ong-term outcomes of myocarditis and pericarditis after Pfizer-BioNTech (Comirnaty) COVID-19 vaccination in children and adults

Medsafe0 sites323 target enrollmentMarch 30, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 30, 2022

End Date

October 10, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Sponsor

Medsafe

•1\) Adults and children 12 years of age or older with a clinical diagnosis of myocarditis and/or pericarditis (includes myopericarditis), after any dose of the Pfizer vaccine, and their healthcare providers.
•2\) A report of myocarditis and/or pericarditis has been submitted to the Centre for Adverse Reactions Monitoring (CARM) by the person themselves, or by someone on their behalf (such as a healthcare professional or family member).
•3\) Participants will not be required to meet specific diagnostic criteria, such as the CDC criteria, to be eligible.
•4\) Myocarditis and/or pericarditis diagnosed up to and including 28 February 2022, and at least 3 months prior to the survey (minimum of 3 months post\-diagnosis).

•1\) Children \<12 years of age.
•2\) People who have not received a clinical diagnosis of myocarditis and/or pericarditis. This includes self\-diagnosis, or where a diagnosis of myocarditis or pericarditis was considered as part of the differential diagnosis but was not given as a final diagnosis.
•3\) Myocarditis and/or pericarditis diagnosed after 28 February 2022, and/or less than 3 months ago by the end of the specified recruitment period.
•4\) People who experienced myocarditis and/or pericarditis after a third or subsequent dose of the Pfizer vaccine.
•5\) People who did not receive the Pfizer vaccine prior to being diagnosed with myocarditis or pericarditis.
•6\) People who experienced myocarditis and/or pericarditis after vaccination with another COVID\-19 vaccine (for example, the AstraZeneca vaccine).
•7\) People who have not provided sufficient contact information in CARM report to be able to make initial contact.
•8\) Circumstances that interfere with the participant’s ability to give informed consent (including a diminished understanding or comprehension of English and an interpreter unavailable).