The reports do not contain any information which suggests that the current recommendations regarding use of the COVID-19 vaccines in Norway should be revised.
Click here to go to see an overview of suspected adverse reactions
Most of the reports concern common, expected adverse reactions, such as pain at the injection site, headache, general malaise with fever, fatigue, nausea and pain in the body. These adverse reactions are known from the clinical studies and usually appear on the first or second day after vaccination and last approximately 2-3 days.
Expert group to assess deaths
The Norwegian Medicines Agency has set up an expert group to review deaths amongst frail elderly people following vaccination against coronavirus.
“The aim of establishing the expert group is to obtain an independent assessment of the extent to which the deaths that have been reported could be linked to vaccination," says senior medical consultant Sigurd Hortemo of the Norwegian Medicines Agency .
Read more about the expert group
How to report adverse reactions
Healthcare professionals are obliged to report suspected new, unexpected and serious adverse reactions. Staffing levels at the Norwegian Institute of Public Health (NIPH) have been strengthened, and the regional pharmacovigilance centres (RELIS) are assisting NIPH in the assessment of reports, enabling them to be assessed more rapidly.
The general population can report adverse reactions via helsenorge.no, but you should consult a doctor or other healthcare professional in the case of suspected serious or unexpected adverse reactions following vaccination.
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 Norwegian ADR Registry, 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.
