In Germany, the Paul-Ehrlich-Institut is the authority responsible for monitoring the safety of vaccines and biomedicines. For this purpose, the institute’s Division Pharmacovigilance 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.
Safety Reports
Open communication of risks, including potential ones, is a prerequisite for a high acceptance rate for vaccines among the population. The benefit of the COVID-19 vaccination for the health of individuals and the population as well as their effect in combating the pandemic essentially depends on the confidence in the vaccination. To meet this requirement, the Paul-Ehrlich-Institut publishes continuously all suspected cases reported in Germany on adverse effects or vaccination complications in a temporal relationship with the COVID-19 vaccination.
Safety Report 27 December 2020 to 30 November 2021
Archive Safety Reports
Safety Studies
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 active pharmacovigilance studies for a high safety standard for vaccinations.
SafeVac 2.0
Reporting Portal for Suspected Cases of Adverse Effects
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.
Online-Reporting of Side Effects – www.nebenwirkungen.bund.de
Further Information
- MYKKE Registry – Registration of Children and Adolescents with Suspected Myocarditis after COVID-19 Vaccination
- Booster Vaccinations with Spikevax or Comirnaty are Equivalent
- Statement: Clinical Trial of Comirnaty from BioNTech
- COVID-19 Vaccine Janssen – Possible Relation to very rare Cases of unusual Blood Clots in Combination with a reduced Platelet Count
- COVID-19 Vaccine AstraZeneca – Safety Assessment Result: The Vaccine is Safe and Effective in the Fight against COVID-19
- Occurrence of Cerebral Venous Thrombosis after Vaccination with COVID-19 Vaccine AstraZeneca
- 19 March 2021: Information for Medical Doctors – COVID-19 Vaccine AstraZeneca
- The Paul-Ehrlich-Institut informs – Temporary Suspension of Vaccination with COVID-19 Vaccine AstraZeneca
- COVID-19 Vaccine AstraZeneca
- Statement: Possible Offerings of COVID-19 Vaccine Dilutions
- What should be considered in case of a positive allergy history before a vaccination against COVID-19?
- Corona Vaccination in Individuals Suffering from Allergies
- Flowchart – Procedure in case of positive allergy history before COVID-19 mRNA vaccination
- Safety and Efficacy of the COVID-19 Vaccine AstraZeneca