Asset Publisher

null Fimea and THL closely monitor adverse effects and safety of coronavirus vaccines – no unexpected side effects have emerged

Fimea and THL closely monitor adverse effects and safety of coronavirus vaccines – no unexpected side effects have emerged

18.1.2021

No unexpected information has emerged concerning adverse effects of the coronavirus vaccine.

By Friday, 15 January, 32 reports had reached the Finnish Medicines Agency Fimea on adverse effects from the Comirnaty vaccine, the first that has been taken into use. Reports have included allergic reactions (including one anaphylactic reaction), reactions at the point of injection, and pain in the limb that was vaccinated, muscle pain, swollen lymph glands, nausea, hives, fatigue/lethargy, headache, and chills. These are side effects that are common for vaccines in general and they have also been considered in the summary of product characteristics.

Deaths among elderly patients who have received the coronavirus vaccine are being investigated in Sweden and Norway, for example. In Finland, elderly residents of care homes, who are at a high risk of dying from pre-existing diseases even in the short term, are among the first to be given the vaccine.

In Finland it has been recommended that persons in terminal care, whose active treatment has been stopped, should not be systematically vaccinated. Decisions on vaccinating persons in a delicate state of health are always considered on a case-by-case basis in cooperation with the doctor giving treatment, the person to be vaccinated, and the next of kin. The reason is that common side effects such as short-term fever can weaken the condition of such a person. Vaccinations are classified as active treatment. In addition to the coronavirus vaccine, the same applies to influenza vaccines, for example.

In Finland, the vaccinations have started among social and health care personnel, as well as residents in care homes for the elderly. As the vaccinations move on to the elderly, deaths in the age group may be expected to occur also among recipients of the vaccine soon after the vaccination has been administered.

The vaccine does not protect against mortality from other illnesses. Death after a vaccination also does not necessarily mean that the death would have resulted from the vaccination.

At present, no reports of deaths of people who have been vaccinated for coronavirus have been received by the population register. There is a time delay before information on deaths reaches the population register system.

Adverse effects of the vaccinations are closely monitored

Vaccinations with the first coronavirus vaccine (Comirnaty) began in the European Union at the end of 2020.

Vaccine safety is monitored closely with the help of reports on adverse reactions, for example. Fimea receives reports of adverse reactions from health care professionals and directly from members of the public.

Based on reports of adverse reactions it is possible to identify signals indicating possible new adverse effects requiring more detailed evaluation.  All available information will undergo a thorough scientific evaluation as part of the constant monitoring of vaccine safety.

Information on notifications of adverse reactions is published on the Fimea website several times a week. The website reports the number of notifications coming from Finland and the most frequently reported adverse reactions.

Read more:

Fimea FAQ on side effects

THL: Vaccines and coronavirus

Further information:

THL:
Hanna Nohynek, Chief Physician, THL, tel. +358 29 524 8246, etunimi.sukunimi@thl.fi

Fimea:
Jukka Sallinen, Head of Unit, tel. +358 29 522 3410
Marjo-Riitta Helle, Head of Unit, tel. +358 29 522 3320
E-mails take the form firstname.lastname@fimea.fi