Real-time pharmacovigilance and cardiac risk communication during the COVID-19 vaccination campaign in Israel
DOI:
https://doi.org/10.17179/excli2026-9596Keywords:
COVID-19 vaccination, pharmacovigilance, risk communication, myocarditis, vaccine safety, informed consentAbstract
During the early phase of the COVID-19 vaccination campaign, the Israeli Ministry of Health (IMOH) informed international health authorities that it had identified “a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine.” This study discloses and analyzes an internal pharmacovigilance dataset obtained from within the IMOH to examine the case-level record associated with this early safety signal and trace how the signal was subsequently communicated to physicians and the public. The anonymized dataset, provided as Supplementary Data File 1, includes 531 hospitalization records and 67 unique deaths reported to Pfizer between March 2021 and May 2022. Reported events spanned cardiac, neurological, inflammatory, and other serious clinical categories and involved a substantial proportion of younger individuals, with 211 of 530 hospitalization records with valid age data (39.8 %) involving patients under 30 years of age. Myocarditis was recorded in two of the nine unique deaths among individuals under 50 years of age (22.2 %), while myocarditis or pericarditis was identified in 250 of 531 hospitalization records (47.1 %), rising to 151 of 211 records involving patients under 30 (71.6 %). Among younger hospitalized patients, 134 of 211 (63.5 %) had no meaningful medical history identified under the study definition; within this subgroup, 99 of 134 (73.9 %) had myocarditis or pericarditis, of whom 90 (90.9 %) were male. The safety signal was communicated to clinicians and the public only after approximately three to four months, primarily in ways that emphasized its rarity, generally mild clinical course, and lower concern relative to COVID-19 outcomes. The accuracy and completeness of this characterization, together with the implications of the case-level patterns and communication timeline documented in this study, are discussed in the broader contexts of pharmacovigilance, risk communication, and informed consent during large-scale public health interventions.
Downloads
Additional Files
Published
How to Cite
License
Copyright (c) 2026 Yaakov Ophir, Yaffa Shir-Raz
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish in this journal agree to the following terms:
- The authors keep the copyright and grant the journal the right of first publication under the terms of the Creative Commons Attribution license, CC BY 4.0. This licencse permits unrestricted use, distribution and reproduction in any medium, provided that the original work is properly cited.
- The use of general descriptive names, trade names, trademarks, and so forth in this publication, even if not specifically identified, does not imply that these names are not protected by the relevant laws and regulations.
- Because the advice and information in this journal are believed to be true and accurate at the time of publication, neither the authors, the editors, nor the publisher accept any legal responsibility for any errors or omissions presented in the publication. The publisher makes no guarantee, express or implied, with respect to the material contained herein.
- The authors can enter into additional contracts for the non-exclusive distribution of the journal's published version by citing the initial publication in this journal (e.g. publishing in an institutional repository or in a book).
