Immunization, Vaccines and Biologicals

WHO/IVB/AM.causality

Aide-memoire: Adverse events following immunization (AEFI): causality assessment

A two-page document intended as a guide to a systematic, standardized causality assessment process for serious adverse events following immunization (including clusters). It proposes a method for individual causality assessment of adverse events following immunization and will take the reader through the steps needed for its implementation. It follows the same format as that set for other aides-memoire done for safety related issues such as that for AEFI investigations. It is intended to be used by staff at national (or first sub-national level) level including staff from immunization programs, regulatory authorities and pharmocovigilance or surveillance departments.

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