The reports do not provide a basis which suggests that the current recommendations regarding use of the COVID-19 vaccines should be revised. The benefits of the vaccines are considered to outweigh the risk of serious adverse reactions.
Of the 104 reports, 46 are classified as serious and 58 as non-serious.
Click here to view the list of reported adverse reactions
As of 21 January, the Norwegian Immunisation Registry (SYSVAK) shows that 71,971 people have received a COVID-19 vaccine in Norway. Two COVID-19 vaccines are currently approved for use in the EU/EEA, including Norway: Comirnaty (BioNTech/Pfizer) and COVID-19 Vaccine Moderna (Moderna). Both are mRNA vaccines and are given in two doses a few weeks apart.
Prompt reporting is important
The use of COVID-19 vaccines must be closely monitored in order to detect any new adverse reactions. Prompt reporting by healthcare professionals and patients is vital in order to detect new, unexpected or serious adverse reactions. Healthcare professionals have been asked to report any suspected reactions and therefore have a low threshold for reporting reactions which occur shortly after vaccination. Elderly nursing home residents, patients receiving care services, and a small proportion of health care professionals, have so far been vaccinated.
"It is very important to report suspected adverse reactions. This enables us to gain more knowledge, so the authorities can react quickly and possibly adjust their advice on the use of the vaccines," says senior medical consultant Sigurd Hortemo.
Common and expected adverse reactions
The vast majority of those who have been vaccinated appear not to have suffered any adverse reaction to the vaccine. Most of the reports concern known adverse reactions, such as transient pain at the injection site, general malaise with fever, fatigue, nausea and body pain. These usually appear on the first or second day after vaccination and last around 2-3 days.
Adverse reaction reports are assessed on an ongoing basis. Serious reports are given the highest priority. The reports may therefore give a skewed picture of the actual distribution between serious and non-serious reports.
A total of 30 reports concerning deaths have been processed. This does not imply that there is a causal relationship between the deaths and the vaccine. A common characteristic of the deaths is that they have occurred amongst frail elderly nursing home residents with serious underlying conditions. Nursing home residents are a priority group for vaccination because they are at very high risk of severe illness or death from COVID-19. In several of these, the reporter states that no relationship with vaccination is suspected and that the event was due to an underlying illness suffered by the patient. However, it cannot be ruled out that common adverse reactions to vaccines, such as fever and nausea, could have aggravated an underlying condition in frail patients. The Norwegian Institute of Public Health has stressed that health professionals must carry out a thorough risk-benefit assessment before vaccinating very frail patients. For those with limited life expectancy, the benefits of being vaccinated may be marginal.
International cooperation
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, which in turn will lead to increased patient safety.
About adverse reaction monitoring
Reports of possible adverse reactions following COVID-19 vaccination are monitored by the Norwegian Medicines Agency in collaboration with the Norwegian Institute of Public Health and the regional medicines information and pharmacovigilance centres (RELIS).
Adverse reactions are reported in the event of suspicion and the reports describe reactions which have occurred following vaccination. The fact that an event is reported does not necessarily imply that it was caused by the vaccine. Known adverse reactions are described in the product information.
