The European Medicines Agency has published statistics on adverse events associated with COVID-19 vaccines reported in the EU/EEA

Production line for COVID-19 vaccine vials_410157556_James Thew

The number of suspected adverse events (AEs) reported in the European Union/European Economic Area (EU/EEA) up to the end of October stands at 749,979 out of almost 575 million doses, according to the latest data from the European Medicines Agency (EMA). The figure suggests a rate of 1.3%, although this may not reflect the true prevalence as the reports related to suspected AEs, and there is also the likelihood that mild AEs may not have been reported.

The incidence of possible AEs with each vaccine range from 0.96% per dose for Comirnaty (PfizerBioNTech), 0.3% for Vaxzevria (AstraZeneca), 0.17% for the Janssen vaccine and 0.15% for Spikevax (Moderna).

A possible link between Comirnaty and Spikevac with myocarditis/pericarditis is still being reviewed. Furthermore, the agency said there is currently insufficient evidence to confirm or rule out a link with multisystem inflammatory syndrome (MIS) with all four vaccines.

It has also been concluded that there is insufficient evidence to support a possible causal relationship between the Janssen vaccine and menstrual disorders. As of 30 September 2021, 1238 cases of menstrual disorders had been reported worldwide following receipt of the vaccine. Of these, 550 were received during the previous monthly reporting period.

This article originally appeared on Univadis, part of the Medscape Professional Network.


Lead image: James Thew/

Image 1: James Thew/