Questions and answers concerning side effects of COVID-19 vaccines and vaccine damage law

The quality, efficacy and safety of the COVID-19 vaccines were tested as part of the approval process and the vaccines were certified as having a positive benefit-risk ratio. The benefit-risk ratio of licensed COVID-19 vaccines is subject to continuous monitoring by the competent authorities. In coordination with the European Medicines Agency (EMA), the Paul Ehrlich Institute (PEI) ensures the monitoring process for Germany.

The approved vaccines against COVID-19 provide effective protection against severe progression of the disease. Their benefits substantially outweigh any possible risks. Since the start of the vaccination campaign, more than 197 million vaccine doses have been administered. Therefore, there is a large body of data on the safety of COVID-19 vaccine products.

As with any effective medicinal product, side effects, and in very rare cases even severe side effects and/or vaccine complications, may occur.

Last update: August 2024

Vaccination reactions

Vaccine reactions are short-term, temporary localised and generic reactions to vaccination. Examples include reddening, swelling and pain at the injection site, increase in temperature, fever, tiredness, headache, aching limbs or other flu-like symptoms. These reactions are to be seen as signalising the desired activation of the immune system and usually subside again after a few days without further consequence. Vaccine reactions are a type of side effect.

Side effects

According to section 4 (13) of the Medicinal Products Act (Arzneimittelgesetz), side effects are defined as noxious and unintended reactions to a medicinal product. Serious side effects refer to side effects that are fatal or life-threatening, require hospitalisation or an extension of such hospitalisation, or lead to permanent or significant disability, incapacity, congenital anomalies or birth defects. Details concerning the type and frequency of side effects can be found in Chapter 4.8 “Side effects” in the product information (expert information and instructions for use) for each vaccine. The frequency of side effects is investigated in clinical trials prior to marketing authorisation or in large-scale post-authorisation studies.

Vaccine complications

Vaccine complications are reactions that as “suspected vaccination-related damage to health that exceeds the extent of a normal vaccine reaction” under section 6 (1) no. 3 of the Protection against Infection Act (Infektionsschutzgesetz) need to be reported. These symptoms emerge following vaccination where a causal relationship with the vaccination is deemed possible and which exceed the extent of a normal vaccine reaction. Normal vaccine reactions include short-term, temporary localised and generic reactions or symptoms that could be interpreted as a form of “vaccination illness” (e.g. non-infectious measles-like rash). See also: Vaccine reaction.

The information leaflets on the various COVID-19 vaccines offered in Germany describe the frequently occurring side effects as well as the rarely and very rarely observed vaccine complications for which a causal relationship with the vaccination is deemed possible or is being investigated. “Rarely” means a reaction occurs in between one to ten cases per 10,000 vaccinated people. “Very rarely” means a specific reaction occurs in fewer than one person per 10,000 vaccinated people.

Last update: August 2024

"Post-vac syndrome" is a term used in connection with symptoms following administration of a COVID-19 vaccine, which may sometimes resemble symptoms described in long/post-COVID.

The term “post-vac” does not constitute a medical definition of an illness and there are no internationally recognised, standardised, unique case identifiers when reporting such suspected side effects. 

The Paul Ehrlich Institute (PEI) records and evaluates all suspected cases of side effects and vaccine complications that are reported to it. This applies to the COVID-19 vaccines as well as all the other vaccines authorised in Germany. 

The Paul Ehrlich Institute analysed reported suspected cases following COVID-19 vaccination specifically with respect to long/post-COVID-like symptoms. In these reports from Germany and from other states in the European Economic Area (EEA) and non-EEA states (worldwide) in which the centrally authorised COVID-19 vaccines have been administered, no increased risk of such symptoms occurring was identified.

At this point in time, it is well known that there have also been countless asymptomatic SARS-CoV-2 infections. In these cases, long/post-COVID-like symptoms could also be the consequence of an undetected infection.

Additional information on the safety of COVID-19 vaccines is provided by the Paul Ehrlich Institute on its website: (www.pei.de/sicherheit-covid-19-impfstoffe)

When assessing health complaints following COVID-19 vaccination, please note the information regarding the known side effects of COVID-19 vaccines that are listed in the product information (expert information and instructions for use) and are publicly available.

Last update: August 2024

“Long-term effects” can refer to two separate things. Something that only occurs after a long period of time or something that occurs for a long period of time.

A desired long-term effect of vaccinations in terms of long-lasting consequences is the protection from infection or severe disease. For some people this protection even lasts for their entire lives – for instance with the measles vaccine. With other vaccines, for example those against the flu or COVID-19, repeated vaccinations with adapted vaccines are needed, since the pathogen constantly changes (mutates). However, together these vaccinations lead to ongoing protection against the pathogen.

Decades-long experience has shown that most side effects of vaccines usually emerge within a few hours or days following a vaccine dose. In other words, these are in close temporal relation with the vaccination. In rare cases, side effects may only emerge or be detected a few weeks or months afterwards.

The first COVID-19 vaccines available in Europe were already authorised late 2020 or early 2021. Since then, they have been in general use, initially administered in the context of the vaccination campaign, later only through non-hospital doctors. Since their authorisation, COVID-19 vaccines have been administered billions of times worldwide. In Germany alone, by early July 2024 over 197 million vaccine doses had been administered. In the meantime, the side effects of the COVID-19 vaccines are well known – even side effects that occur very rarely. In individual cases, side effects may result in damage to health that can persist over a long period of time.

Last update: August 2024

Performing a vaccination represents a medical treatment within the meaning of section 630a (1) of the German Civil Code (BGB). Doctor liability therefore only applies to vaccine injuries if, while administering the vaccine, a medical error occurred or the patient was not or only improperly informed.

This means that doctors, for instance, are required to inform patients before a medical treatment of all applicable circumstances needed to obtain their informed consent. Here, the information concerning vaccination risks must be sufficient for the patient to possess the knowledge needed to provide valid consent. In principle, this is also possible using a factsheet, but the patient must in any case then have the opportunity to acquire additional information by way of a personal consultation with the doctor. If the factsheet downplays the risk in its explanations, then this impression must be corrected for the patient.

If this clarification was not or only improperly carried out, then the patient’s consent is rendered void. If a vaccine is still administered in spite of this, it constitutes a violation of medical duties for which doctors are liable for damages.

Last update: June 2023

As with all centrally authorised medicinal products, the safety of the COVID-19 vaccines is continuously reviewed and assessed by the Paul Ehrlich Institute (PEI) and the committees responsible at the European Medicines Agency (EMA) as well as by the pharmaceutical company itself. In this context, information is collected from a variety of sources, such as data from the first reported cases of suspected side effects, data from clinical trials, information from the authorisation holders’ periodic safety update reports and regular analyses of the scientific literature.

Reporting suspected cases of side effects is a core component in the evaluation of medicinal product safety. It allows potential new warning signs to be detected swiftly and the benefit-risk profile of vaccines to be monitored continuously in the context of the marketing authorisation.

If there are indications of possible safety risks, then these are centrally evaluated at the European Medicines Agency (EMA) by the Pharmacovigilance Risk Assessment Committee (PRAC) and, where required, measures are put in place such as communicating these as a new medicinal product risk.

Should new COVID-19 vaccine risks be identified and also confirmed by the PRAC, the Paul Ehrlich Institute then publishes these on its website. For medicinal products and vaccines, all new side effects are listed in the relevant product information and, where required, continuously updated.

Since the start of the vaccination campaign on 27 December 2020 until its conclusion, the Paul Ehrlich Institute published reports on suspected cases of vaccine side effects and vaccine complications in the safety update reports on authorised COVID-19 vaccines.

As an independent body of experts, the Standing Committee on Vaccination (STIKO) develops evidence-based vaccination recommendations for Germany. In doing so, the STIKO considers the benefit to the vaccinated individual as well as the population as a whole. The STIKO is rigorously guided by the criteria of evidence-based medicine. While for the marketing authorisation of a vaccine its efficacy, safety and pharmaceutical quality are important, the STIKO builds on this by assessing the individual benefit-risk ratio, the epidemiology at a population level and the effects of a Germany-wide vaccination strategy so that vaccines can be used to optimum effect. In its recommendations, the STIKO draws on the Paul Ehrlich Institute’s vaccine safety assessments.

Last update: September 2024

Since the availability of COVID-19 vaccines, the Federal Government has provided comprehensive information, especially about the efficacy and the risks and side effects of the available vaccines.

This information is provided in addition to the product information on the COVID-19 vaccines made publicly available by the European Commission and the European Medicines Agency (EMA).

For information on side effects and findings on the frequency of their occurrence, please refer to the current product information texts of licensed vaccines. The Paul Ehrlich Institute’s website (www.pei.de/covid-19-impfstoffe) provides current product information texts on the authorised COVID-19 vaccines. Furthermore, the pharmaceutical companies provide current expert information and instructions for use concerning the COVID-19 vaccines.

For information on the efficacy and safety of the recommended COVID-19 vaccines, please also refer to the scientific justifications of the decisions of STIKO for the COVID-19 vaccination recommendation. It is freely available to the public on the RKI website (https://www.rki.de/DE/Content/Infekt/Impfen/ImpfungenAZ/COVID-19/Impfempfehlung-Zusfassung.htm).

In addition, you can find more detailed information on efficacy and safety in the information and consent documents for the COVID-19 vaccination. The documents are published on the website of the RKI (https://www.rki.de/DE/Content/Infekt/Impfen/Materialien/materialien_fremdsprachig_node.html)

Last update: September 2024

The first point of contact for health complaints after COVID-19 vaccination is the attending physician, so that diagnostic and, if possible, appropriate therapeutic measures can be initiated. Depending on the symptoms, the patient may be referred to a specialist for further diagnosis and treatment.

According to § 6, paragraph 1, sentence 1, number 3 of the IfSG, physicians have an obligation to report to the competent public health authority any suspected damage to health that is more severe than the normal extent of a vaccination reaction. In addition, there are reporting obligations under professional law.

Moreover, some clinics have set up special outpatient clinics that specialise in the treatment of complaints following COVID 19 vaccination. The clinics have the authority to decide on the establishment and operation of special outpatient clinics.

Last update: June 2023

Those affected can report suspected cases of side effects via the online reporting portal at www.nebenwirkungen.bund.de, via email or letter to the Paul Ehrlich Institute. They can report suspected cases on their own behalf or that of another person in their care, for instance on behalf of a child or family member. 

Pursuant to section 8 (1) of the Protection against Infection Act, doctors as well as those responsible for administering the vaccines and, where vaccines are administered at a community pharmacy, those in charge of that community pharmacy, are required to notify the local public health office on a named-patient basis of vaccine complications, in other words health complaints that according to section 6 (1) number 3 go beyond normal vaccine reactions and cannot evidently be traced back to other causes. The public health offices are required, pursuant to section 11 (4) of the Protection against Infection Act, to transmit all reported suspected cases to the competent Land authority and the competent higher federal authority, the Paul Ehrlich Institute.

Last update: September 2024

The Paul Ehrlich Institute records and evaluates all suspected cases of side effects that are reported to it. It does not matter where these reports came from and how they reached the Paul Ehrlich Institute. Suspected cases are published on the www.pei.de website and additionally transmitted to the EudraVigilance database of the European Medicines Agency (EMA). As a member of the Pharmacovigilance Risk Assessment Committee (PRAC), the Paul Ehrlich Institute is directly involved in decision-making in case further measures are needed.

Last update: September 2024

A central issue that the Federal Ministry of Health is dealing with in connection with long/post COVID is the creation of a Germany-wide network of competence centres and interdisciplinary outpatient clinics for long/post COVID and chronic fatigue syndrome (ME/CFS), as mentioned in the coalition agreement between the Social Democratic Party (SPD), Alliance 90/The Greens (BÜNDNIS 90/DIE GRÜNEN) and the Free Democratic Party (FDP).

In this context, the Federal Ministry of Health is preparing to launch a special funding programme for health care-related research projects on long/post-COVID. It is intended to support the creation of a network, stimulate the exchange of information, initiate health services research and improve the care of those affected. Patients who suffer from Long-/Post-COVID-like symptoms that occurred in connection with a vaccination will also benefit from health care research in the field of Long-/Post-COVID.

Last update: November 2024

A vaccine injury exists if, as a result of vaccination pursuant to section 2 no. 9 of the Protection against Infection Act, a person has sustained damage to health that exceeds the extent of a normal vaccine reaction (cf. section 24 sentence 1 Social Code Book Fourteen – Social Compensation (SGB XIV). Whether in an individual case damage to health was caused by vaccination and an inherent claim to benefits therefore exists is determined by the competent Land authority.

Last update: August 2024

COVID-19 vaccinations are subject to the general principles of the law of benefits on account of vaccine injuries and Social Compensation. Effective 1 January 2024, the law of benefits on account of vaccine injuries was transposed into Social Code Book XIV – Social Compensation (SGB XIV). Pursuant to section 24 sentence 1 SGB XIV, damage to health exceeding the extent of a normal vaccine reaction must be present in order for a vaccine injury to exist.

Vaccine injuries sustained in connection with immunisations given since 1 January 2024 especially on the basis of the COVID-19 Prevention Ordinance or, in the case of immunisations given to a person with private health insurance as specified in the entitlement pursuant to the COVID-19 Prevention Ordinance, give rise to a claim to Social Compensation benefits (section 24 SGB XIV). A claim also exists if the immunisation was publicly recommended by the competent Land authority and implemented within its area.

It is for the relevant competent Land authorities to decide on applications for such benefits. In order for a vaccine injury to be recognised, an application has to be submitted to the competent authority. This is usually the Compensation Office (Versorgungsamt). If the immunisation was carried out in Germany, this claim is made against the Land in which the vaccine injury was caused.

Pursuant to section 141 sentence 1 of the SGB XIV, even persons injured before 1 January 2024 receive benefits under SGB XIV if the prerequisites set out in section 60 of the Protection against Infection Act in the version applicable until 31 December 2023 (old version) were met. Up until 31 December 2023, the Protection against Infection Act stipulated that vaccine injuries sustained in connection with immunisations performed particularly on the basis of the Coronavirus Vaccination Ordinance since 27 December 2020 (the day of the first coronavirus vaccination in Germany) or, since 8 April 2023, on the basis of the COVID-19 Prevention Ordinance, give rise to a claim to benefits, with the provisions of the Federal War Victims' Compensation Act (Bundesversorgungsgesetz) applying accordingly (section 60 (1) no. 1a of the Protection against Infection Act old version). In the context of immunisations, this applied accordingly also to persons who have private health insurance cover. These benefit claims also existed if the immunisation was publicly recommended by a competent Land authority and implemented within its area (section 60 (1) sentence 1 no. 1 IfSG old version).

Last update: August 2024

For COVID-19 vaccines approved by the European Commission (EU COM), the same liability rules apply as for all other medicinal products. In Germany, those harmed by a vaccination are extensively protected on the basis of strict liability under medicinal product law and the right to compensation for vaccine damage under the Infection Protection Act.

In order to promote the development of vaccines against COVID-19 and to reduce the financial risks assumed by the manufacturers, the agreements concluded by the EU Commission with the manufacturers provide for the Member States to shoulder financial obligations for the manufacturers in certain cases in the event of liability claims due to side effects. However, there is no agreement with the vaccine manufacturers that limits claims by vaccinated persons for compensation.

The contracts for the purchase of vaccines against COVID-19 do not affect the provisions of the European Product Liability Directive or liability under the applicable Member State law.

In addition to a claim for information against the pharmaceutical operator and the respective higher federal authority, strict liability under pharmaceutical law in accordance with § 84 of the Pharmaceutical Products Act (AMG) also provides for a presumption of causality in favour of the potentially injured party for the occurrence of the damage caused by the medicinal product.

Civil law is applicable for the assertion of liability claims, as this is a private-law dispute between the vaccinated person and the vaccine manufacturer.

Last update: November 2023

Affected persons who suspect that they have suffered vaccination damage can submit an application to the federal state authority in charge of them. As a rule, the competent authorities are the pension offices of the federal states. However, the federal states can also stipulate responsibilities that deviate from this. That is why those affected will need to find out from their Land where exactly to file their claim. The competent federal state authority first decides whether a vaccination damage exists or not. If the vaccination was carried out in Germany, the claim is directed against the federal state in which the vaccination damage was caused.

The claim for care requires neither illegality nor fault, but is based primarily on the causality between the vaccination and its consequences. For the purposes of recognition of an injury that goes beyond the extent of a normal vaccine reaction, the burden of proof in demonstrating causation has been eased. For damage to health as a consequence of an injury to be recognised, the likelihood of a causal link suffices. In assessing whether the prerequisites of the claim are met in the individual case, medical-scientific findings must be referred to. Full proof must be provided for the other prerequisites of the claim, i.e. their existence must be proven with a probability bordering on certainty.

The so-called “Kann-Versorgung” (discretionary recognition of benefits) must be noted as a further easing of the burden of proof. If the probability is not given only because there is some uncertainty in medical science as to the cause of the established suffering, the damage to health may nevertheless be recognised as the result of a vaccine damage with the consent of the supreme federal state authority responsible for war victims' welfare. This approval may also be issued on a general basis. The prerequisite, according to case law, is that according to at least one medical doctrine, the causal connection between the damaging event and the health disorder is not only possible, but probable.

The Working Group of Senior Physicians of the Federal Länder and the Federal Armed Forces (AGLeitÄ) has collected and pooled findings regarding potential vaccine injuries on account of COVID-19 vaccinations from the different Länder. It has developed guiding principles to serve as Germany-wide guidance for assessing and evaluating the causal link between specific health impairments and COVID-19 vaccinations administered. These guidelines are developed further on an ongoing basis to keep abreast of current scientific findings.

Last update: August 2024

No, there is no provision for a reversal of the burden of proof for the compensation claim. This means that, with the exception of the exemptions from the burden of proof outlined above, full proof must be provided, i.e. the prerequisites of the compensation claim must be proven with a probability bordering on certainty. This applies especially if there was damage caused by vaccination.

Last update: August 2024

The public health department can provide assistance in initiating the necessary investigations that will lead to clarification of the case and offer help in initiating the compensation procedure.

If you or other affected persons would like to receive further individual counselling, there is also the option of contacting the Independent Patient Counselling Service Germany (UPD). Alternatively, you can call the UPD's free counselling line at 0800 0117722. For detailed information on the counselling hours and possibilities of online counselling as well as on-site counselling, please visit the UPD website at www.patientenberatung.de.

Last update: June 2023

The assessment of whether a health damage that occurred in a temporal connection with a vaccination was caused by the vaccination is initially the task of the competent federal state authority in the respective federal state.

To challenge the assessment of the competent entity, administrative appeal proceedings filed with the competent authority must in principle precede the judicial clarification (sections 78, 83 et seqq. of the Social Courts Act (Sozialgerichtsgesetz)). Information regarding which authority an appeal must be filed with can be found in the instructions in the official letter from the competent Land authority (advice on legal remedies). 

Should the appeal proceedings also prove unsuccessful, final clarification of whether the rejection of the application for benefits on account of a vaccine injury is lawful can be obtained in a social court.

Last update: August 2024