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null Webpage detailing adverse reaction reports of corona vaccines has been opened

Webpage detailing adverse reaction reports of corona vaccines has been opened

27.1.2021

On 27 January 2021, Finnish Medicines Agency Fimea opened a webpage, which provides information on the adverse reaction reports submitted for corona vaccines. The page is updated several times a week with the number of submitted adverse reaction reports and information on their seriousness. In addition, a weekly report listing the most common reported adverse reactions, background information on patients and the parties that have submitted the reports will be published on Wednesdays.

The most commonly reported adverse reactions associated with vaccines are injection site reactions and mild general symptoms such as fever, fatigue, headache and muscle pain. Healthcare professionals and consumers are asked to report to Fimea reactions that are:

  • Unexpected - i.e. they are not mentioned in the vaccine product information, or
  • Serious - i.e. they have led to death, risk of death, hospitalisation or prolonged the hospital treatment, caused permanent injury, significant disability or congenital malformation.

Adverse reaction reports should include the product name of the vaccine and, if possible, the lot number that can be seen in My Kanta online service. 

Adverse reaction reports are entered into databases, from which signals are sought. Signals are signs of new and rare adverse reactions that occur, when large numbers of people are vaccinated. The product information and vaccination instructions can be updated on the basis of the signals.

Further information:

Finnish Medicines Agency Fimea: Adverse reaction reports of corona vaccines

Submitting a report on an adverse reaction
 

Ask more

  • Maija Kaukonen, Senior Medical Officer, tel. +358 (0)29 522 3308
  • Liisa Näveri, Head of the Pharmacovigilance Unit, tel. +358 (0)29 522 3340
  • E-mail address format: firstname.lastname@fimea.fi