AE Reporting and Causality

Abstract

Adverse effects may be related, unrelated, or unknown in relation to a vaccine and may range from self-limited mild reactions to permanent sequelae. The causal inference of any adverse effect to a vaccine is based on assessing the strength of association, temporal response, consistency and specificity of the association, and biological plausibility. Safety evaluation depends on accurate reporting of adverse events during pre-licensure studies and post-licensure surveillance.