age Gender Vaccine Date Onset Date F 19-Mar-2010 01-Oct-2010 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Oral papilloma
Days 196
Status Date State Received Date 23-Feb-2011 GA 22-Feb-2011 Lot Prev Doses Site 0969Y 2 Unknown
Symptom Text: Information has been received from a registered nurse concerning her 12 year old daughter with no allergies and no medical history who in 2009 was vaccinated with a first dose of GARDASIL (Lot# not reported). There was no concomitant medication. The nurse stated that her daughter completed her third dose of GARDASIL in March 2010 and on 09-NOV-2010 her dentist detected oral papilloma on her tonsil during a routine check. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. Follow up information has been received from the physician concerning a 12 year old female student, with no pre-existing allergies or medical conditions, who on 15-SEP-2009, 19-NOV-2009, and 19-MAR-2010 was vaccinated intramuscularly with a first, second and third dose of GARDASIL (Lot # 662724/0313Y, 663454/0672Y, and 663573/0969Y respectively). Past vaccination history included a first dose of MENACTRA (Lot # U2926AA) IM, a first dose of ACTACEL (Lot # WF451BA) IM, and a first dose of FLUMIST (Lot # 500673P) nasal, all of them given on 15-SEP-2009. In October 2010, the patient was seen by a dentist and he noted to have "growth" of "papilloma" on tonsil. The patient was referred to the oral surgeon who she will see on 18-FEB-2011. The patient would be evaluated for probable removal/biopsy. At the time of this report, the patient still was being evaluated. The patient sought medical attention. Oral papilloma on her tonsil was considered to be an other important medical event by the reporter. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 307
Vaers Id: 417341-1 (O) Age Gender Vaccine Date Onset Date F 29-Nov-2010 27-Jan-2011 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 59
Status Date State Received Date 23-Feb-2011 US 22-Feb-2011 Lot Prev Doses Site 0565Z 1 Unknown
Abortion spontaneous, Drug exposure before pregnancy, Ectopic pregnancy, Muscle spasms
Symptom Text: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient who on 14-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot # 666931/0337Z, dose and route not reported), and on 29-NOV-2010 was vaccinated with a second 0.5ml dose of GARDASIL (Lot # 666162/0565Z, route not reported). It was reported that the patient found out she was pregnant after receiving her second dose of GARDASIL. The patient's last menstrual period (LMP) was on 15-DEC-2010 and the estimated date of delivery (EDD) is on 21-SEP-2011. No adverse side effects were reported. Follow up information has been received from the registered nurse concerning a female patient with no concurrent medical conditions. It was reported that on 27-JAN-2011, an ultrasound was performed because of cramping, the result showed a right ectopic pregnancy. It was reported that on the same day, the patient experienced spontaneous abortion at 6 weeks from LMP. The products of conception were examined (results not reported). Upon internal review, ectopic pregnancy and spontaneous abortion were considered to be other important medical events. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 12/15/2010) Unknown ultrasound, 01/27/11, right ectopic pregnancy


Page 308
Vaers Id: 417342-1 (S) Age Gender Vaccine Date Onset Date F 01-Feb-2011 01-Feb-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Erythema, Loss of consciousness, Tremor
Days 0
Status Date State Received Date 23-Feb-2011 FR 22-Feb-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from the health authorities on 16-FEB-2011 under the reference number ES-AGEMED-623610341. Case was medically confirmed. A 15 year old female patient had received a dose of GARDASIL (lot and batch number was not provided) via intramuscular (site of administration was not reported) on 01-FEB-2011 and on the same day, the patient developed tremor, blackout spell, and erythema. The patient went to the emergency, exactly day not reported. She was kept her under observation until 02-FEB-2011 with favorable progress. The patient recovered from all these adverse events on 01-FEB-2011. Case reported as serious by the health authorities with "hospital admission" (admission and discharge dates not reported) as criteria. Other business partner numbers included: E2011-01030. No further information was reported. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 309
Vaers Id: 417350-1 Age Gender Vaccine Date Onset Date F 14-Feb-2011 15-Feb-2011 17.0 Type Manufacturer VAX Detail: HEPA MERCK & CO. INC. MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 02-Mar-2011 FL 22-Feb-2011 Lot Prev Doses Site 1215Z 0 Right arm U3431AA 0 Right arm 0337Z 0 Left arm
Eye irritation, Lip disorder, Muscle twitching, Neck pain, VIIth nerve paralysis
Symptom Text: 2-15-11 complained to mother of pain in neck and eye irritation. 2-16-11 noticed lazy lip. 2/17/11 twitching & crooked smile. Diagnosed on 2/18/11 with Bell's Palsy in the ER. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Bell's Palsy Unknown None


Page 310
Days 0
Status Date State Received Date 22-Feb-2011 WY 22-Feb-2011 Lot Prev Doses Site 07682 2 Left arm
Gaze palsy, Muscle contracture, Musculoskeletal stiffness, Pallor, Tremor, Visual acuity reduced
Symptom Text: Pt. was sitting in the waiting area, as she had been asked to do after getting her shot. She C/O not being able to see well. She turned pale, her eyes rolled back, she stiffened and her arms flexed, hands drew into fists, hands shook quickly 2-3 times. She relaxed, and her eyes opened. We laid her on a cot with her feet elevated. When she started to get some color in her face and responded well, she was given a glass of fruit drink through a straw. She left with her mother, when she felt better. Her mother was called later in the day. She reported that pt. was "doing fine". She further said that when they got home, pt. said, "Wow, I don't even feel wierd or anything." Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: They drove to a game. No further follow-up done. Called office to report. Neither medical associate was available. Contacted another HP later in day Seasonal Allergies Only None


Page 311
Vaers Id: 417370-1 (S) Related reports: 417370-2 Age Gender Vaccine Date Onset Date F 07-Aug-2007 01-Mar-2009 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, LIFE THREATENING, SERIOUS
Days 572
Status Date State Received Date 23-Feb-2011 CA 22-Feb-2011 Lot Prev Doses Site 0530U 1 Right arm
Convulsion, Dizziness, Epilepsy, Hypoaesthesia, Syncope, Tunnel vision, Vomiting
Symptom Text: Seizure, Syncope, Vomiting The following information was obtained through follow-up and/or provided by the government. 03/01/11. ER report for DOS 02/25/11. DX: seizure disorder. C/o sudden onset of tunnel vision, lightheadedness, hands/feet numb. Pt on Topamax after abnormal EEG. Discharged home in stable condition. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: was on Ortho Tri-Sprintec at time of vaccination for birth control MRI, EEG, Blood Work, Results came back and was diagnosed with Epilepsy The following information was obtained through follow-up and/or provided by the government. Labs and DX studies: EEG abnormal, sodium 135 (L) NONE The following information was obtained through follow-up and/or provided by the government. PMH: Allergies: none. NONE


Page 312
Vaers Id: 417421-1 (O) Age Gender Vaccine Date Onset Date F 13-Jan-2011 23-Jan-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Epilepsy
Days 10
Symptom Text: Information has been received from a physician concerning a 15 year old female with no relevant history reported who was vaccinated with a first dose of GARDASIL (lot # and batch # not reported) on 13-JAN-2011. 10 days after vaccination the patient developed an epileptic seizure. The electroencephalogram was normal. An MRI was scheduled on 14-FEB-2011. Additional information was received on 16-FEB-2011. The reporting physician had no new information. The reporter thought that was juvenile epilepsy. Should the suspected diagnosis be confirmed, the reaction would not be attributable to vaccination. On 16-FEB-2011 the patient's outcome was not reported. Case medically confirmed. Upon internal review, the company upgraded the case to serious due to other important medical event. Other business partner numbers included E2011-00937. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Electroencephalography, normal Unknown


Page 313
Vaers Id: 417426-1 Age Gender Vaccine Date Onset Date F 22-Feb-2011 22-Feb-2011 13.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MEN SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Fall
Days 0
Status Date State Received Date 23-Feb-2011 TX 23-Feb-2011 Lot Prev Doses Site 1038Z 1 Right arm AC52B054BA 0 Right arm U3462AA 0786Z 0 0 Left arm Left arm
Mfr Report Id Route Subcutaneously Intramuscular Intramuscular Intramuscular
Symptom Text: Client was walking out of entrance when she slumped to the floor. First encountered lying on floor, awake, no compliants. BP 118/64 P 72 R 16. Able to sit in chair, no visual signs of injury. Stated she felt okay. No dizziness, nausea or discomfort. Stayed 15 minutes. family with client. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none none


Page 314
Vaers Id: 417432-1 Age Gender Vaccine Date Onset Date F 07-Feb-2011 07-Feb-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR FLU SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 24-Feb-2011 OR 23-Feb-2011 Lot Prev Doses Site 1437Z 1 Right arm 1310Z 1 Left arm C3490AA 0 Left arm U3513AA 0 Left arm U3734AA 1 Right arm
Mfr Report Id Route Intramuscular Subcutaneously Intramuscular Intramuscular Intramuscular
Bone pain, Crying, Discomfort, Oedema peripheral, Pain
Symptom Text: Pt received vaccines 2/7/11 at 8:30 am. Around 8-8:30 p.m. she started hurting - "deep bone ache". Around 9:30pm started crying and c/o body aching from head to toe. Parents took to E.R. at 9:49 pm. Pt. was discharged home in "improved, stable" condition at 11:10 pm. Pt. did not run a temperature. Was given TYL #3 for discomfort. Had swelling in left arm. "Back to normal" in 3 days according to mother. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Albuterol Inhaler; TYLENOL; MOTRIN None Acetaminophen; Amoxicillin; VICODIN; Hx asthma None


Page 315
Vaers Id: 417446-1 Age Gender Vaccine Date Onset Date F 28-Jan-2011 29-Jan-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Fatigue, Lymphadenopathy
Days 1
Status Date State Received Date 02-Mar-2011 MN 23-Feb-2011 Lot Prev Doses Site 0886Z 0 Left arm
Symptom Text: 1/28 pt received her vaccine in her left arm Fri. afternoon Sat. and Sun. she felt tired. Sun. she developed some swollen lymph nodes in her (L) axilla that grew to between 3-4 cm in diameter - these have slowly resolved. They were very painful. She also developed swollen lymph nodes in (R) axilla. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Physical exam was normal today. CBC with diff was normal today and on 1/28/11 None None


Page 316
Vaers Id: 417457-1 Age Gender Vaccine Date Onset Date F 22-Feb-2011 22-Feb-2011 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dyskinesia, Unresponsive to stimuli
Days 0
Status Date State Received Date 02-Mar-2011 CO 23-Feb-2011 Lot Prev Doses Site 0565Z 0 Right arm AHAVB443BA 1 Left arm
Symptom Text: A few minutes following vaccine administration, client became unresponsive with jerking movements which lasted for 15 to 20 seconds. Client became responsive immediately afterward. Juice given and client was observed for 15 minutes. Recovered fully. No injury. No fall. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 317
Vaers Id: 417469-1 Age Gender Vaccine Date Onset Date M 15-Feb-2011 15-Feb-2011 16.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 03-Mar-2011 TX 23-Feb-2011 Lot Prev Doses Site U3513AA 0 Right arm C3446AA 0 Left arm 0886Z 0 Left arm
Chest pain, Cough, Decreased appetite, Nausea, Oropharyngeal pain, Pyrexia, Sleep disorder
Symptom Text: Pt received HPV, TDAP, & MCV4 vaccines on 2/15/11 approximately 930am. By 3pm had cough, which worsened considerably & kept him up at night. Approximately 9pm had nausea & decreased appetite. On 2/16 approximately 630am had sore throat & chest pain. Fever at 7am. In clinic responded to albuterol nebulizer treatment. Rapid flu & rapid strep tests negative. CXR showed perihilar markings. Pt went to ED on 2/18 due to worsening symptoms given azithromycin & prednisone. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CXR with prominent perihilar markings; rapid flu test negative; rapid strep test negative. Webbing of both hands S/P multiple surgeries None


Page 318
Vaers Id: 417492-1 Age Gender Vaccine Date Onset Date F 22-Feb-2011 22-Feb-2011 14.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 03-Mar-2011 TX 23-Feb-2011 Lot Prev Doses Site U3430AA 0 Right arm 1178Y 1 Left arm
Hypotonia, Immediate post-injection reaction, Muscle rigidity, Somnolence
Symptom Text: HPV vaccine was adm. 1st, immediately after vaccine was adm. pt. held (R) side of her head & went limb. Her body then became rigid while in the chair. I held her head & instructed her to take deep breaths, she followed command. Rigidness lasted approx. 20 - 30 sec. she then came to. When asked what she felt she replied she did not recall anything. Monitored pt. for extra 30 min. after vaccine c/o sleepiness only on exit. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 319
Vaers Id: 417493-1 Age Gender Vaccine Date Onset Date F 15-Feb-2011 18-Feb-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Hypersensitivity, Pruritus generalised, Rash
Days 3
Status Date State Received Date 03-Mar-2011 SC 23-Feb-2011 Lot Prev Doses Site 0565Z 1 Left arm
Symptom Text: Pt awoke 02-18-11 with rash & itching all over body. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Amoxicillin 02/23/11 RN made phone call to family. Mother stated that pt saw MD & was dx'ed with allergic reaction with unknown cause. None No


Page 320
Vaers Id: 417499-1 (S) Age Gender Vaccine Date Onset Date F 13-Jan-2009 Unknown 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: HOSPITALIZED, SERIOUS
Days
Status Date State Received Date 28-Feb-2011 FR 24-Feb-2011 Lot Prev Doses Site 1427U 0 Gluteous maxima
MedDRA PT
Acute stress disorder, Asthenia, Cognitive disorder, Cough, Decreased appetite, Disturbance in attention, Dizziness, Encephalitis, Fatigue, Hemicephalalgia, Hepatomegaly, Hypersomnia, Hypotension, Immune system disorder, Immunisation reaction, Memory impairment, Migraine, Mitral valve prolapse, Oropharyngeal pain, Performance status decreased, Postural orthostatic tachycardia syndrome, Reading disorder, Respiratory tract infection viral, Rhinitis, Sensory disturbance, Sinus tachycardia, Speech disorder, Splenomegaly, Vestibular disorder, Visual impairment, Weight decreased
Symptom Text: Case received from a county court on 10-FEB-2011. Case medically confirmed. A 17-year-old female patient was vaccinated with a dose of GARDASIL (lot # not reported), site and route not reported on 13-JAN-2009. On 05-FEB-2009 she presented at the family physician with a severe viral respiratory tract infection accompanied by dizziness and rhinitis. EFFORTIL was administered . She was referred to an ear-nose throat specialist who ruled out sinusitis/sinus suppuration. There, the girl additionally complained of right sided headache. All ENT examinations showed normal results. Tentative diagnosis was "vestibulopathy". On 16-FEB-2009, she presented again at the family physician. Dizziness was ongoing, she additionally complained of decreased appetite and loss of strength. Blood pressure was low and sinus tachycardia was seen. She was admitted to a hospital to rule out carditis. The girl was hospitalized from 16-FEB-2009 till 20-FEB-2009 in a hospital. At that time she complained additionally of decreased performance status, concentration impairment, cough, sore throat, tiredness and weakness. Treatment included BRONCHIPRET (phytotherapy), LEMOCINE (throat preparation) and GRIPOSSTAD. Initial symptoms of respiratory tract infection (dizziness and rhinitis) were ongoing. Exhaustive diagnostic including ENT ophthalmologic examination, EEG, chest x-ray, lab findings, infection serology and stool examination for pathogenic germs were all normal except for increased fT4 and TSH. Abdominal sonography showed slightly enlarged liver and spleen, EEG showed elongation of QT (normalised in the course). Schellong's test was pathological, diagnosis of orthostatic dysregulation was established. Posture deficit of the cervical spine (previously known) was described. On 06-MAR-2009 she was referred to the cardiologic department of the hospital. Exhaustive cardiologic check up revealed all normal results except for a slight mitral valve prolapse. At that time, dizziness had improved under EFFORTIL therapy. Cranial MRI and MRI of cervical spine were normal. On 17-MAR-2009 she had presented to the surgical department to rule out orthopedic causes of headache. At that time, the girl additionally reported about vision disturbances. The same day she presented at a neurologist. According to the patient and her mother, meanwhile reading and speaking was impaired and she suffered from memory impairment. The neurologist assumed a "disorder of the vestibulo-ocular system". A psychosomatic disorder was assessed to be unlikely. On 30-MAR-2009 she presented at another neurologic outpatient department to rule out "inflammatory central nervous system disorder". She was hospitalized in the same hospital from 30-MAR-2009 till 03-APR-2009. At that time she additionally complained of "sensory disturbances (not further specified). Exhaustive examinations including lumbar puncture/cerespinal fluid (included Borrelia serology, oligoclonal bands), EOP, SEP, VEP showed normal results. It was stated that a somatoform disorder could not be ruled out. On 07APR-2009 she presented to a neuro-psychologist. Test for acuity were below average, memory tests were at average. The physician stated, that concentration and memory impairment may be "early signs" of somatoform disorder. At that time, the patient considered that GARDASIL vaccination had caused the symptoms. On an unspecified day, gynecologic examination was performed and showed normal results. On 21-APR-2009 the patient presented at the neurologic department of a university, "neuropsychologic deficits with no pathomorphological correlate" were described. Tentative diagnosis was "cerebellitis post vaccine", all examinations including exhaustive autoantibody determination and EEG were all normal. It was reported that yellow fever vaccination in 2008 was well tolerated. From 23-JUL-2009 till 18-DEC-2009 the patient was in a rehabilitation clinic. Tentative diagnosis was "Immunologic cross reaction after HPV vaccination with


Page 321
Vaers Id: 417499-1 (S) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown electroencephalography, 16?Feb09; chest x-ray, 16?Feb09; abdominal ultrasound, 16?Feb09; slightly enlarged liver and spleen; electrocardiogram, 16?Feb09, elongation of QT; physical examination, 16?Feb09, ear, nose and throat normal; blood p Commotio cerebri; Meniscus operation; Appendicectomy


Page 322
Vaers Id: 417515-1 (O) Age Gender Vaccine Date Onset Date F 01-Jul-2010 01-Jul-2010 28.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Abortion spontaneous, Condition aggravated, Drug exposure during pregnancy
Symptom Text: This case is linked with case E2011-00963 (same reporter, same patient, same product). Case of pregnancy follow-up received from a health care professional, a physician, through a patient. Case medically confirmed. A 28 year old female patient with a medical history of spontaneous abortion in January 2010 when she was 8 weeks pregnant, had received the first dose of GARDASIL (batch number and lot number, and route of administration not reported) in her arm on 01-JUL-2010 and at the middle of July, exact date not reported, the patient suffered a spontaneous abortion, she was 2-3 weeks pregnant. Upon medical review, it was considered this case as serious and spontaneous abortion was determined to be an other important medical event. The patient recovered (date not reported). Other business partner numbers include ES-1577272925-E2011-00964. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Abortion spontaneous


Page 323
Vaers Id: 417520-1 Age Gender Vaccine Date Onset Date M 21-Feb-2011 21-Feb-2011 14.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 03-Mar-2011 WI 24-Feb-2011 Lot Prev Doses Site AC52B057EA 0 Left arm U3339AA 1539Y 1094Z 0 0 1 Right arm Right arm Left arm
Symptom Text: Client had syncopal event after the administration of GARDASIL (HPV) vaccine. Client issue was resolved almost immediately. Client was instructed to lay down to rest and given cool washcloth to apply to forehead as needed and water to drink until he felt good enough to leave. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 324
Vaers Id: 417564-1 Age Gender Vaccine Date Onset Date F 24-Feb-2011 24-Feb-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 03-Mar-2011 TX 24-Feb-2011 Lot Prev Doses Site 1539Y 0 Unknown C3476AA 0 Unknown U3337AA 0 Unknown
Cold sweat, Convulsion, Fall, Gaze palsy, Head injury
Symptom Text: About 1 to 3 min. after administration of vaccines chills seizured. Her eyes rolled back and skin was cold and clammy. Child feel and hit her head. Used ammonia inhalant and she was awake and responsive when ambulance to her to hospital. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 325
Vaers Id: 417571-1 (S) Age Gender Vaccine Date Onset Date M 24-Feb-2011 24-Feb-2011 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 0
Status Date State Received Date 02-Mar-2011 OH 24-Feb-2011 Lot Prev Doses Site 0992Z 0 Unknown
Abdominal pain, Dyspnoea, Hypersensitivity, Rash, Swollen tongue
Symptom Text: 1/2 hr after vaccination, patient went to ER at hospital for swollen tongue and difficulty in breathing. Admitted for IV BENADRYL and SOLUMEDROL. The following information was obtained through follow-up and/or provided by the government. 3/3/11 Received hospital medical records for service dates 2/24-2/25/2011. FINAL DX: acute allergic reaction 3/11/11 Received ER medical records for service date 2/24/2011. FINAL DX: acute allergic reaction Records reveal pt experienced swollen tongue, abdominal pain, facial rash & SOB when home after vaccination. Tx w/IV steroids, IM benadryl. Admitted overnight for observation. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DAYTRANA Patch; INVEGA CBC, BMP, CXR normal The following information was obtained through follow-up and/or provided by the government. 3/3/11 Received medical records w/LABS: wbc 13.4(H). CXR & CT abdomen WNL. Bipolar disorder; ADHD on DAYTRANA AND INVEGA The following information was obtained through follow-up and/or provided by the government. 3/11/11 Received medical records w/PMH: bipolar, ADHD,


Page 326
Vaers Id: 417576-1 Age Gender Vaccine Date Onset Date M 24-Feb-2011 24-Feb-2011 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MMR MERCK & CO. INC. DTAP GLAXOSMITHKLINE BIOLOGICALS TYP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 28-Feb-2011 NC 25-Feb-2011 Lot Prev Doses Site 0653X 0 Left arm 00352 1 Right arm AC14B118BA 0 Right arm D0412 1 Left arm
Feeling cold, Hot flush, Influenza like illness, Nausea
Symptom Text: Patients reported hot/cold flashes, nausea, flu-like symptoms all throughout the night and has remained the same until following morning. After being notified, immediately instructed patient to be seen at Health Clinic for possible reaction to HPV vaccination. Pending doctor visit. Unknown outcome as of 25FEB2011, 10:30AM. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Unknown doctor or HCP plan of action None NOne


Page 327
Vaers Id: 417601-1 (O) Age Gender Vaccine Date Onset Date F 27-Sep-2010 01-Oct-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 4
Arthritis, Autoimmune disorder, Gastrointestinal disorder, Joint swelling, Oedema peripheral
Symptom Text: Case received from a healthcare professional on 13-JAN-2011. Case medically confirmed. A 16 year old female patient had received the first dose of GARDASIL (lot number and injection route not reported) in the upper arm on 27-SEP-2010. One week later she developed swelling of one foot. At the time of reporting the patient also suffered from additional swelling of the other foot and on wrist joint. Rheumatological check-up was planned. The reporter underlined that she had not examined the patient herself. She had been contacted by the mother by phone. Follow up on 17-FEB-2011. Upon new information received from the reporter on 17-FEB-2011 via phone call, the case was upgraded to serious (OME). The reporter contacted the mother of the patient. Diagnosis of autoimmune arthritis after an intestinal disease (not otherwise specified) had been established. The patient still received cortisone at the time of reporting. Symptoms had improved. The reporter assessed the relation to the vaccine as unlikely. Other business partner numbers include E2011-00167. No further information is available. Case was closed. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 328
Vaers Id: 417602-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days
Abasia, Asthenia, Back pain, Headache, Hyporeflexia, Muscular weakness, Myelitis transverse, Pain in extremity, Pleocytosis, Pyrexia, Walking disability
Symptom Text: Case received from a physician and literature on 14-FEB-2011. Case medically confirmed. A 13-year-old female patient had received the second dose of GARDASIL (manufacturer unknown, Batch#, site of administration and route not reported) at unspecified date and 16 days post vaccination, the patient experienced fever that lasted a week, lower limb pain and lower back pain with disability in locomotion. The AE had started one month before admission and during this period, the patient had visited the emergency room for two times having been treated symptomatically with paracetamol and non steroid anti-inflammatory drugs, since no change in the regular clinical observation was detected. At admission, the patient experienced headache and partial improvement on the other algic complaints, while maintaining functional disability of lower limbs. The patient did not make reference to previous trauma and no other relevant personal or family history was reported. Neurologic examination revealed decreased muscle strength of lower limbs, hyporeflexia of patellar and Achilles tendons, cutaneous plantar reflex indifferent bilaterally, T10 no algic sensory level and inability to walk. Without meningeal signs, no changes of sphincters control and no other major changes to the regular clinical observation. The analytical evaluation that included complete blood count, biochemical renal function, hepatic and C-reactive protein was negative. The sedimentation rate was 25 mm/lh. Serology for Campylobacter jejuni, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumoniae ser 1, toxoplasmosis wright reaction, cytomegalovirus, herpes simplex virus I and II, parvovirus and Epstein-Barr virus were negative. Analysis of the cerebrospinal fluid showed mild pleocytosis (7 Leuc/ul), with normal glucose and protein, and bacteriological and virus search for Polymerase Chain Reaction Technique for enterovirus and herpes virus were negative. Immunologic studies with assay of immunoglobulins, complement, ANA and ANCA had revealed no alteration. It was performed a brain and spinal cord MRI which results were normal. The electromyography showed motor and sensory potentials in both upper and lower limbs within the normal, abdominal muscle activation in tibialis anterior and vastus lateralis with normal recruitment and potential of motor unit with normal characteristics, suggesting proximal lesion (medullary/preganglionic). During hospitalization, there was a gradual improvement in motor disability of lower limbs. Specific treatment with gabapentin (600 mg, Tid) was administered, with significant improvement in pain, allowing the patient to have autonomous march, at the time of the discharge (8 days after admission). At this time of discharge, she was able to walk. After discharge, the patient began a program of physiotherapy rehabilitation, keeping the gabapentin therapy at home. Two months later, the patient was asymptomatic and with normal neurological exam and she began a gradual reduction of medication. The patient had repeated a brain and vertebro-medullary MRI and the electromyography that showed no alteration. Ten months later the patient remains without neurological sequelae. Clinical evolution and diagnostic tests were consistent with the hypothesis of transverse myelitis. Note: According to the author's conclusions, although they could not find en etiological factor, the history of fever and the clinical evolution without sequelae suggest a post-infectious etiology. There is also the possibility of a post-vaccinal immunological process. At the time of reporting, the patient had fully recovered. Other business partner numbers include: E2011-01151. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Neurological examination, revealed decreased muscle strength of lower limbs, hyporeflexia of patellar and Achilles tendons; diagnostic laboratory test, PCR for herpes virus was negative; electromyography, showed motor and sensory potentials Unknown


Page 329
Vaers Id: 417603-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cerebrovascular accident
Days
Status Date State Received Date 28-Feb-2011 GA 25-Feb-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a physician via telephone call about a conversation he heard concerning a teenage female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported). On an unspecified date the patient had a stroke. At the time of the report, the patient's outcome was unknown. Upon internal review strokes were considered to be an other important medical event. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 330
Vaers Id: 417615-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Cerebrovascular accident
Days
Status Date State Received Date 28-Feb-2011 GA 25-Feb-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a physician via telephone call about a conversation he heard concerning a teenage female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported). On an unspecified date the patient had a stroke. At the time of the report, the patient's outcome was unknown. Upon internal review strokes were considered to be an other important medical event. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 331
Vaers Id: 417618-1 Related reports: 417618-2 Age Gender Vaccine Date Onset Date F 14-Feb-2011 Unknown 10.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 04-Mar-2011 WI 25-Feb-2011 Lot Prev Doses Site 0337Z 0 Right arm
Fluctuance, Injection site induration, Local reaction
Symptom Text: Pt had delayed local reaction around injection. Total size=3 3/4 cm with slightly fluctuance, with 1 1/4 cm with induration. No tenderness. Pt = obese 1" needle. Occurred 6 days post vaccine ? 10 days post vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Obese; Osgood-Schlatter None


Page 332
Days 0
Status Date State Received Date 28-Feb-2011 CA 25-Feb-2011 Lot Prev Doses Site NULL 2 Unknown
Abdominal pain upper, Dizziness, Headache, Pain, Pyrexia
Symptom Text: Fever of 100, headache, stomachache, body aches, dizziness Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Had a cold


Page 333
Vaers Id: 417659-1 Age Gender Vaccine Date Onset Date F 25-Feb-2011 26-Feb-2011 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chills, Pain, Pyrexia, Tremor
Days 1
Status Date State Received Date 28-Feb-2011 CA 27-Feb-2011 Lot Prev Doses Site NULL 0 Left arm
Symptom Text: achy-ness, soreness to touch, chills, shakiness grew intensity into the evening, fever broke mid-morning after sleep and ibuprofen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none no


Page 334
Days 0
Status Date State Received Date 01-Mar-2011 FR 28-Feb-2011 Lot Prev Doses Site MN01990 0 Left arm
Asthenia, Asthenopia, Condition aggravated, Eye swelling, Fatigue, Headache, Immediate post-injection reaction, Malaise, Muscular weakness, Musculoskeletal chest pain, Myalgia, Pain in extremity, Sensation of heaviness, Somnolence, Syncope, Vision blurred, Visual impairment
Symptom Text: Information has been received from a Cancer specialist nurse concerning a 16 year old female patient a medical history of being prone fainting who on 24-SEP-2010 at 12:35 was vaccinated in the left deltoid with the first dose of GARDASIL (batch # MN01990), route not reported. Immediately felt unwell, was made to lie down and was assessed by the medical doctor present. One hour later felt generally unwell, had difficulty focusing and felt heavy and groggy. She was sent home from school and her mother took her to see her general practitioner. At this stage she also had rib pain, and arm pain and not feeling herself. Her mother telephoned the reported on 27-SEP-2010 stating that she was still unwell, felt weak, had no energy and eyes were very heavy. On 28-SEP-2010, the patient fainted at school and was again taken to see the general practitioner who stated that it was a reaction to the vaccine and that it would possibly happen after the next dose. The patient was hesitant to continue with the vaccination program. On 29-SEP-2010, the patient was reported to be feeling much better. The patient's mother had been offered the services of a pediatrician to look at the patient and she was yet to decide if she requires this. The reporter spoke to the patient's mother on 29-SEP-10 and the mother denied that her daughter had to lie down after receiving the vaccine. The reporter was not happy the information that she was provided to be put on the legal or otherwise document as the information originally provided changed each time the reporter spoke to the mother. Follow up information received on 25-OCT-2010: The patient received GARDASIL intramuscularly. On 24-SEP-2010 the patient had difficulty focusing and heavy groggy feeling which were moderated in severity (not severe as previous reported). On 25-SEP-2010, one day post vaccination the patient experienced pain in her ribs and arm and was not herself (initially reported as onset date 24-SEP-2010). The events were of unknown severity (previously reported as severe). On 27-SEP-2010 the patient fainted in school, fell unwell with not energy and heavy eyes (severity not reported). On 29-SEP-2010 the patient was still feeling unwell. The outcome of all the events was unknown. The relationship to vaccination was unknown. Follow up received from the initial reporter. The patient had not yet fully recovered. The reporter was planning to report the case to the IMB but did not consider the case to be serious and was only going to report the case at the request of the patient's mother. Follow up received from the IMB, reference 2010-001068 on 15-FEB-2010: This case had been updated to serious. Information received by the IMB from a member of the public: The patient experienced two episodes of fainting within 6 weeks prior to vaccination, the patient's mother also fainted easily. The patient had been tired for a few weeks prior to vaccination. The patient had received antibiotics for a strep throat infection in May 2010. One hour post vaccination on 24-SEP-2010 the patient experienced visual disturbance, headache, swollen eyes and went home from school. The following day, 25-SEP-2010, the patient experienced malaise, myalgia and weakness in the legs and fainted on 25-SEP-2010. Tiredness had continued but was improving. Time to onset was one hour for the initial symptoms and a few days for the others. The patient was taken to the GP after the faint on 28?SEP-2010 (previously reported as 25-SEP-2010), and the GP took blood with nothing abnormal detected. The GP advised no further doses of GARDASIL, the patient had not recovered. Information received by the IMB from the patient's HCP (GP), case medically validated by the IMB: The duration of the patient's reaction was approximately 4 days and no corrective treatment was administered. The patient was not taking any concomitant medications. The patient's recovery was complete and the GP confirmed that the patient was not hospitalized as a result of he Other Meds: Lab Data: History: Unknown Diagnostic laboratory test, 28Sep10, nothing abnormal detected Tiredness


Page 335
Vaers Id: 417680-1 (O) Prex Illness: Prex Vax Illns: Syncope; Familial risk factor


Page 336
Vaers Id: 417681-1 (O) Age Gender Vaccine Date Onset Date F 20-Jan-2011 02-Feb-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 13
Status Date State Received Date 01-Mar-2011 US 28-Feb-2011 Lot Prev Doses Site 1539Y 1 Right arm
Symptom Text: Information has been received from a Nurse Practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no pertinent medical history or drug/allergies reactions, who was vaccinated with the first and second dose of GARDASIL (dose, route and lot # unspecified) on 18-AUG-2010 and 20-JAN-2011 respectively. There was no concomitant medication. The nurse reported that the patient discovered to be pregnant the same day (on 20-JAN-2011) GARDASIL was received, through urine pregnancy testing. It was reported the last menstrual period (LMP) was on 29DEC-2010 and the estimated delivery (EDD) date on 05-OCT-2011. The nurse also mentioned patient was tested because she was being followed for an IUD, and the IUD was found to have been expelled. No adverse effects were reported by the patient. In follow up information the nurse practitioner reported that the 20 year old female patient had two previous pregnancies with two live births in the last two years of which neither had any birth defects in 20-JAN-2011 (also reported as 20-JAN-2010) received intramuscularly into the right deltoid the second dose of GARDASIL (Lot # 666118/1539Y). On 25-JAN-2011 the patient underwent an ultrasound to clarify the estimated delivery date (EDD), result which 10 wld IUP, which was reported as 22AUG-2011. On 02-FEB-2011 the patient terminated her pregnancy at 4 weeks from LMP. The EDD was reported as being 22-AUG-2011. It was stated that the patient did not want a third baby in 3 years. She got pregnant due to spontaneous expulsion of MIRENA. It was unknown if the products of conception were examined. It was unknown if the fetus was normal. The nurse practitioner stated that the patient had an elective termination which was not at all related to GARDASIL. Upon internal review, patient had terminated the pregnancy was determined to be an other important medical event. The patient sought for unspecified medical attention. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 12/29/2010) None Ultrasound, 01/25/11, "10 weeks intrauterine pregnancy to clarify estimated delivery date"; Urine beta-human, 01/20/11, Positive


Page 337
Vaers Id: 417682-1 (O) Age Gender Vaccine Date Onset Date F 12-Jan-2011 12-Jan-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Hypoglycaemia
Days 0
Status Date State Received Date 01-Mar-2011 FR 28-Feb-2011 Lot Prev Doses Site NULL 0 Unknown
Symptom Text: Information has been received from the health authorities on 16-FEB-2011 under the referenced number ES-AGEMED-523582341. Case was medically confirmed. A 14 year old female patient had received a dose of GARDASIL (lot and batch number was not provide) via intramuscular on 12JAN-2011 and 90 minutes later, the patient experienced dizziness. The patient presented hypoglycaemia on the same day. The patient was taken to the hospital after vaccination. She was kept under observation during 10 hours, and afterwards she left the hospital. The patient recovered from all these adverse events on 12-JAN-2011. Case reported as a serious by the health authorities with other medically important condition as criteria. Other business partner numbers included: E2011-01032. No further information was reported. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 338
Vaers Id: 417697-1 Age Gender Vaccine Date Onset Date F 17-Feb-2011 18-Feb-2011 10.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Chills, Headache, Pyrexia
Days 1
Status Date State Received Date 04-Mar-2011 AR 28-Feb-2011 Lot Prev Doses Site 1178Y 2 Left arm
Symptom Text: High fever 104 degrees, chills, bad headache about 10 hrs after vaccine. No redness or swelling at vaccine site treated with ROCEPHIN, then oral antibiotics (? viral illness). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Nl CBC; Blood cx (-) None None


Page 339
Vaers Id: 417706-1 Age Gender Vaccine Date Onset Date Days M 01-Dec-2010 01-Dec-2010 0 15.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. MNQ NOVARTIS VACCINES AND DIAGNOSTICS FLUN MEDIMMUNE VACCINES, INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pruritus, Rash
Status Date State Received Date 01-Mar-2011 OH 28-Feb-2011 Lot Prev Doses Site 0163Z 1 Left arm 100001 0 Left arm 501053P 0664Z 0 0 Unknown Right arm
Mfr Report Id Route Subcutaneously Intramuscular Unknown Intramuscular
Symptom Text: Pt had rash & itching on both arms within 1 hr. of getting shots. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 340
Vaers Id: 417723-1 Age Gender Vaccine Date Onset Date F 14-Feb-2011 14-Feb-2011 17.0 Type Manufacturer VAX Detail: HEPA MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Days 0
Status Date State Received Date 04-Mar-2011 PA 28-Feb-2011 Lot Prev Doses Site 1628Z 0 Left arm 0651X 0 Left arm
Symptom Text: Child passed out for 1 to 2 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 341
Vaers Id: 417726-1 Age Gender Vaccine Date Onset Date F 22-Feb-2011 22-Feb-2011 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 07-Mar-2011 VA 28-Feb-2011 Lot Prev Doses Site 1017Z 0 Left arm
Symptom Text: Syncope. Vitals. 96/62, 50, pulse ox 97. Revived with ammonia salts, O2 administered by nasal canula. Supportive therapy administered. Vitals 102/65, 74, 100% O2 sat. RR 16. Released to mother 40 min later. Sent for head CT. Other Meds: Lab Data: History: Prex Illness: None Prex Vax Illns: Syncope.~Vaccine not specified (no brand name)~UN~0.00~Patient YAZ None


Page 342
Vaers Id: 417752-1 Age Gender Vaccine Date Onset Date F 01-Aug-2008 20-Mar-2010 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 596
Status Date State Received Date 01-Mar-2011 NY 01-Mar-2011 Lot Prev Doses Site NULL 2 Unknown
Activities of daily living impaired, Asthenia, Cardiac disorder, Constipation, Diarrhoea, Headache, Hypoaesthesia, Paraesthesia, Skin discolouration
Symptom Text: It appeared patient was having a cardiac event and was rushed by ambulance to the nearest hospital. 11 months later, she is still symptomatic with no definite diagnosis. Her energy level is depleted. She can not attend a full week of school. She does not go out with friends because she knows she can't keep up with them. She fluctuates between constipation and diarrhea. Frequent headaches. Hands tingle, go numb and change colors. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: EKG, EEG, Endoscope with biopsy, numerous blood/urine tests, ultrasound, CAT scans... Nothing had been prediagnoses. There were no known illnesses prior to vaccine.


Page 343
Vaers Id: 417762-1 (S) Age Gender Vaccine Date Onset Date F 22-Sep-2010 01-Nov-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 40
Status Date State Received Date 02-Mar-2011 FR 01-Mar-2011 Lot Prev Doses Site NK25010 0 Left arm
Confusional state, Dyskinesia, Epilepsy, Eye movement disorder, Flank pain, Headache, Loss of consciousness, Migraine, Photophobia, Psychosomatic disease, Trance, Unresponsive to stimuli
Symptom Text: Information has been received from a physician on 18-FEB-2011. This case was linked to E2011-001187 (WAES # 1102USA02965; same patient, same reporter, same vaccine, events after second dose). This case was medically confirmed. A 13 year old female patient with an unreported medical history and concomitant medication received the first dose of GARDASIL (lot number NK25010, batch number NM11420) route not reported in the left deltoid on 22-SEP-2010. On 21-NOV-2010, two months post vaccination the patient experienced a sore head, confusion and a few days pain in the left side and abdominal migraine was suspected. On 21-NOV-2010, the patient experienced the first episode where the patient got up from bed complaining of a sore head and became confused. The GP on call was contacted and the patient was taken the accident and emergency department by ambulance. The patient was discharged after two days. A few days later, the patient complained of pain in her side and was seen by the GP who took bloods. The patient then became confused and was taken by ambulance to hospital and admitted for two days. A CAT scan was normal and abdominal migraine was queried. In November, the patient's parents were called into school after the patient experienced what look like an epileptic fit and was again confused. The patient was seen by the General Practitioner. In December a week before Christmas the patient went into a trance in school, there was no jerking but was not responding. This episode continued for about 40 minutes. Afterwards the patient was not confused or drowsy and was taken to accident and emergency and was admitted. The patient was last seen by the consultant on 10-JAN-2011 and was due to be seen again in three months time. On 03FEB-2011, the patient again complained of a sore head and went to the schools office to sit down where she blanked out for 15 minutes and then went home. The patient was not normally tired or upset after episodes. The patient always complained of headaches in the region of the left occiput prior to the episodes, did not like bright lights and these bring on a trance. The patient was at a Christmas pantomime recently where there were lots of flashing lights but this did not bring on an episode. The patient received the second dose of GARDASIL (lot number NK25010, batch number NM311130) route not reported in the left deltoid on 04-FEB-2011. On 04-FEB-2011, whilst the patient was in the nurses room after receiving the vaccine, the patient had suddenly gone into a trance. Her colour was good, she did not respond to any questions. The parents informed the physician at this time, that the patient had been having these episodes since 22-SEP-2010 but they had not expected her to have an episode that day. The patient was taken to the couch and was lying flat. Her colour continued to be good and her blood pressure was 108/65, pulse was 84 and regular. From the time of the vaccine on 15.25 pm and 15.54 hours the patient remained lying on her back on the couch and did not respond to any questions or commands. On one occasion the patient partially opened her eye and the physician noted coarse jerking of both eyes for a short period. She occasionally appeared to come what look frightened and the shudder and then close her eyes again. At 15.45 hours she was noted to be alert and talkative. The patient was transferred but to the chair and after a short time appeared to go back into a trance where she held both eyes closed. The patient had two more episodes lasting about 5 minutes each. The patient went home with her family at 16.45 hours, she was conscious at this time and they walked her out to the car. The parents refused to take the patient to the emergency department. The father confirmed that the patient had been investigated for these episodes and a CAT scan was normal and the patient was waiting for an EEG which had been booked but was not considered urgent. The parents had arranged an urgent appointment at a clinic Other Meds: Lab Data: History: Unknown Computed axial tomography, ??Nov10, Normal; Electroencephalography, ??Feb11, Normal; Blood pressure measurement, ??Feb11, 108/65; Total heartbeat count, ??Feb11, 84, and regular Unknown


Page 344
Vaers Id: 417762-1 (S) Prex Illness: Prex Vax Illns:


Page 345
Vaers Id: 417777-1 Age Gender Vaccine Date Onset Date F 28-Feb-2011 28-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Headache, Vomiting
Days 0
Status Date State Received Date 07-Mar-2011 NC 28-Feb-2011 Lot Prev Doses Site 0337Z 2 Right arm
Symptom Text: Third GARDASIL given of approx. 9am on 2-28-11. Per dad approx. 15-20min after leaving office pt developed a headache then started vomiting x2. Father brought pt back for a nurse to assess. Pt was feeling better at office c/o just a headache. Advised father to give MOTRIN and watch her the rest of day. Called father at 2:15pm he states pt was feeling better. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acute otitis media Dx on 2-23-11 BENZACLIN 1-5% gel; Melatonin 5mg; Sertraline 50mg; Amoxicillin 500mg


Page 346
Days 4
Status Date State Received Date 10-Mar-2011 TX 02-Mar-2011 Lot Prev Doses Site 0337Z 2 Unknown
Dizziness, Feeling hot, Nausea, Rash, Rash pruritic
Symptom Text: Itchy rash on arms, legs, warm face, rash on abdomen, back, dizzy, nauseated now for 7 days. Rx - Prednisone 20mg, BENADRYL 25mg, Hydrocortisone. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 347
Vaers Id: 417882-1 Age Gender Vaccine Date Onset Date F 02-Mar-2011 02-Mar-2011 17.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Days 0
Status Date State Received Date 03-Mar-2011 MI 02-Mar-2011 Lot Prev Doses Site U3744AA 0 Right arm 1095Z 1 Left arm AHAVB446BA 0 Left arm 1016Z U3464AA AC52B051CB 0 0 Right arm Right arm Left arm
Mfr Report Id Route Unknown Subcutaneously Intramuscular Unknown Unknown Intramuscular
Symptom Text: Six vaccines were administered today - the last of which was the GARDASIL. After administration of the GARDASIL the pt. passed out. Pt was observed in clinic for about one hour. Promethazine 12.5 mg was administered. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None Lateral meniscus tear - Rt. knee


Page 348
Vaers Id: 417888-1 Age Gender Vaccine Date Onset Date F 23-Feb-2011 23-Feb-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Lip swelling, Swelling, Urticaria
Days 0
Status Date State Received Date 03-Mar-2011 MS 02-Mar-2011 Lot Prev Doses Site 07682 0 Right arm
Mfr Report Id MS0032011 Route Intramuscular
Symptom Text: GENERALIZED SWELLING/WHELPS 2/23; RELIEVED WITH BENADRYL; 2/24/11 AM GENERALIZED SWELLING HAS RETURNED; PATIENT WENT TO FACILITY AND SPOKE WITH MD; PATIENT STATES SHE HAD GENRALIZED WHELPS/SWELLING INCLUDING LIPS, BACK, BEHIND EARS, AND SOME WHELPS ON HER LEGS AND ARMS. WILL RECEIVE INJECTION OF DECADRON 2/24/2011 A.M. HAD TO RETURN TO FACILITY ON 2/25 WITH SWELLING AND INABILITY TO WALK. MOM SAYS MD GAVE TWO PRESCRIPTION BUT SHE DOES NOT KNOW WHAT THEY WERE. ALL SYMPTOMS RESOLVED 2/27/11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE REPORTED NONE REPORTED


Page 349
Vaers Id: 417910-1 (O) Related reports: 417910-2 Age Gender Vaccine Date Onset Date F 03-Nov-2009 Unknown 29.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 04-Mar-2011 US 03-Mar-2011 Lot Prev Doses Site NULL Unknown
Mfr Report Id Last Edit Date WAES0912USA01998B 31-Mar-2011 1 Other Vaccine Route Unknown
Drug exposure during pregnancy, Neonatal disorder
Symptom Text: Information has been received from a physician concerning a 29 year old female, for the Pregnancy Registry for GARDASIL, who on approximately 03NOV-2009, "between week 4 and 5 of the patient's pregnancy", was vaccinated with a dose of GARDASIL (Lot No. not reported). It was reported that on 15-JUL-2010, 40 weeks from LMP, the patient delivered a female baby with 7 pounds and 1 ounces of weight, apgar score 8/9. Additional information has been received from the patient. She stated that her baby was doing well, but the pediatrician was following the baby's hemangioma on her neck (from birth), and an MRI of the fontanel was scheduled for next week. The mother's experience was captured in WAES# 0912USA01998. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 350
Vaers Id: 417911-1 (O) Age Gender Vaccine Date Onset Date F 01-Jan-2011 01-Jan-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Dizziness, Epilepsy, Syncope
Days 0
Status Date State Received Date 04-Mar-2011 FR 03-Mar-2011 Lot Prev Doses Site NULL Unknown
Mfr Report Id Last Edit Date WAES1102MEX00014 04-Mar-2011 Other Vaccine Route Intramuscular
Symptom Text: Information has been received from a physician concerning a 20 year old female who in January 2011, was vaccinated with GARDASIL. In January 2011, the patient experienced convulsion, dizziness and syncope; therefore the patient was transferred to neurologist. An electroencephalography was performed that showed epilepsy. The patient was diagnosed with epilepsy by the neurologist. The patient received treatment for epilepsy (name, start and stop date and dose neither were nor reported). In January 2011 the patient recovered from convulsion and dizziness. The syncope did not recover. The reporter felt that convulsion was not related to therapy with GARDASIL and she stated that the neurologist did not relate the epilepsy diagnosis with GARDASIL too, dizziness and syncope were reported as unknown. The action taken was reported as none. The same source from WAES 1102MEX00015. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown electroencephalography, ??Jan11, Epilepsy Unknown


Page 351
Vaers Id: 417965-1 Age Gender Vaccine Date Onset Date M 03-Mar-2011 03-Mar-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness
Days 0
Status Date State Received Date 11-Mar-2011 PA 03-Mar-2011 Lot Prev Doses Site 1271Z 2 Left arm
Symptom Text: Patient felt dizzy after HPV injection, symptoms lasted about 30 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Patient had orthostatic blood pressures which were normal Hearing loss (sensory neural) congenital Right OM


Page 352
Vaers Id: 417970-1 Age Gender Vaccine Date Onset Date F 07-Feb-2011 07-Feb-2011 27.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Urticaria
Days 0
Status Date State Received Date 04-Mar-2011 CA 03-Mar-2011 Lot Prev Doses Site 0887Z 1 Left arm
Symptom Text: Urticaria all over entire body daily. tx with Zyrtec daily. However when tapering off Zyrtec x7 days, urticaria remains. Other Meds: Lab Data: History: Prex Illness: no no
Prex Vax Illns: urticartia~HPV (Gardasil)~1~27.00~Patient


Page 353
Vaers Id: 417992-1 (S) Age Gender Vaccine Date Onset Date F 02-Feb-2011 02-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS Fatigue, Presyncope, Tremor, Vomiting
Days 0
Status Date State Received Date 07-Mar-2011 FR 04-Mar-2011 Lot Prev Doses Site NJ51180 0 Left arm
Symptom Text: Case received from the Health Authority on 24-FEB-2011 under the reference number L201102-356 via local agency. Case medically confirmed. A 12 year old female patient had received the first dose of GARDASIL (Batch# NM14120; lot# NJ51180, in left deltoid area) via intramuscular route on 02FEB-2011 and 3 hours post vaccination the patient had presented lipothymy during seconds, tremor during minutes and vomiting (food content) without other manifestations. The AEs also included prostration during about 1 hour. The girl was observed in a pediatric urgency room from an hospital and has been discharged, since she had no further clinical changes. There was no suspected drug interaction. The same drug was not reintroduced. There were no known previous reactions to other drugs. It was not administered a specific treatment for the AE. There was a reference to the administration of paracetamol indicated to fever/pain, with unknown dose in SOS, oral route, with start date unknown and which was still administered. The patient had fully recovered. No relevant clinical history. Family history: uncle with epilepsy. Lipothymy during seconds, tremor during minutes, vomiting (food content) and prostration during about 1 hour were considered by the agency to be disabling. Other business partner numbers include: E2011-01255. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 354
Vaers Id: 418003-1 (S) Age Gender Vaccine Date Onset Date F 29-Oct-2008 29-Oct-2008 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days 0
Status Date State Received Date 07-Mar-2011 WV 04-Mar-2011 Lot Prev Doses Site 0573X 2 Right arm
Asthenopia, Astigmatism, Corrective lens user, Eye irritation, Vision blurred
Symptom Text: After my daughter received the three shots of GARDASIL vaccine she was left with permanent blurred vision. Before the shot she had just passed an athletic physical with 20/15 vision. After the shots she kept complaining of blurred vision. I called her doctor and the nurse called me back and the only response I received from her was that blurred vision was not a side effect of the vaccine. Now my daughter has to wear contacts and glasses. The following information was obtained through follow-up and/or provided by the government. 3/11/2011 Ophtho consult records received for DOS 11/26/2008 w/ Dx: compound myopic astigmatism OU. Pt presented c/o blurred vision x approx 1 mo, tired & burning eyes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: My daughter reported to the doctor that she was allergic to Codeine, Penicillin, Loritabs, Prednisone and Cortisone. The following information was obtained through follow-up and/or provided by the government. PMH: depression/"nerves". Allergy: prednisone, PCN, codeine.


Page 355
Vaers Id: 418014-1 Age Gender Vaccine Date Onset Date F 01-Mar-2011 02-Mar-2011 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Epistaxis
Days 1
Status Date State Received Date 14-Mar-2011 MD 04-Mar-2011 Lot Prev Doses Site 1317Y 0 Left arm
Symptom Text: Pt received GARDASIL #1 on 3/1/11. On 3/2/11 awoke with nosebleed in am, felt "dizzy" for about 5 hours. Resolved. Felt fine on 3/3/11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 356
Vaers Id: 418022-1 Age Gender Vaccine Date Onset Date F 11-Feb-2011 Unknown 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy
Days
Status Date State Received Date 14-Mar-2011 NY 04-Mar-2011 Lot Prev Doses Site 0768Z 2 Left arm
Symptom Text: 3/1/11 Positive pregnancy test in office sono in office confirmed pregnancy. EDC - 10/25/11 6 weeks LMP - 1/17/11 pregnancy precautions were advised. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 357
Vaers Id: 418029-1 Age Gender Vaccine Date Onset Date F 01-Mar-2011 02-Mar-2011 16.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 07-Mar-2011 PA 04-Mar-2011 Lot Prev Doses Site 0225Z 1 Right arm AHAVB462AA 0 Right arm 1178Y 0 Left arm
Erythema, Injection site pruritus, Mass, Nausea, Oedema peripheral
Symptom Text: Back of right arm became red and swollen. Went from a lump size of a small plum to a size of an orange. Skin was red and warm to the touch. Seen by school nurse-ice applied, administered Tylenol, and applied Caladryl Anti-Itch Cream beacause she c/o of itching at the injection site. Patient also complained of nausea for 24 hours. No fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None No


Page 358
Vaers Id: 418046-1 Age Gender Vaccine Date Onset Date F 05-Mar-2011 05-Mar-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 14-Mar-2011 MN 05-Mar-2011 Lot Prev Doses Site 1167Z 1 Right arm
Dysarthria, Headache, Paraesthesia, Paraesthesia oral, Speech disorder
Symptom Text: About 1 hour after vaccine tingling tongue & hand (R), poor speech/articulation, headache. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 359
Vaers Id: 418076-1 (O) Related reports: 418076-2 Age Gender Vaccine Date Onset Date F 13-Feb-2009 05-Jul-2009 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 142
Status Date State Received Date 08-Mar-2011 PA 07-Mar-2011 Lot Prev Doses Site 0548X 2 Right arm
Abdominal pain upper, Apathy, Arthralgia, Back pain, Cardiac murmur, Chest pain, Chills, Confusional state, Convulsion, Dyspnoea, Fall, Fatigue, Gaze palsy, Grand mal convulsion, Impetigo, Loss of consciousness, Malaise, Muscular weakness, Musculoskeletal pain, Myalgia, Nasopharyngitis, Neck pain, Pain, Pain in extremity, Rash, Syncope, Upper respiratory tract infection
Symptom Text: Information has been received from a physician concerning an approximately11 year old female who in October 2008, was intramuscularly vaccinated with the first dose of GARDASIL (lot# not reported) and the third dose of 0.5ml GARDASIL (lot# not reported) in February 2009. After the third dose, the patient experienced seizures and developed a lack a motivation to go to school because she was in pain. Heavy metal screen, MRI, EEG and liver function testing were performed with no results reported. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested. The following information was obtained through follow-up and/or provided by the government. 3/11/11. PCP records. DOS 4/2/09 3/1/11. Numerous OV for WCC et minor health problems. On OV 7/6/09 pt DX c syncope & collapse, however EEG confirmed sz activity; pt referred to neurologist. Pt was started on anticonvulsants, but still had breakthrough sz episodes. OV on 3/1/11 DX:Impetigo; URI, fatigue. CC: fatigue, joint pains/aches; rash to cheek, slight colds X 1week. At this visit pt reported that since initial vax of the series has been having significant S/S including: confusion, chills, feeling unwell, leg pain, SOB, chest pain, achy muscle, weak muscle, sz, backache, stomachache, knee pains, shoulder pains, elbow pains, neck pains been ongoing X 2 years. Perceives normal life has been interrupted since vax; believes symptoms are related to vax. Has had 4 breakthrough sz in previous 4-weeks; resistant to increasing anticonvulsant dose as it affects pts AFFECT. 3/11/11. Consultant records DOS 1/11/10 - 8/31/10. DX Generalized convulsive epilepsy; syncope and collapse. Pt seen by neurology et cardiology at intermittent OV. CC: passing out spells, eyes rolling upwards, spinning in circle, falling, convulsions, breakthrough sz. On initial OV to neuro on 1/11/10 notation indicates pt tolerating anticonvulsant increase well; initially had had tiredness, but not anymore. Denies joint pain & resp problems. DOS 8/27/10 OV c cardiologist. DX: Innocent heart murmur, trivial MR. PE: systolic murmur to LSB. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown The following information was obtained through follow-up and/or provided by the government. 3/11/11. Labs/diagnostics. EEG: generalised epileptiform discharges. Echocardiogram: trivial mitral regurgitation. Video EEG: generalised sp Unknown The following information was obtained through follow-up and/or provided by the government. 3/11/11. PCP records. PMH: essential HTN 8/08; febrile sz as toddler. NKDA.


Page 360
Vaers Id: 418076-2 (S) Related reports: 418076-1 Age Gender Vaccine Date Onset Date F 11-Aug-2008 01-Oct-2008 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, LIFE THREATENING, SERIOUS Convulsion
Days 51
Status Date State Received Date 10-Mar-2011 PA 07-Mar-2011 Lot Prev Doses Site 1968U 0 Left arm AL52BO24EN Unknown 42359AN 0 Left arm
Symptom Text: See attached - "Patient timeline - Seizures". Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Lisinopril - 2.5 mg/day None performed. High Blood Pressure


Page 361
Vaers Id: 418100-1 Age Gender Vaccine Date Onset Date F 31-Jan-2011 10-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 10
Status Date State Received Date 15-Mar-2011 PA 07-Mar-2011 Lot Prev Doses Site 9670403 2 Left arm
Urinary tract infection, Vaccine positive rechallenge
Symptom Text: Patient develops UTI symptoms after each GARDASIL injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 362
Vaers Id: 418118-1 Age Gender Vaccine Date Onset Date F 03-Mar-2011 03-Mar-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. FLU SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash, Rash erythematous
Days 0
Status Date State Received Date 09-Mar-2011 AZ 07-Mar-2011 Lot Prev Doses Site 0565Z 2 Left arm U3732AA Right arm
Symptom Text: Receive Flu (Influenza) & 3rd HPV, at home developed mask like rash, erythematous on entire face. No fever or other systemic signs. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No None None- (Acne)


Page 363
Vaers Id: 418135-1 Age Gender Vaccine Date Onset Date F 28-Feb-2011 02-Mar-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Abdominal pain, Diarrhoea
Days 2
Status Date State Received Date 16-Mar-2011 NY 07-Mar-2011 Lot Prev Doses Site 1377Y 1 Left arm
Symptom Text: On Wednesday, 3/2/11, pt started having severe abdominal pain. She then started with diarrhea, no vomiting or nausea. As of 3/7/11, pt's symptoms have resolved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 364
Vaers Id: 418160-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days
Status Date State Received Date 09-Mar-2011 FR 08-Mar-2011 Lot Prev Doses Site 0276U 2 Unknown
Activities of daily living impaired, Arthralgia, Chlamydial infection, Pain in jaw
Symptom Text: Information has been received from a health professional concerning a mean while adult 20 year old (also reported as an approximately 18 year old) female patient with no relevant medical history reported who had received a complete series of three doses of GARDASIL (lot number, injection route and site not reported) on unspecified dates in 2008. About six months post vaccination she developed pain in one knee joint. Another six months later, she also had pain in the other knee and in the elbow joint. Later she also suffered from jaw pain. Several investigations including magnetic resonance imaging (MRI) did not show any pathologies. The patient was no more able to do sports as she did in the past. At the time of reporting the symptoms were ongoing. Joint pain was considered to be disabling by the health professional. Follow-up information received on 21-FEB-2011 by the reporting gynaecologist: The patient was vaccinated in 2008 with 3 doses of GARDASIL with the following lot numbers: lot # 0276U, batch # NF58550, lot # 1475F, batch # NF37120, Lot # 1339F, batch # NF23310 (exact vaccination dates were not reported). The reporting gynaecologist was no more consulted by the patient, she was treated by a rheumatologist. As to the rheumatologist, a causal relation to the GARDASIL vaccine is unlikely, given the fact, that Chlamydia infection was diagnosed in the patient. The final outcome was not reported. The case is closed. Case medically confirmed. Other business partner numbers include: E2011-00008. Joint pain and Chlamydial infection were considered to be disabling by the health professional. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown magnetic resonance imaging, ??08, did not show any pathologies Unknown


Page 365
Vaers Id: 418161-1 (S) Age Gender Vaccine Date Onset Date F 06-Jul-2010 01-Nov-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Cervical root pain, Neuralgia
Days 118
Status Date State Received Date 09-Mar-2011 FR 08-Mar-2011 Lot Prev Doses Site NULL 2 Unknown
Symptom Text: Case received from a physician on 24-FEB-2011. Case medically confirmed. A 17 year old female patient with no relevant history reported had received the third dose of GARDASIL (batch number not reported) on 06-JUL-2010. In the beginning of November 2010, she developed cervicobrachial neuralgias on the left side. X-ray work-up was normal. There was no arthrosis. The patient was hospitalized in December 2010. A battery of tests was performed (viral, inflammatory, Lyme) and was negative. The pain was still present with a slow evolution. The patient experienced neuralgic discharges. She had rehabilitation with physiotherapist and was prescribed tablets of morphine. On 20-JAN-2011 she was seen at the physician's office. She was given CYMBALTA. DAFALGAN was replaced by IXPRIM. She was seen again on 04-FEB-2011. Her mobility was better, but the cold increased the pain and the nerve as painful on its whole length. Other business partner numbers included: E2011-01244. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown X-ray, 01?Nov10, normal. There was no arthrosis; diagnostic laboratory test, ??Dec10, Battery of tests were performed (viral, inflammatory, LYME...) and was negative. Unknown


Page 366
Vaers Id: 418184-1 Age Gender Vaccine Date Onset Date F 08-Mar-2011 08-Mar-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 08-Mar-2011 NY 08-Mar-2011 Lot Prev Doses Site 1437Z 0 Left arm
Symptom Text: Syncope 10 seconds Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none NO


Page 367
Vaers Id: 418189-1 Age Gender Vaccine Date Onset Date M 02-Mar-2011 03-Mar-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Urticaria
Days 1
Status Date State Received Date 16-Mar-2011 NE 08-Mar-2011 Lot Prev Doses Site 1016Z 1 Left arm
Symptom Text: Hives located on body randomly comes & goes started within 24 hours of vaccine administration. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None BACTRIM None


Page 368
Vaers Id: 418192-1 Age Gender Vaccine Date Onset Date F 08-Mar-2011 08-Mar-2011 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR VARCEL MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 08-Mar-2011 AZ 08-Mar-2011 Lot Prev Doses Site U3436AA 0 Right arm 0898Z 1 Left arm AC52B054BA 5 Left arm 0786Z 0 Right arm
Mfr Report Id Route Intramuscular Subcutaneously Intramuscular Intramuscular
Dizziness, Hypotension, Loss of consciousness, Nausea
Symptom Text: Dizziness and nausea, loss consciousness, lowered patient to floor, and patient regained consciousness, BP initially low and returned to 118/60 with standing Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: no no


Page 369
Vaers Id: 418218-1 Age Gender Vaccine Date Onset Date F 21-Jan-2011 24-Jan-2011 11.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. FLU SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Skin warm
Days 3
Status Date State Received Date 16-Mar-2011 TX 09-Mar-2011 Lot Prev Doses Site AC52B060BA Left arm 0664Z UT3565BA U3356BA 1 Right arm Left arm Right arm
Symptom Text: Patient complained of having left anterolateral arm with marked swelling, erythema and mild warmth noted by school nurse on 1-24-11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None 1-24-11 CBC with diff - WBC count 4.3 Bilat knee pain due to running (school sports) Bilat knee pain due to running


Page 370
Vaers Id: 418221-1 Age Gender Vaccine Date Onset Date F 08-Mar-2011 08-Mar-2011 11.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 09-Mar-2011 AZ 09-Mar-2011 Lot Prev Doses Site AC52B054BA 5 Left arm U3436AA 0786Z 0 0 Right arm Right arm
Conversion disorder, Crying, Loss of consciousness
Symptom Text: Patient was hysterical and crying during administration of vaccinations. After the vaccinations were administered she was informed to sit in the chair for 10-15 minutes, but she insisted sitting on the floor. A few minutes later she began to lose consciousness. She was laid to floor and regained consciousness immediately. Blood pressure was slightly low 90/50 and slowly increased to 108/90 from lying, to sitting, to sitting in chair, to standing, to walking. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: no no


Page 371
Vaers Id: 418232-1 Age Gender Vaccine Date Onset Date M 09-Mar-2011 09-Mar-2011 13.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 09-Mar-2011 OH 09-Mar-2011 Lot Prev Doses Site U3774DA Left arm AHAVB462BA 0 Left arm 0768Z 2 Right arm
Fatigue, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Nervousness, Pallor
Symptom Text: Flu shot & Hep A given in L deltoid; Gardasil given in R deltoid. Immediately after Gardasil injection, patient stated "that one hurt"; started getting pale and as RN laid him back on exam table, patient stiffened arms and legs. No LOC. Elevated legs and applied cool rag to face and neck. After about 5 minutes, patient was able to sit up and drink a couple ounces of orange juice and ate a few pretzels. Patient had not eaten any breakfast this AM. Patient remained alert and oriented, but continued to be shaky for several more minutes. By 9:20 AM, all s/s were gone but patient stated that he felt tired. BP=108/70 and HR=88. PCP was called for any further recommendations for the patient. PCP states that patient OK to return to school if BP OK. Mom to call HD and/or PCP for further questions or concerns. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None No


Page 372
Vaers Id: 418234-1 Age Gender Vaccine Date Onset Date F 08-Mar-2011 Unknown 24.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR IPV SANOFI PASTEUR HPV4 MERCK & CO. INC. FLU SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Arthralgia, Dizziness, Pain
Days
Status Date State Received Date 10-Mar-2011 WY 09-Mar-2011 Lot Prev Doses Site C3819AA 0 Left arm E0330 0 Right arm 0768Z 0 Left arm U3804AA 0 Right arm
Symptom Text: Joint pain, dizziness, body aches. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Not sick at time of vaccination. TYLENOL; MOTRIN; PPD


Page 373
Vaers Id: 418236-1 (O) Age Gender Vaccine Date Onset Date F 14-Feb-2011 16-Feb-2011 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 2
Status Date State Received Date 10-Mar-2011 CT 09-Mar-2011 Lot Prev Doses Site 1317Y 0 Unknown
Blood pressure increased, Condition aggravated, Rash, Rash macular, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 23 year old female patient with the medical history of high blood pressure who on 14-FEB2011 was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 662529/1317Y, Expiration: 30-May-2011). Concomitant therapy included MICARDIS for her high blood pressure and ethinyl estradiol (+) etonogestrel (MSD). The physician reported that the patient had a rash and increased blood pressure. On 23-FEB-2011 the patient went back to the physician because of the onset of the rash which started on 16-FEB-2011. It was on her arm and leg and it was itchy and blotchy. One thing to note about the increased blood pressure, she was on MICARDIS (manufacturer unspecified). She was also on ethinyl estradiol (+) etonogestrel (MSD) prior to getting the GARDASIL vaccine. One thing her primary doctor added after the AE was the metoprolol 50mg (manufacturer unspecified). She did visit her primary care physician and that's who prescribed it. At time of report, the patient's status was unknown. Blood pressure increased was considered to be another important medical event by the reporter. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood pressure high NUVARING; MICARDIS Unknown


Page 374
Vaers Id: 418263-1 Age Gender Vaccine Date Onset Date Days M 28-Feb-2011 01-Mar-2011 1 11.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ NOVARTIS VACCINES AND DIAGNOSTICS VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pruritus, Urticaria
Status Date State Received Date 10-Mar-2011 PA 09-Mar-2011 Lot Prev Doses Site UT3775BA Right arm 0786Z 0 Left arm 090601A 0 Right arm 0713Z AHAVB446BA 1 0 Right arm Left arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Subcutaneously Intramuscular
Symptom Text: Received vaccines at approximately 4pm on 2/28/11. 1st reported issue when arrived at Dep of Health bldg 3/2/11 at 1030 am with c/o itchy skin that first started 3/1/11 at 5pm and by 8pm - welts appeared all over body. 3/2/11 at 1030 - Mom indicated much better hardly noticeable and less itchy. Was not seen by MD and no fever indicated. Pt does not have any known allergies. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: (No testing. No medical visit)


Page 375
Vaers Id: 418279-1 Age Gender Vaccine Date Onset Date M 03-Mar-2011 06-Mar-2011 12.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS FLU SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash
Days 3
Status Date State Received Date 09-Mar-2011 MI 09-Mar-2011 Lot Prev Doses Site U3543AA 1 Right arm C3486AA 0 Right arm 0337Z 0 Left arm AHAVB461CA 1 Left arm 03744AA 0 Left arm
Symptom Text: Rash appeared after showering at 10 am 3/06/2011. Rash on both elbows and knees. Mother states it looks like "several circles on both elbows, both knees, darker rim, white on inside of circle". Child denies itching or discomfort. PMD states he feels is delayed reaction from immunizations given on 3/3/2011. Benadryl was recommended by PMD. Mother states Bedadryl was effective and rash "is going away". Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE None NONE NO


Page 376
Vaers Id: 418309-1 Age Gender Vaccine Date Onset Date F 14-Feb-2011 Unknown 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Alopecia, Asthenia, Pallor
Days
Status Date State Received Date 17-Mar-2011 CA 09-Mar-2011 Lot Prev Doses Site 0331Z 2 Left arm
Symptom Text: Weakness pallor after 3rd HPV hair loss after 1st HPV vaccine. Hair loss worsened after the 3rd vaccine of HPV. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 377
Vaers Id: 418347-1 Age Gender Vaccine Date Onset Date F 16-Feb-2011 Unknown 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy
Days
Status Date State Received Date 18-Mar-2011 GA 09-Mar-2011 Lot Prev Doses Site 0331Z 2 Left arm
Symptom Text: Pt. received HPV (GARDASIL) at well check on 2/16/11. Pt was found to be pregnant on 2/28/11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None - (pregnancy)


Page 378
Vaers Id: 418355-1 Age Gender Vaccine Date Onset Date M 19-Feb-2011 20-Feb-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR HEP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site cellulitis
Days 1
Status Date State Received Date 18-Mar-2011 IL 09-Mar-2011 Lot Prev Doses Site 11110162 1 Right arm U3517AA 0 Left arm 11AHEVB803B 1 Left arm A
Symptom Text: Cellulitis (L) shoulder Clindamycin 300 TID x 3 days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 379
Vaers Id: 418356-1 Age Gender Vaccine Date Onset Date Days F 08-Mar-2011 08-Mar-2011 0 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA UNKNOWN MANUFACTURER Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Status Date State Received Date 22-Mar-2011 NJ 09-Mar-2011 Lot Prev Doses Site NULL 0 Unknown NULL 0 Unknown
Back pain, Dyspnoea, Hyperventilation, Lymph node pain, Neck pain
Symptom Text: Difficulty breathing/hyperventilating pain in neck and upper back/pain in lymph nodes - within 3 hrs of vaccination. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Pending Bee stings; shell fish; psoriasis None


Page 380
Vaers Id: 418440-1 (O) Age Gender Vaccine Date Onset Date F 01-Feb-2010 31-Mar-2010 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 58
Status Date State Received Date 14-Mar-2011 NY 11-Mar-2011 Lot Prev Doses Site NULL 0 Unknown
Symptom Text: Information has been received from a 26 year old female consumer with no pertinent medical history or drug reactions/allergies, who on 31-MAR-2010 was vaccinated with the second dose of GARDASIL and was pregnant (gestation= 5 weeks), method of confirmation: urine pregnancy test. There was no concomitant medication. At the time of the report, the patient's outcome was unknown. The patient sought medical attention (office visit). Follow up information was received via telephone call from a Registered Nurse, who indicated that the patient did not have any delivery or pregnancy information from December 2010, the last delivery date for this patient was 19-AUG-2009. The patient had been seen in the office on 18-JAN-2010 for an annual visit and at that time her baby was 5 months old. The nurse then found in the chart a note from 23-JUN-2010 that said the patient had been advised that GARDASIL was not a live virus vaccine and that the patient and her husband felt it would be better to terminate the pregnancy. As far as the Registered Nurse knew this pregnancy was terminated sometime after that but did not have any additional information to provide. There was not a LMP listed for this pregnancy. She did provide the dates of the patient's GARDASIL vaccinations: 1st dose in Feb 2010 (specific date not given), 2nd dose on 31-MAR2010 and 3rd dose on 14-JUL-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 3/9/2010) None urine beta-human, pregnant


Page 381
Vaers Id: 418454-1 Age Gender Vaccine Date Onset Date M 02-Mar-2011 02-Mar-2011 10.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 11-Mar-2011 WY 11-Mar-2011 Lot Prev Doses Site 0886Z 0 Left arm 0860Z 1 Right arm
Mfr Report Id Route Intramuscular Subcutaneously
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Symptom Text: Patient's right upper arm developed swelling and redness the evening of 3/2/11. By 3/4/11 patient had developed a 12cm x 6cm area of erythema with a 6cm x 4 cm area of darker red in the center. The injection site was within the center. Area was warm to touch and itched. Patient was seen at Walk In Clinic by PA-C. Patient was told to use oral Benadryl for itching. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None No No


Page 382
Vaers Id: 418476-1 Age Gender Vaccine Date Onset Date F 09-Mar-2011 09-Mar-2011 12.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness
Days 0
Status Date State Received Date 11-Mar-2011 OK 11-Mar-2011 Lot Prev Doses Site AC52B056AA 0 Left arm 1324Z 1 Left arm 0886Z 0 Right arm
Mfr Report Id Route Intramuscular Subcutaneously Intramuscular
Symptom Text: Patient passed out. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NA None None


Page 383
Vaers Id: 418481-1 Age Gender Vaccine Date Onset Date F 08-Mar-2011 08-Mar-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Fall, Headache, Pain in extremity, Syncope
Days 0
Status Date State Received Date 21-Mar-2011 MA 11-Mar-2011 Lot Prev Doses Site 0768Z 0 Right arm
Symptom Text: Two minutes after pt received immunization, a thud was heard and pt was found sitting on the floor. Pt says she felt pain in her arm, was standing & texting on her phone & fell. Next thing she remembered is sitting on floor. Denied nausea, dizziness, neck pain, back pain, numbness. (+) headache. Vitals: pulse 60, BP 110/70 supine; pulse 76, BP 110/60 sitting up. Pt had fainted. She was monitored about 20 minutes. No treatment. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: FLORINEF Vasomotor instability None


Page 384
Vaers Id: 418487-1 Age Gender Vaccine Date Onset Date F 21-Feb-2011 21-Feb-2011 18.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Injection site erythema, Vomiting
Days 0
Status Date State Received Date 14-Mar-2011 ND 11-Mar-2011 Lot Prev Doses Site 1001Z Left arm 0766Z 2 Right arm AHAVB462AA 1 Right arm 43762AA 0 Left arm
Mfr Report Id ND1107 Route Subcutaneously Intramuscular Intramuscular Intramuscular
Symptom Text: 15 MINUTES AFTER LEAVING THE CLINIC, APPROX 25 MINUTES AFTER RECEIVING VACCINATIONS PT VOMITED AND FELT FAINT. DEVELOPED 1" REDNESS IN LEFT ARM - DELTOID REGION. REDNESS LASTED APPROX 24 HOURS. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NO NO


Page 385
Vaers Id: 418501-1 Age Gender Vaccine Date Onset Date F 03-Mar-2011 03-Mar-2011 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 14-Mar-2011 CA 13-Mar-2011 Lot Prev Doses Site NULL 0 Left arm
Acne, Headache, Injection site haematoma, Injection site pain, Somnolence
Symptom Text: Hematoma at injection site accompanied by menagerie of pimples, lasting more than one week. Two weeks later, injection site still produces pimples and remains sore. Headaches and sleepiness the day of. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Adderall, Birth Control Vaccine administrator said it was a hematoma and she would perform injection herself next time. Not sure if I want that now. none None


Page 386
Vaers Id: 418506-1 Age Gender Vaccine Date Onset Date F 09-Mar-2011 09-Mar-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Eye swelling, Nasal congestion, Pruritus
Days 0
Status Date State Received Date 22-Mar-2011 KY 12-Mar-2011 Lot Prev Doses Site 0768Z 0 Unknown
Symptom Text: Head was itching. Nose stopped up. Swelling under (L) eye. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: TYLENOL NKA None


Page 387
Vaers Id: 418553-1 (S) Age Gender Vaccine Date Onset Date F 19-Nov-2010 04-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 77
Abdominal pain, Headache, Malaria, Oedema peripheral
Symptom Text: Information has been received from a physician concerning a 12 year old female patient with no medical history or drug allergies, who on 19-NOV-2010 was vaccinated with the second dose of GARDASIL (lot# not reported) intramuscularly. There was no concomitant medication. On 04-FEB-2011 the patient was admitted to hospital with headache and abdominal pain. It was reported that the blood smear test was positive for malaria. The patient was given unspecified treatment for malaria. On 23-FEB-2011, the patient was discharged from the hospital. On 01-MAR-2011 the patient complained of headache, abdominal pain and leg swelling. The patient was referred to the traditional healer and was given traditional medicine. No laboratory test or diagnostic studies were performed. No diagnosis was given. It was reported that the symptoms were resolved by 07-MAR-2011. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Diagnostic laboratory test, ??Feb11, blood smear positive for malaria None


Page 388
Vaers Id: 418559-1 Age Gender Vaccine Date Onset Date Days M 11-Mar-2011 Unknown 11.0 Type Manufacturer VAX Detail: TDAP UNKNOWN MANUFACTURER TD UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Allergy to vaccine, Rash generalised
Status Date State Received Date 14-Mar-2011 CO 14-Mar-2011 Lot Prev Doses Site NULL 1 Right arm NULL 1 Right arm NULL 1 Left arm
Symptom Text: got a allergic reaction for the Gardasil shot has a rash all over his body Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 389
Vaers Id: 418587-1 (S) Age Gender Vaccine Date Onset Date F 28-Dec-2010 02-Jan-2011 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 5
Status Date State Received Date 15-Mar-2011 IN 14-Mar-2011 Lot Prev Doses Site 0866Z Left arm 1042Z 1 Right arm C3539AA Left arm
Mfr Report Id Route Intramuscular Subcutaneously Intramuscular
Blister, Cellulitis, Dermatitis, Dermatitis bullous, Erythema, Hypokalaemia, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Localised infection, Pruritus, Rash, Rash vesicular, Varicella post vaccine
Symptom Text: Patient had VARIVAX in the right arm. She had one varicella vaccination previously in her lifetime. 3 days after present vaccination, she developed blistered lesions in a circle around the site of vaccination. These worsened and she went to emergency room on Jan 2, 2011 and was treated for cellulitis with ROCEPHIN and KEFLEX. The area continued to worsen with increasing vesicles and more redness and swelling and some pruritis. She returned to the emergency room on Jan 5, 2011 and was admitted. Infectious disease consult was done and diagnosed with attenuated varicella virus localized infection after vaccination. The following information was obtained through follow-up and/or provided by the government. 03/14/2011 ER record received for DOS 01/02/2011 and hospital discharge summary, H&P, labs, ER rec and consult records received for DOS 01/03/11 to 01/07/11. Final DX: Local infection to attenuated varicella virus and varicella vaccine, Cellulitis, Hypokalemia. Patient presented to ER with c/o redness & swelling to right arm. Patient reported receiving vaccination 5 days ago and subsequently noted redness and swelling around area. Examination noted diffuse, vesicular like rash to posterior aspect of arm. The patient had full range of motion of her shoulder. The patient was treated with IV Ancef, Solu-Medrol and Benadryl and advised that this was possibly allergic versus a cellulitis. The patient was discharged home on Keflex and prednisone. The patient returned the next day to the ER due to worsening redness of arm. Exam of the right arm noted 10 cm area made up of multiple small blisters. An area of redness (described as itchy) extended to the top of the shoulder and an area of redness extended to the elbow. Upon ER presentation, the patients temperature was 97.8 Fahrenheit, BP was 150/81 mm Hg, and respirations were 18. The patient was treated with Rocephin and vancomycin. ID consultation impression was attenuated varicella virus localized "infection" after vaccination. The patient was treated with acyclovir. The redness resolved and the bullous lesions were crusting. The patient improved and was discharged home on acyclovir. 03/14/2011 PCP office records and labs received for DOS 12/28/10 and 01/14/11. Assessment: Dermatitis. Patient seen for follow-up check of right arm on 01/14/11. Patient reported she still has residual rash but no pain. Examination noted skin healed over deltoid area where she had blisters. On lower arm, erythema noted where patient initially had redness. Assessment: Dermatitis. Plan: restart acyclovir. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The following information was obtained through follow-up and/or provided by the government. 03/14/2011 records received. Ultrasound right arm: neg (no evidence of DVT), Blood cultures: no growth (negative), WBC: 12.39 (WNL), HGB: 13.3 (WN The following information was obtained through follow-up and/or provided by the government. 03/14/2011 records received. History: Allergy to IVP dye, allergy to iodine, asthma, irregular periods.


Page 390
Vaers Id: 418594-1 Age Gender Vaccine Date Onset Date F 23-Feb-2011 24-Feb-2011 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. PPV MERCK & CO. INC. FLU SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 16-Mar-2011 MN 14-Mar-2011 Lot Prev Doses Site 1016Z 2 Left arm 0956Z 0 Right arm U3716AA 3 Right arm
Symptom Text: (R) deltoid redness & swelling x 2 days. Improved with ice & BENADRYL. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 391
Vaers Id: 418606-1 Age Gender Vaccine Date Onset Date F 03-Feb-2011 04-Feb-2011 12.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Petechiae, Rash, Rash macular
Days 1
Status Date State Received Date 23-Mar-2011 MT 14-Mar-2011 Lot Prev Doses Site AHAVB461AA 0 Left arm U3441BA 1130X 0 0 Right arm Left arm
Symptom Text: No fever. Vaccines given 2-3-11 at 4:30pm. Mom states she noticed the rash the next morning. Started on her chest as a red, macular blotchy rash, moved to back then down trunk and to her legs. None on hands, feet or face. I examined her 2/12/11 and rash persisted, petechiae noted along panty line over mons pubis and along bra line. Child is obese. BMI 99% (34). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Saw a dermatologist x 2. Lab: CBC, diff, protime, platelets all WNL. ALT/SGPT, AST, Lipid panel, TSH all WNL. (within normal limits). Obesity None


Page 392
Days 0
Status Date State Received Date 24-Mar-2011 OR 14-Mar-2011 Lot Prev Doses Site 1178Y 1 Left arm
Mfr Report Id OR201110 Route Intramuscular
Loss of consciousness, Presyncope, Syncope
Symptom Text: Syncopal episode following vaccination with GARDASIL - full vasovagal reaction, unconscious for 30 seconds. BP initially 62/30. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No No


Page 393
Vaers Id: 418677-1 Age Gender Vaccine Date Onset Date F 23-Feb-2011 23-Feb-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion, Syncope
Days 0
Status Date State Received Date 24-Mar-2011 OR 14-Mar-2011 Lot Prev Doses Site 0786Z 0 Left arm U3473AA 0 Left arm
Mfr Report Id OR201111 Route Intramuscular Intramuscular
Symptom Text: Syncope vs convulsions. Pt appeared to have syncopal episode s/p administration of HPV vaccine. I was not present, *see RN note. Spoke with mother following incident and she states observed convulsions (?) and gurgling sound in throat/gasping for air, pt was laid back onto exam table, no falls. Sister experienced a similar episode following administration of the same vaccine prior to this appt. Pt still with nausea, dizziness, pale clammy skin, pt resting in exam room until recovered. Much improved following vomiting episode. Sent home with mother and sister stable. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Hx of asthma None


Page 394
Vaers Id: 418678-1 Age Gender Vaccine Date Onset Date F 23-Feb-2011 23-Feb-2011 16.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 24-Mar-2011 OR 14-Mar-2011 Lot Prev Doses Site AHAVB453AA 2 Left arm U3486DA U3542AA 0786Z Left arm Left arm Right arm
Mfr Report Id OR201112 Route Intramuscular Intramuscular Intramuscular Intramuscular
Cold sweat, Convulsion, Dizziness, Dyspnoea, Gaze palsy, Loss of consciousness, Nuchal rigidity, Pallor, Posture abnormal, Syncope
Symptom Text: Syncope. Arrived to pt side at 1419. Pt sitting in chairs next to lab. Staff assisting. Pt's mother states pt had a seizure, and lost consciousness mother in chair next to her witnessed, first to arrive at chairside MA. Mother states pt c/o dizziness/lighthheadness and "her eyes rolled back in her head", states body position was with neck extended to left rigidly, gasped for air a few times with arms bent at elbow does not recall if hands were opened or closed and extension of the legs with toes pointed. Pt did not have bowel or bladder incontinence. Eyes: 3mm/3mm PERRL Skin: pale, cool and clammy. When asked her name and dob answered appropriately, conversing with staff and mother denies pain, HA, nausea, SOB, HR 54 RA O2sat: 100% pt tearful states is embarassed. Pt had just received four vaccines and was awaiting labwork. Mother and pt state that pt has an "intense" needle phobia. Pt also states has only eaten a couple pretzels today and nothing else. Juice given. Dr at chairside 1425 examining pt. 1455: HR 59 BP: 108/62. States a little dizzy but improving. 1510: HR 60 BP: 96/60. States feeling "back to normal" with mild dizziness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 395
Vaers Id: 418725-1 (S) Age Gender Vaccine Date Onset Date F 21-Sep-2010 18-Nov-2010 17.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 58
Status Date State Received Date 16-Mar-2011 IL 15-Mar-2011 Lot Prev Doses Site AHAVB446BA 0 Left arm 0565Z 0 Right arm
Mfr Report Id Last Edit Date WAES1103USA00608 25-Mar-2011 Other Vaccine Route Intramuscular Intramuscular
ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Chemotherapy, Contusion, Epistaxis, Headache, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Menorrhagia, Nausea, Splenectomy, Thrombocytopenia, Weight increased
Symptom Text: Information has been received from a physician concerning a 17 year old female with no drug allergies and no pertinent medical history who on 21-SEP2010 was vaccinated with her only dose of GARDASIL (lot# 666162/0565Z, expired date on 15-SEP-2012) IM. Concomitant therapy included HAVRIX (Lot #AHAVB446BA) on the same day as GARDASIL. On 18-NOV-2010 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP). After this she was hospitalized. She had not recovered. She had experienced "weight gain with prednisone use". The patient was considered to be disabling as she was not able to play contact sports. Blood test was performed (but no results were provided). Patient's platelet count on 18-NOV-2010 was 1 (1, 000). Since that time the platelet count had gone up and down based on the prednisone dosing. Patient had already received a few doses of intravenous immune globulin (IVIG) and recently was placed on a chemotherapeutic agent (no cancer involved). In February 2011, patient underwent a splenectomy. When asked if the event was life threatening, the physician said she did not know. The physician gave the location of the hospital and reported that the patient was initially referred to another pediatric hematology/oncology physician. The patient was also being seen by another specialist at another hospital, but the physician did not have that contact information available. Additional information has been expected. The following information was obtained through follow-up and/or provided by the government. 3/24/2011 hospital records received for DOS 11/19-21/2010 w/ Dx: thrombocytopenia, most likely ITP. Pt presented w/ menorrhagia (3 mo), easy bruising (1 mo). Pt c/o periods being unusually heavy, w/ clots, lasting longer than usual (7 days as opposed to 4-5) for past 3 mos. Noted large bruise to lt forearm 1 mo prior to admission, several smaller bruises to LE for 1 week, light dry blood when blowing nose (1 week), moderate frontal non-throbbing headache (2 days), nausea w/ onset of menses. Pt admitted. Received IVIG. D/c'd home w/ monitoring & f/u instructions. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown platelet count, 11/18/10, 1(100; platelet count, had gone up and down based on the prednisone dosing The following information was obtained through follow-up and/or provided by the government. 3/24/2011 lab/diagnostic records received for D None The following information was obtained through follow-up and/or provided by the government. PMH: menorrhagia (periods unusually heavy, w/ clots, lasting longer than usual (7 days as opposed to 4-5) for 1 mo).


Page 396
Vaers Id: 418726-1 (O) Age Gender Vaccine Date Onset Date F 02-Feb-2011 11-Feb-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Muscle spasms
Days 9
Symptom Text: Case received from a consumer via the Health Authorities on 04-MAR-2011 under the reference number DK-DKMA-ADR-20933822. Case not medically confirmed. A 14 year old female patient had received an injection of GARDASIL (dose 1, batch number not reported) on 02-FEB-2011 and later on, on 11-FEB-2011, she experienced cramps and dizziness. The patient was previously healthy with no history of cramps. Nine days post vaccination, the patient felt dizzy on several occasions and she also experienced cramps. Upon medical review the company upgraded the case to serious due to other medically important condition. At the time of reporting, the outcome was unknown. Other business partner number included E201101416. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 397
Vaers Id: 418727-1 (O) Age Gender Vaccine Date Onset Date F 21-Apr-2010 21-Apr-2010 22.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 16-Mar-2011 US 15-Mar-2011 Lot Prev Doses Site 1178Y 0 Unknown
Drug exposure during pregnancy, Premature labour
Symptom Text: Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient with no pertinent medical history and allergic to latex and DEMEROL who on 21-APR-2010 was vaccinated with her first 0.5 ml IM dose of GARDASIL (lot# 663559/1178Y). Concomitant therapy included vitamins (unspecified) and LO/OVRAL. On 21-APR-2010 the patient was seen in Family Planning and a urine pregnancy test was performed which was positive. The patient's LMP was 17-MAR-2010 and her EDD was 22-Dec-2010. Follow up information has been received via telephone call from a registered nurse, who reported that the patient had been "into see them" on 28-OCT-2010 (no reason was provided). The registered nurse reported that the patient had delivered on 14-SEP-2010 and the baby had been in the Neonatal Intensive Care Unit (NICU) (WAES # 1004USA03561B1). At the time of the report the gestational age of the baby at birth was unknown. Upon internal review premature labour was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP= 3/17/2010); Drug hypersensitivity; Latex allergy LO/OVRAL; Vitamins (unspecified) Beta-human chorionic, 04/21/10, positive


Page 398
Vaers Id: 418728-1 (S) Age Gender Vaccine Date Onset Date F 21-Apr-2010 21-Apr-2010 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Status Date State Received Date 16-Mar-2011 US 15-Mar-2011 Lot Prev Doses Site 1178Y Unknown
Mfr Report Id Last Edit Date WAES1004USA03561B 31-Mar-2011 1 Other Vaccine Route Unknown
Drug exposure during pregnancy, Premature delivery
Symptom Text: Information has been received from a registered nurse, concerning a patient's mother who on 21-APR-2010 was vaccinated with a dose of GARDASIL (lot # not reported). (Mother experience reported in WAES # 1004USA03561). The registered nurse reported that on 14-SEP-2010, at 26 gestational weeks, the mother had a baby. The baby had been in the Neonatal Intensive Care Unit (NICU). At the time of the report the gestational age of the patient at birth was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: LO/OVRAL; Vitamins (unspecified) Unknown Unknown


Page 399
Vaers Id: 418739-1 Age Gender Vaccine Date Onset Date M 14-Mar-2011 14-Mar-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 15-Mar-2011 TN 15-Mar-2011 Lot Prev Doses Site 1167Z 1 Right arm AC52B056BB 0 Left arm
Loss of consciousness, Pain, Urinary incontinence
Symptom Text: Pt c/o pain. Blacked out. Voided on herself and came to within 30 seconds. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergy - PCN. No birth defects or medical conditions. No


Page 400
Vaers Id: 418809-1 Age Gender Vaccine Date Onset Date Days F 03-Mar-2011 06-Mar-2011 3 17.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. MNQ NOVARTIS VACCINES AND DIAGNOSTICS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Nausea, Vomiting
Status Date State Received Date 16-Mar-2011 PR 16-Mar-2011 Lot Prev Doses Site NULL Unknown NULL Unknown NULL 0 Right arm
Mfr Report Id Route Unknown Intramuscular Intramuscular
Symptom Text: Nausea, vomiting that persisted for a week Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: no Mild URI symptoms--runny nose, mild cough, sore throat


Page 401
Vaers Id: 418887-1 (S) Age Gender Vaccine Date Onset Date M 15-Feb-2011 21-Feb-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 6
Status Date State Received Date 18-Mar-2011 NY 16-Mar-2011 Lot Prev Doses Site 1231Z 0 Unknown
Blindness, Blindness unilateral, Borderline glaucoma, Eye pain, Optic atrophy, Optic discs blurred, Optic neuritis, Pupillary reflex impaired, Retinal disorder, Vision blurred
Symptom Text: Reproted Blindness which led to hospital admission with diagnosis of optic neuritis The following information was obtained through follow-up and/or provided by the government. 3/30/11. Hospital records DOS 3/6 - 10/2011. DX: optic neuritis. CC: visual loss in od; eye pain started c eye movements, now constant; blurry vision progressed to total loss of sight in od. PE: R afferent pupillary defect; mild blurring of optic disc margins in R eye; completely blind in od; minimal LP in OD. Symptom relation to vax suspicious but not conclusive. 4/27/11 Received Ophtho consult for DOS 3/11-3/19/2011. FINAL DX: right eye optic neuritis, resolved; retinal degeneration, lattice; optic atrophy, partial; open angle borderline glaucoma. Pt seen s/p hospitalization, continuing on ASA & prednisone. Other Meds: Lab Data: Depoprovera 150 mg IM ( head previous injections Optic Neuritis The following information was obtained through follow-up and/or provided by the government. 3/30/11. Labs/diagnostics. CSF RBC: 74 (H), CSF neutr 20% (H), CSF glucose 91 mg/dL (H). PT 13.7 secs (H), INR 1.2 (H). Lupus profile: dRVVT 35.6 sec (H). Anticardiolipin IgG 25 GPL (H). HbA1C 5.7% (H). ALT 37 u/L (H). WBC 13.5 K/mm3 (H). Orbital MRI: R intraorbital optic neuritis. none The following information was obtained through follow-up and/or provided by the government. 3/30/11. Hospital records. NKDA none


Page 402
Vaers Id: 418888-1 Age Gender Vaccine Date Onset Date F 15-Mar-2011 15-Mar-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS HEPA GLAXOSMITHKLINE BIOLOGICALS VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 28-Mar-2011 MN 16-Mar-2011 Lot Prev Doses Site 0337Z 0 Right arm U3463AA 0 Right arm 045BA 0 Left arm AHAVB446AA 1179Z 0 1 Left arm Left arm
Symptom Text: Child fainted after receiving 5 immunizations. Immediately came to. Was given juice. Opened door to exam room and turned on fan in room to increased ventilation. Monitored for 15 minutes before was allowed to leave with parent. BP was checked up PHN and was normal. Other Meds: Lab Data: History: Prex Illness: None Tested negative for Ehlers-Danlos syndrome but mom states she exhibits some of the symptoms. None
Prex Vax Illns: High fever.~Vaccine not specified (no brand name)~UN~0.00~Patient


Page 403
Vaers Id: 418894-1 Age Gender Vaccine Date Onset Date F 16-Mar-2011 16-Mar-2011 11.0 Type Manufacturer VAX Detail: HEPA MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 17-Mar-2011 NJ 16-Mar-2011 Lot Prev Doses Site 12152 1 Left arm 14372 2 Right arm
Contusion, Face injury, Head injury, Laceration, Loss of consciousness, Syncope
Symptom Text: fainting hit head and face unconscious for less than ten seconds contusion crown of head contusion nose and cheek (left) three superficial lacerations cheek (left) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: no none no no


Page 404
Vaers Id: 418895-1 Age Gender Vaccine Date Onset Date M 16-Mar-2011 16-Mar-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope, Unresponsive to stimuli
Days 0
Status Date State Received Date 17-Mar-2011 OH 16-Mar-2011 Lot Prev Doses Site 0337Z 1 Left arm
Symptom Text: SYNCOPE, unresponsive for 5 minutes, gave fluids, snacks, VS taken, VS stable. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 405
Vaers Id: 418897-1 Age Gender Vaccine Date Onset Date F 16-Mar-2011 16-Mar-2011 12.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 17-Mar-2011 MA 16-Mar-2011 Lot Prev Doses Site C3490AA 0 Left arm U3541AA 0 Left arm 1561Z 0 Right arm
Dizziness, Immediate post-injection reaction, Malaise, Myoclonus, Syncope
Symptom Text: Syncope with myoclonic jerks immediately following HPV vaccine last aprox 30 seconds, vital signs showed blood pressures 90's/50's, heart rate 50's70's. Felt dizzy, unwell. After 1 hour of drinking fluids, resting, felt well again. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none no


Page 406
Vaers Id: 418947-1 Age Gender Vaccine Date Onset Date F 25-Jan-2011 25-Jan-2011 13.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Condition aggravated, Dizziness, Pallor
Days 0
Status Date State Received Date 17-Mar-2011 PR 17-Mar-2011 Lot Prev Doses Site AHAVB462BA 0 Left arm 03372 0 Right arm
Mfr Report Id PR1107 Route Intramuscular Intramuscular
Symptom Text: PATIENT WAS OBSERVED PALE AND DIZZY. BP - 100/60 WAS TAKEN TO THE ER IN A WHEEL CHAIR. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: IN THE ER - BP- 108/57 P- 77 TREATMENT - DXT HX OF DIZZINESS AFTER RECEIVING INJECTIONS.


Page 407
Vaers Id: 418957-1 (S) Age Gender Vaccine Date Onset Date F 09-Nov-2010 01-Jan-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT LIFE THREATENING, SERIOUS
Days 53
Status Date State Received Date 18-Mar-2011 OK 17-Mar-2011 Lot Prev Doses Site 0768Z 0 Unknown
Contusion, Infectious mononucleosis, Injury, Road traffic accident
Symptom Text: Information has been received from a licensed practical nurse concerning a 19 year old female patient with penicillin allergy who on 09-NOV-2010 was vaccinated with the first dose of GARDASIL without incident. At 09:00 on 01-MAR-2011 the patient received a dose of GARDASIL (Lot# 666597/0768Z, Expiration: 17-OCT-2011) (dose, strength and therapy route were unspecified). A lot check has been initiated. Concomitant therapy included SEASONIQUE and ZYRTEC. In January 2011, the patient experienced mononuceleosis. At 13:26 on 01-MAR-2011, the patient was involved in an automobile accident and suffered some bumps and bruises. The patient was not hospitalized. At the time of report, the patient was recovering. Therapy was not discontinued. There was no lab diagnostics. The patient sought medical attention. Bumps, bruises and automobile accident were considered to be life threatening by the reporter. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy ZYRTEC; SEASONIQUE None


Page 408
Vaers Id: 418958-1 (S) Age Gender Vaccine Date Onset Date F 11-Jan-2011 12-Jan-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Angioedema
Days 1
Status Date State Received Date 18-Mar-2011 FR 17-Mar-2011 Lot Prev Doses Site NJ53460 0 Unknown
Symptom Text: Case received from the Health Authorities on 04-MAR-2011 (reference number PEI2011006109). Case medically confirmed. A 14 year old female patient had received the first dose of GARDASIL (batch#NM36280, lot# NJ53460) into the upper arm on 11-JAN-2011. One day later, on 12-JAN-2011, she developed Quincke's oedema leading to hospitalization for an unspecified time. Laboratory test on 18-JAN-2011 showed "increased titers for parainfluenza, EBV and Chlamydia". No detailed information regarding symptoms and treatment were provided. At the time of reporting to HA (28-JAN2011), the patient had not recovered. Other business partner number included E2011-01399. No additional information was available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Serum Chlamydia psittaci Ab, 18Jan11, increased titers for chlamydia; Serum human parainfluenza (1,2,3) IgA Ab, 18Jan11, increased titers for parainfluenza; Serum Epstein-Barr virus antibody test, 18Jan11, increased titers for EBV Unknown


Page 409
Vaers Id: 418973-1 Age Gender Vaccine Date Onset Date M 09-Mar-2011 10-Mar-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 28-Mar-2011 PA 17-Mar-2011 Lot Prev Doses Site 1569Z 0 Left arm 1233Z 1 Right arm
Hypersensitivity, Inflammation, Pain, Skin warm, Swelling
Symptom Text: Regional hypersensitivity reaction in (R) arm with rubor, calor, tumor and dolor all of which are receding since initial reaction about 12 h. after injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 410
Vaers Id: 418983-1 Related reports: 418983-2 Age Gender Vaccine Date Onset Date F 07-Mar-2011 07-Mar-2011 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Arthralgia, Pain in extremity
Days 0
Status Date State Received Date 18-Mar-2011 MN 17-Mar-2011 Lot Prev Doses Site 14357Z 2 Left arm
Symptom Text: Severe pain/ache in upper arm/elbow at time of vaccination and dissipating after the vaccination Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ? none no no


Page 411
Vaers Id: 418987-1 Age Gender Vaccine Date Onset Date F 14-Mar-2011 15-Mar-2011 13.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Injection site erythema
Days 1
Status Date State Received Date 18-Mar-2011 NC 17-Mar-2011 Lot Prev Doses Site U3741AA 1 Right arm 03372 2 Left arm
Symptom Text: erythema right deltoid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none NONE NO


Page 412
Vaers Id: 418991-1 Age Gender Vaccine Date Onset Date F 25-Feb-2011 Unknown 11.0 Type Manufacturer VAX Detail: DTAPIPV GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Wrong drug administered
Days
Status Date State Received Date 28-Mar-2011 IN 17-Mar-2011 Lot Prev Doses Site AC20B172AA 0 Left arm U3555AA 0337Z 0 0 Left arm Left arm
Symptom Text: Wrong vaccine received. KINRIX instead BOOSTRIX ->. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 413
Vaers Id: 419075-1 (S) Age Gender Vaccine Date Onset Date F 01-Dec-2010 Unknown 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days
Pain in extremity, Partial seizures with secondary generalisation
Symptom Text: Information has been received from a gynecologist. Case medically confirmed. A 15 year old female had received the first dose of GARDASIL (batch number not reported) in the end of 2010. 48 hours after vaccination, she experienced pain in the forearm which lasted during 15 days. It was in fact a partial seizure. Afterwards, the seizure became generalized. The patient experienced a second episode on an unspecified date. The patient was hospitalized in pediatric service. The patient was given DEPAKINE for 2 years as corrective treatment. At the time of reporting, the patient had not yet recovered. Other business partner numbers include E2011-01730. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 414
Days 4
Status Date State Received Date 21-Mar-2011 CA 18-Mar-2011 Lot Prev Doses Site NULL Left arm
Abnormal sensation in eye, Anxiety, Ear discomfort, Fatigue, Feeling abnormal, Headache, Hyperacusis, Hypoaesthesia, Irritability, Muscle twitching, Palpitations, Paraesthesia, Peripheral coldness, Photophobia, Sinus headache, Vein discolouration, Vertigo, Visual impairment
Symptom Text: Onset of symptoms started within 4 days of the vaccine and have progressivly gotten worse, starting with change in vision, light sensitivity, sound sensitivity, a feeling of "brain fog", veins getting darker all over my body, headaches, irritabillity, anxiety, heart palpitations, occasional vertigo (gound felt like it was moving up and down), constant fatigure, a feeling of pressure in head/ears/eyes, a feeling of sinus pressure, tingling of legs and arms, numbness in legs and arms, feet and hands constantly cold, twitching in face/neck/arms/legs associated with loud noises/bright lights, overall feeling of malice, I have noticed I feel far worse at night than I do in the morning. doctors have found nothing wrong with me nor attempted to treat me. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CBC, abnormal results: Potassium 5.1, RBC 3.83, MCV 106, WBC was on the higher side of normal none Post viral cough


Page 415
Vaers Id: 419174-1 (D) Age Gender Vaccine Date Onset Date F 04-Oct-2010 07-Oct-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 3
DIED, HOSPITALIZED, LIFE THREATENING, SERIOUS Cardiac disorder, Condition aggravated, Cough, Death, Haemoptysis, Malaise, Renal disorder
Symptom Text: Information has been received from a physician concerning a 15 year old female patient with longstanding health problems (according to mother) since childhood who on 04-OCT-2010 was vaccinated IM with a second dose of GARDASIL (Lot# not reported). In September 2010, the patient experienced cough and was sick. On 07-OCT-2010, the patient experienced cough and haemoptysis. On 30-OCT-2010, the patient was diagnosed with kidney "problem" and heart "problem". The patient was admitted to hospital. The patient's mother cannot recall treatment or hospital ID number and had not kept files. On 03-NOV-2010, the patient died. The cause of death was not reported. Cough, sickness, haemoptysis, kidney "problem" and heart "problem" were considered to be immediately life-threatening by the reporter. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 416
Vaers Id: 419175-1 (O) Age Gender Vaccine Date Onset Date F Unknown 21-Apr-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Papilloma viral infection
Days
Symptom Text: Information has been received from the Health Authorities (HA) (reference number PEI2011006814). Case medically confirmed. Case was considered as serious by HA due to "other medically important condition". A 16 year old female patient received a complete vaccination series with three doses of GARDASIL on unspecified dates in 2007. Reportedly, the patient had no sexual intercourse before completion of the vaccination series. On 21-APR2010, human papilloma virus (HPV) test (Hybrid Capture II test) was positive for high risk HPV types. Other business partner numbers include: E201101506. The case is closed. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Cervix HPV DNA assay, 21Apr10, Hybrid capture II test was positive for high risk HPV types Unknown


Page 417
Vaers Id: 419198-1 Age Gender Vaccine Date Onset Date F 18-Mar-2011 18-Mar-2011 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash generalised, Rash pruritic, Urticaria
Days 0
Status Date State Received Date 22-Mar-2011 AK 21-Mar-2011 Lot Prev Doses Site 0765Z 2 Left arm
Symptom Text: Itchy rash/hives started on chest and moved to all skin surfaces. Patient has tried Benadryl po and calamine lotion, without relief. Seen at Clinic today and given loratidine and hydrocortisone cream. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 418
Vaers Id: 419218-1 Age Gender Vaccine Date Onset Date F 04-Aug-2010 05-Aug-2010 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 22-Mar-2011 CA 21-Mar-2011 Lot Prev Doses Site 8410 1 Left arm
Activities of daily living impaired, Areflexia, Back disorder, Bed rest, Complex regional pain syndrome, Dyspnoea, Joint dislocation, Musculoskeletal disorder, Myalgia, Pain, Pain in extremity
Symptom Text: Burning pain in both legs at 1:30 am, and more burning pain in both legs again at 4:00 am. I took her to urgent care after 11 am that day, and she was seen by the Childrens ER August 8, 2010 for soreness and tenderness in leg muscles and shortness of breath. Doctors could not find her reflexes that visit. She saw her doctor the following morning which was the 9th and he kept her out of school for a week and wanted rest. Since then my daughter has had numerous incidents in limbs of her body that still continue now 6 months later ranging from neck, legs, arms, buttocks and back. She has seen numerous doctors and has been diagnosed with RSD and chronic pain in her limbs. She has also had a dislocated knee patella three months ago by taking a step her knee did not respond and it popped out. No physical education since vaccine and has stopped doing martial arts. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Blood work EMG scheduled Spinal Tap Scheduled


Page 419
Vaers Id: 419223-1 Related reports: 419223-2 Age Gender Vaccine Date Onset Date F 15-Jul-2010 01-Aug-2010 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Lymphadenopathy, Myalgia
Days 17
Status Date State Received Date 22-Mar-2011 FL 21-Mar-2011 Lot Prev Doses Site NULL 0 Left arm
Mfr Report Id FL Route Unknown
Symptom Text: Swollen Lymphnodes on upper area of my body (neck, shoulder and lungs). I have also suffered muscular pain for 5 months or so. Have had to perform multiple test, including Biopsy, Pet Scan, Sonogram, etc. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE No cancer found after performing biopsy. Doctors have been unable to explain the multiple swollen lymphnodes after visits to multiple doctors including, specialists. NONE NONE


Page 420
Vaers Id: 419236-1 (O) Age Gender Vaccine Date Onset Date F Unknown 01-Dec-2010 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Papilloma viral infection, Vaccination failure
Days
Symptom Text: Information has been received from a gynecologist concerning an adolescent (18 year old) female patient who received a complete vaccination series with three doses of GARDASIL on unspecified dates in 2008. The patient had no sexual intercourse before vaccination. Before vaccination, cervical smear was Pap II, as well as a first control after vaccination. Three months later, second and third control showed Pap III D and HPV test was positive for human papilloma virus (HPV) 18 and 51. Three months later, another control was performed with the same results. Vaccination failure was suspected. At the time of reporting the patient had not recovered. Upon medical review the case was assessed as serious by the company. Papanicolaou smear abnormal, class III D, human papilloma virus test positive and vaccination failure were considered to be other important medical events by the company. Case medically confirmed. Other business partner numbers included: E2011-01468. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Cervical smear, ??11, papanicolau smear abnormal, class III D; Cervical smear, Pap II before vaccination as well as a first control after vaccination; Cervix HPV DNA assay, ??11, positive for HPV 18 and 51 Unknown


Page 421
Vaers Id: 419237-1 (D) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT DIED, LIFE THREATENING, SERIOUS Unevaluable event
Days
Status Date State Received Date 23-Mar-2011 US 22-Mar-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a website concerning thousands of other young girls who on unspecified dates were vaccinated with a dose of GARDASIL (lot # not reported). The girls have experienced "life-destroying side effects" or death following their HPV vaccines. Life-destroying side effects were considered to be immediately life-threatening. This is one of two reports from the same source. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 422
Vaers Id: 419309-1 Age Gender Vaccine Date Onset Date M 22-Mar-2011 22-Mar-2011 18.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Loss of consciousness, Syncope
Days 0
Status Date State Received Date 01-Apr-2011 NY 23-Mar-2011 Lot Prev Doses Site U3543AA 1 Left arm 1569Z 0 Right arm 0040AA 1 Left arm
Symptom Text: Patient fainted after GARDASIL vaccine (+) LOC; then no sequelae. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 423
Vaers Id: 419337-1 Age Gender Vaccine Date Onset Date F 18-Mar-2011 18-Mar-2011 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Urticaria
Days 0
Status Date State Received Date 24-Mar-2011 TX 23-Mar-2011 Lot Prev Doses Site 07687 0 Right arm
Symptom Text: Pt reports that 3-4 hours after receiving first Gardasil vaccine, she broke out in widespread hives. She saw her PCP and was told possible reaction to Gardasil and was advised to discontinue the series. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Implanon Asthma No


Page 424
Vaers Id: 419354-1 Age Gender Vaccine Date Onset Date M 23-Mar-2011 23-Mar-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Head injury, Myoclonus, Syncope
Days 0
Status Date State Received Date 24-Mar-2011 CO 23-Mar-2011 Lot Prev Doses Site 0331Z 0 Left leg
Symptom Text: syncope with myoclonic jerks The following information was obtained through follow-up and/or provided by the government. 3/31/2011 PCP records received for DOS 3/23/2011 w/ assessment: syncopal episode. Approximately 10 min after vaccination pt had syncopal episode w/ myoclonic jerks. Pt hit head, no evidence of concussion. Pt observed for 20 min after episode, released home. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none asthma The following information was obtained through follow-up and/or provided by the government. PMH: asthma, snores. Allergies: dust, grass. mild URI


Page 425
Vaers Id: 419361-1 Age Gender Vaccine Date Onset Date F 21-Mar-2011 22-Mar-2011 13.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site reaction, Rash erythematous
Days 1
Status Date State Received Date 01-Apr-2011 MI 23-Mar-2011 Lot Prev Doses Site C3353AA 5 Gluteous maxima U3541AA 0 Left arm 0337Z 0 Gluteous maxima 0962Z 1 Left arm AHAVB462BA 0 Right arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Subcutaneously Intramuscular
Symptom Text: 2in x2in red raised rash at site of injection. Ice 2-3 days as needed per Dr. Area of rash was Lt arm at varicella vac site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: URI


Page 426
Vaers Id: 419374-1 (O) Age Gender Vaccine Date Onset Date F Unknown 15-Mar-2011 30.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Grand mal convulsion, Syncope, Trismus
Days
Mfr Report Id Last Edit Date WAES1103POL00002 25-Mar-2011 Other Vaccine Route Unknown
Symptom Text: Information has been received from a 30 year old female with papilloma viral infection who probably in the beginning of 2011 was vaccinated with the first dose of GARDASIL. On 15-MAR-2011 the patient received the second dose of GARDASIL. On 15-MAR-2011 the patient experienced syncope, tonicclonic seizures and trismus. Subsequently, the patient recovered from syncope. The reporter felt that syncope, tonic-clonic seizures and trismus were related to therapy with GARDASIL. Upon internal review tonic-clonic seizures were determined to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Papilloma viral infection Unknown Unknown


Page 427
Vaers Id: 419376-1 (S) Age Gender Vaccine Date Onset Date F 01-Feb-2011 01-Feb-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Abdominal pain lower, Asthenia, Body temperature increased, Decreased appetite, Ear pain, Hypoaesthesia facial, Oropharyngeal pain, Pain in extremity, Peripheral vascular disorder, Tremor, Weight decreased
Symptom Text: A 16 year old female (weight: 51.5 Kg; height : 180 cm) with neurodermatitis and multiple allergies was vaccinated with a dose of GARDASIL on 01FEB-2011 at 10 a.m. On 01-FEB-2011, three hours later, the patient developed peripheral circulatory disorders, another two hours later she complained of a feeling of trembling in legs and arms. From the following day on, she still suffered from feeling of trembling (trembling cannot be seen, but was felt by the patient), weakness and loss of strength. A blood sample, taken on 07-FEB-2011, showed normal values. On 15-FEB-2011, check-up in a neurological department of a university hospital showed no pathologies. On 25-FEB-2011, beginning of menstruation, heavy pain in the lower abdomen, numbness on her left face, pain in her legs. Symptoms were increasing in the following days. On 03-MAR-2011 in the evening, the patient complained of throat pain, increasing on 04-MAR-2011. That day, also slight ear pain and body temperature of 38.2 C degree. On 05-MAR-2011, body temperature was 37.8 C degree, heavy ear pain and complete loss of strength. From 09-MAR-2011 to 11-MAR-2011, inpatient the patient was admitted to a neurological department to rule out polyneuritis. Several exams including CRF (Borrelia serology negative), EEG, tibialis and median somatosensory evoked responses, nerve conduction velocity of right peroneal, tibialis, suralis and median nerve and cranial MRI showed no pathological findings. Routine lab parameters (including blood cell count, Ionogram, liver parameters) did not show abnormalities (no infectious serology permormed). Only TSH (10-MAR-2011) was slightly increased with 4.74 uU/ml (normal range: 0.3- 4.0 uU/ml), free T3 and free T4 within the normal range. On 13-MAR2011, the patient had not yet recovered, her weight had decreased to 49.5 kg following inappetence. Other business partner numbers include E201101799. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Neurodermatitis; Multiple allergies Unknown body temp, 04Mar11, 38.2 C; body temp, 05Mar11, 37.8 C; serum TSH, 10Mar11, 4.74 uU/ml


Page 428
Days 3
Status Date State Received Date 04-Apr-2011 PA 24-Mar-2011 Lot Prev Doses Site 0766Z 0 Left arm
Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Symptom Text: Cellulitis on right upper arm. Sx's: erythema, warmth, tenderness at injection site, one week after injection - treated with Doxycycline 100mg BID x 10days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None NKDA; No other chronic diagnosis/birth defect None


Page 429
Vaers Id: 419388-1 Age Gender Vaccine Date Onset Date M 15-Mar-2011 Unknown 6.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. FLU CSL LIMITED Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 30-Mar-2011 DE 24-Mar-2011 Lot Prev Doses Site L437Z 0 Unknown M53309 1 Unknown
Drug administered to patient of inappropriate age
Symptom Text: Pt was given GARDASIL due to confusion between he and a siblings info, pt is too young for the vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 430
Vaers Id: 419391-1 Age Gender Vaccine Date Onset Date M 16-Mar-2011 17-Mar-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR HEPA MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Headache, Oedema peripheral
Days 1
Status Date State Received Date 04-Apr-2011 NH 24-Mar-2011 Lot Prev Doses Site 0766Z 0 Right arm U3431AA 0 Right arm C3475AA 0 Left arm 1215Z 1 Left arm
Symptom Text: Onset of symptoms noted by mom over 24 hrs after vaccines administered-c/o headache and swollen arm (L)-red area size of grapefruit and elevated area size of quarter-TYLENOL given & heat applied. Recovering well 48hrs after vaccines. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Albuterol qd for Nebulizer; FLOVENT inhaler RAD Healthy


Page 431
Days 0
Status Date State Received Date 24-Mar-2011 MD 24-Mar-2011 Lot Prev Doses Site NULL 1 Left arm
Chest pain, Dizziness, Dyspnoea, Headache, Pain, Paraesthesia
Symptom Text: headache, dizziness, tingling in arms and legs, breathing problems, chest pains, body aches within 6 hours of receiving vaccine Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None were taken. Migraines, dust and mold allergies. None. had visited the dr for dizziness. it was time to receive the 2nd round.


Page 432
Vaers Id: 419414-1 Age Gender Vaccine Date Onset Date F 23-Mar-2011 Unknown 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 04-Apr-2011 SD 24-Mar-2011 Lot Prev Doses Site 0886Z 0 Right arm
Abdominal discomfort, Abdominal pain, Dizziness, Feeling abnormal, Pallor
Symptom Text: 3/11 few hours after vaccine given c/o faintness/abd pain/feeling "weird". PE - alert oriented pale color, "lightheaded"; abd exam nl. Phone f/u next AM mother states feeling better, some abd discomfort, no D/V. Went to school. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 433
Vaers Id: 419423-1 Age Gender Vaccine Date Onset Date F 22-Mar-2011 22-Mar-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 25-Mar-2011 CA 24-Mar-2011 Lot Prev Doses Site 0672Y 0 Right arm U3435AA 0 Left arm C3446AA 0 Left arm
Dizziness, Gait disturbance, Unresponsive to stimuli, Urinary incontinence
Symptom Text: After HPV vaccine given, pt. walked toward the waiting room and began to stagger and sway. Clinic RN stabilized her against the hallway wall as patient lost control of her bladder. Though patient did not appear to lose consciousness, she did not immediately respond to verbal commands. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None none None reported. None reported.


Page 434
Days 0
Status Date State Received Date 04-Apr-2011 NJ 24-Mar-2011 Lot Prev Doses Site 0337Z 0 Left arm
Dizziness, Dyspnoea, Headache, Hypoaesthesia, Oropharyngeal pain, Paraesthesia
Symptom Text: Received vaccine at 4pm-observed for 15 minutes in office. At 8pm she started having trouble breathing, sore throat, tingling, numbness of left leg and the next day morning woke up with a headache and dizziness. By 10 am today 03/24/2011-she did not have any of those symptoms. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Naproxen for back pain Atopic dermatitis; mild back pain, none other. Mild back pain; Possible scoliosis


Page 435
Vaers Id: 419451-1 Age Gender Vaccine Date Onset Date F 25-Jan-2011 25-Jan-2011 13.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 04-Apr-2011 MS 25-Mar-2011 Lot Prev Doses Site AC52B058AA Right arm U3440AA 0768Z 0 1 Left arm Left arm
Crying, Dizziness, Hypotonia, Throat tightness
Symptom Text: ADM Tdap, GARDASIL and MENACTRA at 1620 on 1-25-11. At this time pt c/o dizziness closed eyes became limp aroused in 1/2-1 min. started crying left clinic with mom after fully aroused. After leaving clinic c/o throat tightness. Seen in local ER. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 436
Vaers Id: 419527-1 (S) Age Gender Vaccine Date Onset Date F 18-Mar-2011 Unknown 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days
Status Date State Received Date 31-Mar-2011 IN 25-Mar-2011 Lot Prev Doses Site 0664Z 0 Left arm
Abdominal pain, Abdominal tenderness, Decreased appetite, Depression, Gastritis, Lymphadenopathy, Nausea, Stress
Symptom Text: Vaccine 3-18-2011; onset of severe abd pain 3-20-2011. ER 3-21-2011 and admission to hospital for poss. Crohn's exacerbation. Dr did not find evidence of Crohn's exacerbation. The following information was obtained through follow-up and/or provided by the government. 4/4/2011 Hospital records received for DOS 3/21-23/11 with d/c dx: Gastritis. Depression. Crohn's Disease. Pt presented with 1 day hx of abdominal pain 8/10, minimal appetite and nausea. PE (+) diffuse abd tenderness and cervical LAD. Little improvement despite pain meds initially. EGD/Colonoscopy (+) for gastritis. Additional meds added with improvement. Neuro psych consult for depression r/t family stress. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The following information was obtained through follow-up and/or provided by the government. Labs and Diagnostics: CBC and CMP WNL. Lipase 178-214 (H). KUB (-). Abd US (-). EGD/Colonoscopy (+) gastritis. Crohn's; Eczema The following information was obtained through follow-up and/or provided by the government. PMH: allergy PCN. Crohn's. T&A, rectal surgery. recent GI infection. Crohn's The following information was obtained through follow-up and/or provided by the government. sore throat, cough.


Page 437
Vaers Id: 419533-1 Age Gender Vaccine Date Onset Date M 15-Mar-2011 15-Mar-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Immediate post-injection reaction, Syncope
Days 0
Status Date State Received Date 28-Mar-2011 CA 25-Mar-2011 Lot Prev Doses Site 0886Z 1 Right arm
Symptom Text: SYNCOPE EPISODE IMMEDIATELY AFTER RECEIVING HPV VACCINE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: VITAL SIGNS TAKEN - NORMAL VALUES NONE NO


Page 438
Vaers Id: 419631-1 (O) Age Gender Vaccine Date Onset Date F 10-Feb-2011 12-Feb-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pruritus, Rash
Days 2
Symptom Text: Information has been received from a health authority (reference number 2011-00708) on 15-MAR-2011. Case medically confirmed. A 17 year old female received a first dose of GARDASIL (batch number, dose and site of administration not reported) via intramuscular on 10-FEB-2011 and two days later, on 12-FEB-2011, she developed a small area of exanthema, more pronounced on the torso, with severe itch. Despite anti-allergic treatment, the patient had still not completely recovered when the report was made (07-MAR-2011: date first). No indications of alternative causes of the exanthema were found. The Health Authority assessed the causality between GARDASIL and the exanthema as probable. This case was classified as medically significant by the reporter. Other business partner numbers include E2011-01920. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 439
Vaers Id: 419632-1 (S) Age Gender Vaccine Date Onset Date F 01-Mar-2010 01-Apr-2010 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 31
Arthralgia, Loss of consciousness, Malaise, Migraine, Myopia
Symptom Text: Information has been received from a pharmacist on 17-MAR-2011. Case medically confirmed. An 18 year old female patient had received the third dose of GARDASIL (batch # not reported) in March 2010. One month after vaccination, she started to experience numerous malaises with loss of consciousness. The patient was hospitalized. The diagnosis of epilepsy was suspected and then ruled out. On an unspecified time of onset after vaccination, the patient also developed episodes of migraine, joint pain and vision disorder described as "myopia worsened since one year". At the time of reporting, the events were still ongoing. No diagnosis was established. An electroencephalogram (EEG) was performed, but the result was unknown. Other business partner numbers include E2011-01900. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 440
Vaers Id: 419724-1 Age Gender Vaccine Date Onset Date F 15-Mar-2011 17-Mar-2011 11.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS HEP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 2
Status Date State Received Date 06-Apr-2011 GA 28-Mar-2011 Lot Prev Doses Site D0439Z 1 Left arm U3035BA 0 Left arm AHBVB453BA 0 Left arm AHBVB846AA 0597Z 0 0 Right arm Right arm
Mfr Report Id GA11007 Route Subcutaneously Intramuscular Intramuscular Intramuscular Intramuscular
Injection site erythema, Injection site swelling, Injection site warmth
Symptom Text: Pt returned with mom to county health dept with redness, swelling, and warmth to left arm near varicella vaccine site. Mom reports using cool compresses & Ibuprofen. Pt with no distress. Instructed to see doctor and call with updates. Mom returned call to confirm pt saw urgent care MD & received meds. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 441
Vaers Id: 419730-1 Age Gender Vaccine Date Onset Date M 21-Mar-2011 21-Mar-2011 17.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. FLU SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 31-Mar-2011 NM 28-Mar-2011 Lot Prev Doses Site 1106Z 1 Left arm 1167Z 0 Right arm UH180AB 5 Left arm
Dizziness, Immediate post-injection reaction, Pallor, Presyncope, Vaccination complication
Symptom Text: Adverse reaction to GARDASIL in.j immediately after injection. Pt said he felt - lightheaded - like he was going to faint & paled. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA None


Page 442
Vaers Id: 419745-1 Age Gender Vaccine Date Onset Date F 17-Mar-2011 17-Mar-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 06-Apr-2011 TX 28-Mar-2011 Lot Prev Doses Site 1167Z 0 Left arm
Dizziness, Face injury, Fall, Hyperhidrosis, Mouth injury, Pain, Pallor, Pulse abnormal, Syncope, Tooth injury
Symptom Text: Patient watched sibling receive vaccine. Patient then received HPV #1. Advised by RN to stay sitting on table for a time then when able to wait 20 min. Nurse then turned around to write note in chart. Patient then fell off table, after fainting, hit face onto floor. Was pale and sweaty. Injury to mouth and teeth. Patient with braces. No other apparent injury. Patient then was alert with pain. Patient still pale and lightheaded. Approximately 15 min with thready pulse. 1st BP 96/50 2nd 104/60. On O2 approximately 10 min. Called EMS to transport to ER to evaluate mouth. Patient alert and awake when EMS arrived. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 443
Vaers Id: 419748-1 Age Gender Vaccine Date Onset Date F 16-Mar-2011 18-Mar-2011 16.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 2
Status Date State Received Date 06-Apr-2011 WI 28-Mar-2011 Lot Prev Doses Site 0965Z 1 Left arm 0768Z 2 Left arm
Mfr Report Id Route Subcutaneously Intramuscular
Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Symptom Text: On 3-18-11 in the morning, patient woke with a very itchy arm. In spot where Varicella vaccine was given was red, swollen, and hot area. After school on 3-18-11, patient complained of even itchier, red, swollen, and hot spot on arm. Mom put on BENADRYL cream and gave ice pack to put on. Mom may give anti-inflammatories. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 444
Vaers Id: 419759-1 Age Gender Vaccine Date Onset Date F 16-Mar-2011 18-Mar-2011 15.0 Type Manufacturer VAX Detail: TD SANOFI PASTEUR FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. MNQ SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Swelling face
Days 2
Status Date State Received Date 07-Apr-2011 MI 28-Mar-2011 Lot Prev Doses Site U2591AA 5 Left arm U3719AA 1 Left arm 1167Z 0 Right arm 1184Z 1 Left arm U3334AA 0 Right arm AHAV427AA 0 Right arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Subcutaneously Intramuscular Intramuscular
Symptom Text: 3-18-11 client woke up with swollen facial features especially eyes and into nose area. Denies SOB; Resp. distress. No new foods. 1st ever reaction like this. BENADRYL given prior to school - encouraged to take child to medical provider. Other Meds: Lab Data: History: Prex Illness: None None 1st DTP vaccine fever - seizure like activity within 24 hours of DTP None
Prex Vax Illns: 1st Dtp after seizure like reaction always given DT vaccine only.~DTP (no brand name)~1~0.20~Patient


Page 445
Vaers Id: 419760-1 Age Gender Vaccine Date Onset Date F 21-Mar-2011 25-Mar-2011 20.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site rash, Rash, Rash pruritic
Days 4
Status Date State Received Date 07-Apr-2011 GA 28-Mar-2011 Lot Prev Doses Site AHAVB406AA 0 Right arm 1778Y 0 Left arm
Symptom Text: Client states that at 4 days (Friday) after receiving 2 shots and DEPO, she noticed a rash in the "crease" of both arms and legs, and chest. C/o itching at the rash sites. No treatment. States will get "cream" & BENADRYL. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: (Given 3/21/11) DEPO PROVERA 150mg IM None Eczema None


Page 446
Vaers Id: 419778-1 (S) Age Gender Vaccine Date Onset Date F 01-Aug-2010 17-Nov-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 108
Brain oedema, Cerebral venous thrombosis, Convulsion, Extensor plantar response, Headache, Hemianopia, Sensorimotor disorder, Sensory loss
Symptom Text: Information has been received from the Health Authorities under reference number (TO20110215) concerning a 15 year old female patient, who had received a dose of GARDASIL (batch # and site of administration not reported) via intramuscular route in the end of August 2010 and on 17-NOV-2010, the patient was hospitalized for management of cerebral venous thrombosis. On her admission, she presented an first-ever (inaugural) seizure, headache, left sensory-motor brachio-facial deficit, a left Babinski sign and left lateral hemianopia. The patient had a medical history of occasional smoking. A brain CT scan was performed on her admission and found a swelling in the right temporal parieto-temporal regions. Cortical venous thrombosis was confirmed by a brain MRI. Brain CT scan: No picture suggestive of malignancy or hyperdensity suggestive of hemorrhage. Venous angio-CT: no abnormality. Etiology of cerebral venous thrombosis remained undetermined for physicians. Biological workup of thrombophilia: normal. Non-drug causes ruled out. Anticoagulant therapy with heparin was started on 17-NOV-2010 and replaced by PREVISCAN. Evolution was favourable and the patient was discharged from the hospital on 02-DEC-2010 with left lateral hemianopia. She no longer had sensory-motor deficit. She would be reviewed in consultation on 28-FEB-2011. At the time of reporting, the patient had recovered with sequelae. The Health Authorities assessed the causal relationship between the reported reactions and GARDASIL as "doubtful". Other business numbers include: E201101908. Case medically confirmed. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown head computed axial tomography, 17Nov10, Swelling in the right temporal parieto-temporal regions. No picture suggestive of malignancy or hype; magnetic resonance imaging, 17?Nov10, Brain: Cortical venous thrombosis was confirmed. No picture Smoker


Page 447
Vaers Id: 419784-1 Age Gender Vaccine Date Onset Date M 23-Mar-2011 24-Mar-2011 21.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. PPV MERCK & CO. INC. FLU SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 29-Mar-2011 MI 29-Mar-2011 Lot Prev Doses Site AHAVB456AA 0 Right arm 1327Y 6321Z U3744AA 0 0 0 Right arm Left arm Left arm
Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Symptom Text: Individual is incarcerated. Nursing staff notified at 8:00am that patient's had left arm pain. Nurse noted Left deltoid area 1 1/2 diameter area reddened, swollen, tender to touch and warm to touch. Temp taken and was 100.6. Tylenol and Benadryl was given. Left arm evaluated at 10:00am and no change noted, temp taken was now 99.1. Contact on 3/29 and information that arm is normal at this time. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Doxyclycline None known None known


Page 448
Vaers Id: 419801-1 Age Gender Vaccine Date Onset Date Days F 20-Feb-2008 Unknown 14.0 Type Manufacturer VAX Detail: TDAP UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Status Date State Received Date 08-Apr-2011 TX 29-Mar-2011 Lot Prev Doses Site NULL Unknown 1424F Unknown
Contraception, Depression, Headache, Hyperhidrosis, Mood altered
Symptom Text: Birth control, no PMS for 3 years, headaches, depressed, moody, sweaty hand and feet (extremely). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 449
Vaers Id: 419837-1 Age Gender Vaccine Date Onset Date F 28-Mar-2011 29-Mar-2011 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Feeling hot, Nausea
Days 1
Status Date State Received Date 29-Mar-2011 US 29-Mar-2011 Lot Prev Doses Site 0331Z 1 Right arm
Symptom Text: Pt. states woke up feeling nauseous and hot. States she feels like she has a fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Not that patient knows of.


Page 450
Vaers Id: 419839-1 Age Gender Vaccine Date Onset Date F 01-Mar-2011 02-Mar-2011 14.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Swelling
Days 1
Status Date State Received Date 08-Apr-2011 TX 29-Mar-2011 Lot Prev Doses Site 0714Z 1 Unknown 0886Z 1 Unknown
Mfr Report Id Route Subcutaneously Intramuscular
Symptom Text: 14 y/o received Varicella and HPV vaccines to left arm on 3-1-11. Pt presented on 3/3 and 3/4 with large area of swelling and erythema 15x16 cm pink changes 6x4 cm of induration & erythema. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ALLEGRA; NASONEX; XOPENEX None Asthma; Allergic Rhinitis Dysuria o/w well


Page 451
Vaers Id: 419932-1 (S) Age Gender Vaccine Date Onset Date M Unknown 01-Mar-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Encephalomyelitis
Days
Mfr Report Id Last Edit Date WAES1103CRl00003 31-Mar-2011 Other Vaccine Route Unknown
Symptom Text: Information has been received from a company representative concerning a 15 year old male who in 2011 was vaccinated with [therapy unspecified]. Preliminary information indicates that the patient was vaccinated with a unspecified GARDASIL along with other unspecified number of vaccines as a school requirements. The patients parents decided to return to a foreign country. In March 2011, the patient experienced encephalomyelitis and was hospitalized. The patient's encephalomyelitis persisted. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 452
Vaers Id: 419933-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days
Abdominal pain, Colitis ulcerative, Drug exposure during pregnancy
Symptom Text: Case received from a physician on 18-MAR-2011 and medically confirmed. A 21 year old female patient with no relevant personal or familial medical history had received the first dose of GARDASIL (batch# not reported) in the 3rd or 4th trimester 2010. 15 days after vaccination, she presented with severe abdominal pain. The patient was hospitalized, and ulcerative colitis was diagnosed. A treatment was prescribed. Pain regressed. The reporter would try to obtain further information. He precised that according to the hospital, there was a link between the vaccination and the events. At the time of the reporting, the outcome was not provided. Other business partner numbers included: E2011-01927. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 453
Days 23
Status Date State Received Date 31-Mar-2011 FR 30-Mar-2011 Lot Prev Doses Site NG31250 0 Right arm
Bursitis, Expired drug administered, Injected limb mobility decreased, Injection site pain, Motor dysfunction, Muscular weakness, Neuralgic amyotrophy, Neuropathy peripheral, Paresis, Peripheral nerve injury, Radiculitis brachial, Sleep disorder, Winged scapula
Symptom Text: Case received from the Health Authorities on 18-MAR-2011 (reference number PEI2011007698). This was a case of misuse due to expired vaccine used. Case medically confirmed. A 13 year old female patient with a medical history of adipositas had received the first dose of GARDASIL (batch# NJ11450, lot# NG31250, expiry date September 2010) IM into the right upper arm on 05-OCT-2010. On 28-OCT-2010, she experienced brachial neuritis/neuralgic amyotrophy leading to hospitalization on 05-NOV-2010. Anamnesis and examination revealed pain and weakness in the right upper arm, decreased mobility of this arm upon elevation and scapula alata tight at elevation. It was reported that the patient always slept on the elevate arm. Laboratory data showed an elevated CK level at 154 U/L, MRI of the right shoulder on 05-NOV-2010 revealed bursitis subacomial. At that time mechanical irritation of right thoracicus longus nerve due to atypical sleeping position an hereditary neuropathy with a tendency of pressure paresis were suspected, differential diagnosis was early stated of right neuralgic shoulder amyotrophy. The patient was treated with ibuprofen leading to improvement of pain, the motoric weakness persisted. The patient was discharged on 06-NOV-2010. On 22-NOV-2010, the patient was followed-up in the neuropediatric ambulance unit. Neurological examination revealed no pain and an improved but still existing scapula alata right. There was no motoric deficiency. The patient was diagnosed with neuralgic amyotrophy (plexus neuritis of unknown etiology). Causal relationship with the vaccination was not excluded although other unspecified causes (infections) could be the trigger. There were no signs of a hereditary form. The patient was treated with prednisone. On 30-NOV-2010, the patient received the second dose of GARDASIL and did not experience any adverse events. On 23-FEB-2011 the patient was again followed-up in the neuropediatric unit. The paresis had completely resolved under prednisone therapy. Upon internal review the company considered relevant to code expired vaccine used which was not coded by HA. Other business partner numbers included: E2011-01919. Case is closed. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Magnetic resonance imaging, 05Nov10, right shoulder revealed bursitis subacrominal; Serum creatine kinase, 05Nov10, 154 U/L, Elevated Obesity


Page 454
Vaers Id: 419935-1 (O) Age Gender Vaccine Date Onset Date F 21-Oct-2009 21-Oct-2009 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 31-Mar-2011 US 30-Mar-2011 Lot Prev Doses Site 0702X 1 Left arm
Grand mal convulsion, Immediate post-injection reaction, Movement disorder, Syncope
Symptom Text: Information has been received from a certified nurse practitioner (C.N.P.) concerning an 18 year old female with asthma who on 21-OCT-2009 was intramuscularly vaccinated with the second dose of 0.5 ml GARDASIL (lot # 0702X/ exp. 08-SEP-2010) in left deltoid. Concomitant therapy included albuterol. The patient received the first dose and the second dose at the university where the patient was a student. No other vaccine was given at the time of the second dose on 21-OCT-2009. ADACEL was to be administered, but it was not given due to the patient's events immediately following the GARDASIL dosing. The reporter stated that the patient experienced syncope and tonic-clonic like seizure activity after receiving her second dose of GARDASIL on 21-OCT-2009 (date of dose 1 was unspecified). The patient reported that she remained in the provider's (unspecified) office until she recovered from her adverse effects. On 21-OCT-2009, the patient had recovered from syncope and tonic-clonic like seizure activity. Upon internal review, tonic-clonic like seizure activity was determined to be an other important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma Albuterol Unknown


Page 455
Vaers Id: 419943-1 Age Gender Vaccine Date Onset Date M 28-Mar-2011 29-Mar-2011 10.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 31-Mar-2011 NY 30-Mar-2011 Lot Prev Doses Site U3645DA 3 Left arm 0886Z Left arm
Injection site erythema, Injection site induration, Injection site swelling, Local swelling
Symptom Text: Localized redness, swelling and some induration of left deltoid area where HPV and Flu shots were administered 03/28/2011. Manufacturer for Flu Shot is Sanofi Pasteur. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Bicuspid Aortic Valve None


Page 456
Vaers Id: 419971-1 Age Gender Vaccine Date Onset Date F 28-Mar-2010 29-Mar-2010 0.2 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 31-Mar-2011 WA 30-Mar-2011 Lot Prev Doses Site AHAVB453AA 1 Left arm 08866Z U3512AA AC52B048AC 1327Z 0 0 0 1 Left arm Left arm Right arm Right arm
Injection site erythema, Injection site swelling, Injection site warmth
Symptom Text: Redness, swelling and warm to the touch at injection site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: N/A N/A


Page 457
Vaers Id: 419978-1 Age Gender Vaccine Date Onset Date F 27-Jan-2009 01-Aug-2009 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 186
Status Date State Received Date 01-Apr-2011 OR 30-Mar-2011 Lot Prev Doses Site NULL 2 Right arm
Last Edit Date 01-Apr-2011 Other Vaccine HEPA VARCEL
Abdominal pain, Dizziness, Headache, Heart rate increased, Pain in extremity, Pyrexia, Vulvovaginal discomfort, Vulvovaginal pruritus
Symptom Text: Vaginal itching and irritation, abdominal pains, headaches, dizziness, chronic low grade fever, leg pains, rapid heart beat. Other Meds: Lab Data: History: Prex Illness: Developmental Delay, ADD, Non Verbal Learning Disorder No
Prex Vax Illns: vaginal irriations~HPV (Gardasil)~2~9.00~Patient|Headache~HPV (Gardasil)~3~10.00~Patient|Abdominal Pain~HPV (Gardasil)~3~10.00~Patient|Chronic


Page 458
Vaers Id: 420002-1 (S) Age Gender Vaccine Date Onset Date F 03-Jul-2008 29-Mar-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT PERMANENT DISABILITY, SERIOUS
Days 634
Status Date State Received Date 01-Apr-2011 FR 31-Mar-2011 Lot Prev Doses Site NULL 0 Unknown
Arthralgia, Inflammation, Musculoskeletal pain, Oedema peripheral, Pain, Pain in extremity, Rheumatoid arthritis, Synovitis
Symptom Text: Case received from the Health Authorities on 22-MAR-2011 under reference number GR20110021. Case medically confirmed. A 17-year-old female patient, had received a dose of GARDASIL (batch number, site of administration not reported) via intramuscular route on 07-JAN-2009 and on 29MAR-2010, she experienced arthritis rheumatoid. The patient had medical history of repeated otitis in 2009, benign naevus exeresis in December 2009, chilblains investigated in 2009, possible Raynaud syndrome since the age of 10, chicken pox during childhood, tick bite with positive test for Lyme's disease treated with antibiotic therapy in 2008. She had received a first dose of GARDASIL on 03-JUL-2008 and the second dose on 02-AUG-2008. The patient had inflammatory polyarthralgia evolving since December 2009. Symptomatology started with tarsi arthralgia and heel pain which then extended to the hands, shoulders, buttocks, wrists and knees. Progressive apparition of finger and toe swelling with an inflammatory pattern and stiffness in the morning within 1 hour. VAS was at 7/10 in spite of treatment with BREXIN and paracetarrol, opium, LAMALINE. Treatment with non steroidal antiinflammatory drugs with NABUCOX then SPIFEN then VOLTARENE 75 mg SR were ineffective whereas a week-long course of 40 mg daily orally of steroids at the end of February provided effective but temporary relief. On 29-MAR-2010, the patient saw her doctor, clinical examination evidenced hand and finger synovitis, painful bilateral patellar mobilisation without patellar shock and painful shoulder mobilisation. Laboratory test work-up: antiCCP antibodies at 14 IU/mL, antinuclear antibodies at 1/80, dubious appearance of antinuclear antibodies with negative anti MPO and PR3 antibodies, negative HLA B27, active cryoglobulin, blood count showed hemoglobin at 11.5g/dl, ESR (erythrocyte sedimentation rate) at 19 mm and C reactive protein at 1mg/L, transaminases were normal. Patient was finally diagnosed with rheumatoid arthritis in March 2010. Treatment was started in mid-April 2010: methotrexate, speciafoldine, short courses of corticosteroids and non steroidal anti-inflammatory drugs. On 10-JAN-2011 patient was treated with methotrexate 15 mg a week subcutaneously, paracetamol and a course of non steroid anti-inflammatory drugs and PPI during flare-up. VAS at 5/10. Data in the literature did not clearly describe a risk of rheumatoid arthritis with GARDASIL. However, given the chronological sequence of events, a low imputability of GARDASIL in the onset of rheumatoid arthritis was retained. At the time of reporting, the patient had not yet recovered. The seriousness criterion reported by the HA was "disability". The Health Authorities assessed the causal relationship between the reported reaction and GARDASIL as "doubtful" according to the Foreign method of assessment. Other business partner numbers included: E2011-01990. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Diagnostic laboratory test, 29Mar10, normal transaminase; Anti-MPO Ab, 29Mar10, negative; hemoglobin, 29Mar10, 11.5 g/dl; Serum ANA, 29Mar10, 1/80, dubious appearance of antinuclear antibodies with negative anti MPO and PR3 antibodies; Seru Otitis; Exeresis; Chillblains; Tick bite; Lyme disease; Chickenpox Raynaud's syndrome


Page 459
Days 7
Mfr Report Id Last Edit Date WAES1103USA03414 01-Apr-2011 Other Vaccine Route Intramuscular
Dermatitis atopic, Eczema, Skin lesion, Vaccine positive rechallenge
Symptom Text: Case received from the Health Authorities on 22-MAR-2011 under reference number MA20110337. Case medically confirmed. A 15-year-old female patient, had received a first dose of GARDASIL (batch number, site of administration) by intramuscular route on 23-NOV-2010 and 1 week later. On 30NOV-2010, the patient presented an eczema-type rash on the limbs but no reaction at the injection site. Spontaneous regression after one month. On 22-JAN-2011, recurrence of eczema-type rash, 24 hrs after the booster dose of GARDASIL (lot#NK05070, batch NN22980) given on 21-JAN-2011. On 27-JAN-2011, dermatological consultation found that the patient presented lightly pruriginous atopic eczema, located inside the lower and upper limbs and friction zones, with some lesions on the trunk. No reaction at the injection site. The patient received topical corticosteroids and vaccination by GARDASIL was suspended. On 07-FEB-2011, the patient was better, she was recovering. The patient had fully recovered. The seriousness criterion reported by the HA was "other medical important condition". The Health Authorities assessed the causal relationship between the reported reaction and GARDASIL as "likely" (C3 S1 I3) according to the Foreign method of assessment. Other business partner numbers included: E2011-01994. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 460
Vaers Id: 420005-1 (S) Age Gender Vaccine Date Onset Date F 01-Jul-2010 01-Jul-2010 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Abdominal pain, Colitis ulcerative
Days 0
Symptom Text: Case received from a physician on 18-MAR-2011 and medically confirmed. A 21 year old female patient with no relevant personal or familial medical history had received the first dose of GARDASIL (batch number not reported) in the 3rd or 4th trimester 2010. 15 days after vaccination, she presented with severe abdominal pain. The patient was hospitalized, and ulcerative colitis was diagnosed. A treatment was prescribed. Pain regressed. The reporter would try to obtain further information. He precised that according to the physician at the hospital, the event was related to the vaccination. At the time of reporting, the outcome was not provided. Other business partner numbers include E2011-01927. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 461
Vaers Id: 420016-1 Age Gender Vaccine Date Onset Date F 29-Mar-2011 29-Mar-2011 9.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 08-Apr-2011 NY 31-Mar-2011 Lot Prev Doses Site AC52B040BA 0 Left arm U3555AA 1016Z 0 0 Left arm Right arm
Abdominal pain, Condition aggravated, Cough, Dyspnoea, Erythema, Eye swelling, Ocular hyperaemia, Oedema peripheral, Pyrexia, Vomiting
Symptom Text: Almost 10 year girl w/asthma presents 1 day after receiving GARDASIL #1, MENACTRA, and BOOSTRIX. Mom states 3 minutes after arriving home pt's eyes started to swell up and turn red. Her arm also start to swell and turn red. This is the arm where the GARDASIL vaccine was placed (the right arm-MENACTRA and BOOSTRIX were placed in the left). Mom gave dye free children's BENADRYL 5 ml x 1 and the swelling around the eyes and eyes improved. Overnight Patient started coughing. History of vomiting, abdominal pain, fever. Some SOB. Mom brought patient to clinic 3/30/2011. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MD consulted with allergy at hospital: Stated that there is no allergy testing for the HPV vaccine therefore should just treat accordingly for anaphylaxis. As per mother of child positive history of lip and eye swelling about a month ago after using cherry flavored MOTRIN and TYLENOL. None


Page 462
Vaers Id: 420017-1 Age Gender Vaccine Date Onset Date F 30-Mar-2011 30-Mar-2011 15.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Hypoaesthesia
Days 0
Status Date State Received Date 11-Apr-2011 VA 31-Mar-2011 Lot Prev Doses Site 0837Z 1 Left arm 1318Y 0 Left arm
Symptom Text: After receiving GARDASIL vaccine, left arm went numb to touch for approx. 30 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 463
Vaers Id: 420028-1 Age Gender Vaccine Date Onset Date F 04-Feb-2011 04-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Abdominal pain
Days 0
Status Date State Received Date 11-Apr-2011 KY 31-Mar-2011 Lot Prev Doses Site 1778Y 2 Right arm
Symptom Text: Abdominal pain (chronic) per mom's report. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ZYRTEC; NASONEX; MIRALAX; Metformin; RETIN A MICRO Pump Abdominal ultrasound 2/24/11 & lab data 2/9/11 & 2/11/11 Pre diabetes; constipation 07/27/10 Constipation, Acne, & Enlarged thyroid


Page 464
Vaers Id: 420045-1 Age Gender Vaccine Date Onset Date F 28-Mar-2011 29-Mar-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. PPV MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 11-Apr-2011 LA 31-Mar-2011 Lot Prev Doses Site 1437Z 1 Right arm 1426Y 0 Left arm
Body temperature increased, Headache, Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain, Pain
Symptom Text: (L) delt, baseball sz, swelling, redness, warmth, (102.0, headache, sore throat, achy). Warm compress, TYLENOL, cool compresses. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 465
Vaers Id: 420071-1 Age Gender Vaccine Date Onset Date F 31-Mar-2011 31-Mar-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pain, Pain in extremity, Paraesthesia
Days 0
Status Date State Received Date 11-Apr-2011 MA 31-Mar-2011 Lot Prev Doses Site 0886Z 1 Left arm
Symptom Text: 1/2 hour after injection c/o arm sore tingly, hurts to move arm. Also recently had tattoo in same arm. Advised Ibuprofen, cool compresses, call if change/worse. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 466
Vaers Id: 420088-1 (S) Age Gender Vaccine Date Onset Date F 30-Aug-2010 13-Sep-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 14
Status Date State Received Date 04-Apr-2011 FR 01-Apr-2011 Lot Prev Doses Site NULL 1 Unknown
Mfr Report Id Last Edit Date WAES1103USA03266 04-Apr-2011 Other Vaccine Route Subcutaneously
Cerebellar syndrome, Dizziness, Encephalitis, Headache, Hypersensitivity, Inflammation, Meningitis aseptic, Nausea, Paraesthesia
Symptom Text: Case received from the Health Authorities on 22-MAR-2011 under reference number TO20101478. Case medically confirmed. A 16 year old female patient, had received a second dose of GARDASIL (batch number unknown and site of administration not reported) via subcutaneous route on 30-AUG2010 and 13-SEP-2010, she presented meningoencephalitis. The patient had received a first dose of GARDASIL. She had no medical history. On 12SEP-2010, she complained from headache during the evening and on 13-SEP-2010, she experienced nausea and dizziness, then paresthesia, she had no fever. She received concomitant therapy with paracetamol and ibuprofen on 13-SEP-2010. She was hospitalized on 14-SEP-2010 at emergency unit. At examination: Frank cerebellar syndrome with enlargement of polygon of support. Biological workup: On 14-SEP-2010: creatinin at 9.7, lymphocytes at 136, cervicospinal fluid proteins at 1.26, glycorrhachia was normal. HIV, Lymes, Herpes/PCR serologies and bacterial culture were negative. Test performed: CT angiography showed no vascular abnormality, MRI showed no damage but an inflammatory disorder, lumbar puncture showed aseptic meningitis. The patient received corrective treatment with CLAMOXYL 12g, ZOVIRAX 500 mg three times a day and corticotherapy. In December 2010: MRI control was normal. The patient did not receive the third dose of GARDASIL. The non-drug etiologies were ruled out. According to a neurologist reaction immunoallergic post vaccination. The patient had fully recovered. The Health Authority assessed the causal relationship between the reported reaction and GARDASIL as "doubtful" (C1 S1 I1) according to the method of assessment. Other business partner numbers included: E201101977. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acetaminophen, 13Sep10; Ibuprofen, 13Sep10 Angiography, 14Sep10, No vascular abnormality; Magnetic resonance imaging, 14Sep10, Showed no damage but an inflammatory disorder; Spinal tap, 14Sep10, Showed aseptic meningitis; Magnetic resonance imaging, ??Dec10, Control was normal; Lymp Unknown


Page 467
Vaers Id: 420160-1 Age Gender Vaccine Date Onset Date Days M 02-Apr-2011 02-Apr-2011 0 11.0 Type Manufacturer VAX Detail: MNQ NOVARTIS VACCINES AND DIAGNOSTICS HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Crying, Dizziness, Fall, Thermal burn
Status Date State Received Date 04-Apr-2011 OK 03-Apr-2011 Lot Prev Doses Site M10030 Left arm 0337Z C3490AA 0 0 Right arm Right arm
Symptom Text: PATIENT WAS GIVEN TDAP, HPV IN RT ARM AND MENVEO IN LEFT ARM. NURSE WAS GETTING READY TO GIVE VARICELLA IN L ARM WHRN HE STOOD UP SAID WAS DIZZY AND SISTER TOLD HIM TO LIE DOWN. HE FELL TO THE FLOOR GETTING A CARPET BURN TO RT CHEEKBONE AREA. WHEN I GOT TO HIM HE WAS CRYING. I ASKED IF HURT ANYWHERE HE REPLIED NO. I ASKED IF HAD BREAKFAST AND SISTER SAID GO-GURT. I SAT HIM UP GAVE HIM SOME O.J AND ANOTHER NURSE BROUGHT COOL COMPRESS FOR FACE. HE WAS HELPED TO CHAIR AND OBSERVED FOR 15 MINUTES. I WALKED OUT TO CAR WITH PATIENT AND SISTER AND ADVISED NO SOCCER GAME TODAY AND TO TAKE TO DR. FOR EVAL OF FACE. I GAVE SISTER MY PHONE NUMBER TO CALL ME OF ANY REPORT FURTHER. AS OF TODAY 4/3/11 NO PHONE CALL RECEIVED. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 468
Vaers Id: 420163-1 Age Gender Vaccine Date Onset Date F 30-Mar-2011 31-Mar-2011 11.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 12-Apr-2011 LA 01-Apr-2011 Lot Prev Doses Site 12782 1 Left arm 14372 0 Right arm U3757AA 0 Left arm U3486DA 0 Right arm
Injection site erythema, Injection site oedema, Injection site vesicles
Symptom Text: Large area (shoulder to elbow) red, edematous with vesicles at injection site (VARIVAX-SQ). Treatment: BENADRYL 25mg po q day, ice, Acyclovir ointment. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Melatonin; SINGULAIR; Ketaconazole


Page 469
Vaers Id: 420168-1 Age Gender Vaccine Date Onset Date M 01-Apr-2011 01-Apr-2011 16.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 11-Apr-2011 AL 01-Apr-2011 Lot Prev Doses Site AHAVB451AB 0 Left arm 0786Z U3102AA U3035BA 0997Z 0 0 0 0 Right arm Left arm Left arm Right arm
Erythema, Head injury, Hypotonia, Localised oedema, Syncope
Symptom Text: Approximately 5 min after pt received IM immunizations (x5) pt was ambulating to d/c area with mother at side & pt went limp of muscle tone with syncopal episode apparent. Pt (L) forehead hit chart holder box. Red without edema to forehead. PT VSS during occurrence. Pt's mother refused transport or transfer to hospital for eval. Pt ambulated out to POV with mother at side & escorted by clinic staff (x2). Pt A & O x 3 at time of leaving clinic. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None (well child visit)


Page 470
Vaers Id: 420180-1 (O) Age Gender Vaccine Date Onset Date F 31-Jan-2011 06-Feb-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Alopecia, Hair disorder
Days 6
Status Date State Received Date 05-Apr-2011 FR 04-Apr-2011 Lot Prev Doses Site NJ51180 1 Left arm
Symptom Text: Case received from a healthcare professional on 21-FEB-2011. Case medically confirmed. A 16 year old previously healthy female patient had received the second dose of GARDASIL intramuscularly in the left upper arm on 31-JAN-2011. Six days later, she developed severe hair loss. Several routine lab parameters including thyroid function showed normal results. At the time of reporting an examination by a dermatologist was pending and hair loss was ongoing. Dose 1 of GARDASIL (lot # NJ51180, batch # NM15330) was vaccinated on 06-DEC-2010 was well tolerated. Follow up 14-MAR-2011: the dermatologist contacted the company by phone. The patient suffered from diffuse hair loss concerning scalp hair only. Hair analysis had not yet been carried out, meanwhile hair growth started again. Follow up information received from the Health Authorities on 24-MAR-2011 (reference number PEI2011008048). New information upon reporting form dated 26-FEB-2011. Onset was reported as 06-FEB-2011, five to six days post-vaccination. Additionally hair disorder was coded. HA considered the case as serious as other medically important condition which led to upgrade the case. Other business partner numbers include: E2011-01149. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown diagnostic laboratory test, 06?Feb11, Several routine lab parameters including thyroid function showed normal results Unknown


Page 471
Vaers Id: 420181-1 (O) Age Gender Vaccine Date Onset Date F 17-Mar-2010 01-Apr-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Autoimmune thyroiditis, Hypothyroidism
Days 15
Symptom Text: Information has been received from the Health Authorities (HA) under reference number BX20110178. Case medically confirmed. A 17 year old female patient, had received a third dose of GARDASIL (batch number and site of administration not reported) via intramuscular route on 17-MAR-2010 and on 01-APR-2010, an hypothyroidism was discovered while performing a work-up because of interruption of the menstrual cycle. The patient had received the first and second dose of GARDASIL from 17-JUN-2009. On 29-APR-2010: thyroid-stimulating hormone (TSH) at 56 mU/L (N: 0.5-1 mU/L) and antiperoxidase antibody positive. Diagnosis of Hashimoto's thyroiditis was done. The patient received corrective treatment with levothyroxine 62.5 ug daily leading to an euthyroidism (TSH at 0.77 mU/L in October 2010). At the time of reporting, the patient had not yet recovered. The seriousness criterion reported by the HA was "other medically important condition". The HA assessed the causal relationship between the reported reaction and GARDASIL as "doubtful" (C1 S1 I1) according to the foreign method of assessment. Other business partner numbers include: E2011-01974. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Diagnostic laboratory test, 29Apr10, antiperoxidase antibody positive; Serum TSH, 29Apr10, 56 mU/L; Plasma asparagine test, 29Apr10, N: 0.5-1 mU/L; Serum TSH, ??Oct10, 0.77 mU/L Unknown


Page 472
Vaers Id: 420182-1 (S) Age Gender Vaccine Date Onset Date F 24-Nov-2010 24-Nov-2010 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Headache, Inflammation, Pyrexia, Sinus disorder, Sinusitis
Symptom Text: Case received from the Health Authorities on 22-MAR-2011 under reference number MP20110154. Case medically confirmed. A 16 year old female patient, had received a third dose of GARDASIL (batch number and site of administration not reported) via intramuscular route on 24-NOV-2010, and on the same day, she presented chronic pansinusitis and fever. The patient had medical history of Von Willebrand's disease ongoing. She had received the first and the second dose of GARDASIL. From 24-NOV-2010 to 01-DEC-2010, she experienced fever, no arguments for an infectious cause. From 01DEC-2010 to 03-DEC-2010, she was hospitalized for fever with inflammatory syndrome (C reactive Protein at 2850). A CT scan showed thickening of the sinus mucosa. Treatment with AUGMENTIN was incomplete: 500 mg three times a day instead of 1 g three times a day for 7 days. On 02-DEC2010, C reactive Protein was at 150. On 07-DEC-2010, C reactive Protein was still high at 12.6 but the patient was apyretic and presented no clinical symptoms except asthenia. On 14-DEC-2010, the patient went to the emergency unit; she presented fever at 38.5C degrees and headache. The final diagnosis was chronic pansinusitis, treatment with PYOSTACINE 1 g three times a day for 10 days was started. At the time of reporting, the patient was recovering. Upon medical review, the company considered relevant to code "chronic pansinusitis", which was mentioned in the narrative but not coded by the Health Authorities. The seriousness criterion reported by the HA was "hospitalization and other medical important condition". The Health Authorities assessed the causal relationship between the reported reaction and GARDASIL as "possible" (C2 S2 I2) according to the method of assessment. Other business partner numbers included: E2011-01998. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Von Willebrand's disease Unknown Computed axial tomography, showed thickening of the sinus mucosa; serum C-reactive protein, 01?Dec10, 2850; serum C-reactive protein, 02Dec10, 150 mg/L; serum C-reactive protein, 07Dec10, 12.6 mg/L, was still high; body temp, 14Dec10, 38.5


Page 473
Days 0
Anaphylactic reaction, Dyspnoea, Injection site paraesthesia, Pharyngeal oedema, Presyncope, Syncope
Symptom Text: Case received from Health Authorities on 22-MAR-2011 under the reference number L201103-924 via the local site. Case medically confirmed. A 42 year old female patient had received the first dose of GARDASIL (batch n. and administration not reported) via intramuscular route on 29-DEC-2010, and on the same day, she experienced shortness of breath, injection site paraesthesia, throat swelling, syncope and vagal reaction similar to anaphylactoid reaction, with no other symptoms. Unknown clinical history. Unknown prior history of allergic reactions to other drugs. There was no suspicion of interaction between drugs. The same drug had not been reintroduced. The patient had acquired the second dose of the vaccine, but this was not administered by physician's indication. It was unknown whether there was specific treatment of the reaction. Vaccination site paraesthesia, syncope, vagal reaction similar to anaphylactoid reaction, throat swelling and shortness of breath were considered to be an other important medical events. The patient had fully recovered. Other business partner numbers included: E2011-02000. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 474
Days 4
Status Date State Received Date 05-Apr-2011 FR 04-Apr-2011 Lot Prev Doses Site NULL Unknown
Abdominal pain upper, Anxiety, Asthenia, Back pain, Body temperature, Cyanosis, Disorientation, Dizziness, Dyspnoea, Feeling abnormal, Headache, Loss of consciousness, Muscle spasms, Muscular weakness, Myalgia, Nasopharyngitis, Nausea, Pain in extremity, Syncope, Urinary incontinence, Viral infection
Symptom Text: This case was received from the health authority on 24-MAR-2011. Agency ref 2010-000793. This case is medically confirmed. A 12 year old female patient with no risk factors available and no significant medical history received an injection of GARDASIL (batch number not reported) on 13-SEP-2010. On 17-SEP-2010, four days post vaccination, the patient fainted. The patient was sitting at breakfast and just blacked out for 10-15 seconds and then when she came round she was weak on her feet, disoriented and urinated in her clothes. The patient then urinated again five minutes later. About three weeks later, on 08-OCT-2010, the patient was doubled over with tummy aches (was unable to stand up with cramps) and feeling nauseous. On 20OCT-2010 the patient was sent home from school as her teacher said she had a temperature, headache and minor cold symptoms. The patient was seen by her GP on 21-OCT-2010 and a viral infection was diagnosed. Corrective treatment was ibuprofen. On 02-NOV-2010 the patient fainted and experienced dizziness, headaches, no power in her legs, was very weak and was blue around the mouth. On 03-NOV-2011 the patient experienced bad headaches again. The patient was seen by the doctor again and referred to the hospital. The patient had an ECG and chest x-ray and was referred to a consultant. The patient was still having headaches, weakness, trouble breathing with pains in her back. The patient went to the hospital again on 10NOV-2010. Her sugar level and oxygen were tested all usual tests were normal. The patient was subsequently seen by the consultant who diagnosed a viral bug. The patient had pain mostly in her lower legs and muscles in her legs especially. According to the patient's mother she still had bad headaches and was taking PANADOL every four hours and NUROFEN every two hours in between as advised by a pharmacist for the previous two weeks and the headaches were still there. The patient had also had trouble breathing the day before. On 17-NOV-2010 the patient's mother reported that the patient still had had headaches, pains in her back and under her ribcage and was feeling rather "crappy". The patient had been taken to the hospital the night before. The patient had not got worse but was not feeling any better. The patient had first been seen by the GP on 03-NOV-2010 and referred to A&E. The GP had not received any discharge letters at the time of reporting. The patient's mother had verbally reported to the GP that the final diagnosis was "anxiety". No drugs were prescribed by the GP. At the time of reporting the patient had not yet recovered. The events were considered serious as they were medically significant and required intervention. Other business partner numbers included: E2011-02034. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown diagnostic laboratory test, 10Nov10, oxygen and all usual tests were normal; serum glucose, 10Nov10, normal None


Page 475
Vaers Id: 420185-1 (S) Age Gender Vaccine Date Onset Date F 26-May-2010 Unknown 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days
HOSPITALIZED, LIFE THREATENING, SERIOUS Anal fissure, B-cell lymphoma, Back pain, Catheter placement, Central nervous system lesion, Chemotherapy, Clostridium colitis, Febrile neutropenia, Gastroenteritis norovirus, General physical health deterioration, Genital herpes, Grip strength decreased, Hyporeflexia, Mediastinal disorder, Menorrhagia, Monoparesis, Mucosal inflammation, Muscular weakness, Neutropenic sepsis, Night sweats, Nodule, Non-Hodgkins lymphoma, Pain in extremity, Peripheral nerve lesion, Swelling, Weight decreased
Symptom Text: Case received from the Health Authorities on 24-MAR-2011 (reference number PEI2010038739). Case medically confirmed. A 13 year old female patient with a medical history of varicella at kindergarten-age, had received all three doses of GARDASIL (manufacturer, dates of administration for first and second dose, site and route not reported), third dose on 26-MAY-2010. The same day, on 26-MAY-2010, the patient presented to the ambulance unit and complained of back pain, irradiating to the right arm, pain relief therapy with indomethacine and ointment was initiated. In the future course strength weakness and reduction of reflex in the right arm developed, which was unsuccessfully treated with physiotherapy. In addition, the patient experienced a weight loss of about 3 kg within 3 weeks and night sweats. From 07-JUL-2010 to 12-JUL-2010 the patient was hospitalized for further investigations. Upon admission she reported that she had been suffering from back pain for over three months. Neurological examination including neurography showed radicular lesion at level C7 and C8. Thoracic x-ray revealed a clear broadened mediastinum. MRI of 09-JUL-2010 showed an extensive process on the right from the neck area up to the upper thoracic aperture with nodular structures. On 12-JUL-2010, the patient was transferred to the hematological-oncological unit. Clinical examination on admission showed reduced general health state of patient, with right arm paresis, drop hand, weakness by closing the first and infraclavicular solid swelling. Laboratory values data: 12-JUL-2010: CRP slight increased at 12.2mg/l, fibrinogen 4.72 g/l (norm 2.0 - 4.0), D-dimer 0.7 mg FEU/1 (norm: < 0/.5 mg FEU/l), complex sonography : no signs of typical malignant lymphoma; ECG normal 14-JUL-2010: PET-CT : soft tissue formations laterocervical right, in upper mediastinum possibly consistent with M. Hodgkin, ECG generalized function disorder, no clear epileptic-like potential 15-JUL-2010: MRI cranial/spinal : no sign of brain metastasis, evidence of suspect multilocular of suspect multilocular focus cervical and thoracic bilateral. CT thorax: suspect lymphoma-like formations cervical, mediastinal and left axillar. Echocardiography: no pathological findings. 16-JUL-2010: Tc-scintiscanning no evidence of bone marrow or osseo participation. 23-JUL-2010/06-AUG-2010: histopathological finding: left axilla, diffuse large B-cell lymphoma 23-JUL-2010: bone marrow biopsy : conventional-morphologically and immunohistologically no signs of infiltration of the B-cell lymphoma. 30-JUL-2010: MRI cranial/spinal : regression 02-AUG-2010: liquor cytology: blast/tumor cell free liquor. 23-AUG-2010: MRI neck/pharynx/ thorax /mediastinum : size regression of lymphoma. 24-AUG-2010: ENG: evidence of regression of paresis in C5, C6 and C7 core muscles. 20-OCT-2010: MRI cranial/spinal : minimal tumor residuum, regressive changes under chemotherapy. 20-OCT-2010: cervical / thoracic: minimal further regression. 17-DEC-2010: evidence of E. coli in urine culture. 13-JAN-2011: MRI cranial : no pathological lymphoma-suspected parechym enhancement. 13-JAN-2011: MRI spinal: no evidence of further lymphoma-suspected enrichments. 14-JAN-2011: MRI neck/ thorax/ mediastinum pharynx: evidence of T2 signal lifting in the area of right cervical / supraclavicular in the upper thoracic aperture 14-JAN-2011: X ray thorax: no pathological finding. Several examinations (e.g. MRIs, CTs, and axillary biopsy on 20-JUL-2010) led to the diagnosis of B-Non-lymphoma (B-NHL) including infiltration of right brachial plexus. B-NHL was treated with polychemotherapy including cyclophosphamide, cytarabine, vincristine sulfate, vindesine, etoposide, doxorubicin, methotrexate, dexamethasone (manufacturer unknown), prednisolone and ifosfamide. During / after chemotherapy following events occurred: neutropenic sepsis (14-AUG-2010), neutropenic fever (14-AUG2010), clostridium enterocolitis (14-AUG-2010), Norovirus gastroenteritis Other Meds: Unknown


Page 476
Vaers Id: 420185-1 (S) Lab Data: History: Prex Illness: Prex Vax Illns: ultrasound, 12Jul10, no signs of typical malignant lymphoma; electrocardiogram, 12Jul10, normal; computed axial tomography, 14Jul10, soft tissue formations laterocervical right, in upper mediastinum possibly consistent with M. Hodgki; elect Varicella


Page 477
Vaers Id: 420186-1 (O) Age Gender Vaccine Date Onset Date F 01-Mar-2008 30-Jul-2008 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 151
Abdominal pain, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Proctocolitis
Symptom Text: Information has been received from the Health Authorities on 28-MAR-2011 the reference number TO20110226. Case medically confirmed. A 14 year old female patient had received the second dose of GARDASIL (batch # not reported) on 01-MAR-2008 and 12 weeks later, on 30-JUL-2008, she developed diarrhea with mucus and blood associated with abdominal pain. The symptoms persisted in September 2008 and led to a diagnosis of haemorrhagic proctocolitis on the basis of rectum and sigmoid biopsies in September 2008 and April 2009. The patient received the third dose of GARDASIL. Investigation for cytomegalovirus, papillomavirus and Epstein-Barr virus were negative. Corrective treatment was instaured in April 2009. Local treatment consisted of enema with QUADRASA and corticosteroids such as SOLUPRED. Systemic treatment included RAFTON 9mg/day for 15 days and then 6mg/day for 15 days associated with PENTASA at least 2mg/day. At the time of reporting, the patient had haemorrhagic proctocolitis that was still active and moderately severe. According to the health authorities the patient recovered with sequelae. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 II) according to the foreign method of assessment. Haemorrhagic proctocolitis was considered to be an other important medical event. Other business partner numbers included E2011-02096. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown rectal biopsy, ??Sep08, haemorrhagic proctocolitis; colonic biopsy, ??Sep08, sigmoid: haemorrhagic proctocolitis; colonic biopsy, ??Apr09, sigmoid: haemorrhagic proctocolitis; rectal biopsy, ??Apr09, haemorrhagic proctocolitis; diagnostic l Unknown


Page 478
Vaers Id: 420226-1 Age Gender Vaccine Date Onset Date F 30-Mar-2011 01-Apr-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 2
Status Date State Received Date 13-Apr-2011 GA 04-Apr-2011 Lot Prev Doses Site 0768Z 1 Right arm AHAVB469AA 0 Right arm AC52B067GA U3442BA 0 0 Left arm Left arm
Erythema, Injection site erythema, Injection site warmth, Pallor
Symptom Text: Right deltoid erythematous and warm to touch, several blanching red areas of skin - face & upper torso. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 479
Vaers Id: 420232-1 (S) Related reports: 420232-2 Age Gender Vaccine Date Onset Date M 14-Feb-2011 05-Mar-2011 39.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 19
Status Date State Received Date 05-Apr-2011 IL 04-Apr-2011 Lot Prev Doses Site 1437Z 1 Left arm
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Adverse drug reaction, Arthralgia, Arthritis bacterial, Aspiration joint, Cellulitis, Erythema, Joint effusion, Joint swelling, Oedema, Oedema peripheral, Pain, Pain in extremity, Polyarthritis, Pyrexia, Renal failure acute, Serum sickness, Skin warm, Somnolence, Wound complication
Symptom Text: I was starting a low grade fever. I bilateral hand/knuckle joints were sore and swollen. My R Knee was the size of a softball and my right foot was swollen with pitting edema around 2+. I had seen Dr with this earlier in the week and he had prescribed a 100 mg prednison taper along with pain meds. Later the next day or so I called Dr's cover and upon explaining my first recent bout with serum sickness from abx and the size of swelling when I described my right knee he told me to waste no time and go to hospital which I did. In the meantime I had ace wrapped my knee. Upon arriving at hospital I was seen promptly but had noticed that my swelling had gone down sufficiently along with my hands and R lower leg. M.D's did not know why this would happen and agreed I needed to see an immunologist, rheumatologist in case my rt knee needed draining again, and a pain consult since this was continuing to be a pain problem. The ER doctor thought that since all my lands had not come back out of range I was safe to go home and have this all done outpatient despite the fact I explained I was on limited COBRA. I know have what seems to be chronic joint pain and have to wear a special medical alert band because any drug you put in my I can most likely to have a reaction too. I also lost a lucrative nursing contract over this disease because I was too sick to show up for work. The following information was obtained through follow-up and/or provided by the government. 04/06/11 PCP internal medicine office note record received for DOS 04/01/11. Assessment: Edema and joint pain. Patient presented with c/o right shoulder and both knees, legs swollen. Patient `s temperature was 99.0 Fahrenheit. No rash. Assessment: edema and joint pain. Plan: Pred taper and OxyContin PRN. Record noted 4/1/11: not convinced that Gardasil caused acute recurrence of pt. stated belief that this reactivated his serum sickness. 04/06/2011 vaccination record received for DOS 02/14/2011. Report updated. 04/08/2011 ER , lab records received for DOS 03/05/11, 03/26/11 DX: Polyarthritis. Patient presented to ER on 03/05/11 for c/o leg pain, redness. Patient reported hitting leg while moving 3 days ago. Exam noted wound on shin w/surrounding erythema & warmth. Impression: Cellulitis right leg. Patient presented to ER on 03/26/11with c/o joint pain in knees, ankles, hands and elbows. Impression: diffuse joint pain. The patient reported past a hospitalization this past month w/serum sickness and related his pain to serum sickness. The patient was seen on 04/02/11 with c/o pain and swelling of right knee and swelling down to the foot. Exam noted min. effusion to right knee and min. swelling to shin and foot. DX: polyarthritis. 04/14/2011 Hospital discharge summary received for DOS 03/13/11 to 03/16/11. Primary DX: Polyarthralgia secondary to drug reaction. The patient presented with c/o acute onset of joint pain (R. shoulder, fingers, wrists, feet, toes). The patient had a history of recent treatment for lower extremity cellulitis with IV vancomycin and then a 5 day course of cephalosporin and Bactrim. The patient underwent joint aspiration, which revealed acute infection or septic joint and so antibiotics were held due to concern that patient was having reactive arthritis versus eruptive polyarthralgias from drug reaction. Rheumatology was consulted and the patient was started on IV Solu-Medrol and within 24 hrs, polyarthralgias improved. It was also noted that upon admission, the patient was significantly drowsy (presumably from taking too much narcotics). On day of discharged, it was recommended that patient take no further narcotics. The patient was discharged home on prednisone taper. Patient to F/U with PCP. Other Meds: Lab Data: History: Duricef and Bactrim, Vanc, All anti-epliptic drugs Acute Renal Faluire and associated labs. Low CBC (hematocrit), Chronic Pain, many others. The following information was obtained through follow-up and/or provided by the government. 04/08/11 records received. Chest x-ray: negative (no active disease). ADHD, Anxiety, multiple drug allergies The following information was obtained through follow-up and/or provided by the government. 04/06/11 records received. History: Allergic reactions (Bactrim DS-serum sickness), Contrast Dye, Duricef, Embeda (nausea), Flagyl (syncope), Lamictal (hypomania), Topamax (Mania), Ultram, Gabapentin (slurred speech), Vancomycin (Red man). 04/08/11 ER records received for DOS 1/08/10, 01/06/11. History:


Page 480
Vaers Id: 420232-1 (S) chronic low back pain, gastritis, drug abuse, chronic sinusitis, costochondritis, shingles, R. knee surgery, abdominal pain. 04/08/11 Discharge summary for DOS 01/01/11 to 01/03/11 and labs 01/14/10 -01/09/11. History: hospitalization for abdominal pain. None


Page 481
Vaers Id: 420236-1 Age Gender Vaccine Date Onset Date M 26-Jan-2010 04-Apr-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Abdominal pain, Headache
Days 433
Status Date State Received Date 05-Apr-2011 OR 04-Apr-2011 Lot Prev Doses Site 0672Y 2 Unknown
Symptom Text: Patient has had chronic headaches and stomach aches in the last year since the last vacccine. Other Meds: Lab Data: History: Prex Illness: none Work up for GI complaints seen by GI had routine lab Developmental Delay and Autism none
Prex Vax Illns: seizure~ ()~~0.00~Patient


Page 482
Vaers Id: 420247-1 Age Gender Vaccine Date Onset Date F 04-Apr-2011 04-Apr-2011 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 13-Apr-2011 TN 04-Apr-2011 Lot Prev Doses Site 1016Z 0 Left arm
Dizziness, Syncope, Trendelenburg position, Unresponsive to stimuli
Symptom Text: Patient experienced lightheadedness and fainted within 15 minutes of receiving HPV. She was standing at the onset of symptoms. We laid her down in the Trendelburg position after she awoke (lasting 10-15 seconds of unresponsiveness). She felt fine and fully recovered and left our office 15 minutes later. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PEPCID Patient had been fasting and had blood work done prior to receiving the shot. None None


Page 483
Vaers Id: 420276-1 (O) Age Gender Vaccine Date Onset Date F 22-Mar-2011 22-Mar-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Cyanosis, Immediate post-injection reaction, Mobility decreased, Oedema peripheral, Pain in extremity, Peripheral coldness, Vasculitis
Symptom Text: Case was received from a nurse (patient's mother) then confirmed by a physician on 25-MAR-2011. Case is medically confirmed. A 12-year-old female patient had received the first dose of GARDASIL (batch number, site of administration and route not reported) on 22-MAR-2011 and experienced immediately severe pain in left arm and hand, later on the same day, the girl presented distal cyanosis (hand), cold hand with swelling and functional impotence. Ibuprofen was taken without improvement, so 3 days later, the patient visited the primary care centre, where she was referred to the hospital. During the patient observation at the emergency room, it was confirmed the cold hand with pain, distal cyanosis and functional impotence of left hand but no other signs such as trauma or bruising at the injection site or oedema of arm and forearm were seen. However, the physician observed that the vascular refill time was increased on both sides, more significant on the left hand; it was also observed that local warming improved the signs and symptoms which was, for the physician, suggestive of a vasculitis clinical picture. She was medicated with steroids, ATARAX and local heating. The patient had no medical history but her mother had medical history of myasthenia gravis. At the time of report the patient had not yet recovered. The reporter considered the events medically significant. Other business partner numbers include E201102102. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 484
Days
Basilar migraine, Crying, Dizziness, Emotional distress, Feeling abnormal, Headache, Tremor
Symptom Text: This case was identified from an article in a magazine on 25-MAR-2011. This was one of a cluster of three linked cases from the same article involving the same vaccine and was linked with E2011-02049 (WAES# 1103USA03823) and E201102061 (WAES# 1103USA03825). This case is not medically confirmed. A 15 year old female patient, who was previously very sporty and perfectly healthy, received an injection of GARDASIL (manufacturer and batch number not reported) on an unreported date. On an unreported date, post vaccination, the patient was diagnosed with basilar migraines. On the day of vaccination the patient's father had to be called to collect the patient from school as she was very distressed, crying and shaking and appeared traumatized. This was out of character as the patient was normally very down-to-earth. The patient stated that she didn't feel right. The patient was taken home and by the evening was herself again. Then the patient began getting headaches and dizziness. Weeks went by and the headaches worsened. She had an MRI scan and was diagnosed with basilar migraine. The patient started on an unspecified medication but got no better. She would go out occasionally but spent most of her time in her room. The patient then found an unspecified way of treating the migraines and she improved dramatically. The headaches were less severe and she did not need to take time off college. She was happy and smiling again. Her consultant stated that the vaccine may have triggered an underlying tendency to headaches such as migraine which has persisted. At the time of reporting (one year post vaccination) the patient was recovering. Upon internal medical review the events were considered medically significant. Other business partner numbers include E201102052. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown magnetic resonance imaging, basilar migraine Unknown


Page 485
Days
Abnormal behaviour, Activities of daily living impaired, Aggression, Autoimmune disorder, Basilar migraine, Condition aggravated, Convulsion, Emotional distress, Encephalitis, Mood altered, Personality change, Screaming
Symptom Text: This case was identified from an article on 25-MAR-2011. This was one of a cluster of three linked cases from the same article involving the same vaccine and was linked with E2011-02049 (WAES # 1103USA03823) and E201102052 (WAES # 1103USA03826). This case was not medically confirmed. A female patient of unknown age received the third dose of GARDASIL (manufacturer and batch number not reported) on an unreported date. On an unreported date, post vaccination, the patient was diagnosed with encephalitis. The patient had a first dose of GARDASIL (manufacturer and batch number not reported) on an unreported date and was moody and emotional. The patient had the second dose of GARDASIL (manufacturer and batch number not reported) on an unreported date and one week later the patient punched her sister (she was normally a kind and mild-mannered girl). Four days after the third dose the patient was found convulsing on the bed. The patient's mother called an ambulance she was taken to hospital but discharged a few hours later. In the week that followed the patient had 17 more seizures and was eventually diagnosed with encephalitis. The consultant said the it was normally caused by an infection but in the patient's case was an auto-immune reaction where an antibody attacked the brain. Magnetic resonance imaging (MRI) scan showed basilar migraine. The patient was prescribed an unspecified medication and was in and out of hospital over the next few months. Her personality had changed and she would scream at the nurses and threaten to kill people. She slapped a nurse and attacked her mother leaving her with black eyes. She also threatened to burn down the hospital and punched her father in the face. Four months after vaccination the patient was admitted to the brain injury rehabilitation unit to relearn simple tasks such as getting dressed. At the time of reporting the patient was recovering and was more like her old self. Upon internal medical review the events were considered medically significant. Other business partner numbers include E2011-02061. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Magnetic resonance imaging, basilar scan Mood change; Emotional problems; Violent behaviour


Page 486
Days
Activities of daily living impaired, Arthralgia, Asthenia, Balance disorder, Body temperature increased, Chronic fatigue syndrome, Condition aggravated, Crying, Dysstasia, Fatigue, Gait disturbance, Nasopharyngitis, Oropharyngeal pain, Pain, Pallor, Speech disorder, Viral infection, Weight decreased
Symptom Text: This case was identified from an article in a magazine on 25-MAR-2011. This was one of a cluster of three linked cases from the same article involving the same vaccine and was linked with E2011-02052 and E201102061. This case is not medically confirmed. A 13 year old female patient received the third dose of GARDASIL (manufacturer and batch number not reported) on an unreported date. On an unreported date, post vaccination, the patient was diagnosed with chronic fatigue syndrome (ME). The patient had the first dose of GARDASIL (manufacturer and batch number not reported) on an unreported date with no adverse effect reported. The patient received the second dose of GARDASIL (manufacturer and batch number not reported) on an unreported date and the same day the patient stated that she thought she was getting a cold and had a raised temperature, was pale and tired. The outcome was not reported. The day after the patient's third dose her temperature soared, she had trouble walking because of the pain in her joints and her throat was so sore she could hardly speak. In the weeks that followed the patient saw the doctor many times and went to the hospital and kept getting told it was a virus. The patient was too ill to go to school and had to have home tuition. She was so weak she couldn't get up the stairs and had to sleep in the living room at night. The patient's mother slept in the same room to keep an eye on her as she became deathly pale and began to cry out in pain. The patient lost three stone in weight and struggled to keep her balance when she was standing up. Almost two years after the vaccinations the patient was diagnosed with chronic fatigue syndrome (ME). The patient had physiotherapy and hydrotherapy every week and she hoped to go into remission. She only left the house for hospital appointments or to attend school if she was well enough. At the time of reporting the patient had not yet recovered. Upon internal medical review the events were considered medically significant. Other business partner numbers include E2011-02049. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Cold; Body temperature increased; Pallor; Tiredness


Page 487
Vaers Id: 420281-1 (S) Age Gender Vaccine Date Onset Date F 17-Jan-2011 15-Mar-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 57
Status Date State Received Date 06-Apr-2011 FR 05-Apr-2011 Lot Prev Doses Site 1334X 0 Unknown
Asthenia, Dysaesthesia, Guillain-Barre syndrome, Malaise
Symptom Text: Case received from the foreign health authorities on 24-MAR-2011 (reference number PEI2011007866). Case medically confirmed. A 14 year old female patient had received the second dose of GARDASIL (Batch # NN04440; Lot # NK05090) into the upper arm on 14-MAR-2011. On 15-MAR-2011, she developed dysaesthesia, weakness and felt ill. Guillain-Barre syndrome was suspected leading to hospitalization. Polyneuropathy and somatisation were excluded. At the time of reporting to HA (16-MAR-2011) the patient had not recovered. After first vaccination with GARDASIL (Batch # NL31810; Lot # 1334X-this batch was imported from a foreign country and not released by HA for SPMSD) on 17-JAN-2011, the patient experienced similar symptoms (dysaesthesia, weakness and felt ill. Guillain-Barre syndrome was suspected already at that time) the patient recovered after two weeks (no further details reported). Other business partner number included E2011-02010. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 488
Vaers Id: 420282-1 (O) Age Gender Vaccine Date Onset Date Days F 24-Feb-2011 25-Feb-2011 1 17.0 Type Manufacturer VAX Detail: DTP UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Eyelid oedema, Labia enlarged
Status Date State Received Date 06-Apr-2011 FR 05-Apr-2011 Lot Prev Doses Site NULL Unknown NULL 2 Unknown
Mfr Report Id Last Edit Date WAES1103USA03212 06-Apr-2011 Other Vaccine Route Unknown Unknown
Symptom Text: Case received from a healthcare professional on 22-MAR-2011. Case medically confirmed. A 17 year old female patient with a medical history of hay fever with daily sublingual desensitization, had received the third dose of GARDASIL (Lot # not reported) into the upper arm and a dose of DPT (manufacturer not reported) on 24-FEB-2011. Concomitant therapy included immunotherapy (unspecified), oral. One day later she developed lid oedema and swelling of labia majora. The patient received corrective treatment with "cetirizine". As the symptoms did not improve she received cortisone orally (80mg). She recovered within four days. Dose 1 and dose 2 of GARDASIL given on unknown dates were well tolerated. Upon medical review the company considered this case serious. Lid oedema and swelling of labia majora were considered to be other medically important conditions. Case was closed. Other business partner number included E2011-01957. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Hay fever


Page 489
Vaers Id: 420283-1 (O) Age Gender Vaccine Date Onset Date M 11-Jan-2010 Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy
Days
Status Date State Received Date 06-Apr-2011 US 05-Apr-2011 Lot Prev Doses Site 1099Y 2 Unknown
Mfr Report Id Last Edit Date WAES1002USA01532B 07-Apr-2011 1 Other Vaccine Route Unknown
Symptom Text: Information has been received from a physician concerning a male baby was born to a 23 year old female patient who on 11-JAN-2010 was vaccinated with the third dose of GARDASIL (lot # 662299/1099Y). It was reported that the baby was a healthy male, with a clubfoot. At the time of the report, the outcome was unknown. The reporting physician stated that "the clubfoot had nothing to do with GARDASIL". It was unknown if the patient sought medical attention. The mother's experience was previously reported in WAES 1002USA01532. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 490
Vaers Id: 420289-1 (O) Age Gender Vaccine Date Onset Date Days F 24-Feb-2011 25-Feb-2011 1 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP UNKNOWN MANUFACTURER Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Eyelid oedema, Labia enlarged
Status Date State Received Date 06-Apr-2011 FR 05-Apr-2011 Lot Prev Doses Site NULL 2 Unknown NULL Unknown
Mfr Report Id E201101957 Route Unknown Unknown
Symptom Text: Case received from a healthcare professional in a foreign country on 22-Mar-2011. Case medically confirmed. A 17-year-old female patient with a medical history of hay fever with daily sublingual desensitization, had received the third dose of GARDASIL (lot-no. not reported) into the upper arm and a dose of DTP (manufacturer not reported) on 24-Feb-2011. One day later she developed lid oedema and swelling of labia majora. The patient received corrective treatment with Ceterizine. As the symptoms did not improve she received cortisone orally (80mg). She recovered within four days. D1 and D2 GARDASIL given on unknown dates were well tolerated. Upon medical review the company considered this case serious. CASE IS CLOSED. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Immuntherapy Medical history of hay fever with daily sublingual desensitization.


Page 491
Days 1
Status Date State Received Date 14-Apr-2011 CA 05-Apr-2011 Lot Prev Doses Site 1437Z 0 Left arm
Musculoskeletal discomfort, Musculoskeletal pain
Symptom Text: Patient c/o "shoulder" pain x 1 month after HPV vaccine. X-ray shoulder - neg. MD examined - deltoid area discomfort - mild, no limited ROM. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: X-ray on 3/9/11 - results neg


Page 492
Vaers Id: 420312-1 Age Gender Vaccine Date Onset Date F 28-Mar-2011 28-Mar-2011 16.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Urticaria
Days 0
Status Date State Received Date 14-Apr-2011 NY 05-Apr-2011 Lot Prev Doses Site AHAVB464BA 1 Unknown 0766Z 2 Unknown
Symptom Text: Urticaria to trunk. No redness or swelling to mouth. Lungs clear. BENADRYL 50mg given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Chiari malformation Type I; H/O Serum sickness to PCN Yes, H/O fatigue


Page 493
Days 1
Status Date State Received Date 14-Apr-2011 CA 05-Apr-2011 Lot Prev Doses Site 1437Z 2 Left arm
Injected limb mobility decreased, Pain in extremity
Symptom Text: Patient complaint of pain in (L) arm since HPV injection. Doctor found no tenderness, no swelling, difficulty with full extension of (L) arm. No s/s of infection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 494
Vaers Id: 420338-1 Age Gender Vaccine Date Onset Date M 04-Apr-2011 04-Apr-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 14-Apr-2011 MO 05-Apr-2011 Lot Prev Doses Site 13744 0 Left arm AHAVB462AA 0 Left arm
Symptom Text: Administered vaccinations about 3:17pm. Hep A in the left deltoid and HPV in the right deltoid. Pt had left the room to go into waiting room and then fainted. He awakened, responded to us, was assessed then was able to be put in chair for further evaluation. Totally recovered by 3:25pm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Pigeon chested; No other diagnosis None


Page 495
Vaers Id: 420376-1 (O) Age Gender Vaccine Date Onset Date F 26-Feb-2010 26-Feb-2010 15.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 07-Apr-2011 IL 06-Apr-2011 Lot Prev Doses Site NULL 0 Unknown 1378Y 2 Right arm
Mfr Report Id Last Edit Date WAES1003USA02197 07-Apr-2011 Other Vaccine Route Unknown Intramuscular
Drug exposure during pregnancy, Uterine haemorrhage
Symptom Text: Information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with no pertinent medical history and allergy to pork who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, IM. On 29-MAY-2008, the patient received the second dose of GARDASIL 0.5 mL, IM. It was reported that the patient received the third dose of GARDASIL (lot# 665266/1378Y) 0.5 mL, IM into her right arm on 26-FEB-2010 and was pregnant. Concomitant vaccination included the first dose of HAVRIX given on 26-FEB-2010. It was reported that the patient had a urine pregnancy test which came back positive on the same day of vaccination. The patient's last menstrual period was on 02-FEB-2010 and the estimated delivery date is 09-NOV-2010. Follow up information was received from a physician. It was reported that the patient had no significant past medical history or concurrent conditions and had no previous pregnancies. On 26-FEB-2010, the patient was vaccinated IM with third 0.5mL dose of GARDASIL (lot number 665266/1378Y). There was no other concomitant medication used in this pregnancy. The patient's LMP was on 02-FEB-2010 with an EDD of 09-NOV-2010. Follow up information was received via telephone call from the medical assistant who stated that the patient reported that on an unspecified date she had a possible miscarriage (no HCP confirmation) and had bled profusely. The medical assistant also reported that on an unspecified date the patient's ultrasound revealed an empty uterine sac, however her blood work confirmed pregnancy. The medical assistant reported "it may had been too early to see the baby with the ultrasound". The medical assistant reported it was noted in the chart "the patient possibly had a miscarriage and then the patient got pregnant again. It was not clear if the patient's first pregnancy ended as a miscarriage, and then the patient became pregnant again". The medical assistant went on to report that the patient was referred to OB/GYN. At 40 weeks gestation on 21-DEC2010 the patient had a healthy male baby (WAES# 1103USA03674). Upon internal review possible miscarriage was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 2/2/2010); Food allergy Ultrasound, empty uterine sac; Urine beta-human, 02/26/10, positive; Beta-human chorionic, Blood work confirm pregnancy


Page 496
Vaers Id: 420377-1 (O) Age Gender Vaccine Date Onset Date F 25-Mar-2009 25-Mar-2009 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Gaze palsy, Malaise, Pain, Syncope
Days 0
Symptom Text: This case was received from the health authority on 29-MAR-2011 (ADR 20976037). This case is medically confirmed. A 14-year-old female patient received an injection of GARDASIL (manufacturer and batch number not reported) on 25-MAR-2009. On 25-MAR-2009, the same day as vaccination, the patient's mother stated that she had a severe reaction with malaise, collapse, eyes rolled up and widespread pain. The patient did not have a problem with the first few human papillomavirus vaccine or any other immunisations. An ambulance was called but the patient was not taken to hospital. The patient recovered on an unspecified date in March 2009, 1-2 days later. The reporter considered the events medically significant. Other business partner numbers include E2011-02110. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 497
Vaers Id: 420394-1 Age Gender Vaccine Date Onset Date F 30-Sep-2010 25-Nov-2010 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 56
Status Date State Received Date 15-Apr-2011 PA 06-Apr-2011 Lot Prev Doses Site 0075Y 0 Left arm
Abdominal pain upper, Arthralgia, Chest pain, Chills, Dyspnoea, Fatigue, Lymphadenopathy, Muscular weakness, Myalgia, Pain, Pain in extremity, Paraesthesia
Symptom Text: Pt. was administered GARDASIL vaccination on 9/30/10. Approximately around Thanksgiving pt.'s 1st symptoms were legs & arms tingling & hurting. Pt. received her 2nd GARDASIL vaccination on 12/10/10 and reported her whole body hurt. She reports having swollen glands, joint pain, tiredness, chills, leg pain, SOB, chest pain, aching muscles, muscle weakness, & stomach ache. Pt. had several doctor appointments in December who stated it may be caused by the vaccine. Pt. reports she is fine now. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 498
Vaers Id: 420408-1 Age Gender Vaccine Date Onset Date F 27-Jul-2010 28-Jul-2010 24.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS HEPA GLAXOSMITHKLINE BIOLOGICALS HEP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 15-Apr-2011 GA 06-Apr-2011 Lot Prev Doses Site AC52B061BA 0 Right arm AHAVB402AA AHBVB891CA 1377Y 0 1 1 Left arm Right arm Left arm
Asthenia, Fatigue, Headache, Malaise, Pyrexia, Rash
Symptom Text: Pt reports fever, headache and rash within 24 hrs. of receiving vaccine. Pt also reports extreme tiredness & weakness. Pt reports going to the emergency room 1 week later, and then saw her doctor. Reports sickness lasted 1 mth. No treatment was ever provided/needed. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DEPO PROVERA None reported None reported


Page 499
Vaers Id: 420441-1 Age Gender Vaccine Date Onset Date F 06-Apr-2011 06-Apr-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 WV 07-Apr-2011 Lot Prev Doses Site 1016Z 0 Right arm
Diarrhoea, Headache, Hypoaesthesia oral, Nausea, Rash
Symptom Text: Patient had headache, nausea, diarrhea, rash on upper torso, numbness of tongue. Mother took child to ER was advised by physician not to get anymore HPV vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None known None


Page 500
Vaers Id: 420455-1 Age Gender Vaccine Date Onset Date M 06-Apr-2011 06-Apr-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Hypersensitivity, Urticaria
Days 0
Status Date State Received Date 07-Apr-2011 VA 07-Apr-2011 Lot Prev Doses Site 1016Z 0 Left arm AC52B048AC 0 Right arm U3102AA 0 Left arm
Symptom Text: Allergic reaction to face, urticaria and hives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none no


Page 501
Vaers Id: 420460-1 Age Gender Vaccine Date Onset Date F 31-Mar-2011 01-Apr-2011 11.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 15-Apr-2011 IL 07-Apr-2011 Lot Prev Doses Site AC52B053DB 0 Left arm 0597Z U3102AA 0 0 Unknown Left arm
Symptom Text: Pt received MENACTRA & Tdap in left arm. Following day developed swelling/redness around injection site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Started on KEFLEX for possible cellulitis


Page 502
Vaers Id: 420473-1 Age Gender Vaccine Date Onset Date F 18-Aug-2010 14-Dec-2010 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 118
Status Date State Received Date 15-Apr-2011 MO 07-Apr-2011 Lot Prev Doses Site 0571X 2 Left arm
Bruxism, Confusional state, Convulsion, Crying, Disorientation, Fatigue, Fear, Grand mal convulsion, Headache, Loss of consciousness, Lymphadenopathy, Mental status changes, Musculoskeletal stiffness, Palpitations, Presyncope, Rash maculo-papular, Swelling, Syncope, Tongue biting, Tremor, Visual impairment, Vomiting
Symptom Text: C/O headaches starting 2 wks after 1st vaccination. Had seizure 3 months after 3rd vaccination. The following information was obtained through follow-up and/or provided by the government. 04/08/2011 Consult Pediatric Neurology note received for DOS 12/21/10 and Pediatric cardiology note for DOS 02/12/11. Dx: Post syncopal seizure. Neurology evaluation noted patient with normal development and neurologic exam. Upon symptom review, it was noted that patient did describe a dimming of her vision prior to episode, which is a symptom of presyncope. Cardiology consultation due to syncopal and presyncopal episodes. The patient described mild palpitation during events. Assessment: normal Halter monitor and EKG, events unlikely related to any rhythm issue. Events do not appear to be cardiac in nature. DX: syncopal episodes, seizures. 04/08/2011 Clinic records received for DOS 12/15/10. Impression: Seizure Disorder. Patient seen on 12/15/10 due to ER F/U due to possible new onset seizure. Patient had convulsion at school yesterday. Patient noted having also had a headache yesterday, and mother reported that patient had been having headaches for last 6 months. Patient reported feeling fine on day of clinic presentation. Plan: EEG. Patient seen on 02/09/11 due c/o maculopapular rash and lump on back of head. On exam, rash noted to be fading and pea -size, movable swelling on back of head. Assessment: Rash disappearing suggested could be a viral infection and pea size swelling could be secondary to viral infection. Impression: Rash, Lymphadenopathy. Patient seen 2/16/11 due to rash which developed today. Patient on Trileptal for seizure disorder, and has been seizure free on Trileptal. Assessment: Possible drug reaction rash to Trileptal. Plan: Benadryl and cut back on Trileptal. 02/18/11 call from parent: rash much better. 04/08/2011 Hospital records received: ER records for DOS 12/14/10, ER record for DOS 12/30/10, ER record for DOS 01/12/11, ER record for DOS 01/24/11. Impression: Seizures. Patient presented to ER on 12/14/10 with c/o passing out and vomited x1 after running four laps at school. Patient transported via EMS and upon presentation the patient was alert and crying. The patient was discharged. On 12/30/10, patient presented to ER due to witnessed seizure at home. Patient became stiff, clinched teeth and was trembling. Afterward patient had confusion and disorientation. Impression: Altered Mental Status. The patient was discharged home. Plan: start Keppra, cardiology consult. Patient presented to ER on 01/12/11 due to c/o seizure during basketball practice. Associated symptoms: fatigue, loss of consciousness, frightened. Impression: Seizure. Plan: increase Keppra. Patient discharged home. On 01/24/11, patient presented to ER due to witnessed tonic-clonic seizure (2 min.) at school. Upon presentation, patient was alert and c/o headache. Exam noted that patient had bitten L. side of tongue. The patient was discharged home. Plan: increase night-time Keppra dose. Other Meds: Lab Data: The following information was obtained through follow-up and/or provided by the government. 04/08/2011 records received: EEG: normal (normal awake and asleep EEG), MRI brain [01/12/11]: normal (no imaging evidence to explain pt. seizures), Halter monitor [01/04/11]: normal (no premature atrial or ventricular complexes, no symptoms were recorded, Head MRI [01/12/11]: negative, ECG [12/12/10]: abnormal (sinus tachycardia, L. atrial enlargement, Non-specific T wave changes), [12/30/10] Potassium: 3.3 (L), AST: 40 (H), Alk Phosphatase: 278 (H), ECG [2/12/11]: normal. NKA None


Page 503
Vaers Id: 420519-1 (S) Age Gender Vaccine Date Onset Date F 04-Nov-2008 04-Feb-2009 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS Gait disturbance, Visual impairment
Days 92
Symptom Text: Information has been retrieved from a local newspaper on 28-MAR-2011. This is a non valid case as identifiable patient is missing. Case not medically confirmed. An under-aged (exact age not reported) female patient, received a dose of GARDASIL (manufacturer unknown; batch number, route and site of administration not reported) on 04-NOV-2008, according to the article, three months after vaccination, she was almost unable to walk and had to be hospitalized. The patient also suffered vision problems in one eye for a period of 10 months. Outcome was not reported. Other business partner numbers include E2011-02099. No further information was reported. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 504
Vaers Id: 420525-1 Age Gender Vaccine Date Onset Date M 31-Mar-2011 31-Mar-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dizziness, Headache, Vomiting
Days 0
Status Date State Received Date 15-Apr-2011 OK 08-Apr-2011 Lot Prev Doses Site 1016Z 2 Left arm
Symptom Text: Onset of vomiting, headaches and dizziness 30 minutes after HPV vaccine. (Non-allergic or non-hypersensitivity). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Prednisone 50mg; PROGRAF 2mg BID Nephrotic syndrome: MCNS Pre-existing -->.


Page 505
Vaers Id: 420527-1 (S) Related reports: 420527-2 Age Gender Vaccine Date Onset Date Days F 11-Oct-2010 29-Oct-2010 18 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. FLUN MEDIMMUNE VACCINES, INC. Seriousness: MedDRA PT ER VISIT, LIFE THREATENING, SERIOUS
Status Date State Received Date 11-Apr-2011 TN 08-Apr-2011 Lot Prev Doses Site 0786Z 0 Unknown 0639Z 1 Unknown 501036P 1 Unknown
Mfr Report Id Route Intramuscular Intramuscular Unknown
Abdominal tenderness, Arthralgia, Condition aggravated, Contusion, Cushingoid, Dyspnoea, Fatigue, Gingival bleeding, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Increased tendency to bruise, Menorrhagia, Nausea, Oropharyngeal pain, Petechiae, Thrombocytopenia
Symptom Text: thrombocytopenia, bruising, gum bleeding, heavier periods The following information was obtained through follow-up and/or provided by the government. 4/8/11. Consultant records DOS 11/17/10 - 2/22/11. DX: thrombocytopaenia; ITP. Several OVs for CC: easy bruising; increased bruising since 11/2010, worsening over time; decreased platelets; bleeding when brushing teeth; fatigue; SOB; joint pains in knees/ankles/shoulders. PE: multiple bruises et petichiae on arms/legs. 4/8/11. ER records DOS 2/27/11. DX: ITP. CC: back pain; dysphagia; menorrhagia; myalgias of anterior neck muscles, arms, abd and back. PE: Cushingoid facial swelling et possible fluid retention; mild diffuse abd tenderness s guarding/rebound; resolving bruises; recently dx c ITP in 11/2010. Rxed c several courses of steroids. 4/11/11. Consultant records DOS 10/11/10. WCC, received vax. RTC 11/16/10, Dx: contusion; thrombocytopaenia. CC: random bruising, bleeding gums; heavier/longer menses; sore throat, menorrhagia; nausea. PE: scattered bruises over UEs/LEs, some lemon sized; petechiae bilateral LEs. Referred to haem/onc. 11/17/11 seen by haem/onc specialist. Nil new. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: initial plts 6 K, remains low, last plt this week 28K followed Heme Onc has had sev courses steroids and IVIG The following information was obtained through follow-up and/or provided by the government. 4/8/11. Consultant records. WBC 5.1 K/ none The following information was obtained through follow-up and/or provided by the government. 4/8/11. 4/11/11. PMH: sacral coccygea tertoma at birth; chronic OM as baby; scarlet fever p episode of strep pharyngitis; fractured foot; neuritis; chronic R foot pain; HA; tympanostomy tubes. NKDA. none


Page 506
Vaers Id: 420569-1 Age Gender Vaccine Date Onset Date M 06-Apr-2011 06-Apr-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Erythema, Oedema peripheral
Days 0
Status Date State Received Date 08-Apr-2011 GA 08-Apr-2011 Lot Prev Doses Site 1016Z 0 Left arm AC52B041BA 0 Right arm U3356BA AHAVB464AA 0 1 Right arm Left arm
Symptom Text: R ARM RED AND SWOLLEN THE TREATMENT IS MOTRIN AND WARM COMPRESS Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE ASTHMA NONE


Page 507
Vaers Id: 420586-1 Age Gender Vaccine Date Onset Date M 05-Apr-2011 07-Apr-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dizziness, Pain, Vision blurred
Days 2
Status Date State Received Date 08-Apr-2011 NY 08-Apr-2011 Lot Prev Doses Site 0450Z 0 Left arm
Symptom Text: Dizziness, Achiness, Blurry Vision Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Vyvanse 40mg


Page 508
Vaers Id: 420589-1 Age Gender Vaccine Date Onset Date F 08-Apr-2011 08-Apr-2011 18.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MEN SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 11-Apr-2011 FL 08-Apr-2011 Lot Prev Doses Site AHAVB469AA 0 Left arm 1017Z U3443BA AC52B069AA 0 0 0 Right arm Left arm Right arm
Dizziness, Pallor, Posture abnormal, Unresponsive to stimuli
Symptom Text: 1049 in immunizations room and just received TDaP, MCV4, and HPV. Head went down and unresponsive for 5 seconds. Came to with verbal and tactile stimulation. Pale and c/o light headedness. 1050 assisted to lying down on exam table. BP 101/59 HR 43 Pale and c/o light headedness. AO X3 Mom at bedside and updated on status. 1052 Dr. at bedside. Pt. AO X3. 1055 Slowly to sitting position BP 9057 HR 52. Denies light headedness at this time. Remains slightly pale. 1100 Assisted to waiting area and instructed to remain in waiting area for 20 minutes and if no further sx will administer Hep A vaccine per her request. Instructed on drinking water and cup of water given to her. Parents both with her. Remains slightly pale, but color improving. Instructed for future HPV's to tell provider what happened and have vaccine adminsitered while lying down. Verbalizes understanding. 1120 Denies light headedness. Color improved. Hepatitis A administered. 1130 no further sx. Instructed to not do any strenuous exercise or work today and to drink increased water. Her and her mother verbalize understanding. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 509
Vaers Id: 420623-1 Age Gender Vaccine Date Onset Date F 06-Apr-2011 06-Apr-2011 17.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 11-Apr-2011 KS 08-Apr-2011 Lot Prev Doses Site 1187Z 1 Left arm 0768Z 0 Left arm AHAVB461AA 0 Right arm
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Symptom Text: Redness at left posterior upper arm measuring 11 x 5.5 cm, warm to touch, itches, sore. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Claritin, Celexa None Asthma, Allergies None


Page 510
Vaers Id: 420624-1 Age Gender Vaccine Date Onset Date F 06-Apr-2011 06-Apr-2011 15.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 11-Apr-2011 KS 08-Apr-2011 Lot Prev Doses Site AHAVB461AA 0 Left arm 0768Z 1187Z 0 1 Left arm Left arm
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Symptom Text: Redness in left posterior upper arm measuring 8 x 5 cm, soreness, itching, warm to touch, aching in left elbow. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Prevacid None None None


Page 511
Vaers Id: 420642-1 Age Gender Vaccine Date Onset Date M 22-Mar-2011 22-Mar-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 IN 08-Apr-2011 Lot Prev Doses Site 0337Z 0 Right arm
Choking sensation, Pharyngeal disorder, Pruritus generalised, Rash erythematous
Symptom Text: A few minutes after injection - red rash over hand, itching all over, BENADRYL given, pt worse, felt like choking, EPI PEN given, after 20 minutes pt left with mother. At 18:42 pm. pt went to ER for throat sx and small rash. Given BENADRYL & EPI again. Released from hospital at 20:29. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BUSPAR; FOCALIN Cyproheptadine allergy; dx ADHD None


Page 512
Days 1
Status Date State Received Date 15-Apr-2011 MS 08-Apr-2011 Lot Prev Doses Site 0249Y 2 Right arm
Dysarthria, Hypoaesthesia, Muscular weakness
Symptom Text: 3/31/11 3:30 pm (24 hours post vaccine) patient experienced mild numbness and muscle weakness in (L) leg & arm. 4:00 pm took BENADRYL. 415 speech slightly slurred for a few minutes. Symptoms lasted 3-4 hours. Father is OB/GYN. He observed her at home. By the next morning symptoms gone. Child went to school. No other problems noted. Note symptoms on (L) side. Vaccine given (R) arm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None No


Page 513
Vaers Id: 420667-1 Age Gender Vaccine Date Onset Date F 24-Nov-2010 25-Nov-2010 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Musculoskeletal stiffness, Pyrexia
Days 1
Status Date State Received Date 15-Apr-2011 NM 08-Apr-2011 Lot Prev Doses Site 0597Z 2 Left arm
Symptom Text: Fever 104.0. Muscle stiffness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UA; influenza test None None


Page 514
Vaers Id: 420680-1 Age Gender Vaccine Date Onset Date Days M 07-Apr-2011 07-Apr-2011 0 18.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ NOVARTIS VACCINES AND DIAGNOSTICS TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dizziness, Fall, Head injury, Syncope
Status Date State Received Date 11-Apr-2011 OK 11-Apr-2011 Lot Prev Doses Site U3732AA 0 Right arm 1016Z 0 Right arm M10030 0 Left arm AC52B048AC 0 Left arm
Mfr Report Id Route Unknown Intramuscular Intramuscular Intramuscular
Symptom Text: After receiving the four vaccines patient complained of being dizzy. Had client put head between legs. Had client sit like this for a few minutes. Asked client to sit up and asked if was still dizzy. He stated "no". Had client stand by seat to see if became dizzy when he stood up. He stated that he was not dizzy and client's cloring was normal. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Reported he was not taking any medication. Client sent to the emergency room. He fainted and hit his head when he fell. None reported or observed. None reported


Page 515
Vaers Id: 420735-1 Age Gender Vaccine Date Onset Date F 29-Mar-2011 01-Apr-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 3
Status Date State Received Date 15-Apr-2011 AZ 11-Apr-2011 Lot Prev Doses Site 0886Z 0 Right arm U3509AA 0 Right arm AC52B056BB 0 Left arm 1377Z 1 Left arm
Symptom Text: Patient presented with redness and swelling measuring 1.5 inch in width and length. The site was in the back of the (L) arm where Varicella was given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No


Page 516
Vaers Id: 420737-1 Age Gender Vaccine Date Onset Date F 05-Apr-2011 05-Apr-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pallor, Vomiting
Days 0
Status Date State Received Date 15-Apr-2011 PA 11-Apr-2011 Lot Prev Doses Site 1016Z 1 Unknown
Symptom Text: Vomited without 3 minutes of getting vaccine - pale in color - symptoms resolved without 10 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Taking MOTRIN q 6 hours for tooth ache. Allergic rhinitis; Overweight; Tooth pain None


Page 517
Vaers Id: 420752-1 Age Gender Vaccine Date Onset Date F 15-Feb-2007 01-Aug-2008 25.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 533
Status Date State Received Date 15-Apr-2011 US 11-Apr-2011 Lot Prev Doses Site NULL 2 Unknown
Cervical dysplasia, Loop electrosurgical excision procedure, Papilloma viral infection, Vaginal dysplasia
Symptom Text: I was given the 3 series GARDASIL Vaccines as directed by my MD and was diagnosed w/the HPV virus - CIN Grades 1 & 2, VaIN 1 and/or 2 -. I do understand it may not cover all forms of the virus, but I think it is important for the FDA to know that in spite of women being given the vaccine series they are being diagnosed w/the virus. Other Meds: Lab Data: Multiple PAP Smears every 6 months since the date of finding out I had the HPV virus and Several Cervical biopsies of suspicious lesions, including LEEP in 1/2009. To this day, I still continue w/regular PAP Smears every 6 months and cervical biopsies as the MD sees necessary, which in fact ,was last month-March 2011. None that would affect the cervix or HPV.


Page 518
Vaers Id: 420753-1 Age Gender Vaccine Date Onset Date F 24-Aug-2010 08-Nov-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 76
Status Date State Received Date 14-Apr-2011 US 11-Apr-2011 Lot Prev Doses Site 1312X Left arm
Amnesia, Anxiety, Arthralgia, Back pain, Blepharospasm, Chest discomfort, Chest pain, Condition aggravated, Confusional state, Conversion disorder, Convulsion, Cough, Dizziness, Eye movement disorder, Eye pain, Head titubation, Headache, Lethargy, Loss of consciousness, Migraine without aura, Muscular weakness, Nasal congestion, Nausea, Non-cardiac chest pain, Paraesthesia, Photophobia, Presyncope, Tremor, Unresponsive to stimuli, Vomiting
Symptom Text: My daughter had her last dose of GARDASIL on September 2010. Since November 2010 she has had 6 seizures, being hospitalized. No report of seizure history in our family and no answers as of the cause. They are medicating her for stress or non epileptic seizures, but I do not believe this is the cause. She also experiences headaches, constant headaches and joint pain and back pain. The following information was obtained through follow-up and/or provided by the government. 04/12/2011 ER records and labs received for DOS 12/14/10, 01/10/11, 03/25/11 and 04/11/11. Impression: Non-cardiac chest pain. Acute headache, seizure. On 12/14/10, patient presented to ER with c/o aching chest pain and episode of fluttering of eyes and head shaking back and forth. The patient also reported one episode of non-bloody emesis and left hand paresthesias during eye fluttering episode. Chest x-ray and ECG were normal. Impression non-cardiac chest pain. The patient was discharged home. On 01/10/11, the patient presented to ER with c/o seizure. The seizure was witnessed by school nurse. The patient experienced a headache, and then became lethargic and unresponsive. Upon ER presentation, the patient was alert. Review of symptoms was positive for lethargy, nausea, headache, lightheadedness, eye fluttering and seizure activity. The patient underwent MRI brain which was unremarkable. Impression: Acute headache, Seizure. The patient was discharged home. On 03/25/11, the patient presented with c/o seizure. Seizure was reported to have been triggered by light reflecting off a guitar. The patients eyes were fluttering and she was unresponsive x 10-15 minutes. In ER, the patient had c/o of pain behind her eyes and in head and chest pressure. The patient was reported to have had a cough and congestion over past week. Impression: seizure. The patient was treated with Lorazepam and Naprosyn. The patient was discharged home and to F/U with physician tomorrow. The patient presented to the ER on 04/11/11, with c/o of probable seizure. The patient experienced loss of consciousness for an unknown period of time at school. Exam noted photophobia, dizziness, headache, loss of consciousness, seizure activity and some weakness in legs. Impression: seizure. The patient was discharged home. 04/12/11 & 04/13/11 Neurology Consult records and diagnostics [EEG] received for DOS 01/06/11, 01/21/11, 02/17/11, 03/28/11 Impression: Pseudo seizures, Migraine without aura, Anxiety. The patient was seen on 01/06/11 at pediatric neurologic clinic. The patient had history of anxiety for past few years and had been seen at this office and started on Lexapro, with improvement in anxiety and panic attacks. The patient was doing fine until mid- November, when she began having incidents of passing out, her eyes would flutter and patient would not remember what has happened. The patient has also had constant headaches for past few months. The patient reported having difficulty understanding things and feeling dizzy when having the headache. Bright lights seem to worsen symptoms. Emotional stress and anxiety are among the triggers of symptoms. Assessment/plan: schedule 24 hr. EEG and patient has some features of migraine headaches and will start on Topamax. The patient was seen on follow-up on 01/21/11. It was felt that spells were not epileptic. Assessments: Conversion disorder, Anxiety, Headache. Plan: increase Lexapro. The patient was seen on 02/17/11 for follow up of headaches and spells. Assessment: primary 1) Conversion disorder. The patient was noted to be doing better since presented with DX of pseudo seizures and has been seeing a counselor. 2) Migraine without aura. The patient was to continue Naprosyn and increase Topamax. 3) Anxiety. The patient was to continue Lexapro and to start lorazepam. The patient was seen on 03/28/11. Patients anxiety and headaches were better. The patient was reported to have had a recent episode in which the flicker of light brought up symptoms. Plan: Other Meds:


Page 519
Vaers Id: 420753-1 Lab Data: EEG; EKG; Cat Scan; MRI; 8 hr EEG; Ex Rays. The following information was obtained through follow-up and/or provided by the government. 04/12/11 records received. ECG: normal, WBC: 8.6 (WNL), RBC: 4.14 (WNL), Neutrophil%: 69 (H), Lymphocyte%: 23 (L), Monocyte%: 8 (H), Potassium: 3.5 (L), urine HCG: negative, chest x-ray: normal (no active cardiopulmonary process), MRI Brain: unremarkable, EEG [8.5 hr]: normal (no epileptiform activities seen). 04/14/11 records received. Head CT: normal. None The following information was obtained through follow-up and/or provided by the government. 04/12/11 records received. History: Anxiety 04/18/2011 PCP office record received for DOS 08/24/10. HPV vaccine given. History: Attention Deficit Disorder w/o mention of hyperactivity (314.00), Disc Disorder Other & Unspecified Lumbar Region (722.93), Acne Other (706.1), Anxiety State Other (300.09), Sprains & Strains Ankle Other (845.09).
History:


Page 520
Vaers Id: 420789-1 Age Gender Vaccine Date Onset Date M 07-Apr-2011 08-Apr-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 12-Apr-2011 OH 11-Apr-2011 Lot Prev Doses Site 1013Y 0 Left arm
Headache, Musculoskeletal stiffness, Myalgia, Rash
Symptom Text: Headache, muscle stiffness/pain starting in neck and going throughout body, rash on arm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood cultures cinnamon allergy sore throat


Page 521
Vaers Id: 420790-1 Age Gender Vaccine Date Onset Date F 11-Apr-2011 11-Apr-2011 12.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 12-Apr-2011 CA 11-Apr-2011 Lot Prev Doses Site 1320Z 1 Left arm U3487CA 0 Right arm U3711AA 0 Right arm 1437Z 0 Left arm
Symptom Text: Syncope Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Supine blood pressure was taken by a colleague and was normal (106/55 mm Hg). None. No


Page 522
Days 0
Status Date State Received Date 12-Apr-2011 MN 12-Apr-2011 Lot Prev Doses Site 0337Z 1 Right arm
Chest discomfort, Fatigue, Headache, Malaise, Pruritus
Symptom Text: She describes feeling itchy on her arms and legs, but without a rash. Malaise symptoms with headache, chest pressure and fatigue. She went to sleep after dinner and her symptoms were gone by the next morning. Reported this many days after administration as an afterthought when we were scheduling her 3rd and final vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none BMI >95%, Vit D deficiency, No known drug allergies none


Page 523
Vaers Id: 420804-1 Age Gender Vaccine Date Onset Date F 09-Feb-2011 09-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR MNQ SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 OH 11-Apr-2011 Lot Prev Doses Site 0334Z 0 Left arm C3490AA Right arm U3541AA 0 Left arm
Conjunctival hyperaemia, Periorbital oedema
Symptom Text: Patient received Tdap, HPV and Meningococcal immunizations - 15 minutes after, had erythema, edema (periorbital) & conjunctival infection. Fading & resolving within 10 minutes and resolved after 30 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Melatonin Elevated BMI Upper respiratory infection


Page 524
Vaers Id: 420811-1 Related reports: 420811-2 Age Gender Vaccine Date Onset Date F 31-Mar-2011 31-Mar-2011 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 21-Apr-2011 WY 11-Apr-2011 Lot Prev Doses Site 0768Z Unknown 1628Z 1 Unknown
Mfr Report Id WY041111 Route Unknown Unknown
Last Edit Date 20-Jul-2011 Other Vaccine
Abdominal pain upper, Adverse reaction, Arthralgia, Back pain, Cold sweat, Decreased appetite, Depressed mood, Dizziness, Ear pain, Eye pain, Fatigue, Headache, Hypersomnia, Irritability, Lethargy, Listless, Malaise, Musculoskeletal pain, Myalgia, Neck pain, Night sweats, Poor quality sleep, Pyrexia, Rash, Tunnel vision, Vaccination complication
Symptom Text: Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash. The following information was obtained through follow-up and/or provided by the government. 07/19/2011 PCP office records received for DOS 04/06/2011 05/24/11. DX: Headache, Fatigue, lethargy, Malaise, Earache, Otalgia, tiredness, Adverse effects NEC, The patient was seen in the office on 04/06/11 with c/o headache, which started on 04/02/11. The parent reported that patient had been sick since receiving vaccinations on 03/31/11. The headache was in the temple region and Ibuprofen and Tylenol had not helped. The patient reported tunnel vision and pain in and around eyes. Symptoms also included fever/chills, body aches, fatigue, malaise, loss of appetite, not sleeping well, sleeping all the time, crankiness and back pain. The patients temperature was 99.7 Fahrenheit and she did not appear in distress. Tests: urine screen: negative. Plan: return in 2 days if no better. The patient returned on 04/08/11 for F/U fatigue, muscle aches. The patient also reported a rash, which occurred between shoulder blades and went away and dizziness, which has improved. The parent voiced concern that heavy metal in shot may have caused reaction. The patient also noted to be one of the students who licked the toilet for a scavenger hunt on 3/25/11, before receiving vaccines. Impression: (possible vaccine reaction to Gardasil), DX: Adverse effect vaccine, Fatigue. The patient was seen on 04/11/11 and reported feeling sad, listless, lethargic. Exam: noted pt. well hydrated, no pallor icterus, no increased lymph nodes, lungs clear, abdomen non tender, no rash, neuro. intact. Plan: Unclear if vaccine related or fatigue/malaise due to other etiology. On 4/21/11, the patient reported fever/chills, low grade fever daily, body aches, crankiness, feeling more tired. The patient was seen 4/29/11 and patient noted lower back and both hips hurt and c/o extreme fatigue. ROS: Body aches, Fatigue, Night sweats. The patient was seen on 05/24/11 due to c/o earache (left ear) x 2 days. Patient also c/o neck/shoulder pain. Exam: Conjunctiva clear, both eardrums normal. The patients temperature was 98.9 Fahrenheit. Impression: Otalgia of uncertain etiology/allergies. DX Otalgia, unspecified. Other Meds: Lab Data: None The following information was obtained through follow-up and/or provided by the government. 07/19/11 records received. C-reactive protein: 0.02 (WNL), Aluminum serum [4/29/11]: 24 (H), WBC: 6.3 (WNL), RBC: 4.67 (WNL), MCV: 80.5 (L), MCH: 26.3 (L), MCHC: 32.7 (L), RDW: 18.2 (H), Total protein: 8.4 (H), Globulin: 4.2 (H), AST: 8 (L). Amoxicillin allergy; Seasonal allergy The following information was obtained through follow-up and/or provided by the government. 07/19/2011: Allergy to Omnicef, seasonal allergies. None


Page 525
Vaers Id: 420814-1 Age Gender Vaccine Date Onset Date F 06-Apr-2011 06-Apr-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS HEPA MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 CA 11-Apr-2011 Lot Prev Doses Site 1016Z 0 Right arm U3333AA 0 Right arm AC52B044CA Left arm AHAVB375AA 0 Left arm
Abdominal pain, Headache, Injection site erythema, Injection site macule, Injection site pain, Injection site pruritus, Joint swelling, Rash, Rash erythematous, Skin warm, Urticaria
Symptom Text: Pt's mother reported reaction on 4/7/11 & pt. evaluated at clinic on same day. S/S: rash/hives: (L) upper arm w/erythematous raised macules covering approximately 50% of lateral side; (R) upper arm w/ sml single erythematous raised macule (2x3cm). (L) knee w/warm, swollen red rash (5x5cm); some abd. pain, itchiness & burning at site; headache. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None performed NKDA prior to this reaction No


Page 526
Vaers Id: 420815-1 Age Gender Vaccine Date Onset Date F 21-Jan-2011 Unknown 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Amenorrhoea, Non-consummation
Days
Status Date State Received Date 15-Apr-2011 WA 11-Apr-2011 Lot Prev Doses Site 0768Z 0 Left arm
Symptom Text: Amenorrhea (no period) x 3 1/2 + months (ongoing) in non sexually active pt given GARDASIL vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 527
Vaers Id: 420819-1 (S) Age Gender Vaccine Date Onset Date F 11-Jun-2009 Unknown 12.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: ER VISIT, HOSPITALIZED, SERIOUS
Days
Status Date State Received Date 13-Apr-2011 UT 12-Apr-2011 Lot Prev Doses Site U2913AA Unknown 0100Y 0 Unknown C3158AA Unknown
Mfr Report Id Last Edit Date WAES1104USA00214 24-May-2011 Other Vaccine Route Unknown Unknown Unknown
MedDRA PT
Abdominal distension, Abnormal faeces, Activities of daily living impaired, Allodynia, Alopecia, Anorectal discomfort, Anxiety, Aphthous stomatitis, Appetite disorder, Arthralgia, Asthenia, Autonomic nervous system imbalance, Bedridden, Chills, Chronic fatigue syndrome, Constipation, Cough, Delirium, Diarrhoea, Dizziness, Dysphagia, Dysphonia, Dysstasia, Early satiety, Eructation, Eye movement disorder, Faecal incontinence, Fatigue, Feeling hot, Fibromyalgia, Flat affect, Flushing, Gait disturbance, General physical health deterioration, Headache, Hyperaesthesia, Hyperhidrosis, Immediate post-injection reaction, Lethargy, Lymphadenopathy, Malaise, Menstruation delayed, Movement disorder, Muscle fatigue, Musculoskeletal pain, Nausea, Orthostatic intolerance, Pain, Peripheral coldness, Pruritus, Pyrexia, Reflux laryngitis, Speech disorder, Staring, Swelling face, Tinnitus, Weight decreased
Symptom Text: Information has been received from a physician concerning a 14 year old female patient with a family history of neurological conditions of unknown origin who "in summer 2009", in approximately June 2009, completed three dose series of GARDASIL (lot number, dose and site of administration not reported). In 2009 "right after" receiving the third dose, the patient had a "slow downward path" and developed nausea, weakness, fatigue, hair loss, lost control of her bowels, sore joints, anxiety, a movement disorder and seizure like activity. It was also reported that "currently", she could not walk with out assistance and was bedbound and she was currently in the hospital since she took a "turn for the worst last week". Also, the physician reported that the patient was a straight a student two years ago. Unspecified treatment was given for the adverse event. At the time of the report, the patient had not recovered. The sister's experience has been captured in WAES # 1104USA00837. Additional information has been requested. The following information was obtained through follow-up and/or provided by the government. 4/19/11 PCP note dated 5/3/10 with Assessment: Lethargy. Flushing. Delayed menses. Could have low grade sinus infection. Pt presents with c/o 1 month hx of feeling unwell, tiredness, fever, cold hands and feet with facial and head warmth, itching, constipation/diarrhea, burping and afternoon lethargy. Pt reports swollen glands at start of episode. Has missed 1 month of school recently. At times, delirious and speaking "another language". Difficulty in standing. No menses yet despite Tanner 4 development. 4/19/11 ENT consult also received for DOS 2/8/11 with assessmet: Laryngopharyngeal reflux. Pt presented for eval of dysphagia x several months and long hx of chronic cough. Pt reports hoarseness, fatigue, hot sweats, chills, facial swelling, appetite changes, weight loss, tinnitis, cold feet/legs as well. Multiple tx tried but ineffective. PPI meds increased. 4/28/11 Multiple outpt consults received. GI consult with DOS 7/28/10 with Impression: Constellation of findings (oral apthae, perianal bumps, early satiety & nausea) raises concern for Crohn's. Features of irritable bowel with nausea, bloating, early satiety and variable stools may be 2' to inflammatory state. Consider gluten sensitive enteropathy, unlikely with (-) celiac serology. Cardiology consult 12/8/10 with (-) cardiac w/u. Pt evaluated for longstanding hx of fatigue, dizziness, diarrhea, joint complaints, muscle fatigue and inability to perform daily functions. Rheumatology consult 12/15/10 with Impression: Severe Chronic Fatigue syndrome and Fibromyalgia. Pt presents with 9 month hx of fatigue, H/A, musculoskeletal pain above normal baseline. Pt has had episodes of fatigue since Mono episode at age 6, but current episode has lasted 9 months and pt unable to participate in normal life. PE (+) for appearing fatigued, 7/18 tender points. Endocrinology consult 3/10/11 with (-) w/u. 5/23/11 Neuromuscular consult with EMG received for DOS 4/25/11. No final dx offered. Pt presented for eval of prolonged fatigue episode which has progressed to pt being non-ambulatory and with significant decline in function. Pt also reports worsening dizziness/orthostasis, neck weakness, headaches, allodynia, pain with movement, staring spells, sleep dysfucntion, eye fluttering episodes. PE (+) for flat affect, minimal speech, increased touch sensitivity. One episode of eye fluttering during exam. Clinical hx more c/w autonomic dysfunction, 2' deconditioning from chornic pain and fatigue.


Page 528
Vaers Id: 420819-1 (S) Referred for PT, PT, behavioral therapy as well as pain mgmt eval. Other Meds: Lab Data: Unknown Unknown The following information was obtained through follow-up and/or provided by the government. Labs and diagnostics: MRI brain WNL. nasopharyngoscopy (+) for Intra-arytenoid erythema. EGD/Colonoscopy (+) gastritis and prominant lymphoid aggregates in the colon. 4/28/11 EKG WNL. Echo (-). ESR 20. MRI brain WNL. MRI neck WNL. 5/4/11 DHEAS 289 (H). Fecal Pancreatic elastase >500 (H) 5/5/11 EEG WNL. 5/23/11 EMG/NCS WNL. Unknown The following information was obtained through follow-up and/or provided by the government. PMH: As infant would pass out with crying. Croup. Infectious Mono age 6.
History: Prex Illness:
Prex Vax Illns: Autism~HPV (no brand name)~~0.00~Sibling


Page 529
Vaers Id: 420820-1 (O) Age Gender Vaccine Date Onset Date F 04-Mar-2011 06-Mar-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Asthenia, Pyrexia, Vaccination complication
Days 2
Symptom Text: Case received from the Health Authorities on 30-MAR-2011 under the reference number ES-AGEMED-223795341. Case medically confirmed. A 14 year old female patient received a dose of GARDASIL (batch# not reported) by intramuscular route on 04-MAR-2011 and 2 days after, on 06-MAR2011, she presented with a 39-40 degree C fever and was diagnosed with a postvaccination reaction. On 09-MAR-2011 the patient visited her pediatrician who also considered that the patient presented loss of strength in lower limbs (start date coded by the HAs as 06-MAR-2011). At the time of reporting, the patient had not recovered. Case reported as serious by the Health Authorities with other medically important condition as criteria. Other business partner numbers included: E2011-02146. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 530
Vaers Id: 420821-1 (S) Age Gender Vaccine Date Onset Date F 01-Oct-2008 01-Oct-2008 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 0
Status Date State Received Date 13-Apr-2011 WI 12-Apr-2011 Lot Prev Doses Site NULL 1 Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Activities of daily living impaired, Emotional disorder, Mental disorder
Symptom Text: Information has been received from a registered nurse and Cancer Administrator and the patient's mother who works in Nuclear Medicine concerning a 13 year old female patient with a medical history of dermographism and grass or tree allergies and allergic to cephalosporins who in August 2008 and in October 2008 (also reported as in approximately 2009 ("about two years ago") ) was vaccinated with the first and second dose of GARDASIL (dose, route and lot # were not reported) respectively. The registered nurse reported that in approximately 2009 ("about two years ago") the patient experienced severe mental, emotional side effects from the vaccine. The patient had to go to see a psychiatrist. The registered nurse learned of this event while in conversation with the patient's mother. The patient's mother mentioned that in approximately October 2008 ("within a week or two of receiving the second dose") the patient experienced the severe mental, emotional side effects. The patient was referred to many specialists and performed much diagnostic testing. All physical workups were okay. The patient currently was on psychiatry medications and in a special learning program at school. It was unknown if there was any relationship to GARDASIL, but the third dose would not be given (a younger sister would also not be receiving the GARDASIL series). At the time of reporting, the patient's status was unknown. The severe mental, emotional side effects were considered to be disabling for a number of reasons including missed school. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Dermographism; grass allergy; allergic reaction to antibiotics Unknown Unknown


Page 531
Days 0
Hyperhidrosis, Malaise, Nausea, Pallor, Vomiting
Symptom Text: This case was reported by the Regulatory Agency, reference ADR 20980343. This case is medically confirmed. A 16 year old female patient with a history of asthma and two previous doses of GARDASIL (manufacturer not reported, lot not reported, administration dates not reported), received a third dose of GARDASIL (manufacturer and lot not reported) on 09-MAR-2011. The patient arrived home from school on the same date at 5:00 pm, vomited and then felt unwell, nauseous, looked pale and was sweating. The patient took paracetamol and went to bed, the patient had to take the day off school. The patient recovered from all the events on an unspecified date. The Regulatory Authority considered the case to be serious as an other medically significant condition. Other business partner numbers include E2011-02174. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma Unknown Unknown


Page 532
Vaers Id: 420823-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Autism, Condition aggravated
Days
Status Date State Received Date 13-Apr-2011 UT 12-Apr-2011 Lot Prev Doses Site NULL 2 Unknown
Symptom Text: Information has been received from a physician concerning a female patient with autism who on unspecified date, was vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported). On unspecified date, the patient worsened after receiving vaccine. Upon internal review, autism was determined to be an other important medical event. The sister's experience has been captured in WAES1104USA00214. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Autism Prex Vax Illns: Arthralgia, arthralgia, bedridden, convulsion, difficulty in walking, fatigue, hair loss, intestinal functional, movement disord~HPV (Gardasil)~UN~12.00~Sibli Unknown Unknown


Page 533
Vaers Id: 420852-1 Age Gender Vaccine Date Onset Date F 09-Mar-2011 09-Mar-2011 18.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 NY 12-Apr-2011 Lot Prev Doses Site 1332Y 0 Left arm AHAVB467BA 0 Right arm
Headache, Muscle tightness, Neck pain, Pain in jaw, Skin tightness
Symptom Text: Pt. rec. immunizations on afternoon of 3-9-11. Later that evening - c/o pain in neck, jaw, headache and tightness in face and jaw. Began to feel better, no further s/s of above after 3-14-11 - F/u call on 4-12-11. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MD vs. on 3-14-11 - No Rx


Page 534
Vaers Id: 420870-1 Age Gender Vaccine Date Onset Date F 11-Apr-2011 12-Apr-2011 12.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 14-Apr-2011 PA 12-Apr-2011 Lot Prev Doses Site C3489AA 0 Right arm C3776DA 0 Left arm 1016Z 0 Left arm U3537AA 0 Right arm
Asthenia, Chills, Dysphagia, Headache, Injection site erythema, Injection site pain, Injection site swelling, Lip swelling, Pyrexia, Viral infection
Symptom Text: Difficulty swallowing, lip swelling. Fever & chills. The following information was obtained through follow-up and/or provided by the government. 4/14/11. PCP records DOS 4/12/11. DX: Viral syndrome; ? immunisation rxn. CC: redness, swelling & mild tenderness at vax site; fever, HA; feels weak; chills. PE: no lip/eye/tongue swelling; no RDS. Managed as outpt. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None. None. The following information was obtained through follow-up and/or provided by the government. 4/14/11. PCP records. PMH: HA & tiredness 5-days before vax.


Page 535
Days 0
Status Date State Received Date 26-Apr-2011 FR 13-Apr-2011 Lot Prev Doses Site NN05340 2 Left arm
Asthenia, Mobility decreased, Neuropathy peripheral, Pain
Symptom Text: Information has been received from health authority (case n. 137628) through foreign agency (local case n. IT149/11) concerning an 11 year old female patient who on 22-MAR-2011 was vaccinated IM on the left arm with the third dose of GARDASIL (batch#NN05340, dose not reported). It was also reported that the patient was diagnosed with a herpes zoster infection to the left arm on 19-NOV-2009. On the same day of the vaccination, the patient presented with burning pain of the upper left limb with flexo-extension deficit associated with strength deficit. It was suspected post-vaccination neuropathy. She was administered analgesic and neurotrophic therapy and advised an electromyography (EMG). At the time of the reporting her condition had improved. The final outcome was not reported. Upon medical review the company judged relevant to code the adverse event "burning pain of the upper left limb", "flexo-extension deficit", and "strength deficit" which were mentioned in the narrative but not coded by health agency. The AEs were considered to be other important medical events. The case was closed. Other business partner # included: E2011-02232. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Herpes virus infection


Page 536
Days 0
Status Date State Received Date 13-Apr-2011 TN 13-Apr-2011 Lot Prev Doses Site 1016Z 0 Left arm
Bronchitis, Dizziness, Dyspnoea, Headache, Pyrexia, Tinnitus, Visual impairment
Symptom Text: "Splitting headache" started early evening on 4/7/2011, day of vaccine. Was given IBU with some relief, but headache came back. Went to school on 4/8/2011 as usual. Was given IBU at school for headache. Upon returning home from school at about 4:30 PM, c/o headache, fever 101.2, light-headed, ringing in ears, vision changes and some trouble breathing. Was taken to ER and dx with bronchitis. Was given a RX for Zithromax and a "high dose of IBU". Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Had just seen dentist for a routinue cleaning. Fluoride varnish was applied. None


Page 537
Vaers Id: 420986-1 Age Gender Vaccine Date Onset Date F 08-Apr-2011 08-Apr-2011 15.0 Type Manufacturer VAX Detail: FLU SANOFI PASTEUR HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 NY 14-Apr-2011 Lot Prev Doses Site U3573FA Right arm 0331Z 0 Left arm 1276Z 1 Right arm AHAM462PA 0 Left arm
Dehydration, Dizziness, Feeling hot, Syncope
Symptom Text: Patient felt hot & dizzy 5 minutes after vaccine, then syncopes for a few seconds approx 20 minutes after vaccines were administered. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: FeSO4; PROVENTIL Sent to Emergency Room labs & fluid given. Diagnosed with dehydration. PMH - Asthma; Anemia; Allergy: PCN


Page 538
Vaers Id: 421009-1 Age Gender Vaccine Date Onset Date F 06-Dec-2010 06-Dec-2010 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 15-Apr-2011 FL 14-Apr-2011 Lot Prev Doses Site 07867 2 Left arm
Fall, Head injury, Loss of consciousness, Syncope
Symptom Text: After receiving her third dose of GARDASIL approx. 30 seconds after vaccine, patient had a syncopal episode. Patient fell off exam table hitting her head - LOC approx 30 sec. Pt. was examined by doctor & ice applied to head & observed for 30 min. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 539
Vaers Id: 421027-1 Age Gender Vaccine Date Onset Date F 12-Apr-2011 12-Apr-2011 13.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR MMR MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 14-Apr-2011 MI 14-Apr-2011 Lot Prev Doses Site U3543AA 1 Left arm C3486AA 0 Left arm 0603Z 1 Right arm 1016Z 3 Right arm
Inappropriate schedule of drug administration
Symptom Text: Clts was living with father, recently moved back to mother's care. HD called provider for IMMs record at which time there was 1 sheet received, with 1 Gardasil recorded. There was only the 1 recorded on MICR. This RN administered HPV on 4/12/2011 as 2nd dose. There was a subsequent fax that came to the HD after clt's visit that 3 doses of HPV vacc. recorded. The 4/12/2011 dose was then clts. 4th dose. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Denied Denied


Page 540
Vaers Id: 421035-1 Age Gender Vaccine Date Onset Date M 25-Mar-2011 25-Mar-2011 11.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Rash erythematous
Days 0
Status Date State Received Date 15-Apr-2011 UT 14-Apr-2011 Lot Prev Doses Site AHAVB453AA 0 Left arm 08862 U3509AA C3249AA 13132 0 0 0 0 Left arm Right arm Right arm Right arm
Symptom Text: Pts mother called office on 3/25/11 to report red bump/rash. Mom gave pt Claritin and Bendaryl. No difficulty breathing at this time. Neg n/v. Was seen at the Urgent Care on 3/29/11 and given an epi injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Mom wishes to pursue allergy testing in the near future. Trileptal No


Page 541
Vaers Id: 421042-1 Age Gender Vaccine Date Onset Date F 10-Dec-2009 Unknown 20.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Papilloma viral infection
Days
Status Date State Received Date 15-Apr-2011 CA 14-Apr-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: I GOT THE GARDASIL SHOT AND IT PERMANENTLY GAVE ME THE HPV VIRUS, I NOR MY DOCTORS KNOW IF IT WILL GET WORSE, BUT IT IS NOT CURABLE. I AM STUCK WITH THIS VIRUS FOR THE REST OF MY LIFE. BECAUSE OF THE GARDASIL SHOT THAT WAS SUPPOSED TO PREVENT ME FROM GETTING HPV. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PAP SMEARS VAGINAL TESTS. NONE NONE


Page 542
Vaers Id: 421071-1 (S) Age Gender Vaccine Date Onset Date M 01-May-2009 01-May-2009 0.1 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 0
Acute myeloid leukaemia, Chemotherapy, Rash, Wrong drug administered
Symptom Text: Information has been received from the parents of a patient via agency as part of a business agreement concerning a 6 weeks old male patient who on an unspecified date was accidentally vaccinated with a dose of GARDASIL instead of a different infant vaccine. At the time of the report, the baby seemed fine and the parents stated that the patient had not had any health issues since the vaccine had been administered. The parents were counseled by their doctor. There was no medical treatment. The reporter felt that the suspect vaccine was the highly probable cause of the adverse event. Followup information was reported in a newspaper article and the internet that the 6 weeks old male patient who in May 2009 was accidentally vaccinated with a dose of GARDASIL instead of one to prevent meningitis. In approximately March 2011, at two years of age, the patient was diagnosed with acute myeloid leukaemia after his parents took him to the doctor when they noticed a rash on his neck and blood test results came back abnormal. On 17-MAR-2011 the patient began 10 hours of aggressive chemotherapy a day for the M7 strand of acute myeloid leukaemia in hospital. The patient was doing "remarkably well", despite being cooped up in hospital ward for 23 hours a day. The doctors can not tell whether the GARDASIL he was injected caused the cancer. The parents were concerned about a possible link between GARDASIL vaccination mistake and leukaemia. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown diagnostic laboratory test, blood test results abnormal Unknown


Page 543
Vaers Id: 421072-1 (O) Age Gender Vaccine Date Onset Date F Unknown Unknown Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Convulsion
Days
Status Date State Received Date 18-Apr-2011 US 15-Apr-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a registered nurse who "heard" about a female patient that was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported) and developed seizures which reoccured. The female did not have seizures prior to the vaccination. Nurse stated this did not happen at her medical facility and she had no other information regarding this event. The patient's outcome was unknown. Upon internal review seizure was considered to be other important medical event. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 544
Vaers Id: 421073-1 (S) Age Gender Vaccine Date Onset Date F 10-Mar-2011 13-Mar-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 3
Status Date State Received Date 25-Apr-2011 FR 15-Apr-2011 Lot Prev Doses Site NK05090 0 Left arm
Abdominal pain, Agitation, Anxiety, Blood pressure systolic increased, Fatigue, Headache, Nausea, Sinus tachycardia, Syncope, Vomiting
Symptom Text: Case received from a health care (pediatrician) on 04-APR-2011. Case medically confirmed. A 14 year old female patient (weight 62 kg; height 171 cm) had received a first dose of GARDASIL (Lot number: NK05090; Batch number NN01980) IM into the left upper arm on 10-MAR-2011. Three day later, on 13-MAR-2011, she developed syncope, abdominal pain, nausea, vomiting, headache and tiredness. At the request of the parents, who were worried about reports in the internet, the patient was admitted to hospital on 16-MAR-2011. Upon admission, the patient was anxious and in a dither. She had sinus tachycardia and increased systolic blood pressure (>150 mmHg). Laboratory values, abdominal sonography and Schellog test showed normal results. During further course, blood pressure normalized and the patient complained only of nausea only in the morning. She received corrective treatment with MAALOXAN (to be reduced after discharge). In case of persistent nausea, gastroscopy was recommended by the hospital physicians. On 18-MAR-2011, the patient was discharged completely recovered. Concomitant medication included hormonal contraceptive (unspecified). Regarding the causality assessment, the reporter crossed both "possible" and "unlikely" on the reporting form. The case is closed. Other business partner numbers include E2011-02199. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: hormonal contraceptives (unspecified) Unknown None


Page 545
Vaers Id: 421074-1 (O) Age Gender Vaccine Date Onset Date F 14-Feb-2008 13-Oct-2008 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Fatigue, Petit mal epilepsy
Days 242
Symptom Text: Information has been received from the health authorities under the reference number NY20110216. Case medically confirmed. A 16-year-old female patient had received the first dose of GARDASIL (batch number not reported) on 14-FEB-2008, the second dose on an unspecified date and the third dose (lot number 1526U, batch number NH36020) via intramuscular route on 13-OCT-2008. The girl had a medical history of epilepsy since childhood, with generalised tonic-clonic movements. She had not experienced any epileptic fit for three and a half years. Since the day when she had received the third dose of GARDASIL, she experienced one or two fits of absence seizure type almost every day at the end of the day. These fits where of short duration, with a feeling of exhaustion at regaining consciousness. There was no precursor symptom. The epileptic treatment was modified. At the time of reporting in March 2011, the frequency of the fits was of 2 per week. The health authorities assessed the causal relationship between the reported reaction and vaccination as doubtful according to the foreign method of assessment. Absence seizure was considered as an other important event. Other business partner number included: E2011-02272. No further information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Epilepsy


Page 546
Vaers Id: 421083-1 (O) Age Gender Vaccine Date Onset Date F 22-Jun-2010 Unknown 15.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 18-Apr-2011 WI 15-Apr-2011 Lot Prev Doses Site NULL Unknown 1487Y 0 Unknown
Abortion induced, Drug exposure during pregnancy, No adverse event
Symptom Text: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old pregnant female with no previous pregnancies, no medical history and no known drug allergies who on 22-JUN-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 1487Y). The patient also was administered MENACTRA during the same visit. No adverse effect reported. The urine pregnancy test was performed and the result was positive. Ultrasound was performed on an unknown date and the result was unknown. The patient's LMP was 25-MAY-2010 (also reported as 26-MAY-2010) and estimated delivery date was 01-MAR-2011. The outcome of the patient's pregnant was unknown. Follow-up information has been received from the healthcare who reported that the pregnancy was terminated. Upon internal review, pregnancy terminated was considered to be an other important medical event. Additional information has been requested. This is an amended report, SAE "pregnancy terminated" was added. "Upon internal review, pregnancy terminated was considered to be an other important medical event." Was added to narrative. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 5/25/2010) Urine beta-human, positive


Page 547
Vaers Id: 421084-1 (S) Age Gender Vaccine Date Onset Date F Unknown Unknown 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS Abscess sterile
Days
Symptom Text: Information has been received from a registered nurse concerning a "11 or 12 years old" female patient who "about a year ago" (in approximately 2010), was vaccinated with a dose of GARDASIL 0.5 ml, intramuscularly (expiration date and lot number not reported). "About a year ago" (in approximately 2010), the patient experienced a sterile abscess after she received GARDASIL. The patient was hospitalized "duration and location were unspecified". The patient received "unspecified" treatment for the event. Therapy with GARDASIL was discontinued. Therapy was not reintroduced. At the time of the report the outcome of the patient was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 548
Vaers Id: 421085-1 (S) Age Gender Vaccine Date Onset Date Days F 01-Mar-2011 01-Mar-2011 0 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. DTAP UNKNOWN MANUFACTURER Seriousness: MedDRA PT
Status Date State Received Date 18-Apr-2011 US 15-Apr-2011 Lot Prev Doses Site NULL 0 Unknown NULL Unknown
Mfr Report Id Last Edit Date WAES1104USA00869 18-Apr-2011 Other Vaccine Route Intramuscular Unknown
ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Amnesia, Fall, Head injury, Loss of consciousness, Speech disorder
Symptom Text: Information has been received from a registered nurse concerning a female patient who in March 2011 "sometime in March" was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (Lot number not reported). Concomitant therapy included DTAP (unspecified). The nurse reported that in March 2011 "sometime in March" after received the first dose of GARDASIL intramuscularly, the patient experienced passing out, falling and hitting her head. She was taken to an unspecified hospital, received unspecified treatment and stayed there for an unspecified duration. The patient had been released from the hospital and was currently having speech problems and had short term memory loss. Therapy with GARDASIL was discontinued. At the time of the report, outcome of the patient was unknown. It was reported that the patient was not reintroduced to the therapy. Passing out, fall, hitting her head, speech problems and short term memory loss were considered to be disabling. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 549
Vaers Id: 421114-1 Age Gender Vaccine Date Onset Date F 08-Aug-2010 Unknown 16.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days
Status Date State Received Date 18-Apr-2011 OH 15-Apr-2011 Lot Prev Doses Site 1377Y 1 Right arm
Chest pain, Dyspnoea, Fatigue, Respiratory disorder, Wheezing
Symptom Text: Respiratory reactions, trouble breathing, wheezing, SOB, fatigue, chest pains. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: DEPO PROVERA None None


Page 550
Vaers Id: 421161-1 Age Gender Vaccine Date Onset Date F 13-Apr-2011 13-Apr-2011 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Feeling abnormal, Loss of consciousness
Days 0
Status Date State Received Date 18-Apr-2011 NY 17-Apr-2011 Lot Prev Doses Site 0096N 0 Right arm C3486AA 0 Left arm
Symptom Text: Approx 20 sec after receiving Gardasil vacc patient stated felt funny, slumped over and passed out. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PPD done on same date of vaccination none none


Page 551
Vaers Id: 421196-1 Age Gender Vaccine Date Onset Date F 13-Apr-2011 15-Apr-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site urticaria
Days 2
Status Date State Received Date 18-Apr-2011 KY 15-Apr-2011 Lot Prev Doses Site 1167Z 0 Left arm U3461CA 0 Right arm C3489AA 0 Right arm 1499Z 1 Left arm
Symptom Text: Whelps (R) deltoid at Tdap & MCV4 site & (L) arm where Ch. Px was given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 552
Vaers Id: 421218-1 Age Gender Vaccine Date Onset Date Days F 01-Nov-2010 01-Nov-2010 0 14.0 Type Manufacturer VAX Detail: MNQ NOVARTIS VACCINES AND DIAGNOSTICS HPV4 MERCK & CO. INC. HEPA GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Drug administration error, No adverse event
Status Date State Received Date 19-Apr-2011 US 15-Apr-2011 Lot Prev Doses Site 027011 Unknown 04502 AHAVB441BA Unknown Unknown
Mfr Report Id Last Edit Date PHHY2010US75745 29-Apr-2011 Other Vaccine Route Intramuscular Unknown Intramuscular
Symptom Text: Initial health care professional report received on 02 Nov 2010: This patient was vaccinated with MENVEO (batch number: 100001) 0.5 ml intramuscularly on 01 Nov 2010. The patient was vaccinated with only the Men CWY component of the MENVEO instead of being reconstituted with the lyophilized Men A component. No adverse event was reported following this administration error. Follow-up report received from a physician on 25 Jan 2011: On 01 Nov 2010, the patient concomitantly received GARDASIL and HAVRIX. No apparent ill reaction occurred to the patient. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown No other medications


Page 553
Vaers Id: 421226-1 (O) Age Gender Vaccine Date Onset Date F 25-Jun-2010 25-Jun-2010 12.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 19-Apr-2011 CA 18-Apr-2011 Lot Prev Doses Site NULL Unknown 1569Z 2 Unknown NULL Unknown
Mfr Report Id Last Edit Date WAES1104USA00665 19-Apr-2011 Other Vaccine Route Unknown Intramuscular Unknown
Cold sweat, Convulsion, Musculoskeletal stiffness, Syncope, VIIth nerve paralysis, Vaccine positive rechallenge
Symptom Text: Information has been received from a medical assistant concerning a 12 year old female patient with no pertinent medical history and no drug reactions or allergies reported, who on 25-JUN-2010 was vaccinated with her first dose of GARDASIL (Lot #: 666118/1539Y, Exp: March-2013), 0.5ml, intramuscularly. Concomitant medications administered on 25-JUN-2010 included: ADACEL, MENACTRA. Secondary suspect include VARIVAX (Merck) (lot # not reported). The medical assistant reported that after receiving the GARDASIL, the patient had a "fainting spell" where the patient turned stiff, convulsed and experienced facial paralysis which lasted for 5 seconds. Medical assistant reported that the entire event lasted 7 seconds, and the patient's vital signs were stable. Medical assistant reported that the patient "was a little clammy" following the "fainting spell" and stayed in the physician's office for 30 minutes after the events, so that she could be observed, and she completely recovered. On 27-AUG-2010, the patient received the second dose of GARDASIL (Lot#: 666929/0331Z, Exp: 05-APR-2013), 0.5 ml, intramuscularly, and fainted for 3 seconds, but the patient had no facial paralysis. Medical assistant reported that the patient experienced "a little stiffness", but she did not experience convulsions following the second dose of GARDASIL. Unspecified treatment was given for the events. No laboratory diagnostic studies were performed. Medical assistant reported that the patient completely recovered from this experience. On 06-APR-2011, the patient received her third dose of GARDASIL (Lot #: 668229/1569Z) (dose and route not reported), with no other vaccines and with no problems. Upon internal review convulsion and facial paralysis were considered to be other important medical events. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 554
Days 1
Complex regional pain syndrome, Cyanosis, Oedema peripheral, Pain in extremity, Peripheral coldness
Symptom Text: This case was received from the health authority on 05-APR-2011. IBM ref 2011-002901. This case was medically confirmed. A 13 year old female patient with no medical history or risk factors available and no concomitant medications, received the second dose of GARDASIL (lot number not reported) on 14-MAR-2011. On 15-MAR-2011, one day post vaccination, the patient experienced pain and swelling in her arm distal to the injection site. There was no swelling or tenderness at the injection site. She had purplish discolouration of the hand and her hand felt colder than contra lateral hand. The reported stated that is was clinically a reflex sympathetic dystrophic-type reaction. The patient was seen at A&E and referred to the pediatric clinic. At the time of reporting the patient's symptoms were persistent. The events were considered serious as they were medically significant and required intervention. Other business partner numbers include 2011-02233. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown None


Page 555
Vaers Id: 421228-1 (O) Age Gender Vaccine Date Onset Date F 22-Mar-2011 22-Mar-2011 12.0 Type Manufacturer VAX Detail: HEP MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 20-Apr-2011 FR 18-Apr-2011 Lot Prev Doses Site NULL Unknown NULL Unknown
Dizziness, Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness, Posture abnormal, Staring
Symptom Text: Information was obtained on a request by the Company from the agency via a Public Case Detail (local reference# 2011MSDA0517) concerning a 12 year old female who on 22-MAR-2011 was vaccinated with GARDASIL IM and a dose of RECOMBIVAX HB (MSD). Immediately after needle removed from arm, child's head thrust backwards, eye rolled up, fixed stare, laid on floor, body stiffness and slight dizziness. The treatment included laid on floor, stayed with child until collected by parent. Outcome was unknown. The agency felt that the event was possibly related to therapy with GARDASIL and RECOMBIVAX HB (MSD). This event was considered to be an other important medical event. The original reporting source was not provided. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 556
Vaers Id: 421230-1 Age Gender Vaccine Date Onset Date F 25-Mar-2011 26-Mar-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site pain, Injection site swelling
Days 1
Status Date State Received Date 18-Apr-2011 GA 18-Apr-2011 Lot Prev Doses Site 1437Z 2 Right arm
Symptom Text: pain and swelling at injection site without infection for 3 weeks Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Ultrasound pending


Page 557
Vaers Id: 421284-1 Age Gender Vaccine Date Onset Date M 14-Feb-2011 14-Feb-2011 15.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HEP GLAXOSMITHKLINE BIOLOGICALS HEPA GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. IPV SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Joint swelling, Rash generalised, Swelling
Days 0
Status Date State Received Date 18-Apr-2011 KS 18-Apr-2011 Lot Prev Doses Site U3512AA 0 Right arm AHBVB832BB 2 Right arm AHAVB461AA 0786Z D10861 AC52B056AA 0 0 1 0 Left arm Right arm Left arm Left arm
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Intramuscular Subcutaneously Intramuscular
Symptom Text: Rash and swelling throughout body. States rash lasted approximately one week. Swelling in ankles still not resolved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown. No No


Page 558
Vaers Id: 421288-1 Age Gender Vaccine Date Onset Date F 18-Apr-2011 18-Apr-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash generalised
Days 0
Status Date State Received Date 18-Apr-2011 OH 18-Apr-2011 Lot Prev Doses Site 1178Y 0 Left arm
Symptom Text: PT'S FATHER STATES APPROXIMATELY ONE HOUR AFTER RECEIVING GARDASIL SHE BROKE OUT IN A RASH ALL OVER HER BODY. INSTRUCTED TO TAKE BENADRYL. F/U IN ER IF S/S ANAPHYLACTIC SHOCK. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE ALLERGY TO PCN AND CEPHALOSPORINS NONE


Page 559
Vaers Id: 421362-1 Age Gender Vaccine Date Onset Date U 06-Apr-2011 06-Apr-2011 21.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Pain in extremity
Days 0
Status Date State Received Date 25-Apr-2011 LA 19-Apr-2011 Lot Prev Doses Site 0331Z 2 Right arm U3486CA 0 Left arm
Symptom Text: Pt c/o pain to right arm evening after vaccine. Pain to entire arm the following day continuing for 1/1 wk. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 560
Vaers Id: 421367-1 Age Gender Vaccine Date Onset Date F 29-Mar-2011 30-Mar-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Mobility decreased, Pain
Days 1
Status Date State Received Date 25-Apr-2011 NH 19-Apr-2011 Lot Prev Doses Site 03312 1 Right arm
Symptom Text: Patient seen 3/29/11 and was given GARDASIL in (R) arm. Parent called on 4/6/11 with worsening pain and difficulty raising arm due to pain. Seen in our office 4/6/11. MRI was ordered and consult with orthopedics. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None MRI None None


Page 561
Days 3
Status Date State Received Date 29-Apr-2011 FR 19-Apr-2011 Lot Prev Doses Site NK05090 0 Left arm
Abdominal pain, Anxiety, Blood pressure systolic increased, Fatigue, Headache, Mental status changes, Nausea, Sinus tachycardia, Syncope, Vomiting
Symptom Text: Information has been received from a pediatrician concerning a 14 year old female patient who on 10-MAR-2011 had received a first dose of GARDASIL (Batch # NN01980; Lot # NK05090) into the left upper arm. Three days later, on 13-MAR-2011, she developed syncope, abdominal pain, nausea, vomiting, headache and tiredness. At the request of the parents, who were worried about reports in the internet, the patient was admitted to a hospital on 16-MAR-2011. Upon admission, the patient was anxious and in a dither. She had sinus tachycardia and increased systolic blood pressure (>150 mmHg). Laboratory values, abdominal sonography and Schellong test showed normal results. During the further course, blood pressure normalized and the patient complained only of nausea only in the morning. She received corrective treatment with MAALOXAN (to be reduced after discharge). In case of persistent nausea, gastroscopy was recommended by the hospital physicians. On 18-MAR-2011, the patient was discharged, completely recovered. Concomitant medication included hormonal contraceptives (unspecified). Regarding the causality assessment, the reporter crossed both "possible" and "unlikely". The case was medically confirmed. Other business partner numbers include: E2011-02199. This case is closed. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Hormonal contraceptives (unspecified), Unk, Unk Blood pressure measurement, 16Mar11, >150 mmHg, systolic; Abdominal ultrasound, 16?Mar11, normal; Orthostatic hypotension measurement, 16?Mar11, normal Unknown


Page 562
Vaers Id: 421374-1 (O) Age Gender Vaccine Date Onset Date F 09-Apr-2011 09-Apr-2011 22.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Adverse drug reaction, Convulsion, Dizziness, Fall, Lip injury, Tooth injury
Symptom Text: Information has been received from a nurse (local reference # COL1104001) concerning a 22 year old female patient who on 09-APR-2011 was vaccinated with a dose of GARDASIL (lot number not provided). It was reported that on 09-APR-2011, patient who was treated at the center of vaccination, after 5 minutes of application of the vaccine, experienced dizziness, so the nurse should sat the patient down and after 5 minutes the patient had seizure and fell to the floor, breaking her lower lip and knocking her teeth. The patient's father attended the vaccination center 2 hours after the event and moved the patient to the emergency. The patient was informed that the event corresponded to an adverse drug reaction. On 09-APR-2011 the patient recovered from seizure and dizziness. At the time of the report, the patient was unable to work for 5 days. The reporting nurse felt that seizure and dizziness were related to therapy with GARDASIL. It was reported that the therapy with GARDASIL was discontinued. At the time of the report, the outcomes of fall to the floor, breaking her lower lip and knocking her teeth, were unknown. Seizure and dizziness were considered to be an other important medical event by the reporter. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 563
Vaers Id: 421375-1 (O) Age Gender Vaccine Date Onset Date F 14-Mar-2011 15-Mar-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Chills, Decreased appetite, Vomiting
Days 1
Status Date State Received Date 29-Apr-2011 FR 19-Apr-2011 Lot Prev Doses Site NK25010 2 Unknown
Symptom Text: This case was received from the Health Authority (Agency ref 2011-002919). This case was medically confirmed. A 13 year old female patient with no history of significant concomitant illness or previous drug reaction and no risk factors reported an no concomitant medications received the third dose of GARDASIL (batch# NM31130, lot# NK25010) IM on 14-MAR-2011. On 15-MAR-2011, one day post vaccination, the patient was shivery. She also vomited once and was not eating. The patient was seen by the general practitioner and the doctor on call and went to A&E. At the time of reporting the patient had not yet recovered (also reported as unknown). The events were considered to be medically significant. Other business partner numbers included: E2011-02332. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 564
Days 0
Status Date State Received Date 29-Apr-2011 FR 19-Apr-2011 Lot Prev Doses Site NK10770 Left arm
Immediate post-injection reaction, Injection site pain, Pain
Symptom Text: This case was received from the Health Authority (Agency ref 2011-002991). Case medically confirmed. A 14 year old female patient with no medical history or risk factors reported and no concomitant medication received an injection of GARDASIL (batch# NM25090, lot# NK10770) 0.5 ml in the left deltoid on 24-NOV-2010. On 24-NOV-2010, immediately post vaccination, the patient experienced sharp stinging in fingers of the left hand which radiated to the elbow and then the site of injection. Corrective treatment included the applying of a cold compress. The patient was observed for 20 minutes. The reaction was ongoing at the time of reporting (also reported as unknown). The events were considered to be medically significant. Other business partner numbers included: E2011-02330. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown None


Page 565
Vaers Id: 421377-1 (S) Age Gender Vaccine Date Onset Date F 01-Dec-2009 01-Jul-2010 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT HOSPITALIZED, SERIOUS
Days 212
Status Date State Received Date 29-Apr-2011 FR 19-Apr-2011 Lot Prev Doses Site 1535U 2 Unknown
Abdominal pain, Headache, Neutropenia, Pyrexia
Symptom Text: Information has been received from a pharmacist on 08-APR-2011 and medically confirmed. A patient aged 14 or 15 years old had received the third dose of GARDASIL (batch number unknown) on 04-JUN-2010. In JUL-2010 she was hospitalized due to severe fever, severe cephalgias, pain in abdomen. Neutropenia was diagnosed, which was persisting since then. No cause was identified. The neutropenia was constant, consequently the patient was regularly under antibiotics as she was prone to infections. At the time of reporting, she was taking BACTRIM 800 mg morning and evening per day during 4 months and folic acid. A bone marrow sampling had been performed. To be noted that the patient had a good general health status before vaccination. She had received the first dose of GARDASIL (lot number 1535U, batch number NH42160) in December 2009 and the second dose (batch number unknown) in January 2010. Other business partner number include: E2011-02297. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 566
Days 0
Status Date State Received Date 29-Apr-2011 FR 19-Apr-2011 Lot Prev Doses Site NK10770 Left arm
Hypoaesthesia, Immediate post-injection reaction, Nausea, Rash, Swollen tongue, Wheezing
Symptom Text: Information has been received from the health authority on 07-APR-2011. Agency ref 2011-002992. This case is medically confirmed. A 12 year old female patient with no medical history or risk factors reported and no concomitant medication received an injection of GARDASIL (lot number NK10770, batch number NM25090) 0.5 mls in the left deltoid on 23-NOV-2010. On 23-NOV-2010, immediately post vaccination, the patient was nauseated, her left arm was numb, she had a rash and tongue swelling. The patient's pulse was 72 and her blood pressure was 79/69. The patient was observed and put in a supine position with feet elevated. At the time of reporting the patient was well. She had a blood pressure of 119/58 but had a wheeze and her arm was still a little numb. The agency reported that the patient had not recovered from the events of nauseated, left arm numb, rash and tongue swelling. The events were considered to be medically significant. Upon internal medical review the event of wheeze was also coded. Other business partner number include: E2011-02326. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Blood pressure measurement, 23Nov10, 79/69; Blood pressure measurement, 119/58; Total heartbeat count, 23Nov10, 72 Unknown


Page 567
Vaers Id: 421384-1 Age Gender Vaccine Date Onset Date M 18-Apr-2011 18-Apr-2011 14.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Rash erythematous, Rash pruritic
Days 0
Status Date State Received Date 19-Apr-2011 PA 19-Apr-2011 Lot Prev Doses Site 1333Y 1 Right arm
Symptom Text: itchy red raised rash on abdomen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Symbicort 8am None No


Page 568
Days 7
Status Date State Received Date 20-Apr-2011 MI 19-Apr-2011 Lot Prev Doses Site 1016Z 1 Left arm
Epistaxis, Fatigue, Headache, Hyperaesthesia, Pain, Pain of skin, Rash generalised, Vomiting
Symptom Text: Headaches and body aches then nose bleeds. Fatigue and emesis last few days. Full body rash for past week and skin hurts to touch. Saw Dr. 4/19/2011. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Depo provera, was given RX today for antidepressant ? name Urinalysis and finger poked uncertain what test was performed. PG test and mono test. CT to be ordered. sinus infection on antibiotics for sinus infection


Page 569
Vaers Id: 421401-1 (S) Age Gender Vaccine Date Onset Date M 30-Dec-2010 06-Mar-2011 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, HOSPITALIZED, SERIOUS
Days 66
Status Date State Received Date 21-Apr-2011 NJ 19-Apr-2011 Lot Prev Doses Site 0672Y 1 Unknown
Abasia, Diplegia, Dyspnoea, Hyperreflexia, Hypoaesthesia, Hyponatraemia, Immunoglobulin therapy, Mobility decreased, Muscular weakness, Paraesthesia, Reflexes abnormal, Respiratory disorder, Salivary gland mass, Sinus disorder
Symptom Text: Guillain-Barre ?, was hospitalized in hospital. Received IVIG, steroids. Work-up did not confirm. The following information was obtained through followup and/or provided by the government. 4/19/11 Discharge summary received. Service dates 3/6/11/to 3/11/11. Diagnosis: Transient lower extremity paralysis felt most likely to be an early Guillain-Barre syndrome, Left parotid nodule. Patient presented with acute onset of paraesthesia of the lower extremities and inability to move his legs. Prompt response to IVIG. Mild hyperreflexia lower extremities. Possibility of mononucleosis. 4/21/11 Hospital records and discharge summary received. Service dates 3/6/11 to 3/13/11. Additional information abstracted. Diagnosis: Lower extremity weakness, probably due to psychosomatic disorder. Chronic sinus disease. Patient presents with hyperreflexia, hyponatremia, sinus symptoms. Numbness in legs and feet. paresthesias, weakness in arms. Prior visit to ER for respiratory symptoms. Abnormal reflexes. Unable to walk. Low grade fever post IVIG. Feeling better, discharged. Other Meds: Lab Data: Takes asthma medicine as needed. Was unable to move lower extremities, trouble breathing. The following information was obtained through follow-up and/or provided by the government. 4/21/11 Labs and Diagnostics: CBC - HGB 14.4% (L) MCHC 35.7 g/dl (H) Platelets 138 x10E9/L (L). CSF - WNL. CHEM - Sodium 131 mmol/L Chloride 96 mmol/L Glucose 112 mg/dL (H) Creatine 0.4 mh/dL (L). C117 20 (H). EMG/NCS Report - Normal. CT Brain - WNL. MRI Spine - WNL. CT Chest WNL. MRI Head - WNL. CT Spine - WNL. X-ray Spine - WNL. Asthma varicocele; seizure; syncope The following information was obtained through follow-up and/or provided by the government. 4/19/11 PMH: Asthma, "missing tricuspid valve". 4/21/11 PMH: Fainting episodes. Stress. No


Page 570
Vaers Id: 421491-1 Age Gender Vaccine Date Onset Date F 18-Apr-2011 20-Apr-2011 11.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 2
Status Date State Received Date 25-Apr-2011 TX 20-Apr-2011 Lot Prev Doses Site 0886Z 0 Right leg U3464AA 0 Left arm C3517AA 0 Left arm
Injection site erythema, Injection site swelling, Local swelling
Symptom Text: Local swelling and redness on area where HPV vaccine was administered. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 571
Vaers Id: 421500-1 Age Gender Vaccine Date Onset Date F 20-Apr-2011 20-Apr-2011 16.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Syncope, Tremor
Days 0
Status Date State Received Date 25-Apr-2011 CA 20-Apr-2011 Lot Prev Doses Site 1569Z 0 Left arm U3874CA 0 Right arm
Symptom Text: Dizzy, shook, fainted. Laid patient down, raised feet, cool cloth patient recovered and patient reevaluated by doctor. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 572
Days 0
Chills, Decreased appetite, Headache, Listless, Malaise, Pallor, Presyncope, Syncope
Symptom Text: Information has been received from a Health Authority on 11-APR-2011 under the reference number NO-NOMAADVRE-FHI-2011-12235 and 11/681. Case medically confirmed. A 13 year old female patient had received an injection of one dose of GARDASIL (batch number not reported) on 30-MAR2011 and a few hours later she developed listlessness, near syncope, chills, headache, appetite impaired and feeling unwell. It was reported that the girl was near syncope in the evening of the vaccination day. the next morning she collapsed and was pale. She was hospitalized for observation a day and a night (Dates not reported). Patient had a history of sinusitis (not reported as an AE after vaccination) started on 30-MAR-2011 to 01-APR-2011. MR caput performed on 31-MAR-2011, no results provided. The girl had previously received 2 doses of GARDASIL. At the time of reporting the outcome was recovered. According to the reporter, the reactions were possibly related to vaccination. Other business partner numbers include E2011-02336. No further information is expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Sinusitis


Page 573
Vaers Id: 421539-1 Related reports: 421539-2 Age Gender Vaccine Date Onset Date F 20-Apr-2011 20-Apr-2011 12.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR VARZOS MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site erythema, Pruritus
Days 0
Status Date State Received Date 22-Apr-2011 ME 21-Apr-2011 Lot Prev Doses Site U3754AA 0 Left arm 0565Z 0 Right arm C3828AA 0 Left arm 1361Z 0 Right arm
Symptom Text: Pt experienced localized redness @ injection site- no swelling, itching noted @ that time. Advised to use cool compress prn. Nurse mgr spoke with parent this am and states that pt awoke with increased localized redness and itching; advised to apply cool compress and topical cortisone cream to siteparent then called back and states symptoms relieved with above. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No, pt was here for healthy exam Was not able to correct which type of meningococcal vaccine pt received on 4/20/11- it was Menactra by SanofiPasteur


Page 574
Vaers Id: 421547-1 Age Gender Vaccine Date Onset Date M 13-Apr-2011 15-Apr-2011 11.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Induration, Petechiae, Swelling
Days 2
Status Date State Received Date 22-Apr-2011 WA 21-Apr-2011 Lot Prev Doses Site U3676AA 0 Left arm 0182AA 0 Left arm AC52B060CA 0 Right arm
Symptom Text: Patient developed petechiae, swelling with induration about 10 cm after Tdap in his right arm. On left arm developed a 12cm area of swelling and induration after recieving HPV and MCV4. Evaluated by attending MD here at the clinic. No other symptoms. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 575
Vaers Id: 421573-1 Age Gender Vaccine Date Onset Date F 19-Apr-2011 19-Apr-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 22-Apr-2011 MS 22-Apr-2011 Lot Prev Doses Site 1167Z 0 Left arm U3671AA 0 Left arm AC52B048AC 0 Right arm
Mfr Report Id MS11005 Route Intramuscular Intramuscular Intramuscular
Asthenia, Crying, Dysarthria, Gaze palsy, Hyperhidrosis, Nausea, Pallor, Posture abnormal, Skin warm, Unresponsive to stimuli, Visual impairment, Vomiting
Symptom Text: PT RECEIVED 3 VACCINES. AFTER RECEIVING LAST INJECTION WHICH WAS HPV IN L ARM, PATIENT BEGAN TO FEEL WEAK. PATIENT'S HEAD WENT TO THE LEFT SIDE. PATIENT BECAME UNRESPONSIVE TO NAME. SKIN PALE. PULSE PRESENT. BODY SWEATY AND WARM. PATIENT BECAME ALERT AGAIN. EYES OPEN, SPEECH SLURRED. EYES ROLLING. UNRESPONSIVE TO NAME AGAIN. PT VOICED, "I CAN NOT SEE". PT SWINGING ARMS, CRYING, AND STUMPING FEET ON THE FLOOR BUT NOT RESPONSIVE TO NAME. PT ALERT AGAIN. NOT ANSWERING TO NAME BUT VOICING, "I HAVE TO THROW UP." PT VOMITED MODERATE AMOUNT OF YELLOW SUBSANCE. PT UNRESPONSIVE AGAIN. COOL TOWEL PLACED TO PT HEAD. SPIRITS OF AMMONIA PLACED UNDER NOSTRIL. PT RESPONSIVE SHAKING HEAD. PT BECAME WEAK AGAIN. PT ASSISTED TO FLOOR. B/P 110/72. PULSE 72. INFORMED SCHOOL TO CALL PARENT AND 911. STAFF REPORTED MOTHER ON HER WAY BUT 911 CANCELLED. PT VOICED ONLY EATING MARSHMALLOW TREAT THIS MORNING. PT REMAINED ALERT. PEANUT BUTTER WITH JELLY GIVEN. PT CONTINUED TO SIT UP TALKING. LEFT WITH PARENT TO GO TO CLINIC TO BE ASSESSED BY DR. SPOKE WITH CLINIC DR. ABOUT EPISODE AND VACCINES GIVEN. DR. VOICED MAY HAVE BEEN PATIENT APPREHENSION WHICH THEY SEE WHEN ADOLESCENTS RECEIVE SHOTS. MAY HAVE BEEN MENACTRA BECAUSE THEY USUALLY HAVE PT TO LIE DOWN FOR 30 MINUTES AFTER RECEIVING MENACTRA. STAFF SPOKE WITH MOTHER AFTER DR. VISIT. MOTHER VOICED DR. STATED IT WAS THE HPV VACCINE. PATIENT WAS FEELING OKAY. RECOVERED. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE HISTORY OF FAINTING AFTER DENTAL WORK FOR UNKNOWN REASONS. NONE


Page 576
Vaers Id: 421576-1 Age Gender Vaccine Date Onset Date F 21-Apr-2011 21-Apr-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 25-Apr-2011 NY 22-Apr-2011 Lot Prev Doses Site 1560Z 0 Left arm
Crying, Emotional disorder, Excoriation, Lip haemorrhage, Lip injury, Syncope
Symptom Text: At approximately 2:30pm, patient sustained an abrasion to the bridge of her nose and a bloody lower lip as a result of an apparent unwitnessed syncope. She was found by the nurse sitting on the exam table crying and upset. I examined her and noted the abrasion & lower lip lacerations. I examined her 2 more times before patient left fully recovered at 3:35. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 577
Vaers Id: 421579-1 (O) Age Gender Vaccine Date Onset Date F 22-Mar-2011 12-Apr-2011 19.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 21
Status Date State Received Date 25-Apr-2011 US 22-Apr-2011 Lot Prev Doses Site 1561Z 0 Unknown
Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Haemorrhage
Symptom Text: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient who on 22-MAR-2011 was vaccinated with her first dose of GARDASIL (lot # not reported). Subsequently the patient discovered she was 5 to 5.5 weeks pregnant at the time of vaccination. Pregnancy test was performed which showed positive. Th patient had sought medical attention by office visit. Her last menstrual period (LMP) was approximately on 11-Feb-2011. Follow up information has been received from the women health nurse practitioner (WHNP) concerning the female patient with anxiety who on 22-MAR-2011 was vaccinated with a dose of GARDASIL (lot # 667930/1561Z) (dose # reported as #11). Concomitant therapy included XANAX. Concurrent conditions included GARDASIL for which the patient was treated with ALDARA cream from 22MAR-2011 to the present. From 22-MAR-2011 to present, the patient had been treated with ALDARA cream for papilloma viral infection (HPV). The patient's date of last menstrual period was in early February, and estimated delivery date was on 25-NOV-2011. On 30-MAR-2011, ultrasound performed for checking dates, revealed the patient had an intra-uterine pregnancy (IUP) which was about 5-5 and 1/2 weeks. On 03-APR-2011, an ultrasound was performed, and results revealed fetal bleeding. On 06-APR-2011, an ultrasound was performed, and results revealed bleeding, and possible spontaneous abortion (SAB). On 12-APR-2011, an ultrasound was performed, and results revealed bleeding, SAB. On 12-APR-2011, the patient experienced spontaneous abortion (<20 weeks) at 7 weeks from LMP. The products of conception were not examined. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 2/11/2011) anxiety; Papilloma viral infection XANAX, 0.5 mg ultrasound, 03/30/11, IUP 5-5 1/2 weeks; ultrasound, 04/03/11, bleeding; ultrasound, 04/06/11, bleeding, possible SAB; ultrasound, 04/12/11, bleeding, OX-SAB; beta-human chorionic, positive


Page 578
Vaers Id: 421582-1 (D) Age Gender Vaccine Date Onset Date M 01-Nov-2010 01-Nov-2010 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT
Days 0
DIED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Death, Sudden cardiac death
Symptom Text: Information has been received from a nurse practitioner concerning a patient's nephew, a 17 year old male consumer who she "thought" was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown Unknown


Page 579
Vaers Id: 421598-1 Age Gender Vaccine Date Onset Date F 22-Apr-2011 22-Apr-2011 11.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS HPV4 MERCK & CO. INC. MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Loss of consciousness, Syncope
Days 0
Status Date State Received Date 22-Apr-2011 MN 22-Apr-2011 Lot Prev Doses Site AC52B0676A 0 Left arm 08867 U3530AA 2 0 Right arm Left arm
Symptom Text: A few minutes after giving the hpv vaccine, the patient fainted, was unconscious for 40 seconds. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none no no, patient had not eaten or drank anything that day


Page 580
Vaers Id: 421602-1 Age Gender Vaccine Date Onset Date F 19-Jan-2011 22-Jan-2011 23.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Condition aggravated, Genital herpes
Days 3
Status Date State Received Date 25-Apr-2011 GA 22-Apr-2011 Lot Prev Doses Site NULL 0 Left arm
Symptom Text: A serious and unusually painful genital herpes outbreak occurred shortly after receiving the vaccination and lasted for an unusually long time for me, which was greater than 7 days. Usually outbreaks only last around 4 days for me. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: herpes simplex virus 2 No


Page 581
Vaers Id: 421606-1 Age Gender Vaccine Date Onset Date M 15-Apr-2011 20-Apr-2011 17.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 5
Status Date State Received Date 25-Apr-2011 FL 22-Apr-2011 Lot Prev Doses Site NULL 0 Unknown NULL 0 Unknown
Discomfort, Lethargy, Lip swelling, Oedema peripheral, Pain, Pharyngeal oedema, Pruritus, Rash erythematous, Rash generalised, Throat irritation, Urticaria
Symptom Text: On April 15th, 2011 my son 17 year old son went to see his pediatrician. At that appointment my son was given two vaccinations: Gardasil (1st dose) and Menactra. Five days later (April 20th, 2011) my son noticed he was itchy but thought nothing of it. He went to school and noticed a rash developing all over his body. Took my son back to the pediatrician and she put him on the corticosteroid Prednisone and advised him to take Benadryl as needed. The next morning (April 21st, 2011) my son woke up with horrifying strange looking, raised welts/severe hives all over his body. My son continued with the Prednisone and Benadryl every four hours. The raised welts/severe hives raged all day and night migrating to different body parts. The would also change from welts to red, raised bumps. At the end of this night my son's lips were twice the size they usually were and he was feeling his throat getting inflammed. His hand were also swelling. Gave him another dose of Benadryl and the lip and throat swelling somewhat subsided. My son spent the whole day in severe pain. He attempted to sleep that night but his feet started to swell as well. Today is the 3rd day since these episodes have started (today is April 22nd, 2011. The welts have subsided but every few hours between Benadryl doses a red, bumpy rash starts to redevelop on his arms, back, stomach and legs. Son feels lethargic, very itchy and uncomfortable. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Amoxicillin allergy None


Page 582
Vaers Id: 421607-1 Age Gender Vaccine Date Onset Date M 22-Apr-2011 22-Apr-2011 24.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 0
Status Date State Received Date 25-Apr-2011 MA 23-Apr-2011 Lot Prev Doses Site NULL 2 Left arm
Arthralgia, Back pain, Body temperature increased, Dizziness, Headache, Injection site pain, Malaise, Myalgia
Symptom Text: First my arm where I was injected started to hurt more and more, then my back started to hurt that night. The next morning I woke up all my muscles and joints hurt similar to when a person gets the flu, as the day went on I developed a worsening headache, dizziness, malaise, then that night I had a temperature of 101.5. I'm not sure if this is the worst of it because I am reporting this as it is happening, but it's the worst reaction I've ever had to a vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Morphine, Monastat and Benadryl allergies none


Page 583
Days 0
Status Date State Received Date 25-Apr-2011 OH 24-Apr-2011 Lot Prev Doses Site 1016Z 1 Left arm
Back pain, Gait disturbance, Musculoskeletal pain, Pain in extremity
Symptom Text: Patient developed left sided back pain that was severe and without trauma. He had difficulty walking and went to urgent care for immediate treatment. He was evaluated and did not receive any medication for the musculoskeletal pain. He took Tylenol for 3 days and the pain completely resolved at that point. Two weeks later he developed severe left leg pain that is similar in nature to the back pain that he felt. He had no swelling or fever etc and it also resolved in a few days. He took Motrin for this pain as well. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Adderall XR 30mg, Motrin 600 mg ADHD, Allergic Rhinitis None


Page 584
Vaers Id: 421617-1 Age Gender Vaccine Date Onset Date F 19-Apr-2011 20-Apr-2011 10.0 Type Manufacturer VAX Detail: TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Pain, Urinary tract infection, Vomiting
Days 1
Status Date State Received Date 26-Apr-2011 CA 22-Apr-2011 Lot Prev Doses Site U3872AA 0 Unknown 1569Z 0 Unknown
Symptom Text: Later that night, 10 yo taken to ER bec. in pain & emesis. Diagnosed w/ UTI & given antibiotics. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Urinalysis Minor hay fever Allergic rhinitis; Headache


Page 585
Vaers Id: 421627-1 Age Gender Vaccine Date Onset Date M 22-Apr-2011 22-Apr-2011 13.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Dizziness, Pallor, Syncope
Days 0
Status Date State Received Date 26-Apr-2011 IL 22-Apr-2011 Lot Prev Doses Site 1570Z 0 Right arm
Symptom Text: Faint/dizzy/pale - 3min after HPV #1. Sitting on exam table. Had just had "finger stick" for hemoglobin. Occurred quickly. NO LOC. Placed supine. VS. monitored for 20 min -> full recovery. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Multi-vitamins None None None


Page 586
Days
Status Date State Received Date 26-Apr-2011 NC 25-Apr-2011 Lot Prev Doses Site NULL Unknown
Symptom Text: Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning a female patient, who on an unknown date, was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported), and experienced a miscarriage. At the time of the report, the patient's outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) Unknown Unknown


Page 587
Vaers Id: 421642-1 (O) Age Gender Vaccine Date Onset Date F 12-Oct-2010 15-Apr-2011 Unknown Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 185
Status Date State Received Date 26-Apr-2011 NC 25-Apr-2011 Lot Prev Doses Site NULL Unknown
Mfr Report Id Last Edit Date WAES1104USA02227B 27-Apr-2011 1 Other Vaccine Route Unknown
Drug exposure before pregnancy, Foetal disorder
Symptom Text: Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning an approximately 20 weeks months of gestation fetus, whose mother was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported) on approximately 12-OCT-2010, one month prior to conception (Previously reported in WAES#: 1104USA02227). Physician reported that on an unknown date a serum alpha-fetoprotein test (AFP) screening was performed and it was abnormal, and that on 15-APR-2011, an ultrasound of the fetus showed hypoplastic right heart and open neural tube encephalophy. At the time of the report, the patient's outcome was unknown. Hypoplastic right heart and open neural tube encephalophy were considered to be congenital anomalies by the physician. This is one of several reports from the same source. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Ultrasound, 04/15/11, abnormal; serum alpha-fetoprotein, abnormal Unknown


Page 588
Vaers Id: 421643-1 (O) Age Gender Vaccine Date Onset Date F 05-Apr-2011 Unknown 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days
Status Date State Received Date 26-Apr-2011 US 25-Apr-2011 Lot Prev Doses Site 1437Z 0 Unknown
Symptom Text: Information has been received from a Nurse practitioner and the patient's grandmother, for GARDASIL, a Pregnancy Registry Product, concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies reported, who on 05-APR-2011 was vaccinated with her first dose of GARDASIL (Lot #: 667866/1437Z, Exp: 25-FEB-2013) (Dose and route not reported). Concomitant therapy included a dose of MENACTRA (lot #, dose and route not reported). The nurse reported that the patient received the first dose of GARDASIL and then was found to be pregnant. The patient performed a pregnancy test at home on 05-APR-2011, prior to receiving the first dose of GARDASIL. The office discovered the pregnancy on 05-APR2011, when they performed a pregnancy test in the office (for another procedure) after the patient received the first dose of GARDASIL. The grandmother reported that while her granddaughter was in the clinic on 05-APR-2011, she had a urine pregnancy test before the first dose of GARDASIL. No adverse event reported. Home and office (unspecified type) pregnancy tests were performed with positive results and unspecified blood tests (results not provided). Follow-up information was received from the patient's grandmother who stated that on an unspecified date in April 2011, the patient's pregnancy had miscarried. Upon the internal review, miscarriage was determined to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) beta-human chorionic, 04/05/11, positive (performed at home); urine beta-human, 04/05/11, positive (performed at the office)


Page 589
Vaers Id: 421670-1 Age Gender Vaccine Date Onset Date U 21-Apr-2011 21-Apr-2011 16.0 Type Manufacturer VAX Detail: MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Presyncope, Syncope
Days 0
Status Date State Received Date 26-Apr-2011 CA 25-Apr-2011 Lot Prev Doses Site U3512AA Unknown 0786Z Left arm
Symptom Text: Fainting (vasovagal) post vaccination. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: PPD None None


Page 590
Days 1
Status Date State Received Date 28-Apr-2011 AZ 26-Apr-2011 Lot Prev Doses Site 1561Z 2 Unknown
Dysphonia, Erythema, Headache, Pain in extremity, Pyrexia, Swelling face, Throat tightness, Vaccination complication
Symptom Text: Mother called our office this morning at 8:06 a.m. stating that patient received her HPV vaccine yesterday afternoon and woke up this morning with severe headache. She also mentioned that her face was red and swollen and she had tightness in her throat and her voice was raspy. In addition, her arms were achy. Mother brought her to ER where she was found to have a fever of 101.0 degrees. She was given MOTRIN for headache. She was also discharged on BENADRYL. I called mother at noon and she told me that patient was improving. I spoke with Dr. He felt this was a vaccine reaction. He did not recommend any other treatment at this time. I asked mother to call back in a.m. if she is not improving or sooner if worse. I will file a VAERS report. I told mother I would not file the report until I see what patient's final outcome is. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 591
Vaers Id: 421736-1 Age Gender Vaccine Date Onset Date F 26-Apr-2011 26-Apr-2011 26.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Syncope
Days 0
Status Date State Received Date 28-Apr-2011 NH 26-Apr-2011 Lot Prev Doses Site 0886Z 0 Left arm
Last Edit Date 05-May-2011 Other Vaccine TDAP
Symptom Text: Syncopal event within about 10 min of administration of GARDASIL. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: YAZ OCP None Mild intermittent asthma None


Page 592
Vaers Id: 421737-1 Age Gender Vaccine Date Onset Date F 07-Apr-2011 07-Apr-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Discomfort, Erythema, Pruritus, Skin warm
Days 0
Status Date State Received Date 28-Apr-2011 ME 26-Apr-2011 Lot Prev Doses Site 0819Y 1 Left arm C3554AA 0 Right arm
Symptom Text: Right arm redness, warmth, discomfort, and mild pruritis. No constitutional symptoms. IBU 200mg three times daily - BENADRYL 12.5mg three times daily PRN - Ice area x 15 mins 3-4 times daily - F/U PRN. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No known allergies/Injury to Peroneal Nerve (R) (R) wrist pain


Page 593
Vaers Id: 421742-1 Age Gender Vaccine Date Onset Date F 25-Oct-2010 01-Nov-2010 29.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 7
Status Date State Received Date 27-Apr-2011 FL 27-Apr-2011 Lot Prev Doses Site NULL 1 Right arm
Ankylosing spondylitis, Diplopia, Migraine, Pain, Periorbital oedema, Vision blurred
Symptom Text: Severe peri-orbital edema, migraine headaches resulting in diplopia, blurred vision, and increased pain levels. Symptoms occured bilaterally, and have persisted greater than 5 months. The second shot was administered 12/16/10, and symptoms worsened. Treated in the ER and by primary care physician with a course of steroids, prednisone to decrease the peri-orbital edema. Additionally, ice packs for 10-15 min increments several times daily and ibuprofen up to 600-800mg every 6 hours. Demerol was prescribed for pain management as well. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BCP-OVCON 35 Daily vitamin Allergy to vicodin, and many other pain medications. No known illness at the time. Later diagnosed with ankylosing spondylitis.


Page 594
Vaers Id: 421779-1 Age Gender Vaccine Date Onset Date Days F 19-Apr-2011 19-Apr-2011 0 12.0 Type Manufacturer VAX Detail: MNQ NOVARTIS VACCINES AND DIAGNOSTICS TDAP SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Status Date State Received Date 28-Apr-2011 CA 27-Apr-2011 Lot Prev Doses Site A10031 0 Right arm C3517AA 1167Z 0 0 Left arm Right arm
Dizziness, Headache, Incoherent, Nausea, Pallor, Vomiting
Symptom Text: Nausea, vomiting, pale, H/A, lightheadedness, incoherent. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 595
Vaers Id: 421784-1 Age Gender Vaccine Date Onset Date F 02-Feb-2011 03-Feb-2011 12.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Induration
Days 1
Status Date State Received Date 28-Apr-2011 WA 27-Apr-2011 Lot Prev Doses Site 0565Z 1 Left arm 0896Z 1 Right arm
Mfr Report Id Route Intramuscular Subcutaneously
Symptom Text: Developed a region of erythema and duration. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 596
Vaers Id: 421785-1 Age Gender Vaccine Date Onset Date F 19-Apr-2011 20-Apr-2011 11.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 1
Status Date State Received Date 28-Apr-2011 WV 27-Apr-2011 Lot Prev Doses Site 1326Z 1 Unknown 0992Z Right arm AC52B048AC Left arm U3479AA Right arm
Mfr Report Id Route Subcutaneously Unknown Unknown Unknown
Cellulitis, Erythema, Headache, Nausea, Swelling, Urticaria
Symptom Text: Red, swollen with welt. C/o headache & some nausea. Went to ER 4/21/11 in AM they gave her antibiotic (KEFLEX) & mother has been using ice packs for comfort. ER advised it was cellulitis. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergy cough


Page 597
Vaers Id: 421808-1 Age Gender Vaccine Date Onset Date Days M 25-Apr-2011 25-Apr-2011 0 17.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. MNQ NOVARTIS VACCINES AND DIAGNOSTICS TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Dysarthria, Dyspnoea
Status Date State Received Date 28-Apr-2011 CA 27-Apr-2011 Lot Prev Doses Site 1271Z 1 Left arm M10031 0 Right arm C3517AA 0 Right arm
Symptom Text: Shortness of Breath, B/P 70/42, Pulse 54, O2 sat 88%, slurred speech IV started by ENT Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: O2 Sat 88% none none


Page 598
Vaers Id: 421810-1 Age Gender Vaccine Date Onset Date M 25-Apr-2011 25-Apr-2011 15.0 Type Manufacturer VAX Detail: HPV4 MERCK & CO. INC. TDAP SANOFI PASTEUR Seriousness: MedDRA PT ER VISIT, NOT SERIOUS Chest pain, Dizziness, Dyspnoea
Days 0
Status Date State Received Date 28-Apr-2011 CA 27-Apr-2011 Lot Prev Doses Site 1271Z 0 Left arm C3517AA 0 Right arm
Symptom Text: Difficlty breathing, Chest Pain, Dizziness Patient was put on O2 IV started by ENT Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 599
Vaers Id: 421812-1 Age Gender Vaccine Date Onset Date F 26-Apr-2011 26-Apr-2011 18.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. Seriousness: MedDRA PT ER VISIT, NOT SERIOUS
Days 0
Status Date State Received Date 28-Apr-2011 IL 27-Apr-2011 Lot Prev Doses Site 1038Z 1 Left arm 0096Z 2 Right arm
Hypoaesthesia, Joint swelling, Limb discomfort, Pain in extremity, Paraesthesia, Peripheral coldness
Symptom Text: Pain shooting down (R) arm & fingers hurting started 8pm 4-26-11, 4-27-11 morning noticed (R) hand cold & cold to touch, c/o knuckles swollen & can't bend to a fist w/o pressure & pain, c/o (R) palm tingling & (R) 3-5 fingers numb & tingling. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Rash, swelling~Vaccine not specified (no brand name)~UN~0.00~Patient ZYRTEC Allergies: Sulfa, Iodine, PCN; Medical conditions: migraines


Page 600
Vaers Id: 421897-1 Age Gender Vaccine Date Onset Date F 25-Apr-2011 Unknown 10.0 Type Manufacturer VAX Detail: VARCEL MERCK & CO. INC. HPV4 MERCK & CO. INC. TDAP GLAXOSMITHKLINE BIOLOGICALS Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Injection site erythema
Days
Status Date State Received Date 29-Apr-2011 CA 28-Apr-2011 Lot Prev Doses Site 1196Z Unknown 1167Z Unknown AC52B057EA Unknown
Symptom Text: Red around the vaccine area, in where it was administered. BENADRYL was given at office. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 601
Vaers Id: 421905-1 Age Gender Vaccine Date Onset Date Days M 25-Apr-2011 26-Apr-2011 1 13.0 Type Manufacturer VAX Detail: TDAP GLAXOSMITHKLINE BIOLOGICALS MEN UNKNOWN MANUFACTURER HPV4 MERCK & CO. INC. VARCEL MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS Erythema, Swelling
Status Date State Received Date 29-Apr-2011 CA 28-Apr-2011 Lot Prev Doses Site AC52B056BB 5 Left arm 022011 0097Z 1196Z 0 0 1 Left arm Right arm Left arm
Mfr Report Id Route Unknown Unknown Unknown Subcutaneously
Symptom Text: Redness and swelling to (L) outer aspect, noticed 24 hrs after vaccines. Tx BENADRYL & ice packs to site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 602
Vaers Id: 421912-1 Age Gender Vaccine Date Onset Date F 03-Mar-2011 04-Mar-2011 17.0 Type Manufacturer VAX Detail: HEPA GLAXOSMITHKLINE BIOLOGICALS MNQ SANOFI PASTEUR HPV4 MERCK & CO. INC. Seriousness: MedDRA PT NO CONDITIONS, NOT SERIOUS
Days 1
Status Date State Received Date 29-Apr-2011 MI 29-Apr-2011 Lot Prev Doses Site AHAVB462BA Right arm U3556AA 0887Z Right arm Left arm
Chills, Erythema, Pruritus, Rash generalised, Rash maculo-papular
Symptom Text: Grandmother called and spoke to doctor and states pt awoke with rash from head to toe, positive itching and feels chilled. Grandmother denies SOB and throat swelling. Also, states coughing but feels pt had cough previous. Pt saw Dr. on 03/04/2011. Dr. noted macular papular erythema on face, trunk and extremities. Dr. gave pt Benadryl. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Prilosec QD Levisin PRN Paxil QD No known drug allergies. Allergic to marshmallow causes hives and swelling of the throat. Pt stats hx of neuromuscular disorder, IBS, GERD and anxiety. No


Page 603
Days 1
Status Date State Received Date 29-Apr-2011 PA 29-Apr-2011 Lot Prev Doses Site 1178Y 0 Left arm
Injected limb mobility decreased, Injection site swelling
Symptom Text: Swelling at Immunization site since given 4/4/11. Sometimes as large as an egg. Swelling typically goes down inthe pm and recurrs during the daytime. Inability to lift arm above 45 degree angle. These signs and symptoms reported to provider by patient. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Tramadol prn for back pain. perscribed orthotricyclen that day None that provider was aware None that provider was aware of
Total Non Serious Total Serious Non Fata Total Death: Total All Reports
474 106 5 585
81% 18% 1%

VAERS Line List Report: Vax Type: HPV4 Status Date: 01-JAN-11 - 30-APR-11 All Comb. w/AND

Hochgeladen von

Dokumentinformationen

Originalbeschreibung:

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

VAERS Line List Report: Vax Type: HPV4 Status Date: 01-JAN-11 - 30-APR-11 All Comb. w/AND

Hochgeladen von

Copyright:

Verfügbare Formate

FDA Freedom of Information Distribution

Report run on: 22 SEP 2011 08:06