Vaccination Reactions and Side Effects following COVID-19 Vaccination
Just like any other medicinal product, vaccines, too, can cause adverse reactions. Yet, vaccine reactions are not uncommon and tend to subside quickly. Serious side effects, vaccine complications or vaccine injuries are very rare. Here you can find out more on what to do in the case of suspected side effects.
To achieve their protective effect, immunisations trigger certain reactions in your body: The vaccine “shows” your immune system how to fight off a coronavirus infection. In some cases, this can lead to moderate reactions such as pain at the injection site, tiredness, headache or muscle pain. These reactions are more common and, in some cases, more intense after COVID-19 vaccination than after receiving, for instance, the flu vaccine. They tend to resolve completely after a few days and are a sign that the immune system is responding to the vaccine and producing antibodies. Important: This does not mean, however, that the coronavirus vaccination is less effective or your protection is weaker should you experience no or only mild vaccine reactions. Clinical studies indicate: The vaccines’ effectiveness in preventing severe COVID-19 illness is also at about 90 percent among those who do not experience any symptoms after coronavirus vaccination.
The difference between vaccine reactions and side effects
With medicinal products intended for use in human beings, according to the German Medicinal Products Act, side effects – also known as adverse reactions – are noxious and unintended reactions when a medicinal product is administered as intended. Serious adverse reactions include adverse reactions that are fatal or life-threatening, require hospitalisation or the prolongation of existing hospitalisation, or lead to persistent or significant disability, incapacity, congenital anomalies or birth defects.
The Robert Koch Institute distinguishes between common vaccine reactions and very rare vaccine complications. Vaccine reactions (such as flu-like symptoms) are typical symptoms that 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 adverse reactions that are notifiable and must be documented.
Important to know: All vaccines are extensively trialled before authorisation. The most frequent side effects (vaccine reactions and potential vaccine complications) are listed and documented in the information leaflets by the Robert Koch Institute. In addition, the overview articles on the vaccines approved in Germany thus far contain important information on known vaccine reactions and side effects:
- Comirnaty® by BioNTech/Pfizer
- Spikevax® (Moderna vaccine) by Moderna
- Vaxzevria® by AstraZeneca
- Janssen® by Johnson & Johnson
- Nuvaxovid® by Novavax
Vaccination complications are very rare
The risk of serious adverse drug reactions (side effects) after COVID-19 vaccination is very low. The reporting rate for serious adverse reactions is at no more than 0.02 percent, which means that only one in every 5,000 adverse reactions reported after vaccination is serious. This reporting rate refers to all reports of suspected adverse reactions, which means that at the time of reporting, a causal relationship between the reported event and the vaccination has not yet been confirmed.
Experts also consider late sequelae and long-term side effects as very unlikely, since most side effects tend to develop within a few hours or days of vaccination. At this time, there is no evidence of late sequelae that only develop many years after a vaccination with existing vaccines, nor are they expected with these coronavirus vaccines.
How to report suspected side effects
By reporting suspected side effects, you can support the monitoring of drugs and vaccines. This is an important contribution towards making the use of drugs and vaccines even safer. If you suspect a side effect, you can also report this to the Paul Ehrlich Institute (PEI) via the website www.nebenwirkungen.bund.de. Within the context of an observational study on the tolerability of coronavirus vaccines, people 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 PEI. You can download the app for free from the Apple App Store and the Google Play Store.
If any damage to health exceeding the extent of a normal vaccine reaction is suspected, it needs to be reported. This is usually done by your doctor.
Ongoing safety monitoring
To ensure the safety of coronavirus vaccination, since the vaccine roll-out, in Germany the Paul Ehrlich Institute has been continuously monitoring all suspected cases of vaccine side effects and complications, and reporting on the results of all reported side effects intemporal relation to COVID-19 vaccination in its safety reports. If unknown risks are identified, the experts respond immediately by recommending measures that, where 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 would have to be adapted accordingly.
In addition, the Standing Committee on Vaccination (STIKO) at the Robert Koch Institute can, as a precaution, restrict the group of people for which the vaccine was recommended as suitable. As the vaccines are being rolled out, the PEI, 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 to make sure that the immunisation benefit remains for the respective vaccine. This enables them to swiftly respond to information about possible side effects, such as with the precautionary introduction of an age restriction for the Moderna Vaccine in November 2021.
This case shows that the STIKO can respond swiftly, yet also attentively, by immediately adjusting its recommendation on which vaccine is suitable/unsuitable for specific groups of people.
Where to get help in case of suspected vaccine injuries
While it is very rare for vaccines to have serious side effects, they can never be fully discounted. People suspecting that a vaccine injury might have occurred can file an application for recognition of a vaccine injury with the competent pension office. The Protection against Infection Actdefines 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). People who suspect the occurrence of a vaccine injury should first consult their family doctor. Should the suspicion strengthen, a necessary investigation should be initiated immediately to clarify the case. Doctors will do this by contacting the competent public health office. Responsibility for recognising a vaccine injury lies with the pension offices of the Federal Länder.
For more answers to legal questions on the coronavirus vaccination, click here.
Be aware of false reports
Claims are circulating on social media that vaccination-related deaths have occurred that have been covered up. These claims are disinformation. While in an extremely rare number of cases death may occur in a temporal relation to coronavirus vaccination, this does not mean the vaccination was the cause of the death. The competent authorities also report deaths to the Paul Ehrlich Institute, where they are documented and assessed for possible relation to the vaccination. The results are published in the PEI’s safety reports. This is important to inform both the public and experts transparently about the results of the continuous evaluation of reported side effects relating to coronavirus vaccination. The institute’s safety reports can be found on the PEI’s website.