AEFI

ADVERSE EVENT FOLLOWING

IMMUNIZATION
 Contents of this lecture
• Definition of AEFI
• Classification of AEFIs
• Serious AEFI
• Examples of AEFIs
• Reporting and Surveillance of AEFIs
 Definition
• An AEFI 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
may be any unfavorable or unintended sign,
abnormal laboratory finding, symptom or
disease.
 AEFI Frequency Terminology
Very common* > 1/10 > 10%

Common
(frequent) > 1/100 and < 1/10 > 1% and < 10%

Uncommon
> 1/1,000 and < 1/100 > 0.1% and < 1 %
(infrequent)
> 1/10,000 and <
Rare 1/1,000 > 0.01% and < 0.1%

Very rare* < 1/10,000 < 0.01%

* Optional categories
Classification of AEFIs
CIOMS/ WHO cause specific definition of AEFIs

1 2 3 4 5
Vaccine Vaccine quality Immunization Immunization
product- defect-related error-related anxiety-related Coincidental
related reaction reaction reaction event
reaction

An AEFI that is
caused or
precipitated by
An AEFI that is
An AEFI that is a vaccine that
caused by
caused or is due to one An AEFI that is
An AEFI arising something
precipitated by or more caused by
from anxiety other than the
a vaccine due quality defects Inappropriate
about the vaccine
to one or more of the vaccine vaccine
immunization. product,
of the product handling,
immunization
inherent including its prescribing or
error or
properties of administration administration
immunization
the vaccine device as .
anxiety
product. provided by
the
manufacturer.

AEFI Basic concepts Module B | May 2013 | 6

CIOMS/ WHO cause specific definition of AEFIs

1 2 3 4 5
Vaccine Vaccine quality Immunization Immunization
product- defect-related error-related anxiety-related Coincidental
related reaction reaction reaction event
reaction

EXAMPLE
Failure by the EXAMPLE
EXAMPLE EXAMPLE A fever after
EXAMPLE manufacturer vaccination
Extensive Transmission Vasovagal (temporal
to
limb swelling of infection by syncope in an association)
completely
following DTP contaminated adolescent and malarial
inactivate a
vaccination. multidose following parasite
lot of
vial. vaccination. isolated from
inactivated
polio vaccine blood.
leads to cases
of paralytic
polio.

AEFI Basic concepts Module B | May 2013 | 7

Vaccine Reactions
Two types of vaccine reactions-
Minor and Severe
Two types of vaccine reactions-
Minor and Severe
 Two types of vaccine reactions-
Adjuvants
Minor and S e vaccine
(impr antigens,
ove the most often in
killed vaccine)
Stabilizers [Aluminium
(help the vaccine maintain its
effectiveness during storage)
v e2, MgSO
r e 4] salts]
[MgCl imm une re sponse to
Antibiotics
(to prevent bacterial
contamination of the tissue
Antigen culture cells in which the viruses
are grown)
[Live, Killed, [Neomycin]
Purified, Preservatives
Inactivated (added to multidose vaccines to
prevent bacterial and fungal
toxin] growth)

[Thiomersal,
Formaldehyde
]
AEFI Reporting and Surveillance
Vaccine safety terminology: Serious adverse event/reaction

• Death

• Hospitalization or prolongation of
existing hospitalization
Serious (e.g., encephalopathy, seizures, aseptic meningitis)

• Persistent or significant disability or

AEFI incapacity (e.g., paralysis)
• Congenital anomaly/birth defect

• Life-threatening

‘Serious’ is not synonymous with ‘severe’ (i.e., intensity or severity of the event)
Source: report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance, 2012
| May 2013 | 16
AEFI Basic concepts Module B
 Vaccine safety terminology: Cluster

Aggregation of relatively
"A cluster of AEFIs is uncommon events or diseases
two or more cases of in space and/or time in
the same adverse event frequency that are believed or
related in time, place or perceived to be greater than
vaccine could be expected by
administered".* chance.**

* WHO Aide Memoire: AEFI Investigation, 2004

** Last, John M. 2001. A Dictionary of Epidemiology, 4th ed,
AEFI Basic concepts Module B | May 2013 | 17
Vaccine safety terminology: AEFIs needing special attention

If immunization error is suspected

• e.g. bacterial abscess, severe local reaction, high fever or sepsis, BCG
lymphadenitis, toxic shock syndrome, clusters of AEFIs)

Significant events of unexplained cause

occurring within 30 days after a vaccination

Events causing parental or community

concern

AEFI Basic concepts Module B | May 2013 | 18

AEFI Case selection for Reporting*

Serious AEFI Potential

immunization
error

Cluster

Reporter should
NOT assess
causality

Parenta
l
concern
Community
Unexpected
Unexpected concern
frequency relationship
with
vaccination
* Events to be reported according to context - Routine
surveillance, new vaccine, mass campaign etc
AEFI Basic concepts Module B | May 2013 | 19
 AEFI RECORDING AND
REPORTING IN
INDIA

AEFI Basic concepts Module B | May 2013 | 20

AEFI Basic concepts Module B | May 2013 | 21
CASES TO BE REPORTED

Serious AEFI

Severe AEFI

Minor

AEFI
Which AEFIs should be notified to health system?

Any AEFI that is of concern to the parents or to the health care worker should be notified

Serious AEFIs (death, hospitalization, cluster, disability)

Signals and events associated with a newly introduced

vaccine.

AEFIs that may have been caused by an immunization

In particular, error.
health workers
should notify: Significant events of unexplained cause occurring within
30 days after a vaccination.

Events causing significant parental or community concern.

Swelling, redness, soreness at the injection site IF it lasts

for more than 3 days or swelling extends beyond nearest
joint.
 Serious/severe AEFIs

Reporting formats and channels

CASE REPORTING FORM (CRF)

CASE INVESTIGATION FORM(CIF)
- Preliminary
- Final
Case Reporting Form- Routing, timeline, actions
Health Worker

Immediate • Confirm AEFI

Site • Complete Case Reporting Form
Medical Officer

Pvt Practitioner
24 Hours

• Assign EPID number, complete additional details

• Dist level planning meeting on investigation
District District
Immunization
• Send copy of CRF to local drug inspector, team
Officer conducting autopsy & other stakeholders
• Initiate collection of vaccine, logistic samples,
CSF, Serum (or biological products), if indicated
24 Hours • Start collecting data for completing CIF

State State • Inform if necessary

Immunization  State/regional AEFI committee
Officer  State Drug Controller
• If necessary, convene State AEFI Committee Meeting to
plan course of action

National DC Immunization
Division
MoHFW,
Govt.of India
Case Investigation Form- Routing, timeline, actions
• Convene district AEFI committee meeting and finalize District
District action
Immunization • If indicated and recommended, ship specimens to
Officer appropriate labs
• Site (s) visit and investigation
• Collect additional details
 Vaccine/logistic distribution and utilization
 Other AEFI in the area
Preliminary Final
 Other details such as pre-existing health, medical
CIF CIF
and environmental condition

State
10 days of Notification

70 days of Notification
State
Immunization • Inform state AEFI committee & State Drug Controller
Officer • Request for additional information if necessary
• Do a causality assessment within 100 days
of notification

DC National
Immunization Inform DCG(I) & senior officers in the MoH&FW
Division
MoHFW,
Govt.of India

Inform the Vaccine manufacturers and review GMP

 Serious AEFI Cases (formats and timelines)

Type of Report Responsible Time line

24 hours of
MO
CASE REPORTING
FORM(CRF) notification
48 hours of
DIO
notification

10 days of
Preliminary DIO
notification
N FORM (CIF)

70 days of
Final AEFI investigation team
notification
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