Reports of suspected adverse reactions are of great importance for medicinal product safety, since they can be used to detect possible safety signals at an early stage. The data on these reports is publicly available.
Suspected adverse reactions reported in the European Economic Area (EEA) can be viewed in the central European database of suspected adverse drug reaction reports, also known as the EudraVigilance database.
All medicines authorities of the EEA Member States along with marketing authorisation holders and sponsors of clinical trials in the EEA submit any suspected case reports that they receive to the database within specified deadlines in accordance with the currently valid legal obligations.
The data pool within the EudraVigilance database thus also contains cases of suspected side effects reported from Germany.
The database offers individual information on the number and countries of origin of the reports and the type of reactions reported for each medicinal product or active substance.
European Database of Suspected Adverse Drug Reaction Reports
The following lists contain reports of suspected cases of side effects after the use of a COVID-19 vaccine submitted to the Paul-Ehrlich-Institut in accordance with the Medicinal Products Act (Arzneimittelgesetz, AMG) and/or suspected cases of vaccine complications submitted in accordance with the Infection Protection Act (Infektionsschutzgesetz, IfSG) and reports of suspected cases of serious side effects after the use of a COVID-19 vaccine authorised in the in the European Economic Area (EEA) and therefore also in Germany.
The following lists contain reports of suspected cases of side effects after the use of a COVID-19 vaccine submitted to the Paul-Ehrlich-Institut in accordance with the Medicinal Products Act (Arzneimittelgesetz, AMG) and/or suspected cases of vaccine complications submitted in accordance with the Infection Protection Act (Infektionsschutzgesetz, IfSG) and reports of suspected cases of serious side effects after the use of vaccines (except for COVID-19 vaccines) authorised in the European Economic Area (EEA) and nationally in Germany.
Data is available on a yearly or six-month basis.
Until 14 April, 2022, the Paul-Ehrlich-Institut had maintained a published database with all suspected cases of vaccination reactions and complications reported in Germany (DB-UAW) for the years 2000 to 2021.
Since this national database no longer met the high IT security requirements of the German Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik, BSI), the Paul-Ehrlich-Institut temporarily placed the presentation of the suspected case reports in its previous form on hold until the database receives technical updates.
All suspected cases of adverse reactions to vaccines reported to the Paul-Ehrlich-Institut continue to flow without restriction into the European database of adverse drug reactions, the EudraVigilance database at the European Medicines Agency (EMA). This is because the Paul-Ehrlich-Institut, and all Member States of the European Economic Area (EEA), are subject to a fundamental, legally prescribed obligation – regardless of any parallel database voluntarily maintained by the Paul-Ehrlich-Institut – to enter the suspected case reports into the EudraVigilance database within set deadlines. Therefore, the data pool of the EudraVigilance database contains national data. EudraVigilance also specifically offers the possibility of a targeted searchfor national data.
The Paul-Ehrlich-Institut emphasises that the temporary discontinuation of the national database has no influence on the recording and evaluation of suspected case reports and thus the evaluation of vaccine safety. The Paul-Ehrlich-Institut will of course continue to analyse all suspected cases reported to the Institute after medicinal product administration or vaccination. These reports remain freely searchable in the European database.
The Paul-Ehrlich-Institut has continuously reported all suspected cases of adverse reactions or vaccination complications reported in Germany in connection with COVID-19 vaccinations in the COVID-19 vaccine safety reports up to and including March 31, 2023.
Updated: 05.03.2024
