Adverse reaction reports summarise all reports of suspected adverse reactions that we have assessed. Events following vaccination are reported on the basis of suspicions, which means that there is not necessarily any causal relationship. The challenge is to distinguish symptoms and medical conditions which occur randomly from those which could be linked to vaccination.
All reports are included in the report, regardless of whether or not the event is believed to be linked to vaccination.
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.
The number of COVID-19 vaccines being administered is falling, as is the number of adverse reaction reports being submitted. As a result, we are now publishing an adverse reaction report and news every other week. We are still working hard to assess the reports that we receive. The change in the frequency of publication therefore does not mean that we have reduced the amount of resources that are allocated to this task.
Click here to see an overview of reports of suspected adverse reactions (the adverse reactions report)
When submitting an adverse reaction report, please remember to state whether the report concerns a third dose or a booster dose
It is important to distinguish between the third dose that is given to people with a severely weakened immune system in order to obtain the best possible protection against COVID-19, and the booster dose which can be offered to the entire population. The Norwegian Institute of Public Health (NIPH) has so far only recommended booster doses for people over the age of 65, residents of nursing homes and health professionals who come into contact with patients. As of 22 November 2021, more than 400,000 people have received a third dose, either in the form of an additional dose as part of the primary vaccination of people with a severely weakened immune system or as what is known as a ‘booster dose’.
“The vaccination programme is now being stepped up amongst the municipalities. We ask health professionals and vaccinated people to state which dose their adverse reaction report concerns when they send us a report,” urges Senior Medical Consultant Sigurd Hortemo at the Norwegian Medicines Agency.
In the case of Spikevax (Moderna), a full dose (100 μg) is given as the third dose and a half dose (50 μg) as the booster dose. In the case of Comirnaty (Pfizer/BioNTech), a full dose (30 μg) is given as both the third dose and the booster dose.
Menstrual disorders
We have so far assessed 1,964 reports of menstrual disorders. Most of these reports concern women between the ages of 20 and 49. 145 of these reports are classified as serious.
"In many of these cases, it is not the menstrual disorder, but other ailments that have been reported at the same time, which means that the report is classified as serious overall," says Ingrid Aas, Senior Medical Consultant at the Norwegian Medicines Agency.
If menstrual disorders are prolonged and affect the person’s ability to work and carry out other daily chores, the report will also often be classified as serious.
We have also received 124 reports concerning women who have suffered unexpected vaginal bleeding after menopausal age. 119 of these are classified as serious. Unexpected vaginal bleeding after menopausal age is automatically considered to be serious unless the woman’s last menstruation occurred relatively recently.
NIPH is conducting a major study in an attempt to determine whether or not there is a link between COVID-19 vaccines and bleeding disorders. The results of the study will be available before Christmas.
We do not yet know whether women who have experienced menstrual disorders in connection with their first or second dose are at greater risk of experiencing such disorders again when they receive their third dose or booster dose.
Reports of suspected adverse reactions in adolescents aged 12-17
The assessment of adverse reaction reports from the 12-17 age group is given a high priority. 16- and 17-year-olds are now receiving their second vaccine dose. We are closely monitoring the situation and are particularly alert to reports of serious events following vaccination23
Adolescents normally experience the same common and transient adverse reactions as adults following vaccination. As of 9 November 2021, more than 359,000 doses have been administered to children and adolescents aged 12 to 17. During the period December 2020 to 23 November 2021, we received and assessed 248 adverse reaction reports concerning this age group. 35 of these are classified as serious. We have so far received one report of pericarditis and one report of myocarditis in this age group.
Over 80% of the adverse reaction reports in this age group are from girls. Many reports concern menstrual disorders. Most of these are classified as non-serious.
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.
Find out more about representing other people at helsenorge.no.
How to report adverse reactions
Click here for a link to the report form for patients
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.
