Study by the Paul Ehrlich Institute on Corona vaccines: What vaccine victims should know now
Nearly 740,000 people used the SafeVac 2.0 app to report their reactions to the COVID-19 vaccine to the Paul Ehrlich Institute (PEI). The results were only published in a scientific journal in October 2026, roughly three years after the end of the observation period. On November 10, 2026, the magazine Cicero criticized the fact that the serious cases were barely mentioned. For those affected who are considering claims against a vaccine manufacturer, this is more than just a scientific debate.
What is SafeVac 2.0?
SafeVac 2.0 was a smartphone app that allowed vaccinated individuals to voluntarily report any adverse reactions following their COVID-19 vaccination starting in late 2020. The German government funded the project with approximately €1.6 million. The app was closed to new participants at the end of September 2022, and the monitoring period continued until September 30, 2023.
What's special about this study is that participants were actively interviewed for weeks and months after vaccination. This distinguishes it from the usual spontaneous reporting methods, where doctors or patients only report a suspected case if they think of it themselves.
The figures at a glance
The following picture emerges from responses by the Federal Government, information from the PEI and the publication:
- Participant: The German Federal Government reported 739,515 registered participants in July 2025. The study analyzed data from approximately 733,000 individuals.
- Reported events: A total of approximately four million reports were received. The authors classified 3,617 events as undesirable events of particular interest.
- Serious cases: According to the Federal Government, 3,506 participants reported at least one serious incident.
- Transfer to the EU: According to its own statement, the Paul Ehrlich Institute (PEI) had transmitted approximately 5,000 cases classified as severe from the study to the European database EudraVigilance by the end of August 2026. According to a notification dated October 29, 2026, the transmission is ongoing.
The authors from the Paul Ehrlich Institute (PEI) conclude in the journal Vaccine that the data are reassuring regarding the safety profile of the vaccines. Cicero magazine counters that severe cases are not individually analyzed in the report. A journalist has since filed a lawsuit demanding the release of the raw data.
Why the study is important for vaccine victims
Anyone who becomes seriously ill after a COVID-19 vaccination faces a central question in court: Is the illness a known or at least a seriously possible consequence of the vaccine? Data on side effects plays a crucial role here.
In its 2017 drug safety bulletin, the Paul Ehrlich Institute (PEI) itself pointed out that only a small proportion of all adverse reactions are reported; at that time, it was estimated at around 6 percent, and 5 to 10 percent for severe reactions. An actively surveyed group, such as the one participating in SafeVac 2.0, can therefore provide valuable information that is missing from spontaneous reports.
Study data cannot replace a medical expert opinion in an individual case. However, it can help to substantiate arguments regarding the link between vaccination and symptoms and to convince courts that an evidentiary hearing is necessary.
Your rights under the Medicines Act
The Medicines Act provides victims with two tools that are particularly important when the data is unclear:
- Right to information pursuant to Section 84a of the German Medicines Act (AMG): The manufacturer must provide information about known effects, side effects, and suspected cases if there are grounds to believe that the drug caused the harm. Proof is not required.
- Compensation for damages pursuant to Section 84 of the German Medicines Act (AMG): The manufacturer is liable if the drug, when used as intended, has harmful effects that exceed an acceptable level. Under certain conditions, causality is presumed.
How effective the right to information can be is demonstrated by a partial ruling of the Kassel Regional Court: There, the court must... BioNTech must provide a plaintiff with post-vac syndrome with information about all known side effects of Comirnaty.. In this way, data enters the process that the manufacturer knows but the injured party does not have.
The legal precedent has shifted in favor of the injured parties.
The Federal Court of Justice clarified on March 9, 2026 (VI ZR 335/24) that courts may not dismiss vaccine injury claims without taking evidence if the plaintiff's allegations are sufficiently specific. The Higher Regional Court of Cologne subsequently referred several lawsuits against BioNTech back to the regional courts. In one of these cases, the panel emphasized that The approval of the vaccine does not replace a medical assessment.. The level of knowledge at the time of the last oral hearing is decisive for the benefit-risk ratio.
This is where new findings, such as those from SafeVac 2.0, gain importance. What is known today about side effects is incorporated into ongoing procedures.
There is also clarity regarding the costs: The The Higher Regional Court of Karlsruhe has ruled that legal expenses insurance must pay for a claim for vaccine injury., if the lawsuit has a reasonable prospect of success.
What you can do now
- Collect documents: Vaccination records, doctor's letters, findings, hospital reports and a decision from the social welfare office are the basis of every lawsuit.
- Record progress: Write down what your state of health was like before the vaccination and when which symptoms occurred.
- Report a suspected case: If you suspect an adverse reaction, report it to your doctor or directly to the PEI if you haven't already done so.
- Please observe the deadlines: Claims under the Medicines Act expire three years from the end of the year in which you became aware of the damage and the liable party. Don't wait for the end of the data debate.
- Check legal protection: Clarify whether your legal expenses insurance Legal protection for claims for damages is included.
Rogert & Ulbrich: Your lawyers for vaccine injuries
Rogert & Ulbrich represents vaccine victims nationwide against vaccine manufacturers and Legal expenses insurers. The partners Dr. Marco Rogert and Tobias Ulbrich The firm conducts numerous proceedings under the German Medicines Act, ranging from requests for information under Section 84a AMG to appeals before the Higher Regional Courts. The firm closely monitors the data on side effects and introduces new findings into the proceedings.
Are you suffering from severe symptoms since receiving a COVID-19 vaccination? Take contact and secure your claims.
