Coronavirus and COVID-19

Safety of COVID-19 Vaccines

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 September 2021

The Paul-Ehrlich-Institut (PEI) reports on 172,188 from Germany reported suspected side effects or Vaccination complications related to the time of vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH) and Spikevax (MODERNA BIOTECH SPAIN, S.L.) as well as the Vector vaccines Vaxzevria (AstraZeneca AB) and COVID-19 Vaccine Janssen to protect against COVID-19 from the start of the vaccination campaign on December 27, 2020 to September 30, 2021. Until 09/30/2021 were loud Data from the Robert Koch Institute 107,888,714 vaccinations carried out, of which 82,341,579 vaccinations with Comirnaty, 9,668,138 vaccinations with Spikevax, 12,692,700 vaccinations with Vaxzevria and 3,186,297 vaccinations with the COVID-19 vaccine Janssen. 94,281 suspected cases were vaccinated with Comirnaty reported, 25,713 suspected cases of Spikevax, 45,178 suspected cases Vaxzevria and 6,243 reports on COVID-19 Vaccine Janssen. In 773 reported suspected cases, the COVID-19 vaccine was not specified. The reporting rate was for all vaccines combined 1.6 reports per 1,000 vaccine doses, for serious reactions 0.2 reports per 1,000 vaccine doses.

Reports on suspected cases of adverse effects and vaccination complications following a vaccination for the protection against COVID-19 (reporting period 27 December 2020 to 30 September 2021) (German only)

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

The Paul-Ehrlich-Institut has developed a smartphone app called SafeVac 2.0 to gain further insights into the tolerability of COVID-19 vaccines. All persons vaccinated are invited to use the app to contribute actively to this observational study.

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 -


  1. Role of the Paul-Ehrlich-Institut
  2. COVID-19 Vaccines
  3. Proof of Vaccination as Defined in the COVID-19 Protective Measures Exemption Directive and the Directive on Coronavirus Entry Regulations
  4. FAQ Coronavirus
  5. Biomedicines
  6. Safety of COVID-19 Vaccines
  7. Research Work
  8. SARS-CoV-2 Test Systems