​​​​​​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 29th 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.  

Few COVID-19 vaccines are currently being administered and the number of adverse reaction reports being submitted is falling. We have therefore decided to publish reports and news once a month in the future. We are still working hard to assess the reports that we receive. The change in the frequency of publication does not mean that we have reduced the amount of resources that are allocated to this task.  ​

The next report and news will be published on Thursday, 21 April 2022.  

Click here to see an overview of reports of suspected adverse reactions (the adverse reactions report)​

Vaccination of pregnant women  

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

In Norway, the vaccination rate amongst pregnant women is good. Of all the women who gave birth in January 2022, around 70% had been vaccinated against COVID-19. We have received and assessed 121 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. It is therefore not unexpected that we receive such reports when such complications occur relatively soon after vaccination.  ​​

No increase in the risk of pregnancy complications   

Previous studies have shown that there is no increase in the risk of miscarriage in women who are vaccinated during their first trimester. In a new Nordic study, researchers used data from health registries in Nor​way and Sweden to study whether vaccination during pregnancy was associated with a risk of pregnancy complications. The study compared vaccinated and unvaccinated pregnant women.  No increase in the incidence of complications was observed in women who were vaccinated during pregnancy. Most vaccinated women had rec​eived their vaccine during the second or third trimester.  

"The vaccination rate amongst pregnant women across the Nordic countries is good. It is therefore reassuring that this extensive study shows that there is no increase in the risk of pregnancy complications in vaccinated mothers," says Senior Consultant Ingrid Aas.  

The study was conducted between May 2021 and January 2022. There was no difference between women who had been vaccinated with Comirnaty (Pfizer/BioNTech) and those who had received Spikevax (Moderna). There were also no differences between women who had been vaccinated in the second trimester and those vaccinated in the third trimester of their pregnancy. 

Read COVID-19 vaccination does not increase the risk of pregnancy complications (FHI.no)

Advice and information for pregnant and breastfeeding women (FHI.no)​ 

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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