Coronavirus vaccination
10:30 · 22 June 2022

Vaccination Reactions and Side Effects following COVID-19 Vaccination

As with all medical products, vaccinations can cause unpleasant reactions. Vaccination reactions are not uncommon, however, and tend to subside quickly. Severe adverse effects (side effects), vaccination complications and vaccination injuries are extremely rare. Read on to find out what you should do in the case of suspected side effects.

Vaccine reactions and side effects

To achieve their protective effective, vaccinations trigger certain reactions in the body. The vaccine effectively shows the immune system how to fight off a coronavirus infection. Moderate reactions such as pain at the injection site, fatigue, headaches and aching muscles can occur following vaccination. With a COVID-19 vaccination, these reactions are more common and in some cases more intense than, say, after a flu vaccine. They usually disappear within the space of a few days and are a sign that the immune system is reacting to the vaccine and is producing antibodies. This does not, however, mean that the COVID-19 vaccination is less effective or that recipients are less-well protected if they have no or only mild reactions to the vaccine. Studies show that even in people who experience no symptoms following a COVID-19 vaccination, the vaccine is about 90% effective in protecting against serious COVID-19 infection.

Vaccination reactions versus side effects

According to Germany’s Medicinal Products Act (Arzneimittelgesetz), where products designed for use on humans are used as intended, harmful and unintended reactions are deemed adverse effects (side effects). Severe adverse effects include side effects that are fatal or life-threatening, require hospitalisation or an extended hospital stay, or lead to permanent or severe disability, invalidity, congenital anomalies or birth defects.

The Robert Koch Institute distinguishes between common vaccination reactions and very rare vaccination complications. Vaccination reactions (such as flu-like symptoms) are typical symptoms that usually occur shortly after vaccination and only last a few days. By contrast, vaccination complications that go beyond the usual extent of a vaccination reaction are undesired, serious adverse effects which must be reported and also documented. More on this subject.

Good to know: All vaccines undergo extensive clinical testing prior to approval. The more common side effects (vaccination reactions and potential vaccination complications) are listed in the information leaflets published by the Robert Koch Institute. The various overview articles on the vaccines approved for use in Germany to date also contain important information on the known vaccination reactions and side effects:

Vaccination complications are very rare

Experts such as those belonging to the STIKO also describe side effects as vaccination complications. The risk of serious reactions following COVID-19 vaccination is very small: The Paul Ehrlich Institute (PEF) reports just 0.2 suspected cases per 1,000 vaccinations – that means only one in 5,000 people on average are affected. Experts thus believe that late-onset effects and long-term side effects are highly unlikely as most side effects usually occur within a matter of hours or days following vaccination. No long-term effects that appear years later are known with previous vaccines and none are expected with the coronavirus vaccines.

Reporting suspected side effects

By reporting suspected side effects, you can assist in the monitoring of medicinal products and vaccines. This is an important contribution to ensuring safe use of medicinal products and vaccines. Suspected side effects can be reported to the Paul Ehrlich Institute (PEI) via the website www.nebenwirkungen.bund.de. As part of an observational study on the tolerability of coronavirus vaccines, vaccine recipients can report undesired reactions following vaccination via the PEI’s SafeVac 2.0 app. The app can be downloaded for free from the Apple App Store and the Google Play Store. Suspected health impairments that go beyond a normal vaccination reaction must be reported. This is usually done by your doctor.

Ongoing safety evaluation

To ensure the safety of coronavirus vaccination, the Paul Ehrlich Institute (PEI) has been continuously monitoring all suspected cases of vaccine side effects and vaccine complications since the vaccine roll-out. The PEI uses its safety reports to report on side effects reported in timely relation to receiving a vaccine. When unknown risks are identified, the experts at PEI respond immediately, recommending measures that can be taken – including suspending use of the vaccine if deemed appropriate. Where needed, approvals can be amended by modifying the wording contained in the approved product information. As a follow-up measures, corresponding informational materials must also be amended.

As a preventive measure, the groups of individuals for whom a vaccine has been recommended can be restricted by the Robert Koch Institute’s Standing Committee on Vaccination (STIKO). During use of the vaccine, the PEI, the European Medicines Agency (EMA) and the pharmaceutical manufacturers meticulously and continuously review and document data on the efficacy, safety and duration of protection of coronavirus vaccines to ensure that the benefits of vaccination with each vaccine continue to be provided. This enables rapid action to be taken when there are indications of possible serious side effects, as was the case in November 2021 with the precautionary age restriction placed on the Moderna vaccine.

This case shows that the STIKO is able to respond quickly and diligently by adjusting its recommendations regarding the vaccines deemed suitable or unsuitable for the respective groups.

Strict safety standards for vaccine approval

For approval in the EU and thus in Germany, all vaccines are subject to a multi-phase evaluation process. This ensures that only safe and effective vaccines of suitable quality are used whose proven benefits significantly outweigh the potential risks. This process also applies to COVID-19 vaccines, but in this case the approval processes are accelerated in that the European Medicines Agency (EMA) uses a “rolling review” process, performing a step-by-step evaluation of data from clinical studies prior to application. Even after conditional approval by the European Commission, these coronavirus vaccines are continuously monitored. This is an important control function that ensures the safety of the vaccines. In Germany, it is performed by the experts at the PEI.

Help in the case of suspected vaccine injury

Although it is very rare for vaccines to trigger serious side effects, these can never be completely ruled out. In the case of a suspected vaccination injury, an application for recognition of a vaccination injury can be submitted to the competent pension office. The Infection Protection Act defines a vaccination injury as the “health and economic consequences of 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 case in question, one option would be to hold the pharmaceutical company liable on the basis of various pieces of legislation. The liability clauses that might apply in individual cases can arise from the Medicinal Products Act, the Product Liability Act and the general liability provisions contained in the German Civil Code (BGB). In the first instance, persons with a suspected vaccination injury should contact their doctor. If the suspicion is confirmed, a medical examination should be arranged to clarify the situation. The examining physician(s) will then contact the respective health authority.

Be aware of false reports

Social media channels are full of reports claiming that cases where people have died after receiving a vaccine are being hushed up. These reports are false and aim at spreading misinformation. While in rare cases, a death can coincide with a coronavirus vaccination, it does not means that the vaccine was the actual cause of death. The competent authorities also report deaths to the PEI, where the cases are documented and evaluated for a possible connection with the vaccine. The PEI publishes the results in its safety reports. This is an important to provide transparency for both practitioners and the general public regarding the outcomes of ongoing evaluations of reported side effects that occur in connection with coronavirus vaccines. The safety reports can be viewed on the PEI website.