4.1 Definition and Categorization of AEFI
- Adverse event following immunization (AEFI) is any untoward medical occurrence which:
- Follows immunization.
- Does not necessarily have a causal relationship with the usage of the vaccine.
- May be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.
- Can either be true adverse events - i.e., resulting from the vaccine or immunization process - or coincidental events that are not due to the vaccine or immunization process but are temporarily associated with immunization.