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

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

Jahnavi Gollamudi  1 , Sarah E Sartain  2 , Amir Hassan Navaei  3 , Satinder Aneja  4 , Pawandeep Kaur Dhawan  5 , Dat Tran  6 , Jyoti Joshi  7 , Jane Gidudu  8 , Jayakrishna Gollamudi  9 , Elena Chiappini  10 , Frederick Varricchio  11 , Barbara Law  12 , Flor M Munoz  13
Affiliations
Free article
Review

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

Jahnavi Gollamudi et al. Vaccine. .
Free article

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.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JG, SES, AHN, SA, K(D), DT, JJ, JD, EC, FV BL and FMM declare no conflicts of interest. PKD declares that she now works for Sanofi, India but was an independent consultant when this case definition was developed.

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