​​​​Adverse reactions are reported on the basis of suspicions. The fact that an adverse reaction has been reported does not necessarily mean that there is a causal link with the vaccine. The purpose of the reporting system is to determine what we should investigate further.

All reports are included in the report of possible adverse reactions to Covid-19 vaccines, regardless of whether or not the event is believed to be linked to vaccination. As a result, the figures cannot be used to assess causalities or determine how often an adverse reaction occurs.  Reports of serious events are assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious reports.  

This report is based on reports that are assessed until 1th of March 2022. The assessed adverse reaction reports do not provide a basis for revising the current overall recommendations regarding the use of the vaccines.

Reports concerning pregnant women are monitored particularly closely​

Reports concerning pregnant women are monitored particularly closely
In Norway, the vaccination rate amongst pregnant women has risen over the past six months. Of all the women who gave birth in January 2022, 70% had been vaccinated against COVID-19. We have received and assessed 118 reports concerning events linked to pregnancy, childbirth and newborn babies where the mother had been vaccinated. Reports concerning pregnant women are often automatically classified as serious. The vast majority of reports concern complications which are common during pregnancy, such as miscarriage and bleeding. If these complications arise shortly after vaccination, we would expect to receive such reports. Studies show that there is no increase in the risk of miscarriage following vaccination.

“Our experience is that health professionals have a low threshold for reporting and informing us about events following vaccination so that we can follow the cases up. We pay particular attention to reports concerning pregnant women. Together with the National Institute of Public Health, we are conducting ongoing studies in order to check whether there is an increased incidence of pregnancy complications or illness in the mother and child where the mother has been vaccinated,” says Senior Medical Consultant Ingrid Aas of the Norwegian Medicines Agency.

We are working closely with clinical experts both in Norway and internationally to acquire information from birth registries and other sources. No increase in the incidence of complications in pregnancy or disease amongst newborn babies following vaccination of the mother has so far been observed.

Pregnant women are at greater risk of severe COVID-19 disease, which can have serious consequences for both mother and child. Serious cases of disease have also been reported in pregnant women after infection with omicron. The Norwegian Institute of Public Health therefore recommends that pregnant women be vaccinated.

Reports in children and adolescents

The assessment of reports of suspected adverse reactions in 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.
Adolescents normally experience the same common and transient adverse reactions as adults following vaccination. As of 1 March 2022, more than 464 000 doses had been administered to children and adolescents aged between 12 and 17. During the period from December 2020 to 1 March 2022, we received and assessed 498 reports of suspected adverse reactions in this age group. Of these, 71 are classified as serious. This includes six reports of heart inflammation, pericarditis and myocarditis.

79% of the reports of suspected adverse reactions in this age group relate to girls. Many reports concern menstrual disorders. Most of these are classified as non-serious.

A total of 5 230 children aged 5 to 11 years have so far been vaccinated. We have received and assessed fewer than ten reports of suspected adverse reactions in this age group. 

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

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.​
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