A.E.F.I.

Adverse Event
Following
Immunization

AEFI is defined as:

A medical event that takes
place after an immunization,
causes concern and is believed
to be caused by immunization
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It is important that AEFIs are detected,

investigated, monitored and promptly
responded to for corrective interventions.

Types of AEFIs

Program Errors
Vaccine reactions
Coincidental
Injection reaction
Unknown

Types of AEFI
1. Programmatic Error
Due to error in vaccine preparation, handling or
administration.
Majority of AEFIs occur due to programmatic errors
and preventable
Non-sterile
needle

Suppurative
Lymphadenitis

GROUP WORK
on Programmatic Error

Common programmatic
errors
which can lead to AEFIs

Non-sterile injection

Contact of needle with unsterile surface

e.g. finger, swab, table etc.
Infection
can manifest
Administering
injectionas:
over clothes
Contaminated
Local
reaction vaccine
suppuration,
abscess
or diluent
Use of reconstituted
vaccines
beyond
Systemic
effect sepsis,
toxic shock
the stipulated 4 hours
syndrome
Reuse of reconstituted vaccine at
Blood
borne virus infection HIV, HBV, HCV
subsequent sessions
Reuse of disposable syringe & needle
Time ??

Common programmatic
errors
which can lead to AEFIs
Reconstitution error/ Wrong vaccine preparation
Reconstitution with incorrect diluent
- less vaccine effectiveness
Drug substituted for diluent drug reaction, death
Inadequate shaking of T-series vaccines
local abscess

Injection at incorrect site/route

Injection into gluteal region (buttocks)
sciatic nerve damage
BCG /T series vaccine given subcutaneously
local reaction or abscess

Common programmatic
errors
which can lead to AEFIs
Vaccine transportation/storage
incorrect
Administration of frozen and thawed
freeze-sensitive vaccine -local reaction
such as sterile abscess

Contraindications ignored
DPT2 given after H/O convulsions with DPT1
- convulsions

Common program errors can be

prevented by : training of H.W.
regular supervision
adequate supply / availability of
logistics

Types of AEFI
2. Vaccine Reaction
An event caused or precipitated by the active
component or
one of the other components of the vaccine (e.g.
adjuvant,
preservative or stabilizer).
This is due to the inherent properties of the vaccine.
A. Common, minor vaccine reactions
local reaction (e.g. pain, swelling and/or redness, fever).
- Local reactions and fever should be anticipated in only 10% of the vaccine
recipients, except in the case of whole cell DPT which produces fever in
nearly half of those vaccinated.

Types of AEFI
2. Vaccine Reaction
- Fever and minor local and systemic reactions usually occur within a day
or
two of immunization (except for those produced by measles/MMR
vaccine
which occurs 6 to 12 days after immunization) and only last for few days.
- Fever and minor local reactions can usually be treated symptomatically with
paracetamol.
-

systemic symptoms (e.g. vomiting, diarrhoea, malaise)

B. Rare serious vaccine reactions

High (39-40.4oC / 102-104.7oF) to extreme fevers (>40.5oC/105 oF)
indicate the possibility of:
Anaphylaxis - potentially fatal allergic reaction, but treatable

Types of AEFI
3. Coincidental Event
An event that occurs after immunization but is not caused
by the vaccine. This is due to a chance temporal association
Example: pneumonia after oral polio vaccine administration

4. Injection Reaction
Event caused by anxiety about, or pain from the injection
itself rather than the vaccine
Example: fainting spell in a teenager after vaccination

5.
Unknown
Any event due to undetermined cause.

JIGSAW PUZZLE

Isolated and Clusters of AEFI

Isolated AEFI:
This is a solitary medical incident that takes
place after immunization, causes concern and
is believed to be caused by immunization
Cluster AEFI:
A cluster is defined as two or more cases of the
same or similar event, which is related in time, and
has occurred within the same district or
geographical unit, or associated with the same
vaccine, same batch number administered or same
vaccinator

Reporting AEFIs
Why report AEFIs ?
Effective means of monitoring immunization
safety
Contributes to quality & credibility of program
Helps in clinical management of case
Identify gaps in program implementation (if
any)
Helps identify actual rate of occurrence.
Avoids false rumors
Build confidence of public in program

AEFI Surveillance- Reporting

system

Immediate reporting: Serious AEFIs

Deaths
Hospitalization
Cluster
Disability
Routine Monthly report:
o Abscesses
o Deaths
o Others

Non serious AEFIs

Minor reactions following immunization are
common
These include pain & swelling at the site of
injection, fever, irritability, malaise
These are self-limiting, hardly requiring even
symptomatic treatment
However, it is important to reassure parents
about such events, so that they know about it

MANAGEMENT OF COMMON, MINOR

REACTIONS
Local pain

Application of ice

Fever > 38C / 100.4F

give extra fluids orally
tepid sponging
Paracetamol

Irritability malaise and systemic

symptoms
give extra fluids orally
Paracetamol (ensure correct dose is given)

Examples of Contraindications
(WHO Immunization Policy 2002)
Vaccine

Contraindication

All
vaccines

Anaphylactic reaction to vaccine or

vaccine constituent;
Severe febrile illness

DTP

Anaphylaxis to previous dose or any

constituent

Measles

Severe reaction to previous dose,

congenital or acquired immune
disorders (not asymptomatic HIV),
pregnancy

Hepatitis
B

Anaphylaxis to previous dose

Reporting of AEFIs
What to report

For Immediate
Reporting and
Investigation
SERIOUS AEFIs
Death
Hospitalization
(anaphylaxis,
anaphylactoid reaction, TSS,
Encephalopathy, Sepsis)
Any event where vaccine
quality is suspected
Events occurring in a
cluster

How to
report
Telephone or
any other
quick means
of
communicati
on

Who reports to Whom

HWs
SIO

MO

DIO/CMO

FIR (First Information

Report)

PIR
(Preliminary Investigation
Report)
DIR
(Detailed Investigation
report)

When to
report
Immediately

Within 24
hrs
to District &
48 hrs to
State and
GOI
Within 7
days
Within 90
days

For Routine Monthly

reporting
Deaths
Injection site abscesses
Persistent (> 3hrs) screaming
HHE
Severe local reaction
Seizures including febrile

UIP Report

HWs
SIO

MO

DIO/CMO
Monthly

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