Monitoring the adverse reactions of COVID-19 vaccines
On 27 January 2021, Fimea made a new website available for adverse reaction reports on COVID-19 vaccines. The page is updated more than once a week by the number and severity of adverse reaction reports. In addition, a report on the most common reported adverse reactions and other statistical information is published weekly.
Healthcare professionals and consumers may report suspected adverse effects of coronavirus vaccines to Fimea, particularly from adverse reactions such as:
- unexpected adverse reactions— reactions which are not mentioned in the product information texts, or
- severe adverse reactions — reactions which result in death, danger to life, hospitalization or prolonged hospitalization, cause permanent injury, significant decrease in functional capacity or congenital malformation.
Adverse reaction reports should record the product name of the vaccine and, where possible, the batch number, which can be seen on the online service OmaKanta.
Unfortunately, as there is no specific application or website tool for reporting adverse effects, adverse reactions must be reported to Fimea via normal mail or, for example, via a secure email to . Healthcare professionals access the electronic adverse effect form using the FIMNet username and password.
In Finland, most of the reported adverse reactions have been categorized as non-serious, with approx. 30% categorized as severe. The most notifications have been provided by people of working age who have been vaccinated, with known, non-serious adverse reactions such as fever, headache, pain at the vaccination site and fatigue reported in most cases.
At the end of January, the EMA released its first safety update on the COVID-19 vaccine Comirnacy, noting that the safety data was consistent with the known safety profile of the vaccine and no new adverse reactions were observed.