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 an event is believed to be linked to vaccination.
Reports of serious events are given priority and 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).
What do we know about the mRNA vaccines and "ordinary" blood clots?
No confirmed link has so far been demonstrated between the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) and the risk of "ordinary" blood clots. However, some studies have reported more cases of blood clots amongst those who have been vaccinated compared with those who have not. The European Medicines Agency (EMA) is therefore closely monitoring the situation.
- A high proportion of the adult population has now been vaccinated. As blood clots are a relatively common condition, blood clots will also occur shortly after vaccination without there being any link to the vaccine," says Sigurd Hortemo, Senior Medical Consultant at the Norwegian Medicines Agency.
As of 14 September 2021, over 7.3 million doses of the mRNA vaccines had been administered in Norway, and 296 suspected cases of blood clots had been reported following vaccination with these vaccines.
Only after vaccination with the COVID-19 vaccines from AstraZeneca (Vaxzevria) and Janssen has a link been demonstrated with the rare and serious cases of blood clots with low blood platelet counts and bleeding (VITT /TTS). These vaccines are not available under the COVID-19 vaccination programme.
How to report adverse reactions
Click here for a link to the report form and more information on how to report adverse reactions (information in Norwegian).
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
- whether the reaction occurred after the first or second dose
- whether a different type of vaccine was given as the second dose
- 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:
- 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)