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.
Younger people are experiencing stronger 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. Such adverse reactions have been reported for both the mRNA vaccines (Comirnaty and Moderna) and AstraZeneca’s viral vector-based vaccine. It is common for reactions to be more pronounced following the second dose of the mRNA vaccines, while in the case of the AstraZeneca vaccine, it appears that many people experience the most severe adverse reactions after the first dose, and less pronounced reactions after the second dose.
“A large volume of reports about these known adverse reactions may indicate that many people were not prepared for how strong these reactions might be. The reactions can be unpleasant, and it is not uncommon to feel so ill that it is necessary to stay off work for a few days," says senior medical consultant Sigurd Hortemo.
Many countries have now started vaccinating healthcare professionals and younger age groups. These common but unpleasant adverse reactions are being reported throughout Europe. Older people often experience less severe adverse reactions to the vaccines than younger people. There is not necessarily any link between adverse reactions and the efficacy of the vaccine. Different people react differently to the vaccines, and those who do not experience any adverse reactions following vaccination will also be well-protected against COVID-19.
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.
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.