You are here

Side effects

What is the liability of the manufacturer and Estonia if it turns out that the vaccine causes me a health damage that the manufacturer should have foreseen?

The liability for vaccines, including the COVID-19 vaccine is distributed similarly to other medicines. The vaccinator is liable if the vaccinator has breached its obligations in carrying out the vaccination. The holder of the marketing authorisation is liable in the case of a quality defect due to manufacturing, i.e. there has been a breach of the rules of good manufacturing practices (GMP) or the holder of the marketing authorisation has knowingly hidden information. The prerequisite for applying liability is causation between the damages incurred and the vaccine or the vaccination. It is important to establish causation because all health symptoms that present themselves after vaccination might not have to do with the vaccination but might just be concurrent and coincidental.

In Estonia, the notifications about the side effects are collected and evaluated by the State Agency of Medicines. The symptoms that have occurred are treated the best way possible regardless of whether or not they are connected to the vaccine or vaccination. The patient insurance system through which it would be possible to demand compensation for avoidable damages that occurred as a result of the provision of a healthcare service is still being developed in Estonia. The state also has no plans to create a separate system for compensating damages due to vaccines or vaccination. Every person has the right to turn to the courts to protect their interests or demand compensation for damages incurred. Currently it is also possible to turn to the expert committee on the quality of healthcare services for an expert opinion on whether good clinical practices or the relevant instructions were followed in the course of providing the healthcare service that caused the damages.

Are women who want to have a child, are pregnant or breastfeeding allowed to get vaccinated against COVID-19?

Yes. The protection that the vaccine offers against getting sick outweighs all the risks related to getting vaccinated, including for women who are planning to get pregnant, are pregnant or breastfeeding:

  • if a woman who is pregnant gets infected, it increases the risk of both premature labour and the probability that the woman ends up needing intensive care. Vaccination reduces these risks considerably.
  • if a breastfeeding mother is vaccinated, the child will also obtain somewhat of a protection against COVID-19.

There is no biological reason why corona vaccines should be unsafe for pregnant women, foetuses or children who are being breastfed. This is also supported by animal tests in which multiplied vaccine doses administered to rats did not bring about any direct or indirect harm to pregnancy, the development of the foetus, birth or the postnatal period.

The International Federation of Gynecology and Obstetrics (FIGO), where the Society of Estonian Gyneacologists is also a member, supports vaccinating pregnant and breastfeeding mothers against COVID-19, accounting also for the risk of infection, the size of the pregnancy, the health condition of the mother etc.

If you need further counselling to make a COVID-19 vaccination decision, we recommend consulting with your family doctor or calling the Family Doctor's Advice Line 1220 or 634 66 30. The calls are answered by medical professionals 24/7. Advice is given in Estonian and Russian (advice in English every day between 15.00 and 17.00).

Who should be notified about the side effects of the vaccine?

Side effects may occur after vaccination. The more typical side effects of the COVID-19 vaccines are pain and swelling of the injection site, fever, feeling unwell, nausea, muscle pain and joint pain. The symptoms generally pass within a few days.

If a more serious health problem occurs or the problem lasts more than three days after vaccination, contact your family doctor or call the information line 1220 (634 66 30).

The vaccinators have an obligation to inform the Estonian Agency of Medicines of the side effects that have occurred but the patient himself can notify the State Agency of Medicines of the possible side effect with a relevant notification form (in Estonian) if they so wish. The State Agency of Medicines publishes the information (in Estonian) about the notifications they have received about side effects once a week, on Mondays.

If you have additional questions or need further counselling about the coronavirus vaccines, you can consult your family doctor or the Family Doctor's Advice Line by calling 1220 or 634 66 30. The calls are answered by medical professionals 24/7, giving advice in both Estonian and Russian (in English every day between 15.00 and 17.00).

Information about different options for getting vaccinated is given by the web page vaktsineeri.ee and the state helpline 1247 (+372 600 1247 when calling from abroad).

Do the COVID-19 vaccines have side effects?

All the COVID-19 vaccines that have received a marketing authorisation in Europe have been assessed to be sufficiently safe and effective in fighting the coronavirus by the European Medicines Agency EMA but, as with all medicines, side effects might occur with the coronavirus vaccines as well.

The more common mild side effects of the COVID-19 vaccines are pain and inflammation of the injection site, headache, fever, feeling unwell, nausea, muscle pain, and joint pain. The symptoms generally disappear in a few days.

Allergic (hypersensitivity) reactions are considered to be severe side effects that occur very rarely. An allergic or anaphylactic reaction generally occurs within a short period of time after vaccination. That is why it is necessary to remain under the observation of a health care worker for at least another 15 minutes after receiving the vaccine shot -- the vaccine administrator is always prepared for that eventuality with first aid kits.

All known side effects that can be connected to the vaccine are written down on the information sheet of the vaccine packaging. If a more serious health problem occurs after vaccination or the problem lasts longer than three days, contact your family doctor or call 1220 (or 634 66 30).

If you need counselling on the COVID-19 vaccines, we recommend consulting with your family doctor or calling the Family Doctor's Advice Line 1220 or 634 66 30. The calls are answered by medical professionals 24/7, giving advice in both Estonian and Russian (in English every day between 15.00 and 17.00). An overview of different vaccination options are given by the web page vaktsineeri.ee or the state helpline 1247.


The State Agency of Medicines publishes the information (in Estonian) about the notifications they have received about side effects once a week, on Mondays.

Why do I have to wait for 15 minutes after receiving the shot?

On very rare occasions, anaphylactic shock or a severe allergic reaction might occur immediately after vaccination and in that case the doctors can give proper aid right away.

Do the vaccines cause disruptions in the menstrual cycle?

No connection has currently been found between COVID-19 vaccines and menstrual cycle disruptions but this topic is under constant monitoring: the holders of the marketing authorisations of all four marketed vaccines have to submit monthly reports to the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, that also review the menstrual cycle disruption notifications from all the member states of the European Union, data from the rest of the world, information from literature, and assessment of a causal link.

Considering that there have been notifications of menstrual cycle disruptions with both vaccine types (both mRNA and adenovirus vector vaccines), it is probable that they stem from the expected effect of vaccination, i.e. immune response, and not from a specific vaccine component. The coronavirus vaccines have been designed so that they would leave the immune system with the impression that the virus infection is trying to invade. The general post-vaccination reactions -- fever, headache, weakness -- might have the effect of a stressor and cause disruptions in the menstrual cycle.

The State Agency of Medicines has received 48 notifications of different menstrual cycle disruptions that are temporally linked to COVID-19 vaccines (as of September 20, 2021). Generally the cycle has normalised within one or two months at maximum.

 

Last updated: 27 September 2021