EMA logo European Medicines Agency logo

EMA Safety Committee Investigates Pfizer Vaccine-Associated Facial Swelling

May 11, 2021

The European Medicine Agency (EMA)’s safety committee has concluded there is “at least a reasonable possibility” of a causal link between the Pfizer/BioNTech COVID-19 vaccine and facial swelling in people previously given dermal filler injections.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the vaccine’s product information state that facial swelling be added to the list of possible side effects for this population.

The committee is also monitoring the messenger RNA-based vaccines for reports of blood clots. PRAC said the number of reported cases was lower than for the adenovirus-based AstraZeneca and Johnson & Johnson vaccines.

View today's stories