Presented By- Dr Akshatha N

Guide- Dr B G Parasuramalu
 Definition
 Classification Of AEFI
 Vaccine Reactions-Types
 Events to be reported & investigated
 AEFI Clusters
 Steps in AEFI Investigation
 Contraindications to vaccines
 References
 Adverse event following immunization is any untoward
medical occurrence which follows immunization and
which does not necessarily have a causal relationship
with the usage of the vaccine.
 The adverse event maybe any unfavourable or
unintended sign , abnormal laboratory finding,
symptom or disease.
Vaccine product-related reaction

Vaccine quality defect-related reaction

1. Vaccine product-related reaction- reaction of an
individual’s response to inherent properties of the vaccine,
even when the vaccine has been prepared, handles and
administered correctly.
◦ e.g. Extensive limb swelling post DPT( Due to
adjuvant aluminium phosphate)
◦ Transient minor local erythema, indurations,
tenderness after IPV (formaldehyde used for
inactivation of polio virus)
2. Vaccine quality-related reactions- defect in a vaccine
that has occurred during manufacturing process. Such a
defect may have an impact on an individual’s response
and thus increase the risk of adverse reactions.
e.g. Cutter Case Study, Failure by the manufacturer to
completely inactivate a lot of polio vaccine leads to
cases of paralytic polio.
A. Common, minor vaccine reactions
• Occurs within hours of injection.
• Local reactions include pain, swelling &/or redness at the
injection site & can be expected in about 10% of vaccines,
except for those injected with DTP(whole cell), or tetanus
boosters where up to half can be affected.
e.g. Extensive limb swelling post DPT( Due to adjuvant
aluminium phosphate)
Local reaction following DPT
e.g.- BCG: specific local reaction, starts as a papule 2 or more
weeks after immunization, that becomes ulcerated and heals
after several months leaving a scar.
• Resolve after a short period of time.
• Systemic reactions include fever, malaise, muscle pain, head
ache and loss of appetite
e.g.- Measles vaccine causes fever, rash, conjunctivitis in 5-15%,
can severely affect immuno-compromised individuals
 Common Minor Reactions
Vaccine Possible Minor Expected Frequency
Reactions
BCG Local Reaction Common
Cholera Oral Presentation- none
DTP Local Reaction, Fever Up-to 50%
Hepatitis A Local reaction Up-to 50%
Hepatitis B Local Reaction, Fever Up-to 30% adults & 5%
children
Hib Local Reaction, Fever 5-15%
Measles/ Local Reaction, low Up-to 10%
grade fever Up-to 5%
MMR irritability, malaise, non
specific symptoms
Japanese Encephalitis Local reaction, fever, Up-to 20%
malaise, GI upset
Pneumococcal Vaccine Local reaction 30-50%
OPV None
IPV None
 Rare, Severe vaccine reactions.
◦ Can be disabling, rarely life threatening.
◦ Does not lead to long-term reactions
◦ An AEFI will be considered serious if it is life threatening,
requires in-patient care or prolonged hospitalization, results in
persistent or significant disability/incapacity or requires
intervention to prevent further or permanent damage.
◦ Includes seizures, anaphylaxis, encephalopathy etc
 • Death

SERIOUS
• Serious Hospitalization
• Persistent or significant disability

AEFI
or incapacity
• Congenital anomaly or birth defect
• Life-threatning
Vaccine Reaction Interval Number of
between events per
vaccination & million doses
onset
BCG Suppurative lymphadenitis 2-6 months 100-1000
BCG Osteitis
Disseminated BCG infection 1-12 months 1-700
1-12 months 2
Hepatitis B Anaphylaxis 0-1 hour 1-2
Guillain-Barre Syndrome 1-6 weeks 5
Measles Febrile seizures 5-12 days 333
Thrombocytopenia 15-35 days 33
Anaphylaxis 0-1 hour 1-50
OPV Vaccine- associated paralytic 4-30 days 1.4-3.4
polio
Tetanus Brachial Neuritis 2-28 days 5-10
Anaphylaxis 0-1 hour 1-6
DPT Persistent (>3hrs) inconsolable 0-24 hrs 1000-60000
screaming
Seizures 0-3 days 570
Hypotonic hypo responsive 0-24 hrs 570
Episode 0-1 hour 20
 Immunization error results from errors in vaccine
preparation, handling, storage or administration.
 “Usage” process that occur after a vaccine product has
left the manufacturing/packaging site i.e. Handling,
prescribing and administration of the vaccine.
e.g. Contaminated multi-dose vial of Measles with
Staphylococcus aureus can cause Toxic Shock
Syndrome
 Is associated with a particular provider, or health
facility, or even a single vial or vaccine that has been
inappropriately prepared or contaminated.
 Can also affect many vials e.g. Freezing vaccine during
transport may lead to increase in local reactions. (e.g.
DPT)
 An immunization error-related reaction may lead to
cluster of events defined as two or more cases of same
adverse event related in time place or vaccine
administered.
Error In Exposure to excess heat Systemic or local reactions due
Handling or cold due to to changes in the physical
Vaccines inappropriate transport, nature of the vaccine such as
storage or handling of the agglutination of aluminium
vaccine(or diluents) based excipients of freeze
where applicable. sensitive vaccine.
Use of products after Failure to vaccinate as a result
expiry dates. of loss of potency or non
viability of an attenuated
product.
Error in vaccine Failure to adhere to Anaphylaxis, disseminated
prescribing or contraindications. infection with an attenuated live,
non adherence to VAPP
recommendations Failure to adhere to vaccine Systemic &/or local reactions,
for use indications or prescriptions neurologic, muscular, vascular
or bony injury due to incorrect
site, technique or equipment.
Error in Use if incorrect diluents or Failure to vaccinate due to
administration injection of a product other incorrect diluent, reaction due to
than the intended vaccine. inherent properties of whatever
was administered other than
Incorrect sterile technique intended vaccine or diluent.
or inappropriate procedure Injection at the site of or beyond
with a multidose vial the site of injection.
 Immunization error Possible AEFI
Non-sterile injection: Reuse of •Local injection site reactions (e.g.,
disposable syringe or needle leading to abscess, swelling, cellulitis, induration),
contamination of the vial, especially in •Sepsis
multi-dose vials, •Toxic shock syndrome
Improperly sterilized syringe or needle, •Blood-borne transmission of disease, e.g.,
Contaminated vaccine or diluent. hepatitis B, HIV,
•Death

Reconstitution error: Inadequate shaking •Local abscess,

of vaccine,
Reconstitution with incorrect diluent,
Drug substituted for vaccine or diluent,
Reuse of reconstituted vaccine at
subsequent session.
•Vaccine ineffective*,
•Effect of drug, e.g., insulin, oxytocin,
muscle relaxants,
•Toxic shock syndrome,
•Death.

Injection at incorrect site: •Local reaction or abscess or other local

•BCG given subcutaneously reaction,
•DTP/DT/TT too superficial •Sciatic damage
•Injection into buttocks
Immunization error Possible AEFI
Vaccine transported/stored incorrectly Increased local reaction from frozen
Freezing vaccine during transport, vaccine,
Failure to keep vaccine in cold chain, Ineffective vaccine*
exposing to excessive heat or cold

Contraindication ignored: Vaccination

staff ignoring or not becoming familiar
Avoidable severe reaction
with contraindications for a vaccine.

* Ineffective vaccine is not strictly an adverse event; it is a vaccine failure.

 Individuals and groups can react in anticipation to & as
a result of an injection of any kind.
 This reaction is unrelated to the content of the vaccine.
 Fainting most common.
 Can lead to pale, fearful appearance, symptoms of
hyperventilation(light headedness, dizziness, tingling in
hands & around the mouth); breath holding in young
children leading to unconsciousness.
 Occasionally following immunization there may occur
a disease totally unconnected to the immunizing agent.
 Mechanism- that the individual is harbouring the
infectious agent & the administration of vaccine
shortens the incubation period and produces the disease
or what may have been otherwise only a latent
infection is converted into a clinical attack.
 Any death, hospitalization, disability or any
other serious events.
 Anaphylaxis
 Toxic Shock Syndrome (TSS)
 Anaphylactoid reaction
 Acute Flaccid Paralysis
 Encephalopathy
 Sepsis
 Any event where vaccine quality is suspected
 Any cluster of events
 Two or more cases of abscesses following vaccinations
administered in a single immunization session, weather
fixed or outreach (duration of time in hours)
 Two or more cases of deaths following measles
vaccination during a mass immunization campaign
over several days.
 An outbreak of lymphadenitis 3 months after BCG
immunization was traced to a switch to a different
strain of vaccine. The investigation also highlighted a
number of immunization errors (vaccines not properly
reconstituted, and injections not given intradermally).
 Cause: vaccine reaction compounded by
immunization errors.
 Four children died and a fifth was hospitalized after
receiving measles vaccine from the same vial. The
vaccine was not refrigerated, and was transported from
house to house for immunization. Reactions began 4-5
hours after vaccination, with vomiting,
unconsciousness, and meningeal irritation.
Staphylococcus aureus bacteria were cultivated from
the incriminated vial.
 Cause: sepsis caused by inappropriate vaccine
handling.
1. At field level
2. At PHC level
3. At Medical Institution level
4. At district Level
5. Regional Investigation level
1. At community level
2. At PHC level
3. At District level
4. At State level
 Confirm information in report
◦ Obtain patient’s medical file
◦ Check patient & event related details
◦ Identify other cases
 Investigate & collect data
◦ immunization history, previous medical history, family history
◦ History, clinical description, laboratory results, diagnosis of the
event.
◦ About suspected vaccine- shipping , storage conditions, cold
chain maintenance
◦ About other people- if others suffering from same reactions,
similar illnesses; investigate the local immunization service
 Assess & observe
◦ Assess vaccine storage, distribution, disposal; reconstitution; use &
sterilization of syringes & needles; refrigerators, immunization
procedures, Contamination of vials
 Formulate working hypothesis
◦ On the likely possible cause of the event
 Test working hypothesis
◦ Does case distribution match working hypothesis?
◦ Laboratory tests may help occasionally.
 Conclude investigation
◦ Reach a conclusion on the cause.
◦ Complete AEFI investigation form.
◦ Take corrective action & recommend further action
 https://vaccine-safety-training.org/adverse-
events-classification.html
 http://vaccine-safety-
training.org/examples-aefi-clusters.html
 Park’s Text Book Of Preventive And Social
Medicine 24th Edition
 https://mohfw.gov.in/about-
us/departments/departments-health-and-
family-welfare/immunization