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 192 million vaccine doses have been administered. Therefore, there is a large body of data on the safety of COVID-19 vaccine products.

Nevertheless, side effects, and in very rare cases serious side effects or vaccine complications, may occur.

Last update: June 2023

Vaccination reactions

Vaccination reactions refer to typical symptoms after a vaccination, such as redness, swelling or pain at the injection site, as well as general reactions such as fever, headache, pain in the limbs and a feeling of general malaise. These reactions reflect the desired activation of the immune system and usually disappear after a few days without any consequences.

Side effects

According to the German Medicines Law (AMG), side effects have been defined as harmful and unintended reactions to a medicinal product. Serious side effects refer to side effects that are fatal or life-threatening, require inpatient treatment or prolongation of inpatient treatment, lead to permanent or serious disability, invalidity, congenital anomalies or birth defects. For information on the type and frequency of adverse drug reactions, please refer to the relevant vaccine's product information texts (technical information and directions for use).

Vaccine complications

Vaccine complications refer to adverse drug reactions (ADRs) following the vaccination. For the reported frequency of adverse drug reactions (ADRs) observed in clinical trials, please refer to the product information of the respective vaccines. As a rule, adverse drug reactions are quite rare. This also applies to the vaccines against COVID-19.

The information leaflets on the various COVID-19 vaccines offered in Germany describe the frequently occurring vaccination reactions as well as the rarely and very rarely observed vaccination complications for which a causal relationship with the vaccination is deemed possible or is being investigated. The term rare refers to a reaction that occurs in one to ten out of 10,000 vaccinated persons. The term very rare refers to a specific reaction occurring in less than one vaccinated person per 10,000 vaccinated persons.

Last update: June 2023

The term "post-vac" does not refer to a medically defined disease. Based on the available evidence, the term is used to describe various prolonged complaints after COVID-19 vaccination, such as those associated with long/post COVID (e.g. chronic fatigue syndrome (Myalgic Encephalomyelitis /Chronic Fatigue Syndrome, ME/CFS), postural tachycardia syndrome (POTS), including the complaints known as postexertional malaise (PEM, malaise after exertion)). When classifying health complaints after COVID-19 vaccination, it is important to note information on known side effects of the COVID-19 vaccines, which are listed in the product information texts (technical information and directions for use) and are publicly available.

The Paul Ehrlich Institute (PEI) routinely collects and evaluates all suspected cases of adverse reactions to COVID-19 vaccines. After evaluation of the data available in Germany and internationally on suspected cases after COVID-19 vaccinations by the PEI, a causal relationship between persistent long COVID-like symptoms and COVID-19 vaccination could not be confirmed so far.

For more information on the safety of COVID-19 vaccines, please visit the PEI website (https://www.pei.de/DE/newsroom/dossier/coronavirus/coronavirus-inhalt.html).

Last update: June 2023

There are two possibilities of what is meant by the term "long-term effects". Either it is something that occurs after a long time or something that lasts for a long period of time.

Often, in several forms of media, the term "long-term effects" is used to refer to adverse effects associated with COVID-19 vaccination that occur and last over a long period of time. However, a welcome long-term consequence of vaccination in the sense of a long-lasting effect is protection against infection or serious illness.

Decades of experience have shown that most side effects of vaccines occur within a few hours or a few days after a vaccination, i.e. they are closely related to the vaccination in terms of time. In rare cases, side effects occur or are recognised only after weeks or a few months. The first COVID-19 vaccines available in Europe were already approved in late 2020 or early 2021 and have been in general use to date. Since then, they have been administered millions or even billions of times. These vaccines and their side effects are now well known, including very rare side effects. In individual cases, side effects can cause damage to health that lasts over a long period of time.

Last update: June 2023

he performance of a vaccination constitutes a medical treatment within the meaning of § 630 a paragraph 1 of the German Civil Code (BGB). Doctors are therefore only liable for vaccine damage if a treatment error was committed during the vaccination or if the patient was not informed or not properly informed.

For example, doctors are obligated to inform patients about all circumstances that are essential for consent prior to medical treatment. The information about vaccination risks must be so comprehensive that the patient is provided with the knowledge necessary for effective consent to the treatment. In principle, it is also possible to provide this information on the basis of a leaflet. In any case, the patient must then have the opportunity to obtain further information in a personal discussion with the doctor. If the information sheet contains statements that downplay the risk, this perception must be corrected vis-à-vis the patient.

If the information has not been provided or has not been provided properly, the patient's consent is invalid, so that the protective vaccination that is nevertheless carried out constitutes a breach of duty that obligates doctors to pay damages.

Last update: June 2023

The safety of licensed COVID-19 vaccines is regularly reviewed and assessed by the pharmaceutical company itself as well as by the Paul Ehrlich Institute (PEI) and the responsible committees at the European Medicines Agency (EMA). If there are indications of new findings on the occurrence of side effects, this means that it is possible to take action very quickly and, if necessary, to implement further measures.

The Standing Committee on Vaccination (STIKO) develops evidence-based vaccination recommendations for Germany as an independent expert committee. In doing so, the STIKO takes into account the benefit for the vaccinated individual and for the entire population. The STIKO strictly follows the criteria of evidence-based medicine. While the efficacy, safety and pharmaceutical quality of a vaccination are relevant for its approval, the STIKO then analyses the individual benefit-risk ratio, the epidemiology at the population level and the effects of a nationwide vaccination strategy for Germany, so that vaccines can be optimally used. For this purpose, the STIKO incorporates the assessments of the PEI on the safety of vaccines.

The PEI has the expertise to assess individually occurring adverse reactions after vaccinations. Following the approval of a vaccine, all reports of suspected adverse reactions or vaccine complications are continuously recorded and evaluated.

Information on adverse reactions after vaccination with COVID-19 vaccines can be found in the safety reports of the PEI and in the product information of the respective vaccines.

The reporting of suspected adverse events is a cornerstone for the assessment of the safety of medicinal products. In this way, possible new risk signals can be detected promptly and the benefit-risk profile of the vaccines can be continuously monitored within the framework of the marketing authorisation.

Last update: June 2023

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 in addition to the product information of the COVID-19 vaccines made publicly available by the European Commission and the European Medicines Agency.

For information on side effects and findings on the frequency of their occurrence, please refer to the current product information texts of licensed vaccines. On its website, the PEI provides access to the current product information texts of the licensed COVID-19 vaccines (https://www.pei.de/DE/arzneimittel/impfstoffe/covid-19/covid-19-node.html). In addition, the pharmaceutical companies provide up-to-date technical information and directions for use for 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: June 2023

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

Persons affected can report vaccination side effects directly to the Paul Ehrlich Institute (PEI) as the higher federal authority using an online form at www.nebenwirkungen.bund.de. They can report suspected cases on their own behalf or on behalf of another person they care for, such as a child or a relative. You can report suspected adverse drug reactions by telephone, by letter and especially electronically.

In addition, the reporting of health damage that exceeds the usual extent of a vaccination reaction is obligatory for doctors, for example, according to § 6 paragraph 1 sentence 1 number 3 of the IfSG. The notification is made by the doctor to the public health office. According to § 11 paragraph 4 of the IfSG, the health offices are obligated to report the reported suspected cases to the competent federal state authority and the competent higher federal authority, the PEI.

Last update: June 2023

The Paul Ehrlich Institute (PEI) records all suspected cases of vaccines in Germany and forwards them to the European EudraVigilance database. The PEI regularly evaluates suspected cases of adverse reactions to COVID-19 vaccines and informs the public, for example, in safety reports or in the Bulletin on Drug Safety (publications on medicinal products: https://www.pei.de/DE/newsroom/veroffentlichungen-arzneimittel/ver-am-node.html). In addition, the PEI takes further necessary measures in cooperation with the European Medicines Agency.

Last update: June 2023

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. The timing and financing of the corresponding measures both depend on the concrete design and have not yet been conclusively determined at this point in time.

Last update: June 2023

Vaccine damage refers to "the health and economic consequences of health damage caused by vaccination that exceeds the normal extent of a vaccination reaction" (§ 2 No. 11 of the IfSG) (German Vaccination Protection Act). The competent state authority according to § 64 paragraph 1 of the IfSG ascertains primarily that a vaccine damage within the meaning of § 2 number 11 of the IfSG has occurred in an individual case due to a protective vaccination and that therefore, in principle, the claim to care exists. Normally, the pension offices of the federal states take care of this.

Last update: June 2023

Since 8 April 2023, the same regulations apply to COVID vaccination as to other vaccinations. § 60 of the IfSG regulates the liability for vaccine damage that has occurred in connection with a vaccination. Anyone who has suffered damage to health as a result of a protective vaccination that was publicly recommended by a competent federal state authority and was carried out in its area is entitled to compensation on application in accordance with the Federal Pension Act. For vaccinations carried out between 27 December 2020 and 7 April 2023 on the basis of the Coronavirus Vaccination Ordinance, there is also an entitlement under § 60 paragraph 1 of the IfSG in the event of vaccine damage, irrespective of whether the vaccination was publicly recommended.

Depending on the case, liability of the pharmaceutical companies on the basis of various legal foundations (pharmaceutical law, product liability law as well as general liability rules of the Civil Code) or of the person vaccinating may also be considered.

Last update: June 2023

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: June 2023

Anyone who has suffered vaccine damage as a result of a publicly recommended protective vaccination or a vaccination based on the Coronavirus Vaccination Ordinance receives care under the Federal Benefits Act upon application. This is regulated in § 60 paragraph 1 of the IfSG.

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. Therefore, you have to find out in your federal state where exactly you have to submit the application. 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. In this context, the burden of proof for proving causality for the recognition of a damage to health as a consequence of the health damage exceeding the usual extent of a vaccination reaction is alleviated (§ 61 of the IfSG). For the recognition of a damage to health as a consequence of an injury in the sense of § 60 paragraph 1 sentence 1 of the IfSG, the probability of the causal connection is sufficient. 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.

In this context, the so-called "optional care" according to § 61 sentence 2 of the IfSG must be taken into account as a further simplification of evidence. 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. The consent can also be granted in general (§ 61 sentence 3 of the IfSG). 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 the Chief Physicians of the Federal States and the Federal Armed Forces (AGLeitÄ) has compiled findings on potential vaccine damage caused by COVID-19 vaccinations from the Federal States, bundled them and drawn up guidelines that serve as a nationally uniform orientation for the assessment and evaluation of a causal connection between particular health disorders and a COVID-19 vaccination. These guidelines will be continuously developed according to the current state of scientific knowledge.

With effect from 1 January 2024, §§ 60 et seq. IfSG will be transferred to the new Fourteenth Book XIV of the Social Code. The previous level of protection of the compensation claim under the IfSG will be maintained, so those affected need not fear any adverse consequences as a result of the transfer to Book XIV of the Social Code.

Last update: June 2023

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 (question: "What do I have to consider if I want to assert a claim for compensation under the IfSG?"), 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: June 2023

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.

If you disagree with the assessment of the competent authority in your federal state, you must - prior to judicial clarification - in principle conduct an objection procedure with the competent authority (§ 64 paragraph 2 of the IfSG in conjunction with §§ 78, 83 et seq. Social Court Act (SGG)). The authority to which an appeal must be lodged can be found in the instruction included in the decision of the competent state authority.

If the appeal procedure has also turned out to be ineffective for you, you can take legal action to finally clarify whether the rejection of an application for care in the case of a vaccination damage is lawful. For claims under § 60 of the IfSG, legal recourse can be taken to the social courts under § 68 paragraph 2 of the IfSG.

Last update: June 2023