More than 197,033,944 COVID-19 vaccinations were carried out between 27 December 2020 and 31 December 2024. An exact number of doses administered before the evaluation cut-off date is not available to the Paul-Ehrlich-Institut, since the COVID-19 vaccine digital vaccination monitoring (DIM) program conducted by the Robert Koch-Institut (RKI) only ran until 8 July 2024. The Paul-Ehrlich-Institut received 350,868 reports of suspected adverse events during the evaluation period. A total of 63,909 (18.2%) of these reports were defined as serious according to the criteria in the German Medicinal Products Act (section 4 subsection 13 AMG). The reporting rate of suspected adverse events for all COVID-19 vaccines combined was 1.78 reports per 1,000 vaccine doses. Suspected serious adverse events were reported at a rate of 0.32 reports per 1,000 vaccine doses. An evaluation of reports of chronic fatigue syndrome and Long COVID-like symptoms following COVID-19 vaccination submitted to the Paul-Ehrlich-Institut and a comparison with international reports in the adverse reaction database at the European Medicines Agency showed no safety signals up to the date of this evaluation. No new safety signals have been identified in the application of COVID-19 vaccines since the last safety report from the Paul-Ehrlich-Institut, which had an evaluation deadline of 31 March 2023.
Source: M Photo/Shutterstock
Spontaneous reports of suspected adverse events are important for the timely detection of new safety signals. However, apart from exceptions such as local reactions at the vaccination site or anaphylactic reactions immediately after vaccination, spontaneous reports are not suitable for determining if the reported adverse reaction was caused by vaccination or how frequently it occurs.
In the event that new safety signals are detected, additional investigations, such as observational studies, are essential to quantify or refute a possible safety signal. No new safety signals have been detected for any administered COVID-19 vaccines since the detailed report on the safety profile of the COVID-19 vaccines with the 31 March 2023 reporting deadline. This report therefore only presents an updated overview of the reported suspected adverse events after COVID-19 vaccination.
In addition to an updated overview of all suspected adverse events after COVID-19 vaccination reported to the Paul-Ehrlich-Institut by 31 December 2024, this report includes a separate evaluation of reports of suspected cases in which the persons concerned died after vaccination.
The following also contains an updated overview of suspected case reports in which diseases or symptoms such as chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ ME), postural tachycardia syndrome (POTS), post-exertional malaise (PEM, malaise after exercise), or post-acute COVID-19 syndrome have been reported.
The overview also includes reports of the condition known as post-vaccination syndrome as a suspected adverse event.
In addition, the 30 most frequently reported suspected adverse events of special interest (AESI) are presented and compared with the reporting rates of the AESI that were reported to the Paul-Ehrlich-Institut by 31 March 2023.
This report does not cover all known adverse reactions after COVID-19 vaccinations, such as transient local reactions at the vaccination site or transient systemic reactions that have already been well investigated in the marketing authorisation trials. Non-serious and/or transient adverse reactions that were observed after the authorisation was issued and are listed in the vaccine's Summary of Product Characteristics are not discussed in this report. The processing and evaluation of suspected adverse events or vaccination complications after vaccination has already been described in detail elsewhere (see methodology safety reports on COVID-19 vaccines).
Safety reports on COVID-19 vaccines
The reporting rate of suspected cases of adverse events results from the number of cumulative individual reports at the time of the evaluation in relation to the numbers published at the same time by the Robert Koch-Institut of vaccinations carried out with each of the vaccines. The digital vaccination monitoring (DIM) program was discontinued on 8 July 2024. As of 8 July 2024, the RKI had registered 197,033,944 vaccinations via the DIM, so the reporting rate can only be calculated on the basis of this information. However, the resulting error is negligible, because only 1,910 suspected adverse events after vaccination with COVID-19 vaccines were reported to the Paul-Ehrlich-Institut in the period from 8 July 2024 to 31 December 2024. The date of vaccination was after 8 July 2024 in 150 of these 1,910 suspected cases, so the calculation of the reporting rates in the report is only a slight overestimate.
Updated: 31.03.2025
