Fimea and THL closely monitoring adverse reactions to and safety of corona vaccines - no unexpected adverse reactions have occurred

Publication date 15 Jan 2021

Thus far, the adverse reaction reports submitted in Finland concerning the corona vaccination have not contained any unexpected information.

By Friday 15 January, 32 reports of adverse reactions had been sent to Fimea on the Comirnaty vaccines, which were the first introduced. Reported adverse reactions have included allergic reactions (including anaphylactic reactions), reactions at the vaccination site and pain in the limb where the vaccination was administered, muscle pain, enlarged lymph nodes, nausea, urticaria, fatigue/weakness, a headache and the chills. These are commonly observed and expected adverse reactions to vaccines, and they have also been listed in the summary of product characteristics. 

Suspected adverse reactions expected in connection with the vaccination of older people with a timeline link to the vaccination

The deaths of older patients who have received the corona vaccine are currently being investigated in other countries including in Sweden and Norway. In Finland, the first to receive the vaccinations will include older patients living in nursing homes, whose risk of death from basic illnesses is high even in the short term. 

In Finland, officials have recommended that persons in the terminal care phase whose active treatment has been terminated should not be systematically vaccinated. A decision on the vaccination of persons with fragile health will always made on a case-by-case basis in cooperation with the treating physician, the person being vaccinated and their family members. This is because the most common adverse reactions, such as a temporary fever, may affect the person's condition. Vaccinations are classified as active treatment, and the same practice applies not only to the corona vaccine but also others such as influenza vaccines.    

In Finland, vaccination of the population has begun with the vaccination of social welfare and health care personnel and elderly nursing home residents. As vaccinations progress to older people, it is expected that deaths in the age group will also occur in the groups that have received the vaccine and will timewise be connected to the vaccination.

The vaccine will not protect against mortality related to other diseases. Death after receiving a vaccination also does not mean the death was directly caused by the vaccination.

Currently, no reports of deaths following vaccinations have been recorded in the Finnish Population Register. Data on deaths Is recorded in the Population Information System with a delay.

The adverse reactions to the vaccinations are being closely monitored

Vaccination with the first corona vaccination (Comirnaty) started in the European Union at the end of 2020. 

The safety of the vaccine is closely monitored, for example, by reviewing adverse reaction reports. Fimea receives reports of adverse reactions from health care professionals and directly from citizens. 

Signals of possible new adverse reactions that require a more detailed assessment can be observed on the basis of submitted adverse reaction reports.  All available information goes through a thorough scientific evaluation as part of the ongoing safety monitoring of vaccines. 

Information on received adverse reaction reports is published on Fimea's website several times a week. Information published on the website includes the number of reports submitted in Finland and the most commonly reported adverse reactions. 

Further information:

Hanna Nohynek
Finnish Institute for Health and Welfare
Chief Physician

Jukka Sallinen
Head of Unit
[email protected]

Marjo-Riitta Helle
Head of Unit
[email protected]

Infektiotaudit ja rokotukset Main site coronavirus - thlfi-en koronavirus_en - thlfi-en