Most reports of adverse reactions following COVID-19 vaccination concern known and transient adverse reactions such as headache, fatigue, malaise, fever, nausea and pain in the body. These usually appear on the first or second day after vaccination and last around two to three days. These are known adverse reactions which are described in the product information.
After the administration of more than 3.5 million doses of COVID-19 vaccines in Norway, we have assessed 11,297 adverse reactions reports. 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)
Non-serious reports concerning the Janssen vaccine
The Janssen COVID-19 vaccine is not part of the national COVID-19 vaccination programme in Norway. This is due to the risk of rare, but very serious adverse reactions involving blood clots, low platelet counts and bleeding. Nevertheless, the government has decided that anyone wishing to have this vaccine should be offered it following an assessment by a doctor. The Norwegian Medicines Agency monitors adverse reactions to all the vaccines that are used in Norway.
In Norway, just under 1,000 people have registered to receive the Janssen vaccine since it became available outside the vaccination programme on 15 June 2021. Of these, some post-vaccination registrations of vaccination with the Janssen vaccine have also taken place outside Norway.The Norwegian Medicines Agency has received fewer than ten reports of suspected adverse reactions following vaccination with the Janssen vaccine. These are classified as non-serious.
Reports of menstrual disorders common
Last week, the Norwegian Medicines Agency announced that adverse reaction reports had been received from women concerning various types of menstrual disorders. Reports in the media have led to an increase in the number of patient reports being received.
Menstrual disorders are extremely common and many women will therefore experience disorders soon after being vaccinated. Although menstrual disorders can be unpleasant and distressing, the reports we have received so far have been classified as being non-serious. We do not currently know whether or not the disorders are linked to the vaccine. Other countries have also received similar reports. We will monitor the situation going forward in cooperation with other European authorities. Independent experts in the United Kingdom have assessed similar reports. They believe there is no evidence at the present time to suggest that the risk of menstrual disorders increases following vaccination.
Health professionals are obliged to report suspected adverse reactions. To date, we have not received any serious reports of menstrual disorders from health professionals. It is important to exclude any medical condition that has this as a symptom. We therefore urge women with persistent or worrying symptoms to see a doctor.
There is no evidence to suggest that any of the COVID-19 vaccines affect women's fertility.
Serious reports given priority
The Norwegian Medicines Agency receives many reports of suspected adverse reactions from both health professionals and patients. More than 2.5 million people have now been vaccinated in Norway, and we have assessed more than 11,789 reports so far. By comparison, we normally assess just over 5,500 reports every year for both medicines and vaccines combined.
The fact that an event is reported does not necessarily mean there is a causal link to the vaccine; the timing could simply be a coincidence. The Norwegian Medicines Agency receives reports concerning all types of reactions and events following vaccination, with the majority relating to known and non-serious adverse reactions.
“We are working systematically to identify signals concerning new and unknown adverse reactions and are therefore prioritising the serious reports for assessment. It is particularly important that any suspected cases of new, unexpected and/or serious adverse reactions are reported. To make it easier for us to assess the reports, we urge anyone who submits a report to provide as much detailed information as possible," says Medical Director Steinar Madsen.
Please include the following information when reporting adverse reactions:
- name of the vaccine and date of vaccination
- description of the sequence of events, in as much detail as possible
- when the adverse reaction first started
- whether the reaction is persistent or has passed
- any about medical conditions and the taking of medication
- whether the reaction occurred after the first or second dose
- whether a different type of vaccine was given as the second dose
- results of any blood tests
- whether a doctor has been contacted
How to report adverse reactions
Health care professionals should report adverse reactions via melde.no. The general public can report adverse reactions via helsenorge.no.
It is particularly important to report reactions where any of the following are suspected:
- new adverse reactions not referred to in the patient information leaflet
- unexpected adverse reactions
- serious adverse reactions
- vaccine failure (severe COVID-19 following full vaccination).
