Europe – COVID-19 vaccine safety update COMIRNATY

Swelling of the face in people who have had a dermal filler injection will be added to the
product information of Comirnaty as a side effect.

Case reports of inflammation of the heart muscle and membrane will be further assessed.
Comirnaty is effective in preventing COVID-19.

This safety update follows the last update of 14 April 2021. Safety updates provide information about the assessments of emerging worldwide safety data since marketing authorisation for COVID-19 vaccines. Safety assessments are carried out primarily by EMA’s
Pharmacovigilance Risk Assessment Committee (PRAC). The safety updates are published regularly at COVID-19 vaccines: authorised.

All published safety updates for Comirnaty are available at Comirnaty: safety updates…