Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study.
Xintong LiAnna OstropoletsRupa MakadiaAzza ShoaibiGowtham RaoAnthony G SenaEugenia Martinez-HernandezAntonella DelmestriKatia VerhammePeter R RijnbeekTalita Duarte-SallesMarc A SuchardPatrick B RyanGeorge HripcsakDaniel Prieto AlhambraPublished in: BMJ (Clinical research ed.) (2021)
This study found large variations in the observed rates of AESIs by age group and sex, showing the need for stratification or standardisation before using background rates for safety surveillance. Considerable population level heterogeneity in AESI rates was found between databases.