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

被引：5

作者：

Gollamudi, Jahnavi ^{[1
]}

Sartain, Sarah E. ^{[2
]}

Navaei, Amir Hassan ^{[3
]}

Aneja, Satinder ^{[4
]}

Dhawan, Pawandeep Kaur

Tran, Dat ^{[5
]}

Joshi, Jyoti ^{[6
]}

Gidudu, Jane ^{[7
]}

Gollamudi, Jayakrishna ^{[8
]}

Chiappini, Elena ^{[9
]}

Varricchio, Frederick

Law, Barbara ^{[10
,13
]}

Munoz, Flor M. ^{[11
,12
,14
]}

机构：

[1] Baylor Coll Med, Dept Med, Sect Hematol, Houston, TX USA

[2] Baylor Coll Med, Dept Pediat, Sect Hematol Oncol, Houston, TX USA

[3] Baylor Coll Med, Texas Childrens Hosp, Pediat & Pathol & Immunol Dept, Pediat Crit Care, 6701 Fannin St Suite WB110, Houston, TX 77021 USA

[4] Sharda Univ, Sch Med Sci & Res, Dept Pediat, Gr Noida, India

[5] Oregon Hlth Author, Publ Hlth Div, Acute & Communicable Dis Prevent Sect, Portland, OR USA

[6] Int Ctr Antimicrobial Resistance Solut ICARS, Orestads Blvd 5, DK-2300 Copenhagen, Denmark

[7] CDCP, Atlanta, GA USA

[8] Univ Cincinnati, Cincinnati, OH USA

[9] Univ Florence, Meyer Univ Hosp, Dept Hlth Sci, Florence, Italy

[10] Brighton Collaborat, SPEAC, Vancouver, BC, Canada

[11] Baylor Coll Med, Dept Pediat, Sect Infect Dis, Houston, TX 77030 USA

[12] Baylor Coll Med, Dept Mol Virol & Microbiol, Houston, TX 77030 USA

[13] Univ Cincinnati, Cincinnati, OH USA

[14] Global Med Expert, Sanofi India, Mumbai, India

来源：

VACCINE | 2022年 / 40卷 / 44期

关键词：

Thrombosis; Thromboembolism; Arterial; Venous; Adverse event; COVID-19; immunization; Guidelines; Case definition; DEEP-VEIN THROMBOSIS; SUSPECTED PULMONARY-EMBOLISM; VENOUS THROMBOEMBOLISM; RISK-FACTORS; ARTERIAL THROMBOSIS; NATIONWIDE FAMILY; GENETIC SUSCEPTIBILITY; ISCHEMIC-STROKE; ACUTE INFECTION; UNITED-STATES;

D O I：

10.1016/j.vaccine.2022.09.001

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 develop-ment 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.(c) 2022 Published by Elsevier Ltd.

引用

页码：6431 / 6444

页数：14

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