MHRA warns about myocarditis and pericarditis with Moderna and Pfizer COVID-19 vaccines

Following very rare reports of myocarditis and pericarditis occurring after vaccination with COVID-19 mRNA vaccines, often in younger men and shortly after second dose, the Summary of Product Characteristics and the Patient Information Leaflets for both vaccines have been updated

SPS commentary:

As of 16 June 2021, the MHRA has received 87 Yellow Card reports of myocarditis and pericarditis as suspected side effects after administration of the Pfizer/BioNTech COVID-19 vaccine and 4 reports after the Moderna COVID-19 vaccine.

Up to the same date an estimated 16.8 million first doses and 10.9 million second doses of the Pfizer/BioNTech vaccine had been administered, and an approximate 0.73 million first doses of the COVID-19 Vaccine Moderna have also now been administered.

The Commission on Human Medicines has reviewed the available safety data and advises healthcare professionals to be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinated individuals should be advised to seek immediate medical attention should they experience new onset of chest pain, shortness of breath or symptoms of arrhythmia.

Source:

Medicines and Healthcare products Regulatory Agency