Cause-specific Type of AEFI

   Definition

1

Vaccine product-related reaction

An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product (e.g.,  anaphylaxis, vaccine-associated poliomyelitis)

2

Vaccine quality defect-related reaction

An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product, including its administration device as provided by the manufacturer. (e.g., wild polio virus, insufficient inactivation of wild-type vaccine agent, AE due to contamination of the vaccine)

3

Immunization error-related reaction

An AEFI that is caused by inappropriate vaccine handling, prescribing or administration and thus by its nature is preventable. (e.g., error in vaccine handling, prescribing and administration)

4

Immunization anxiety-related reaction

An AEFI arising from anxiety about immunization.(e.g., fainting (vasovagal syncope or syncope), hyperventilation)

5

Coincidental event

An AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety, but a temporal association with immunization exists.(e.g., sudden infant death syndrome)