Reports of serious events are assessed first. The numbers therefore does not give a true picture of the distribution between serious and non-serious events.
The Norwegian Institute of Public Health (NIPH) has suspended vaccination with the AstraZeneca COVID-19 vaccine after we became aware of cases of serious suspected adverse reactions involving a combination of blood clots, bleeding and low platelet count. As of March 30, no new reports have been received about such cases in Norway.
The reports of adverse reactions that we have received do not provide a basis for revising the current recommendations regarding vaccination with the Comirnaty (BioNtech/Pfizer) and Moderna COVID-19 vaccines.
Most of the reports concern common adverse and expected reactions, such as pain at the injection site, headache, general malaise with fever, fatigue, nausea and pain in the body. These adverse reactions normally last 2-3 days and are known from the studies which formed the basis for the vaccine authorisations.
How to report adverse reactions
Health professionals are obliged to report suspected new, unexpected and serious adverse reactions as soon as possible (remember to quote the batch number). The processing of serious reports is given priority, and these reports are processed as soon as possible.
The general population can report adverse reactions via helsenorge.no, but you should consult a doctor or other health professional in the case of suspected serious or unexpected adverse reactions following vaccination. It is not necessary to report a possible adverse reaction if a health professional has already reported the reaction.
International cooperation
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 National ADR Register, and exchanges adverse reaction data with 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.
