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 15th 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.
COVID-19 vaccine Nuvaxovid now available
Nuvaxovid (Novavax) is a protein-based vaccine developed using traditional vaccine technology. Nuvaxovid has been granted conditional approval for use in persons aged 18 upwards. The vaccine is administered as two doses, three weeks apart.
Studies show that the vaccine is approximately 90% effective in preventing COVID-19 disease against the original Wuhan virus and the alpha variant. We currently know relatively little about how well the vaccine protects against the delta and omicron variants. The studies showed that Nuvaxovid produced common and transient adverse reactions, such as pain and soreness around the injection site, fatigue, headache, muscle and joint pain, nausea, vomiting and general malaise during the first few days after vaccination.
"Based on the studies, it appears that these known adverse reactions are milder and shorter-lived after vaccination with Nuvaxovid than with the mRNA vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna)," said Senior Consultant Ingrid Aas of the Norwegian Medicines Agency.
As of 15 March 2022, 196 doses of this vaccine had been administered in Norway. No reports of suspected adverse reactions have been received. In most cases, adverse reactions will occur during the first few weeks following vaccination. However, even after thorough studies have been conducted, we can never guarantee that very rare adverse reactions will not occur when new vaccines are introduced. The ongoing monitoring of adverse reactions is therefore vital.
Menstrual disorders
The Norwegian Medicines Agency has so far assessed 4 124 reports of menstrual disorders. Most of these reports concern women between the ages of 20 and 49. 442 of these reports are classified as serious.
The Norwegian Medicines Agency has reported menstrual disorders as an adverse reaction signal to the European medicines authorities. This is now being discussed by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).
The Norwegian Institute of Public Health conducts population surveys involving studies of different age groups. More than 60,000 women aged between 12 and 80, both vaccinated and unvaccinated, are taking part in these population surveys. Analyses from the study are under way and will be published on an ongoing basis. The first analyses were carried out in the 18-30 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.
Report adverse reactions on behalf of children
Children under 16: Parents and guardians can report adverse reactions on behalf of their children.
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.
