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.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Suspected case of MIS-C following vaccination in Denmark
MIS-C (multisystem inflammatory syndrome in children) is a rare condition which gives rise to persistent fever and inflammation of multiple organs which has been observed in children who have had COVID-19. The Danish authorities have received a report of one case of MIS-C in a young boy who had not been infected with COVID-19. It is believed that his MIS-C may have been triggered by vaccination with Comirnaty (Pfizer/BioNTech), and the case is therefore being investigated further in collaboration with the European Medicines Agency (EMA).
In Denmark, around 300,000 children in the 12 -19 age group have received at least one dose of coronavirus vaccine.
In Norway, we have recently begun vaccinating 16-17-year-olds, while many young people over 18 years of age have already had their second dose. At present, only children under 16 with underlying medical conditions who are at risk of serious COVID-19 disease have been offered vaccination.
"We have not received any reports of suspected cases of MIS-C as an adverse reaction following vaccination in children and adolescents in Norway. Health professionals should familiarise themselves with the symptoms of MIS-C, and report all cases which they suspect may have arisen following vaccination," urges Medical Director Steinar Madsen.
Over 366 million doses of the Comirnaty COVID-19 vaccine have now been administered in the EU and EEA. Five million of those vaccinated were under 18 years of age.
Multisystem inflammatory syndrome in children (MIS-C) following COVID-19 infection
MIS-C is a very rare, but serious condition which can occur 2-6 weeks after COVID-19 infection. Typical symptoms are persistent high fever, rash and inflammation of multiple organs. Around one case per 3,000 children who have had COVID-19 would normally be expected. Between 25 and 30 cases have been observed in Norway to date. Children who develop this condition normally have to be admitted to hospital. Effective treatment is available and experience so far indicates that those affected have a good prognosis.
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)
How to report adverse reactions
Click here to find out more about how to report adverse reactions (information in Norwegian)