Reports of serious events are processed first. The report will therefore not give an accurate picture of the distribution between serious and non-serious events.
The Norwegian Medicines Agency has received a total of 391 reports of suspected adverse reactions. Of these, 150 reports have been processed. A total of 58 are classified as serious and 92 as non-serious. There are no new signals of unexpected or serious adverse reactions associated with the coronavirus vaccines that are currently in use.
Click here to see an overview of reports of suspected adverse reactions
Good response to requests for reports
The use of coronavirus vaccines must be closely monitored in order to detect any new adverse reactions. Prompt reporting by healthcare professionals and patients if new, unexpected or serious adverse reactions are suspected is vital. This will provide us with more data to enable the authorities to respond rapidly and, where appropriate, update the advice concerning use of the vaccines.
“In Norway, healthcare professionals have a low threshold for reporting suspected adverse reactions and events which occur with a temporal link to vaccination. This is good news. We are now strengthening our staff to enable us to process more adverse reaction reports," says chief medical consultant Sigurd Hortemo.
Even if a suspected adverse reaction is reported, it does not necessarily imply that it was caused by the vaccine. Reports of adverse reactions following vaccination are followed up by the Norwegian Medicines Agency in partnership with the Norwegian Institute of Public Health and the regional medicines information and pharmacovigilance centres (RELIS).
The Norwegian Medicines Agency is responsible for the Norwegian ADR Registry, and transmits adverse reaction data to the European Medicines Agency (EMA) and the World Health Organization (WHO). This provides us with a better basis for assessing causation and implementing measures to safeguard patient safety.