Revised SPC: COVID-19 Vaccine (BioNTech – Pfizer)

SPC update to warn of very rare reports of myocarditis and pericarditis occurring after vaccination, often in younger men and shortly after 2nd dose. These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest.

SPS commentary:

Healthcare professionals are advised to be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinated individuals should also seek immediate medical attention should they experience new onset of chest pain, shortness of breath, palpitations or arrhythmias.

Revisions were made to the information for healthcare professionals and information for UK vaccine recipients for the COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine following a review of extremely rare reports of myocarditis and pericarditis after COVID-19 vaccination by MHRA. It is noted that these events are extremely rare and tend to be mild when they do occur. Advice remains that the benefits of getting vaccinated outweigh the risks in the majority of people.


electronic Medicines compendium

Resource links:

MHRA update