Rationale and background: The global rapid spread of COVID-19 caused by the SARS-CoV-2 triggered the need for developing vaccines to control for this pandemic. This study aimed to generate background incidence rates of adverse events of special interest (AESI) that may be used to monitor benefit-risk profile of COVID-19 vaccines. Data sources: This study included 10 data sources from 7 European countries (Denmark, Germany, France, Italy, Netherlands, Spain, United Kingdom). Data sources contain health insurance data (GePaRD, SNDS), hospitalisation record linkage data (PHARMO, Danish registries (DCE-AU), SIDIAP, ARS) or data from general practitioners (CPRD, PEDIANET, BIFAP, FISABIO). For this final report data from 9 data sources were included. Study size: The study population for the total study comprised approximately 141.6 million individuals. In this final report, a total number of 45 million individuals were included. An update including French data is expected later this year Results This report comprises background rate data on AESI from 6 countries (UK, ES, IT, DK, NL, DE) and 9 data sources(BIFAP, Pedianet (children only), CPRD, ARS, Danish registries, FISABIO, SIDIAP, PHARMO, GeParD). Data from France (SNDS) could not be generated in a timely manner due to administrative constraints in data release. Data sources included different subpopulations based on the availability of numerator data of the observed persontime (Hosp= hospital based, PC= primary care, HOSP-PC= overlap between hospitalization and primary care). This entry also includes the results in excel format and also the links to the codes and event definitions

This protocol has been accepted by EMA as a deliverable of the framework contract No EMA/2018/28/PE. The protocol expresses the expertise of the authors and the ACCESS consortium as well as feedback received from EMA. It may not be understood or quoted as being made on beh behalf, or reflecting the position of the European Medicines Agency or one of its Committees or Working Parties. For questions please contact: m.c.j.sturkenboom@umcutrecht.nl