Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine

Study protocol

Initial protocol

C4591038_PROTOCOL AMENDMENT 2_V3_13MAY2022

English (4.52 MB - PDF) View document

Updated protocol

C4591038_PROTOCOL AMENDMENT 4 V5.0_11JUN2025.pdf

First published: 27/10/2025

English (3.08 MB - PDF) View document

Study results

Study report

C4591038_INTERIM REPORT ABSTRACT_18SEP2023.pdf

English (189.71 KB - PDF) View document

c4591038-interim-report-body.pdf

English (5.56 MB - PDF) View document

c4591038-final report abstract.pdf

English (699.96 KB - PDF) View document

C4591038_FINAL REPORT PART 1_11JUN2025.pdf

English (18.12 MB - PDF) View document

C4591038_FINAL REPORT PART 2_11JUN2025.pdf

English (19.12 MB - PDF) View document

Other information

Study, other information

C4591038_PROTOCOL AMENDMENT 3 V4.0_08AUG2024.pdf

English (1 MB - PDF) View document

Secondary tabs