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.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Reports of serious events are assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious events.
Reports of severely elevated blood pressure
A total of 17 cases of high blood pressure have been reported as suspected adverse reactions following vaccination with the mRNA COVID-19 vaccines, 16 following vaccination with the Comirnaty vaccine and one following vaccination with the Moderna vaccine. The patients were aged between 28 and 98, two of whom were men. At the time of the reports, the vast majority of patients either had recovered or were recovering.
These reports include two cases of severely elevated blood pressure following vaccination. These concerned two elderly patients who had underlying risk factors for high blood pressure, with one patient being admitted for assessment and monitoring. Both patients stabilised within two days and they are reported to be recovering. These cases have been reported to the European Medicines Agency (EMA).
“It has not been ascertained whether these cases of high blood pressure could be linked to the vaccine, but we are distributing information about them to ensure that doctors are aware of the possibility of severely elevated blood pressure in persons who have recently been vaccinated”, says Steinar Madsen, Medical Director at the Norwegian Medicines Agency.
Patients who experience severely elevated blood pressure may have symptoms such as headaches, difficulty breathing, chest pain, visual disturbances, coughing and general malaise.
High blood pressure in general is not a reason to advise against vaccination, and it is recommended that these patients be vaccinated in order to protect them against COVID-19 disease.
Common and expected adverse reactions
Most adverse reactions following COVID-19 vaccination, regardless of the type of vaccine used, concern known and transient adverse reactions such as:
- headache
- fatigue
- malaise
- fever
- nausea
- pain in the body
These usually appear on the first or second day after vaccination and last around 2-3 days. Most people tolerate these transient adverse reactions well, while others experience significant discomfort during the first few days after vaccination. These suspected adverse reactions are in line with what is described in the product information.
How to report adverse reactions
Health professionals are obliged to report suspected serious adverse reactions following vaccination. It is not necessary for the causal relationship to be known; suspicion is sufficient to report an incident.
It is particularly important to report reactions where any of the following are suspected:
- new adverse reactions not referred to in the patient information leaflet
- unexpected adverse reactions
- serious adverse reactions
- vaccine failure (severe COVID-19 following full vaccination)
If a person becomes seriously ill with COVID-19 one to two weeks following the completion of vaccination, this is considered to constitute a possible vaccine failure. Severe or critical cases (COVID-19 symptoms and disease) in persons who have been fully vaccinated must be reported as a suspected adverse reaction via melde.no
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. You do not need to report a possible adverse reaction yourself 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, identifying new adverse reactions and implementing measures to safeguard patient safety.
