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 the event is believed to be linked to vaccination.
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.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Reports of suspected adverse reactions in the 12-17 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. Over 300,000 doses have so far been administered to children and adolescents aged between 12 and 17. During the period from December 2020 to 5 October 2021, we received and assessed 109 adverse reaction reports concerning this age group. Seventeen of these are classified as serious.
- “The reports concern a number of conditions, with the most common being fainting in connection with the vaccination itself. Fainting is not considered to be serious from a medical perspective, but should always be classified as a serious adverse reaction, according to the European Medicines Agency," says Steinar Madsen, Medical Director of the Norwegian Medicines Agency.
Inflammation of the heart
Adolescents normally experience the same common and transient adverse reactions as adults following vaccination. Amongst the more rarely known adverse reactions are inflammation of the heart muscle (myocarditis) and inflammation of the heart lining (pericarditis). We have so far received one adverse reaction report concerning this in the under 18 age group. Symptoms of heart inflammation include chest pain, wheezing or rapid or irregular heart rate in vaccinated people. Fever and cough may also occur. Of those affected, most symptoms develop 1-2 weeks after vaccination.
The Norwegian Institute of Public Health has again underlined its recommendation that adolescents under the age of 18 who are to be vaccinated should be offered Comirnaty, regardless of which mRNA vaccine they received as their first dose. Find out more atfhi.no: Myocarditis in boys and young men can occur more frequently following the Spikevax vaccine from Moderna.
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.
Report adverse reactions on behalf of children
Children under 16: Parents and guardians can report adverse reactions on behalf of their children.
Children over 16: Young people over the age of 16 can report adverse reactions themselves, but they will need an electronic ID, such as Bank-ID. Parents can report adverse reactions if a power of attorney has been set up. Power of attorney can be set up digitally at helsenorge.no.
Find out more about representing other people at helsenorge.no.
How to report adverse reactions
Click here for a link to the report form and more information on how to report adverse reactions.
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:
- adverse reactions not referred to in the patient information leaflet
- unexpected adverse reactions
- serious adverse reactions
- vaccine failure (severe COVID-19 following full vaccination)
Health professionals are obliged to report serious, new and unexpected reactions which they suspect may be caused by a vaccine.
