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The following file contains information on suspected cases of vaccine adverse events reported to the Paul-Ehrlich-Institut following the use of COVID-19 vaccines authorised in the European Economic Area (EEA), including Germany, and administered in Germany.

Background

The collection/registration and evaluation of suspected vaccine adverse events and vaccine complications reported to the Paul-Ehrlich-Institut serves to identify possible safety signals connected to a specific vaccine product at an early stage and, if necessary, to take, coordinate, or initiate measures to minimise risk. Reports of suspected cases are not subject to an individual medical or clinical assessment by the Paul-Ehrlich-Institut, but are used for the ongoing evaluation of the safety of the respective vaccine product.

In the debate on vaccine safety, it is helpful to know the meanings of the relevant terms. The Paul-Ehrlich-Institut explains the most important differences below:

• Suspected cases of vaccine adverse events are reports of medical events that occurred in temporal proximity to a vaccination and cannot be directly attributed to other causes.
• Side effects are all harmful and unintended reactions to a medicinal product (section 4 subsection 13 sentence 1 of the Medicinal Products Act, Arzneimittelgesetz, AMG).
• Vaccination reactions are understood to be short-term, temporary, local, and general reactions to a vaccine that do not exceed the usual extent of a reaction and are to be regarded as an expression of the organism's confrontation with the vaccine, such as redness, swelling and pain at the injection site, increased temperature, fever, fatigue, headache, or other flu-like symptoms. Vaccination reactions are a type of side effect.
• Vaccination complications are defined as any adverse health effects that go beyond the usual extent of a vaccination reaction. Doctors are obliged to report and identify suspected vaccination complications to the public health department in accordance with section 6 subsection 1 sentence 1 no. 3 of the Infection Protection Act (Infektionsschutzgesetz, IfSG). Pursuant to section 11 subsection 4 of the IfSG, the public health department immediately transmits the reports of suspected vaccination complications in pseudonymised form to the competent state authority, which immediately transmits the report to the Paul-Ehrlich-Institut. Vaccine complications are a type of side effect.
• Serious side effects are side effects that are fatal or life-threatening, require inpatient treatment or prolongation of inpatient treatment, lead to permanent or serious disability, invalidity, congenital abnormalities, or birth defects (section 4 subsection 13 sentence 2 of the AMG).
  Suspected cases of serious side effects must be reported by the marketing authorisation holder within a short timeframe to the EudraVigilance system, the European side effect database (section 63c subsection 2 sentence 1 no. 2 of the AMG).
  To support the pharmacovigilance (safety monitoring of medicinal products and taking necessary measures) of authorised COVID-19 vaccine products, the medicines authorities of the EEA have agreed that additional, explicitly defined "Adverse Events of Special Interest" (AESI) will always be classified as "serious". This means that the short notification timeframe for suspected cases of serious adverse reactions applies to the AESI. This procedure serves to detect their occurrence promptly and, if necessary, to allow authorities to react with risk reduction measures.
• Vaccination within the meaning of the Social Code:
  According to section 24 of the Social Code (Sozialgesetzbuch, SGB) XIV, vaccination damage is understood to mean damage to one's health that exceeds the usual extent of a vaccination reaction.
  The vaccine damage assessment is performed as an individual medical and clinical assessment. Section 5 of the SGB XIV regulates the degrees of damage and stipulates that temporary health conditions lasting up to six months are not to be considered as damage.
  If a vaccinated person or their relatives suspect that they have suffered vaccination damage after a publicly recommended vaccination, they can submit an application for relief under the Federal War Victims Relief Act (Bundesversorgungsgesetz) in accordance with section 24 of the Social Code (SGB) XIV in conjunction with section 4 of the Social Code XIV.
  The application for compensation must be submitted to the Social Welfare Office in the federal state in whose territory the vaccination was carried out in accordance with section 113 subsection 5 of the SGB XIV. The Paul-Ehrlich-Institut is not responsible for processing recognition procedures for vaccination damages and therefore does not have any information, figures/data on vaccine damage procedures.

This means:

• Suspected cases of side effects are not identical to recognised side effects as listed in the product information of each vaccine product.
• The frequency of a side effect cannot be inferred from the number of reports on suspected side effects alone.
• Side effects are not identical to vaccine damages.
• Difference between "severe" and "serious" in relation to side effects: The designation of a medical event reported as a suspected side effect as "severe" refers to the severity or course of the event, e.g. "severe" headache (as opposed to "mild headache").
  The classification of a suspected side effect case as "serious", on the other hand, refers to health consequences, treatments, and restrictions resulting from the medical event.
  In accordance with section 4 subsection 13 of the AMG, serious side effects are fatal or life-threatening, require hospitalisation or the prolongation of existing hospitalisation, or lead to persistent or significant disability, incapacity, congenital abnormalities or birth defects. As described above, suspected cases of defined "Adverse Events of Special Interest" (AESI) in connection with a COVID-19 vaccine product are always classified as "serious" due to an agreement of the EEA pharmaceutical authorities, even if they have not caused any of the above-mentioned longer-term health restrictions in every case.

On the Recording and Evaluation of Suspected Cases of Vaccine Adverse Events after COVID-19 Vaccination

Since the beginning of the COVID-19 vaccination campaign in 2020, the Paul-Ehrlich-Institut has been systematically and carefully recording and evaluating the reports of suspected cases of side effects and vaccination complications after COVID-19 vaccination received via the established spontaneous reporting system. This is an integral part of pharmacovigilance and standard for such reports after administration of all authorised vaccines and biomedicines.

The reporting data is supplemented by data from the PSURs (Periodic Safety Update Reports, i.e. regular safety reports) that pharmaceutical companies (marketing authorisation holders) must submit to the bodies of the European Medicines Agency (EMA) and thus also to the national medicines authorities.

If there is an indication of a new safety signal for an authorised vaccine, the Paul-Ehrlich-Institut will, if necessary, take or initiate measures to minimise the risk, or coordinate measures in conjunction with the sister medicines authorities in the competent bodies of the EMA, implement the measures in its area of responsibility and provide information about them.

On the Frequency of Side Effects

Information on the frequency of side effects is obtained from clinical trials, which are a prerequisite for marketing authorisation, or post-authorisation studies. Side effects are listed in the product information of the vaccines in chapter 4.8 (side effects) according to the following frequency categories:

• Very common (≥ 1/10),
• Common (≥ 1/100 to < 1/10),
• Uncommon (≥ 1/1 ,000 to < 1/100),
• Rare (≥ 1/10,000 to < 1/1 ,000),
• Very rare (< 1/10,000),
• Not known (cannot be estimated from the available data).

Links to the current version of the product information on the EMA website are provided by the Paul-Ehrlich-Institut in the list of authorised COVID-19 vaccine products.

The product information of the COVID-19 vaccine Comirnaty, which is the most frequently administered vaccine product in Germany, shows that myocarditis/pericarditis, for example, occurs with a frequency of less than 1:10,000 and thus falls into the "very rare" category. Myocarditis/pericarditis is an AESI and is therefore counted among the serious side effects. The information on the frequency of the very rare adverse reaction myocarditis/pericarditis following COVID-19 mRNA vaccination (less than 1:10,000 vaccinations) was supplemented in the product information due to the results of large pharmacoepidemiological studies.

Various studies have shown that the risk of developing myocarditis after COVID-19 is significantly higher than the risk of it occurring after vaccination.

On "Post-Vac Syndrome"

"Post Vac" is not a designation of a defined disease and is not subject to a clear case definition for reporting a suspected case of a post-vaccination adverse reaction. The term is used for various symptoms that are also associated with Long-COVID-like symptoms.

Reactions such as chronic fatigue syndrome (CFS), post-vaccination syndrome, postural orthostatic tachycardia syndrome (POTS) and post COVID-19, which are currently often subsumed under the term "Post-Vac syndrome", are recorded by the Paul-Ehrlich-Institut as part of the collection of suspected case reports.

There is currently no risk signal for chronic fatigue syndrome in Germany, at the level of the EEA or internationally, or any other symptoms classified as "post-Vac syndrome" following vaccination with COVID-19 vaccines, so the relevant committee, the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA, is currently not addressing the issue.

Reporting Channels and Reporting Sources for Submitting Suspected Case Reports to the Paul-Ehrlich-Institut

Members of the medical professions have professional obligations to report suspected side effects to the Drug Commission of their respective professional bodies (Drug Commission of the German Medical Profession - AkdÄ: www.akdae.de, Drug Commission of Dentists - AKZ: www.bzaek.de or Drug Commission of German Pharmacists - AMK: amk@arzneimittelkommission.de).

In addition, the reporting of suspected cases of vaccination complications is required in the IfSG. The doctor or the manager of the pharmacy carrying out the vaccination must report and identify the case to the public health department, which in turn forwards the reported suspicion of a vaccination complication to the competent federal state authority. The competent state authority forwards the report to the Paul-Ehrlich-Institut without delay.

The Paul-Ehrlich-Institut also receives reports from:

• the marketing authorisation holder via the EMA database,
• directly from doctors and
• from vaccinated persons or their relatives.

The reports are submitted via

• mail,
• email,
• phone,
• or electronically via the Paul-Ehrlich-Institut's reporting portal and
• via the EMA EudraVigilance database.

Reports of a suspected case can therefore come from various reporting sources, which can help to increase the volume of reports.

Duplicate reports (reports on the same case from multiple sources) are merged by the Paul-Ehrlich-Institut into one case that contains all of the information on the report from the different sources.

The recording and evaluation of suspected case reports takes place exclusively at the federal level.

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The Paul-Ehrlich-Institut accepts no liability for the correctness and completeness of the information on its website. In particular, the Paul-Ehrlich-Institut is not liable for errors in the transmission of documents or due to unauthorized modification of the information by third parties. It is also not responsible for the content of other web pages referred to by links. The Paul-Ehrlich-Institut expressly distances itself from all content which may be relevant under criminal or liability law or which offends common decency. Insofar as regulations and laws are reproduced, only the official legal text is authoritative. Notes and information from the Paul-Ehrlich-Institute for pharmaceutical companies do not affect their legal responsibility.

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