Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Nathan A Serazin; Bassey Edem; Sarah R Williams; Justin R Ortiz; Anand Kawade; Manoj Kumar Das; Maja Šubelj; Kathryn M Edwards; Shreemanta K Parida; T Anh Wartel; Flor M Munoz; Patricia Bastero

doi:10.1016/j.vaccine.2021.01.053

Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine. 2021 May 21;39(22):3028-3036. doi: 10.1016/j.vaccine.2021.01.053. Epub 2021 Jan 28.

Authors

Affiliations

¹ Department of Pediatrics, Section of Critical Care Medicine, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
² Department of Vaccines and Immunity, Medical Research Council the Gambia Unit at the London School of Hygiene and Tropical Medicine, UK.
³ Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
⁴ Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
⁵ King Edward Memorial Hospital Research Centre, Vadu Rural Health Program Pune, India.
⁶ The INCLEN Trust International, New Delhi, India.
⁷ National Institute of Public Health, University of Ljubljana, Slovenia.
⁸ Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
⁹ CureVac AG, Frankfurt, Germany.
¹⁰ International Vaccine Institute, Seoul, Republic of Korea.
¹¹ Departments of Pediatrics, Section of Infectious Diseases, and Molecular Virology and Microbiology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
¹² Department of Pediatrics, Section of Critical Care Medicine, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA. Electronic address: [email protected].

Abstract

This is a Brighton Collaboration Case Definition of the term "Acute Respiratory Distress Syndrome - ARDS" to be utilized in the evaluation of adverse events following immunization. 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 vaccines for SARS-CoV-2 vaccines and other emerging pathogens. 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. The comments of the reviewers were taken into consideration and edits incorporated in this final manuscript.

Keywords: ARDS; Acute respiratory distress syndrome; Adult; Adverse event; COVID-19; Case definition; Guidelines; Immunization; Pediatric.

Publication types

Review

MeSH terms

COVID-19 Vaccines
COVID-19*
Data Collection
Humans
Immunization / adverse effects
Respiratory Distress Syndrome* / diagnosis
SARS-CoV-2

Substances

COVID-19 Vaccines