Lists of ADVERSE EVENTS of SPECIAL INTEREST
An adverse event is an undesirable experience associated with the use of a medical product such as a vaccine. The Council for
International Organizations of Medical Sciences (CIOMS) defines an adverse event of special interest (AESI) as a scientific and medical
concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to
the sponsor could be appropriate. Such an event might require further investigation in order to characterize and understand it.
The SPEAC Project identifies AESIs based on three criteria:
Known association with immunization or a specific vaccine platform.
Occurrence during wild-type disease as a result of viral replication and/or immunopathogenesis.
Theoretical association based on animal models.