This document discusses adverse events following immunization (AEFIs). It defines an AEFI as any untoward medical occurrence that takes place after immunization. AEFIs can be categorized based on their cause, such as vaccine reactions, program errors, coincidental events, or injection reactions. Program errors and coincidental events constitute many reported AEFIs. AEFIs should be reported if they are serious, potentially caused by an immunization error, part of a cluster, or a concern to parents or the community. The report should include details about the vaccine, adverse event, medical history, and reporter. Upon an AEFI report, caretakers should be reassured while the event is fully investigated and reported through the national

1. Learning objectives
 At the end of the module, the participants will be
able to:
– Identify adverse events following immunization (AEFIs)
– Explain how to report AEFIs

2. What is an AEFI?
1
Which AEFIs are reported?
3
Key issues
How likely are AEFIs after
vaccinations
2

3. Adverse Event Following Immunization
(AEFI)
 What is an AEFI?
– Any untoward medical occurrence
– Takes place after an immunization
– Causes concern
– it may not necessarily have a causal relationship with the
usage of the vaccine
 How are AEFIs categorized?
Type Severity
- Vaccine reaction
- Programme error
- Coincidental
- Injection reaction
- Unknown
- Minor
- Severe
• Serious
• Non-serious

4. Programme errors
 Errors in vaccine preparation, handling, storage, or
administration
 Preventable
 Often constitute the greatest proportion of AEFIs
 Identification and correction are of great importance
 Examples:
– Non-sterile injection
– Injection at incorrect site
– Administration of frozen vaccine

5. Coincidental events
 Occur after vaccination, but not caused by the vaccine or its
administration
 Occur during infancy when illnesses are common and
congenital or early neurological conditions become apparent
 Onset temporally associated with vaccination, and inevitable
when vaccinating these age groups
 Applying normal incidence of disease and death in these age
groups along with coverage allows estimation of expected
numbers of coincidental events after immunization

6. Injection reactions
 Immunization anxiety-related reactions in anticipation
to and as a result of an injection of any kind
 Not related to the vaccine but to fear of the injection
 You may encounter 4 types of injection reactions :
– Fainting
– Hyperventilation
– Vomiting
– Convulsions

7. Vaccine reactions can be classified into two
levels of severity
 Minor reactions
– Usually occur within few
hours
– Resolve quickly
– Pose little danger
– Local: pain, swelling, redness
at injection site
– Systemic: fever, malaise,
muscle pain, headache, or loss
of appetite
 Severe reactions- require
timely and appropriate
management
– Usually do not result in long-
term problems
– Can be disabling
– Are rarely life threatening
– Include seizures and allergic
reactions caused by body’s
reaction to a particular
component in a vaccine

8. Some severe events can be SERIOUS
A serious AEFI- Any untoward medical
occurrence that at any dose:
– Results in death
– Is life threatening
– Requires in-patient hospitalization or prolongation
of existing hospitalization
– Results in persistent or significant disability or
incapacity

9. The difference between serious and severe
adverse events
 A severe reaction is a broader term which includes SERIOUS
reactions + reactions that do not necessarily lead to long term problems.
 Severe reactions must be reported

11. Objectives of AEFI surveillance
Rapidly detect and respond to AEFI
Identify, correct and prevent immunization error related reactions
Facilitate AEFI causality assessment
Recognize AEFI clustering including mild and/or “expected” AEFI
Identify potential safety signals and generate hypotheses
Generate information for vaccine safety communication

12. Which AEFIs should be reported?
 Any severe events or AEFI that is of concern to the parents
or health care worker

13. Serious
AEFI
Potential
immunization
error
Cluster
Parental
concern
Communit
y concern
Unexpected
relationship
with
vaccination
Unexpecte
d
frequency
AEFI Case selection for Reporting*
Reporter
should NOT
assess
causality
* Events to be reported according to context - Routine
surveillance, new vaccine, mass campaign etc

14.  Report the event through existing AEFI reporting systems
established by national immunization programs
National
authorities
Community, district, and
regional levels
Signs or symptoms
believed to be related
to the vaccine
Where to report AEFI's

15. Conducting an AEFI investigation
 Some AEFI reports will need further investigation by
the immunization programme managers
 Components of AEFI investigation:
– Identify specifications of implicated vaccine
– Examine operational aspects of the programme which may have
led to immunization errors
– Search for other potential AEFI cases/clustering
– Compare background risk to reported rate of AEFI
– Confirm (or propose) the diagnosis and determine outcome
– In collaboration with experts, determine if AEFI was vaccine-
related

16. What information should an AEFI report
contain?
 Client information
 Details about the vaccine
– Type
– Date
– Manufacturer
– Lot/expiration date
– Site/route of immunization, etc.
 Description of adverse event(s)
and any associated events
 Medical and treatment history
 Reporter details

17. Communication with caretakers in case of
an AEFI
 Reassure the caretaker
 Admit uncertainty
 Convey that the AEFI will be reported and
investigated fully
 Keep the community informed with follow-up
information

18. Key messages
 AEFIs can be minor or severe (which include serious events)
 AEFIs should be reported through existing AEFI reporting
systems/forms
 The safety profile of IPV is excellent
 Most infants who get IPV do not experience any side effects
 In case of an AEFI
– Reassure the caretaker
– Admit uncertainty
– Investigate fully
– Keep the community informed

19. End of module
Thank you
for your attention!