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)
Confirmed COVID-19 in vaccinated persons
No vaccine provides 100% protection against either infection or serious illness. The COVID-19 vaccines provide excellent protection against serious illness and death from COVID-19, as well as good protection against infection amongst those who have been fully vaccinated. The results of studies by the Norwegian Institute of Public Health (NIPH) show that the risk of being admitted to hospital with COVID-19 is over 70% lower for partially and fully vaccinated persons compared with those who have not been vaccinated. It has also been shown that fully vaccinated persons tend to have a shorter stay in hospital and are at a lower risk of needing intensive care.
It is important to investigate the cause of inadequate protection following vaccination, so that we can identify the risk groups that could have a poor immune response. NIPH monitors COVID-19 disease in vaccinated persons. As of 7 November 2021, 415 fully vaccinated persons aged 65 to 84 had been admitted to hospital with COVID-19. Almost 80% of those admitted to hospital belonged to risk groups with a higher risk of becoming seriously ill as a result of COVID-19. There have been 107 covid-19 associated deaths among fully vaccinated, all aged 79 to 90 years.
If a vaccinated person becomes seriously ill with COVID-19 more than 1-2 weeks after being fully vaccinated, this is considered to be a breakthrough infection and a possible case of vaccine failure. These events must be reported as adverse reactions via melde.no. So far, 51 cases have been reported, 11 of which concerned deaths.
“Suspected cases of vaccine failure appear to be underreported. We would like to remind health professionals to report serious cases of COVID-19 disease and deaths associated with COVID-19 in fully vaccinated persons. It is important that adverse reaction reports include a detailed description of the patient's condition and the development of the symptoms,” says Sigurd Hortemo, Senior Consultant at the Norwegian Medicines Agency.
Menstrual disorders
We are still receiving many reports of menstrual disorders and unexpected vaginal bleeding following vaccination. We have so far assessed 1,404 reports of menstrual disorders, 105 of which have been classified as serious. Most reports are from women of childbearing age. We have also received 99 reports from women who have suffered unexpected vaginal bleeding after menopausal age. Ninety four of these are classified as serious.
NIPH and the Norwegian Medicines Agency are monitoring this situation closely. 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. Menstrual and bleeding disorders are also investigated within the European Medicines Agency (EMA).
Read more about how this is being followed up (in Norwegian):
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. 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 9 November 2021, more than 336,000 doses have been administered to children and adolescents aged 12 to 17. During the period December 2020 to 9 November 2021, we received and assessed 192 adverse reaction reports concerning this age group. Twenty seven of these are classified as serious.
We have so far received one report of pericarditis and one report of myocarditis in this age group.
Find out more about: COVID-19 vaccines and heart inflammation (in Norwegian)
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 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.
