Thrombosis and thromboembolism: Brighton collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Jahnavi Gollamudi; Sarah E Sartain; Amir Hassan Navaei; Satinder Aneja; Pawandeep Kaur Dhawan; Dat Tran; Jyoti Joshi; Jane Gidudu; Jayakrishna Gollamudi; Elena Chiappini; Frederick Varricchio; Barbara Law; Flor M Munoz

doi:10.1016/j.vaccine.2022.09.001

Thrombosis and thromboembolism: Brighton collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine. 2022 Oct 19;40(44):6431-6444. doi: 10.1016/j.vaccine.2022.09.001. Epub 2022 Sep 20.

Authors

Affiliations

¹ Department of Medicine, Section of Hematology, Baylor College of Medicine, Houston, TX, USA.
² Department of Pediatrics, Section of Hematology/Oncology, Baylor College of Medicine, Houston, TX, USA.
³ Pediatric Critical Care, Transfusion Medicine & Coagulation, Pediatrics and Pathology & Immunology Departments, Texas Children's Hospital, Baylor College of Medicine, 6701 Fannin St, Suite WB110, Houston 77021, TX, USA.
⁴ Department of Pediatrics, School of Medical Sciences & Research, Sharda University, Gr Noida, India.
⁵ Independent Consultant, India(3).
⁶ Oregon Health Authority, Public Health Division, Acute and Communicable Disease Prevention Section, Portland, OR, USA.
⁷ International Centre for Antimicrobial Resistance Solutions (ICARS), Orestads Boulevard 5, 2300 Copenhagen, Denmark.
⁸ Centers for Disease Control and Prevention, Atlanta, GA, USA.
⁹ University of Cincinnati, Cincinnati, OH, USA.
¹⁰ Meyer University Hospital, Department of Health Science, University of Florence, Florence, Italy.
¹¹ Independent Consultant, Venice, FL, USA.
¹² SPEAC, Brighton Collaboration, Independent Consultant, Vancouver, BC, Canada.
¹³ Department of Pediatrics, Section of Infectious Diseases, and Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA. Electronic address: florm@bcm.edu.

PMID: 36150973
DOI: 10.1016/j.vaccine.2022.09.001

Abstract

This is a Brighton Collaboration case definition of thrombosis and thromboembolism to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected expert reviewers prior to submission.

Keywords: Adverse event; Arterial; COVID-19 immunization; Case definition; Guidelines; Thromboembolism; Thrombosis; Venous.

Publication types

Review

MeSH terms

COVID-19 Vaccines
COVID-19* / epidemiology
COVID-19* / prevention & control
Data Collection
Humans
Immunization / adverse effects
SARS-CoV-2
Thromboembolism* / etiology
Thrombosis* / etiology

Substances

COVID-19 Vaccines