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 see an overview of reports of suspected adverse reactions (the adverse reactions report)
Submit another report if the symptoms persist
As of 4 January, more than 1,645,000 people have received a third or booster dose. So far we have not seen any other adverse reactions following the third or booster dose besides those seen after the first and second doses. Health professionals and vaccinated persons must state which dose the adverse reaction concerns when they submit a report
The information we have about possible long-term adverse reactions following COVID-19 vaccination is currently limited. The adverse reaction reports provide a snapshot of the situation, and we therefore do not know how long the symptoms persist. As a result, it may be necessary for the doctor or vaccinated person to submit another report with updated information.
“Anyone who experiences symptoms for many weeks after vaccination should contact their GP, who can then assess the possible causes. The doctor will have experience and a knowledge of the patient and be able to provide us with the supplementary information we need to assess a possible link to the vaccine," says Ingrid Aas, Senior Medical Consultant at the Norwegian Medicines Agency.
Menstrual disorders
The Norwegian Institute of Public Health conducts population surveys involving studies of different age groups. The first analyses were carried out in the 18-30 years age group. The results showed an increased incidence of menstrual disorders in this age group following vaccination. Read the Norwegian Institute of Public Health's recommendations concerning vaccination following menstrual disorders.
The Norwegian Medicines Agency has so far assessed 2,745 reports of menstrual disorders. Most of these reports concern women between the ages of 20 and 49. Less than 10% of reports concerning menstrual disorders are classified as serious.
Suspected adverse reactions in adolescents aged 12-17 years
The assessment of adverse reaction reports from the 12-17 age group is given a high priority. We are closely monitoring the situation and are particularly alert to reports of serious events following vaccination.
Adolescents normally experience the same common and transient adverse reactions as adults following vaccination. As of 4 January, more than 431,000 doses have been administered to children and adolescents aged between 12 and 17 years. During the period from December 2020 to 4 January 2021, we received and assessed 379 reports of suspected adverse reactions in this age group. Of these, 50 are classified as serious. This includes two reports of pericarditis and three reports of myocarditis.
Read the NIPH's recommendations and offers of COVID-19 vaccination for children and adolescents
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
- the dose after which the adverse reaction occurred
- whether a different type of vaccine was given as subsequent doses
- 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.
