Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that need to be considered when preparing safety documents. Notably, the complex multicomponent nature of vaccines necessitates inclusion of additional data elements in vaccine PBRERs, to allow assessment of the resultant impact on the safety profile. In addition, analysis of safety data in vaccine PBRERs requires stratification of data to elucidate the impact of issues such as the effects of patient age and vaccine batch variability on the safety profile.