Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database.
Caitlin N DoddAlexandra C PacurariuOsemeke U OsokoguDaniel WeibelCarmen FerrajoloDang H VoBenedikt F H BeckerJan A KorsMiriam SturkenboomPublished in: Pharmacoepidemiology and drug safety (2018)
Removal of vaccines for signal detection in a pediatric population has an impact on ROR, dependent upon the reporting frequency of the event of interest in combination with vaccines. We recommend stratification by age and removal of vaccine exposures if the investigated adverse drug reactions include those typically reported in association with vaccines for the age strata.