On Saturday 13 March 2021, the Norwegian Institute of Public Health and the Norwegian Medicines Agency announced that three people vaccinated with the AstraZeneca vaccine had been admitted to Oslo University Hospital with severe cases of blood clots, bleeding and low platelet counts. Oslo University Hospital has now announced that one of the three patients has died.
The Norwegian Medicines Agency wishes to emphasise that the three cases concern rare clinical pictures. They involve a very unusual combination of low platelet count, blood clots in small and large blood vessels, and bleeding. Some cases with a similar clinical picture have been reported in a number of other European countries. The European Medicines Agency (EMA) is currently reviewing similar adverse reaction reports in Europe in order to see whether these cases could be linked to vaccination.
Assessment of adverse reaction reports
We have received over 1,000 adverse reaction reports over the past few days. We are now reviewing these reports, with priority being given to the most serious first.
Most reports concern common, expected and transient adverse reactions, such as nausea, fever, headache, muscle pain and pain around the injection site. These reactions can be unpleasant and normally pass after 2-3 days. If you continue to feel ill after this time, you should consider contacting a doctor.
- So far, we have not received any reports of other serious cases with this very rare clinical picture, says Steinar Madsen, Medical Director at the Norwegian Medicines Agency.
He reiterates that it is particularly important that unexpected, rare and serious conditions are reported.
What we are doing
The Norwegian Medicines Agency is currently reviewing reports of blood clots and bleeding for the coronavirus vaccines which are in use in Norway. We ask healthcare professionals who suspect unexpected or serious adverse reactions following vaccination to report the incidents as soon as possible.
The three serious incidents involving blood clots, bleeding and low platelet counts seen following vaccination with the AstraZeneca vaccine have so far not been observed after vaccination with the other coronavirus vaccines.
Oslo University Hospital is assessing whether there are any similarities between the three patients, which may give some indication of why their conditions developed in such unusual ways. We will also investigate possible links with similar cases in other countries.
The European Medicines Agency (EMA) is currently reviewing similar adverse reaction reports in Europe in order to see whether these cases could be linked to vaccination.