Adverse reaction reports summarise all reports of suspected adverse reactions that we have assessed. Events following vaccination are reported on the basis of suspicions, which means that there is not necessarily any causal relationship. The challenge is to distinguish symptoms and medical conditions which occur randomly from those which could be linked to vaccination. All reports are included in the report, regardless of whether or not an event is believed to be linked to vaccination.
Reports of serious events are given priority and assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious events.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report).
Reports of suspected adverse reactions in the 12 to 17 age group
The monitoring of adverse reactions amongst children and adolescents is given a high priority. We are closely monitoring the situation and are particularly alert to reports of serious events following vaccination. As of 21 September 2021, almost 220,000 children and adolescents aged 12 to 17 had received at least one dose of vaccine. Since the vaccination of this age group began, we have received and assessed a total of 44 adverse reaction reports. Eight of these are classified as serious.
- Studies and experiences following vaccination have shown that children generally experience the same common and transient adverse reactions as adults, such as pain around the injection site, headache, fever, muscle aches and joint pain," says Steinar Madsen, Medical Director of the Norwegian Medicines Agency.
No cases of heart inflammation
Amongst the rarer adverse reactions are inflammation of the heart muscle (myocarditis) and inflammation of the heart lining (pericarditis). These are rare, but known adverse reactions listed in the product information for the Comirnaty (Pfizer/BioNtech) and Spikevax (Moderna) COVID-19 vaccines. So far, there have been no reports of such cases in the 12 to 17 age group. Symptoms of pericarditis and myocarditis are: Chest pain, wheezing or rapid or irregular heart rate in those who have been vaccinated. Fever and cough may also occur.
Contact a health professional, such as a public health nurse or a doctor, for an assessment and advice if a child or adolescent is experiencing troublesome adverse reactions. Health professionals are obliged to report serious, new and unexpected reactions which they suspect may be caused by a vaccine.
How to report adverse reactions
Click here for a link to the report form and more information on how to report adverse reactions (information in Norwegian).
Please remember to include the following information when reporting adverse reactions:
- name of the vaccine and date of vaccination
- detailed description of the sequence of events
- when the adverse reaction first started
- whether the reaction is persistent or has passed
- other current medical conditions and medication
- if/when a COVID-19 test has been taken, and the result
- whether the reaction occurred after the first or second dose
- whether a different type of vaccine was given as the second dose
- the results of any blood tests or other medical investigations
- whether a doctor has been contacted (for those submitting a “patient report” via helsenorge.no)
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)
