Information on coronavirus vaccination

Side effects and vaccine injury law

• Are the COVID-19 vaccines safe?

  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), in Germany this is carried out by the Paul Ehrlich Institute (PEI).

  The approved vaccines against COVID-19 protect effectively against severe progression of the disease. Their benefits far outweigh the potential risks. Since the beginning of the vaccination campaign, over 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.

• What are vaccine reactions, side effects and complications?

  Vaccine reactions

  Vaccine reactions are typical symptoms following a vaccination, such as reddening, swelling and pain at the injection site, but also more general reactions such as fever, headache, aching limbs and malaise. These reactions are a sign of the desired activation of the immune system, emerge within 1-2 days of receiving the vaccine and usually subside again after a few days without any consequences.

  Side effects

  According to the Medicinal Products Act (Arzneimittelgesetz – AMG), side effects are defined as noxious and unintended reactions to a medicinal product. Serious side effects are side effects that are fatal or life-threatening, require hospitalisation or the prolonging of existing hospitalisation, or lead to persistent or significant disability, incapacity, 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 (expert information and instructions for use). 

  Vaccine complications

  Vaccine complications are adverse drug reactions (ADRs) following 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. “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.

• What is meant by vaccine injury?

  A vaccine injury exists if, as a result of vaccination pursuant to section 2 number 9 of the Protection against Infection Act (IfSG), 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.

• What is meant by “post-vac syndrome”?

  The term “post-vac” does not constitute a medical definition of an illness. 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 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.

  The Paul Ehrlich Institute (PEI) routinely collects and evaluates all suspected cases of side effects from COVID-19 vaccines. After evaluating the data available in Germany and abroad on reported suspected cases following COVID-19 vaccination, PEI has thus far been unable to confirm a causal relationship between persistent Long COVID-like symptoms and COVID-19 vaccination.

  Additional information on the safety of COVID-19 vaccines is provided by the PEI on its website.

• Who can you contact if affected by health impairments following vaccination?

  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, referral to a specialist may take place for further diagnosis and treatment.

  According to section 6 (1) sentence 1 number 3 of the Protection against Infection Act (IfSG), the person responsible for carrying out the vaccination (in pharmacies, this is the manager of the pharmacy) are required to report suspected vaccination-related damage to health that exceeds the extent of a normal vaccine reaction to the competent public health office. In addition, reporting obligations under the codes of professional practice apply.

  Moreover, some clinics have set up special outpatient clinics that specialise in the treatment of complaints following COVID 19 vaccination. The hospitals themselves decide whether or not to set up and run such specialised outpatient departments.

• What are “long-term effects” of coronavirus vaccination and what is known about them?

  Decade-long experience has shown that most of the 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 occur or are recognised only after weeks or a few months. The first COVID-19 vaccines available in Europe were already licensed late in 2020 or early in 2021. Since then, they have been administered millions or even billions of times. In the meantime, these vaccines and their side effects are well known – even side effects that occur very rarely. In individual cases, side effects may result in health impairments that can persist over a longer period of time.

• What plans are there to improve the care of patients affected by post-/long COVID-like symptoms in a temporal relation with the COVID-19 vaccination?

  The Federal Ministry of Health (BMG) will support patient-centered research into Long COVID within the context of a multi-year funding priority. The focus of this funding will be pilot projects in which innovative types of treatment for those affected by Long COVID are being developed and tested. This Long COVID funding priority will also benefit ME/CFS patients as well as those affected by lingering complaints consistent with Long COVID that emerged in a temporal relation with a COVID-19 vaccination.

  In addition, further healthcare research projects on postviral syndromes such as Long COVID are supported via the Innovation Fund of the Federal Joint Committee (G-BA).

  To ensure faster and more needs-appropriate care for patients suspected to have Long COVID, the Federal Joint Committee (G-BA) also drafted a new directive on 21 December 2023 defining requirements for patient care and specifying care pathways. The directive provides for one designated doctor. That person would be in charge of the specific coordination needed for diagnostics and therapy. For example, existing outpatient structures and offerings will be used and the correct health professions involved based on the patient’s needs as determined by the severity and complexity of the illness.

  As a next step, the G-BA will submit its draft directive to the Federal Ministry of Health for legal assessment. If no objections are raised in this context, the directive can take effect. Subsequently, the Valuation Committee of doctors and health insurance funds examines if or to what extent the doctors' fee scale (EBM) needs to be adjusted. The Valuation Committee has a maximum of six months to do so.

• Who is liable in case of health-related harm as a result of the vaccine?

  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 transferred to Social Code Book XIV (SGB XIV). Pursuant to section 24 sentence 1 SGB XIV, damage to health exceeding the extent of a normal vaccine reaction must be present 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 insured in the 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. For a vaccine injury to be recognised, an application has to be submitted to the competent authority. This is usually the pension office (Versorgungsamt). If the immunisation was carried out in Germany, this claim is made against the Federal Land in which the vaccine injury was caused.

  Pursuant to section 141 sentence 1 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 (IfSG) in the version applicable until 31 December 2023 (old version) were met. Up until 31 December 2023, the IfSG 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 - BVG) applying accordingly (section 60 (1) no. 1a IfSG 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 health authority and implemented within its area (section 60 (1) sentence 1 number 1 IfSG old version).

• When can vaccine manufacturers be held liable for vaccine injuries?

  For COVID-19 vaccines approved by the European Commission (EU COM), the same liability rules apply as for all other medicinal products. People who have suffered harm as a result of vaccination are comprehensively protected in Germany on account of medicinal product-related absolute liability provisions and the benefit claim for vaccine injuries pursuant to the Protection against Infection Act (IfSG).

  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. But no agreement exists with the vaccine manufacturers limiting the compensation claims of vaccinated people. 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 particular, the medicinal product-related absolute liability provision pursuant to section 84 of the Medicinal Products Act (AMG) has proven its relevance. To the benefit of the potentially injured party, in addition to a right to disclosure vis-à-vis the pharmaceutical company and the competent higher federal authority, the medicinal product-related absolute liability provision also provides for the presumption of a causal connection between the injury’s occurrence and the medicinal product. The civil court route is to be taken to assert these liability claims, since they constitute a private-law dispute between the vaccinated person and the vaccine manufacturer.

• Are doctors liable for vaccine injuries?

  Administering a vaccine 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.

  For example, doctors are obliged to inform patients about all circumstances that are essential for consent prior to medical treatment. 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. In any case, the patient must 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.

• What must I consider if I wish to claim compensation pursuant to the IfSG or SGB XIV?

  People who suspect they may have suffered a vaccine injury can submit their claim to the competent Land authority. Generally, these are the pension offices of the Federal Länder. But in some Federal Länder, these responsibilities may differ. That is why those affected will need to find out from their Federal Land where exactly to file their claim. Initially, the competent Land authority determines whether or not a vaccine injury is present. If the immunisation was carried out in Germany, this claim is made against the Federal Land in which the vaccine injury was caused.

  This claim to benefits does not presume unlawfulness nor fault and is based primarily on the causal link between the vaccination and its effects. 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. When determining whether the conditions have been met in an individual case, medical science findings are to be applied. For the remaining claim conditions, full proof must be provided, meaning their existence must be proven with almost absolute certainty.

  The so-called “Kann-Versorgung” (discretionary recognition of benefits) should be noted as a further easing of the burden of proof. In the event that uncertainty in medical science over the cause of the established condition is the only reason preventing this probability from being accepted, then the damage to health may nonetheless be recognised as the consequence of a vaccine injury subject to the approval of the highest Land authority responsible for the pension scheme for war victims. This approval may also be issued on a general basis. In case law, the condition is that according to at least one medical authority a causal link between a harmful event and a health impairment is not only possible but likely.

  The Working Group of Senior Physicians of the Federal Länder and the Federal Armed Forces (AGLeitÄ) has compiled findings on potential vaccine injuries caused by COVID-19 vaccinations from the Federal Länder, bundled them and drawn up guidelines that serve as uniform national guidance for the assessment and evaluation of a causal connection between particular health disorders and a COVID-19 vaccination. These guidelines are developed further on an ongoing basis to keep abreast of current scientific findings.

• Can I invoke a reversal of the burden of proof as part of the claim for compensation under Section 60 (1) IfSG?

  No, a reversal of the burden of proof is not provided for in respect of the compensation claim. This means that, apart from the aforementioned easing of the burden of proof (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, in particular, to the presence of a vaccine injury.

• Is there potential assistance with compensation claim proceedings?

  The public health office can offer assistance in initiating the investigations needed during the evidentiary process and offer support with initiating compensation claim proceedings.

• What options are there if a claim for compensation is rejected?

  The assessment of whether a health impairment in temporal relation to a vaccination was indeed caused by the vaccination initially falls under the jurisdiction of the competent Land authority in each Federal Land.

  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 (SGG)). 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.

• How are vaccine side effects reported?

  Vaccine side effects can be reported directly by the person affected to the Paul Ehrlich Institute (PEI) as the competent higher federal authority for vaccines at www.nebenwirkungen.bund.de using an online form. You can report suspected cases on your own behalf or that of another person in your care, for instance on behalf of a child or family member. Reports of suspected side effects can be submitted by phone, by letter and of course electronically.

  Additionally, pursuant to section 6 (1) sentence 1 number 3 of the Protection against Infection Act (IfSG), doctors, for instance, are required to report vaccination-related damage to health that exceeds the extent of a normal vaccine reaction. This report is sent to the public health office. The public health offices are required, pursuant to section 11 (4) of the IfSG, to transmit all reported suspected cases to the competent Land authority and the competent higher federal authority, the PEI.

• What happens with reports on vaccine side effects?

  The Paul Ehrlich Institute (PEI) records all suspected cases of vaccine side effects in Germany and transmits these to the European EudraVigilance database. The PEI regularly evaluates suspected cases of COVID-19 vaccine side effects and informs the public, e.g. in safety reports or the Pharmacovigilance Bulletin (publications on medicines). Moreover, in cooperation with the European Medicines Agency, the PEI implements further steps if required.

• How is the safety of vaccines evaluated?

  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 committees responsible at the European Medicines Agency (EMA). If new findings indicate the occurrence of side effects, it is possible to respond very swiftly and, where required, take further measures.

  As an independent body of experts, the Standing Committee on Vaccination (STIKO) develops evidence-based vaccination recommendations for Germany. In doing so, STIKO takes into account the benefit for the vaccinated individual and for the entire population. STIKO strictly follows the criteria of evidence-based medicine. While the efficacy, safety and pharmaceutical quality of a vaccine are relevant for its approval, 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, STIKO incorporates the assessments of PEI on the safety of vaccines.

  PEI has the expertise to assess individually occurring adverse reactions after vaccinations. Following the approval of a vaccine, all reports of suspected side effects or vaccine complications are continuously recorded and evaluated. Information on side effects after vaccination with COVID-19 vaccines can be found in the safety reports of PEI and in the product information of the respective vaccines.

  Reporting suspected cases of adverse drug reactions (ADRs) is a core component in the evaluation of medicinal product safety. It allows potential new warning signals to be detected swiftly and the benefit-risk profile of vaccines monitored continuously in the context of the marketing authorisation.

• Where can I get further information about vaccination side effects?

  Since the rollout of COVID-19 vaccines, the Federal Government provides comprehensive information particularly on the efficacy, risks and side effects of the available vaccines.

  This information is provided in addition to the European Commission’s and the European Medicines Agency’s publicly available product information for COVID-19 vaccines.

  Information on the side effects and data on the frequency of occurrence are included in the current product information texts for the authorised vaccines. The PEI website provides current product information texts on the authorised COVID-19 vaccines. Furthermore, the pharmaceutical companies provide current expert information and instructions for use relating to the COVID-19 vaccines.

  Information on the efficacy and safety of the recommended COVID-19 vaccines can also be found in the scientific justifications concerning the Standing Committee on Vaccination’s COVID-19 vaccination recommendation. These are freely available from the RKI website (German).

  Furthermore, clarifications concerning the efficacy and safety can be found in the information and declarations of consent for the COVID-19 vaccine. These documents are available from the RKI’s website.