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. Most of the reports concern common adverse and expected reactions, such as pain at the injection site, headache and general malaise with fever.
Adverse reactions uncovered during studies are specified in the patient information leaflet and the summary of product characteristics. This information is updated if reports are received of new adverse reactions, and when the European Medicines Agency (EMA) decides there is a probable causal link between the vaccine and the adverse reaction.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Young people more likely to experience common adverse reactions
Studies have shown that young adults experience more adverse reactions during the first few days after COVID-19 vaccination than older people. The Norwegian Medicines Agency also receives more reports of adverse reactions from younger adults who have been vaccinated than from older people, even though more older people have so far been vaccinated. Most reports of adverse reactions in adults under the age of 60 concern less serious events.
More reports of adverse reactions amongst younger adults than older people are also received following vaccination against influenza. There may be a number of reasons for this: younger people develop a stronger immune response, healthcare professionals tend to be more likely to submit reports concerning younger people, and younger people also tend to be more likely to report adverse reactions themselves.
"Young people have a more ‘alert’ immune system and must expect to experience some of the common adverse reactions during the first few days after vaccination, especially after the second dose. This can be unpleasant, but it usually passes within a few days", says senior medical consultant Ingrid Aas.
Common and expected adverse reactions:
- Swelling and soreness around the injection area and in the arm
- Fatigue
- Headache
- Fever
- Pain in the muscles and joints
- Chills
- Nausea and diarrhoea
If you experience other symptoms or the symptoms do not pass within a few days, you should contact your doctor or other healthcare professional for assessment and advice.
Reports of cases involving heart problems
Reports have been received concerning 29 cases of acute pericarditis (inflammation of the lining around the heart) following vaccination with the Comirnaty vaccine, five cases after Moderna and one case after Vaxzevria (AstraZeneca). In one case, the patient had received Vaxzevria as the first dose and then Comirnaty as the second. Furthermore, six cases of myocarditis (inflammation of the heart muscle) have been reported following vaccination with the Comirnaty vaccine and one case after vaccination with Moderna. The vast majority of patients were recovering at the time the report was submitted.
The European medicines authorities are now working to determine whether there is a link between vaccination and the cases of pericarditis and myocarditis. It is important to investigate whether these heart problems occur more frequently in those who have been vaccinated than those who have not. Cases which occur after vaccination should be reported.
Anyone who experiences worrying breathlessness or chest pain should seek a doctor, regardless of whether or not they have been vaccinated.
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 ill with COVID-19 following the completion of vaccination, this is considered 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.
