Vaccine reactions and side effects after coronavirus vaccination
Fever, fatigue, headaches – just like with any other medicinal product, vaccines too can cause adverse reactions after administration. Yet, vaccine reactions are not uncommon and tend to subside quickly. By contrast, serious side effects, vaccine complications or vaccine injuries are very rare. This article will tell you what to do in the case of suspected side effects.
Vaccine reactions signal effectiveness
To achieve their protective effect, immunisations trigger certain reactions in your body: The vaccine shows your immune system, so to speak, how to fight off a coronavirus infection. In some cases, this can involve moderate reactions such as tiredness, fatigue, flu-like symptoms or pain at the injection site. After the COVID-19 vaccination, these reactions are more common and, in some cases, more intense than after receiving, for instance, a flu vaccine. They tend to completely resolve after a few days and are a sign that the immune system is reacting to the vaccine and producing antibodies.
The Standing Vaccination Committee (STIKO) distinguishes between these common vaccine reactions and extremely rare vaccine complications. Vaccine reactions (such as flu-like symptoms) are normal, mostly appear shortly after vaccination and only last a few days. By contrast, vaccine complications that exceed the extent of a normal vaccine reaction are serious side effects that need to be reported and must be documented. Here you can find an FAQ on the safety of coronavirus vaccines. These as well as the vaccine complications are also listed in the information leaflets.
Vaccine complications are defined as serious side effects following vaccination
It is extremely rare for serious adverse drug reactions (ADR) to occur after vaccinations. If any damage to health exceeding the extent of a normal vaccine reaction is suspected, it needs to be reported on a named-patient basis. While it will usually be reported by the doctor, it can also be reported by the vaccinated person themselves.
How to report suspect cases
If you suspect a serious side effect, you can report this to your doctor, your local health office or the Paul Ehrlich Institute via the website www.nebenwirkungen.bund.de. Within the context of the observation study on the tolerability of coronavirus vaccines, persons who have been vaccinated can also log any post-vaccine adverse reactions by means of the smartphone app “SafeVac 2.0“ and share them with the Paul Ehrlich Institute. You can download the app for free in the Apple App Store and in the Google Play Store.
To ensure the safety of coronavirus vaccination, since the vaccine roll-out the Paul Ehrlich Institute has been continuously monitoring all suspected cases of vaccine side effects and vaccine complications and reporting on the results of its assessments. If there are any reports suggestive of a risk, the experts react immediately. They investigate the root causes and recommend measures that, if necessary, can culminate in suspending the vaccine. Moreover, the marketing authorisations can be adjusted, if need be, for instance by amending the approved product information texts. In this case, information materials must be adapted accordingly. In addition, the STIKO Vaccination Committee at the Robert Koch Institute can, as a precaution, restrict the group of persons for which the vaccine was recommended as suitable. As the vaccines are being rolled out, the Paul Ehrlich Institute, the European Medicines Agency (EMA) and the pharmaceutical manufacturers continue to painstakingly scrutinise and document the data on the coronavirus vaccines’ effectiveness, safety and period of protection. This enables them to swiftly respond to information about possible side effects, such as with AstraZeneca’s vaccine. This case shows that the Standing Vaccination Committee can react too by adjusting its recommendation on which vaccine is suitable/unsuitable for which groups of persons.
Continuous safety monitoring
To receive a marketing authorisation in the EU and thus also in Germany, all vaccines have to undergo a multi-stage trial process. This ensures that only safe and effective vaccines of appropriate quality, whose proven benefit clearly outweighs any potential risks, will be administered. The procedure was the same for COVID-19 vaccines: Their authorisation processes are sped up by carrying out a rolling review – a real-time review of several safety-relevant steps. Even after the European Commission has granted these vaccines a conditional marketing authorisation, they are continuously monitored – in Germany, by the experts at the Paul Ehrlich Institute: This is an important surveillance function that ensures the safety of immunisations.
Where to get help in case of suspected vaccine injuries
While it is very rare for vaccines to have serious vaccine side effects, they can never be fully discounted. Persons suspecting that a vaccine injury may have occurred can file an application for recognition of a vaccine injury with the competent pension office. The Protection against Infection Act defines it as the “health and economic consequences of a vaccination-related damage to health that exceeds the extent of a normal vaccine reaction”. The Act also stipulates when someone qualifies for a pension under the Bundesversorgungsgesetz (Federal War Victims’ Compensation Act).
Depending on the circumstances of the case, one of several options might be to hold the pharmaceutical company liable on the strength of various pieces of legislation. Which liability provisions apply in the case at hand can follow from the Medicinal Products Law, the Product Liability Act or the generic liability provisions of the German Civil Code (BGB). Persons who suspect a vaccine injury should initiate a necessary examination to clarify the case. Those affected can get help in doing so from the public health office. Responsibility for recognising a vaccine injury lies with the pension offices of the Federal Länder.