In Germany, the Paul-Ehrlich-Institut is the authority responsible for monitoring the safety of vaccines and biomedicines. For this purpose, the institute’s Pharmacovigilance Division collects and reviews reports on adverse drug effects and takes the necessary steps if required.
Reporting suspected cases of adverse effects is a central pillar for being able to judge the safety of medicines. Thus, new signals can be detected in a timely manner, and the risk/benefit profile of vaccines can be continuously monitored. In this context, it must be noted that even reactions with a timely relation to a vaccine do not necessarily have a causal relation.
In the current safety report, the Paul-Ehrlich-Institut summarises reports on suspected cases of adverse events and vaccination complications. These reports were received between 27 December 2020 (start of the vaccination campaign in Germany) and 31 December 2024.
The regular safety reports on COVID-19 vaccines were a special format developed in response to the extraordinary pandemic situation. In a very short time, millions of people in Germany were vaccinated with the newly developed COVID-19 vaccines. It was therefore important to provide the public with as much information as possible on the safety of these vaccines.
There is now extensive data on the safety of COVID-19 vaccine products. The Paul-Ehrlich-Institut therefore intends to cease the preparation and publication of the regular safety reports on COVID-19 vaccine products in its current form.
As with all authorised medicines, the safety of the COVID-19 vaccines continues to be closely monitored by the Paul-Ehrlich-Institut and its sister medicines authorities in the EU. Safety studies are continued by parties such as the marketing authorisation holders in accordance with the vaccine product-specific risk management plan. If new COVID-19 vaccine risks are identified, they will be published by the Paul-Ehrlich-Institut on its homepage or in the Bulletin on Drug Safety. All identified adverse reactions are listed in the product information of each vaccine product. This information is updated on a continuous basis as needed.
In addition to the observation of adverse effects on the basis of incoming reports of suspected cases – the so-called spontaneous recording process of adverse effects – the Paul-Ehrlich-Institut is committed to a high safety standard for vaccinations with active pharmacovigilance studies.
The Paul-Ehrlich-Institut has developed a smartphone app called SafeVac 2.0 to gain further insights into the tolerability of COVID-19 vaccines. Since 1 October 2022, no new participants can register for the SafeVac 2.0 study. The tracking of the persons registered up to that point remains unchanged. After completion of the data collection at the end of 2023, the Paul-Ehrlich-Institut will evaluate the study and publish the results.
The Paul-Ehrlich-Institut together with the Registry for Children and Adolescents with Suspected Myocarditis – the MYKKE Registry – (Register für Kinder und Jugendliche mit Verdacht auf Myokarditis, MYKKE-Register) is conducting a prospective data collection of suspected cases of myocarditis in children and adolescents after COVID-19 vaccination.
The Paul-Ehrlich-Institut accepts reports of suspected cases of adverse effects after vaccinations from healthcare providers, the marketing authorisation holder, and persons vaccinated as well as their relatives.
The following lists contain reports of suspected cases of side effects after the use of a COVID-19 vaccine submitted 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 of suspected cases of serious side effects after the use of a COVID-19 vaccine authorised in the EU and therefore also in Germany.
Reports submitted to the Paul-Ehrlich-Institut of suspected side effects after the use of COVID-19 vaccines (1 January 2024 - 30 June 2024, German only), file size 1 MB
Reports submitted to the Paul-Ehrlich-Institut of suspected side effects after the use of COVID-19 vaccines (27 December 2020 - 31 December 2023, German only), file size 41,1 MB
Updated: 08.04.2025
