Information on coronavirus vaccination

Side effects and vaccine injury law

• Are the COVID-19 vaccines safe?

  As part of the marketing authorisation for COVID-19 vaccines, quality, efficacy and safety were checked and a positive benefit-risk ratio certified. The benefit-risk ratio of authorised COVID-19 vaccines is monitored by the competent authorities on an ongoing basis. In coordination with the European Medicines Agency (EMA), in Germany this is carried out by the Paul Ehrlich Institute (PEI).

  The authorised vaccines against COVID-19 offer effective protection against severe courses of disease. Their benefits far outweigh the potential risks. Since the beginning of the vaccination campaign, over 192 million vaccine doses have been administered. This has resulted in ample data to determine the safety of COVID-19 vaccine products.

  Nonetheless, side effects may occur, in very rare cases even severe side effects and/or vaccine complications.

• 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. Details concerning the type and frequency of the adverse drug reaction can be found in the product information (expert information and instructions for use) for each vaccine.

  Vaccine complications

  Vaccine complications are adverse drug reactions (ADRs) following vaccination. The frequency with which ADRs were detected in clinical studies can be found in the expert information for each vaccine. ADRs are usually very rare. This also applies to the vaccines against COVID-19.

  The information leaflets on the various COVID-19 vaccines used in Germany describe the frequently occurring vaccine reactions as well as the rarely and very rarely observed vaccine complications, where a causal relationship with the vaccine is considered possible or is being examined. “Rarely” means a reaction occurs in between one to ten cases per 10,000 vaccinated people. “Very rarely” means a specific reaction occurs in less than one person per 10,000 vaccinated people.

• What is meant by vaccine injury?

  According to the Protection against Infection Act (IfSG), a vaccine injury is defined as “a health and economic consequence of vaccination-related damage to health that exceeds the extent of a normal vaccine reaction; a vaccine injury shall also be deemed to be present if replication-competent pathogens were used for vaccination and persons other than the person vaccinated were injured” (section 2 number 11 of the IfSG). Whether in an individual case a vaccine injury pursuant to section 2 number 11 of the IfSG was caused by vaccination and an inherent claim to benefits therefore exists is determined by the Land authority competent under section 64 (1) of the IfSG.

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

  The term “post-vac” does not constitute a medical definition of an illness. With the evidence presently available, this term covers various longer-lasting symptoms following a COVID-19 vaccination that are also associated with long/post-COVID (such as chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), postural tachycardia syndrome (PoTS), including the symptoms known as post-exertional malaise (PEM, discomfort following activity). 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) regularly collects and evaluates data concerning all suspected cases of COVID-19 vaccine side effects. After evaluating the data available in Germany and abroad on reported suspected cases following COVID-19 vaccination, the 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 in case of health complaints following COVID-19 vaccination are the attending physicians, who can initiate diagnostic measures and, where possible, suitable treatment options. 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.

  Furthermore, some hospitals have set up outpatient departments that specialise in the treatment of symptoms 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 may only emerge or be detected a few weeks or months afterwards. The first COVID-19 vaccines that were available in Europe were authorised as early as the end of 2020 or beginning of 2021 and have since been in general use. Since then, these have been administered millions, some 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 is in the process of establishing a multi-year funding priority for patient-oriented research projects on long COVID and will fund patient-oriented research projects on long COVID from 2024 in this context. Funding of up to 21 million euros is being allocated for this purpose. 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 those affected by longer-lasting symptoms that emerged in a temporal relation with a COVID-19 vaccination with long COVID-like symptoms.

  Besides information on long COVID, the www.bmg-longcovid.de website contains useful information on side effects of COVID-19 vaccines and vaccine injury law.

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

  Since 8 April 2023, the same regulations apply for COVID vaccination as for other vaccinations. Section 60 of the Protection against Infection Act (IfSG) regulates liability for vaccine injuries that occurred in connection with vaccination. People whose health sustained damage on account of an immunisation publicly recommended by a competent Land authority and implemented within its area are entitled upon application for compensation under the provisions contained in the Federal War Victims’ Compensation Act (Bundesversorgungsgesetz – BVG). For vaccinations performed between 27 December 2020 and 7 April 2023 on the basis of the Coronavirus Vaccination Ordinance, in case of vaccine injuries there is also a compensation claim pursuant to section 60 (1) of the IfSG, irrespective of whether the vaccination was publicly recommended.

  Depending on the circumstances of the individual case, the liability of the pharmaceutical companies on the strength of various legislative bases (medicinal product law, the Product Liability Act (Produkthaftungsgesetz – ProdHaftG) or the generic liability provisions of the German Civil Code (Bürgerliches Gesetzbuch – BGB)) or of the person administering the vaccine can also be considered.

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

  In principle, the same liability rules apply to COVID-19 vaccines authorised by the European Commission (EU COM) as to any 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 compensation claim for vaccine injuries pursuant to the Protection against Infection Act (IfSG).

  To encourage the development of vaccines against COVID-19 and reduce the financial risk to manufacturers engaged in this endeavour, EU COM contractually agreed with the manufacturers that in cases of liability pertaining to side effects, the member states will in certain cases assume the manufacturers’ financial obligations. But no agreement exists with the vaccine manufacturers limiting the compensation claims of vaccinated people.

  The European Product Liability Directive as well as the liability under applicable member state law remain unaffected by the agreements concerning the procurement of vaccines against COVID-19.

  In particular, the medicinal product-related absolute liability provision pursuant to section 84 of the Medicinal Products Act (AMG) has proven its relevance. In 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?

  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 performing the vaccination, a medical error occurred or if 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. 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 vaccination 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?

  People who have suffered a vaccine injury on account of a publicly recommended vaccination or a vaccination pursuant to the Coronavirus Vaccination Ordinance are entitled to a benefit pursuant to the Federal War Victims’ Compensation Act (BVG). This is stipulated in section 60 of the Protection against Infection Act (IfSG).

  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 you will need to find out from your Federal Land where exactly to file your claim. Initially, the competent Land authority determines whether or not a vaccine injury is present. If the vaccination was carried out in Germany, this claim is made against the Federal Land in which the vaccine injury was caused.

  This claim to compensation does not presume unlawfulness nor fault, and is based primarily on the causal link between the vaccine and its effects. Moreover, for the recognition of vaccination-related damage to health that goes beyond the extent of a normal vaccine reaction, the burden of proof in demonstrating causation has been eased (section 61 of the IfSG). The likelihood of a causal link suffices for the recognition of damage to health resulting from an injury within the meaning of section 60 (1) sentence 1 of the IfSG. 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) pursuant to section 61 sentence 2 of the IfSG 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 (section 61 sentence 3 of the IfSG). 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 collected and pooled findings regarding potential vaccine injuries on account of COVID-19 vaccinations from the different Federal 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 guiding principles are developed further on an ongoing basis to keep abreast of current scientific findings.

  Effective 1 January 2024, sections 60 and beyond of the IfSG will be transferred to the new Social Code Book Fourteen (SGB XIV). The existing level of protection provided by the IfSG compensation claim will remain in effect. Those concerned therefore need not fear any negative consequences on account of the transferral to Social Code Book Fourteen.

• As part of the compensation claim pursuant to section 60 (1) of the IfSG, can I invoke a reversal of the burden of proof?

  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 must I consider if I wish to claim compensation in accordance with the IfSG?”), full proof must be provided. In other words, the conditions for a compensation claim must be demonstrable with almost absolute 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. If you or someone else requires a personal consultation, you can also contact the independent patient counselling services (Unabhängige Patientenberatung Deutschland/UDP). The UPD’s counselling hotline can be reached free of charge at 0800 0117722. Information on consultation hours and online consultation options as well as in-person consultation are available from the UPD website (German).

• 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.

  Should you reject the assessment of your Federal Land’s competent authority, then you must file administrative appeal proceedings with the competent authority (section 64 (2) of the Protection against Infection Act (IfSG) in conjunction with sections 78, 83 et seqq. of the Social Courts Act (Sozialgerichtsgesetz – SGG)) before the judicial clarification. 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 a refusal of benefits on account of a vaccine injury is lawful can be obtained in a court of law. Claims arising out of section 60 of the IfSG are to be heard pursuant to section 68 (2) of the IfSG 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 authorised COVID-19 vaccines is monitored and evaluated by the pharmaceutical companies themselves as well as the Paul Ehrlich Institute (PEI) and the competent bodies at the European Medicines Agency (EMA) on an ongoing basis. 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, 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 PEI’s vaccine safety assessments.

  The expertise in assessing individually occurring adverse reactions following vaccination lies with the PEI. After the marketing authorisation of a vaccine, any reports of a suspected side effect and/or vaccine complication are recorded and evaluated on an ongoing basis. Information on side effects following vaccination with COVID-19 vaccines is included in the PEI’s safety reports as well as the product information for the individual vaccine.

  Reporting suspected cases of 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 continuously monitored 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.