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. The reports often concern symptoms and conditions which are relatively common amongst the population. At a time when so many people are being vaccinated, the challenge is to separate out conditions or symptoms which occur coincidentally following vaccination from genuine adverse reactions.
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.
The report summarises all reports of suspected adverse reactions that we have assessed. 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.
Monitoring over time
Although fewer doses of the vaccines are now being administered, the work to monitor adverse reactions is continuing. We expect to continue to receive reports going forward, as it can take time for suspected adverse reactions to be reported. At the same time, we are working on reports that have already been received.
“All reports will be assessed. We give the serious reports the highest priority, which means that non-serious reports still have to be assessed. We also prioritise reports which describe unusual and unknown symptoms over those with non-serious and known adverse reactions," says Senior Consultant Ingrid Aas from the Norwegian Medicines Agency.
The Norwegian Medicines Agency is actively contributing to the European cooperation and will continue to analyse data concerning adverse reactions.
“We urge both those who have been vaccinated and health professionals to submit further reports and provide us with updated and supplementary information concerning persistent and distressing symptoms. No adverse reactions have so far been detected long after vaccination, but we are monitoring the situation closely to pick up any signals of possible late adverse reactions,” says Ingrid Aas.
Suspected adverse reactions in children and adolescents
On 14 January 2022, the vaccination programme was expanded to include children between the age of 5 and 11. At the same time, the programme was opened up to enable 12-15 year olds to receive two doses. 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 15 January 2022, more than 461,000 doses had been administered to children and adolescents aged between 12 and 17. During the period from December 2020 to 15 February 2022, we received and assessed 468 reports of suspected adverse reactions in this age group. Of these, 68 are classified as serious. This includes five reports of heart inflammation, pericarditis and myocarditis.
80% 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 4,475 children aged 5 to 11 years have so far been vaccinated. We have received and assessed fewer than five reports of suspected adverse reactions in this age group. All are non-serious.
Read the Norwegian Institute of Public Health's recommendations and offers of COVID-19 vaccination for children and adolescents.
Menstrual disorders
The Norwegian Medicines Agency has so far assessed 3,741 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.
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.
