Index Entries

March 20, 2024
Danish Medicines Agency

"The European Pharmacovigilance Committee has reassessed whether chronic urticaria can be a side effect after vaccination with the Spikevax vaccine from Moderna...

The Danish Medicines Agency has subsequently carried out further studies of chronic hives as a possible side effect...

Connection found in 286 out of 360 cases

'We have assessed a total of 360 European cases, the vast majority of which come from Denmark, while there are also a significant number of cases from Germany, Switzerland and Italy. In 58 of these cases, we assess that there is a probable link between the vaccine and the patient's development of chronic urticaria, and in 228 cases, we assess that there is a possible connection,' explains team leader Martin Zahle Larsen from the Danish Medicines Agency...

The Danish study shows that the vast majority of cases of chronic hives have occurred 7-13 days after the 3rd vaccine dose in people who have been vaccinated with the Spikevax vaccine. The study also shows that people who have received Spikevax are 3 times more likely to develop chronic urticaria than the background population, and that younger men are at particularly high risk of developing chronic urticaria after vaccination with Spikevax."

document
adverse events,COVID-19,vaccines