PRAC concludes review of signal of facial swelling with Comirnaty (Pfizer) COVID-19 vaccine

PRAC has concluded that there is a reasonable possibility of a causal association between the vaccine and facial swelling in people with a history of injections with dermal fillers and this should be included as an ADR. The benefit-risk balance of the vaccine remains unchanged.

SPS commentary:

PRAC continues to closely review Comirnaty for thromboembolic events and considers that the current evidence does not suggest a causal relation since only a few cases have been reported and they do not seem to present the specific clinical pattern observed with Astra Zeneca and Janssen COVID-19 vaccines.


European Medicines Agency