Abstract Background In May 2020, the ACCESS (The vACCine covid-19 monitoring
readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines.
Within this project, this study aimed to generate background incidence rates of 41 adverse
events of special interest (AESI) to contextualize potential safety signals detected following
administration of COVID-19 vaccines. Methods A dynamic cohort study was conducted using
a distributed data network of 10 healthcare databases from 7 European countries (Italy …

Abstract Background The Global COVID Vaccine Safety (GCoVS) project was established in
2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate
the rapid assessment of the safety of newly introduced vaccines. This study analyzed data
from GVDN member sites on the background incidence rates of conditions designated as
adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Methods
Eleven GVDN global sites obtained data from national or regional healthcare databases …