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.
The current suspension of use of the Vaxrevria (AstraZeneca) vaccine will remain in place until further notice, and the introduction of the Janssen vaccine has been postponed. An expert group has been set up with a deadline of 10 May 2021 to submit recommendations to the Norwegian Government regarding how these EU/EEA-approved vaccines should be used in Norway.
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 acute pericarditis
A total of seven cases of acute pericarditis (inflammation of the lining around the heart) have been reported as suspected adverse reactions, six following vaccination with Comirnaty and one following vaccination with the Moderna COVID-19 vaccine. The patients were aged between 28 and 87, one of whom was a woman. Pericarditis was confirmed between one and three weeks after vaccination. The patients were admitted partly as a result of breathing difficulties, chest pain and shoulder pain. Pericarditis was confirmed through an ECG and echocardiography (ultrasound examination of the heart). At the time the reports were submitted, the patients were recovering.
It is estimated that pericarditis is the cause of approximately 5% of all referrals to accident and emergency departments with chest pain. Pericarditis occurs more frequently in men than in women. The most common cause of pericarditis is viral infection, and a number of reports have indicated that COVID-19 may also lead to pericarditis in some cases. Pericarditis has a good prognosis.
"It is not yet clear whether pericarditis can be linked to the vaccine. We ask doctors to be aware of the possibility of pericarditis in persons who have recently been vaccinated, and that all cases of pericarditis which occur during the first few weeks following vaccination be reported," says Steinar Madsen, Medical Director of the Norwegian Medicines Agency.
Anyone who experiences worrying breathlessness or chest pain should seek a doctor, regardless of whether or not they have been vaccinated.
Emergency preparedness for acute allergic reactions
Most vaccination sites in Norway are now vaccinating adults under the age of 65, and over 150,000 people are being vaccinated every week. Allergic reactions are more common in younger adults than in the elderly. All vaccination sites have established appropriate procedures for managing allergic reactions, including severe allergic reactions such as anaphylaxis. People with known allergies must notify us of this before being vaccinated.
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:
- 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
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.
Health professionals are obliged to report suspected serious adverse reactions to vaccines. It is not necessary for the causal relationship to be known; suspicion is sufficient to report an incident.
Health care professionals should report suspected adverse reactions 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.¨
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.