Anosmia: Brighton Collaboration case definition and guidelines for data collection,analysis, and presentation of immunization safety data |
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| Institution: | 1. Department of Surgery, Division of Pediatric Otolaryngology, Baylor College of Medicine, and Texas Children’s Hospital, Houston, TX, USA;2. Department of Pediatrics, Division of Infectious Diseases, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX, USA;3. Office of Vaccine Research and Review (OVRR), CBER, U.S. Food and Drug Administration, Silver Spring, MD, USA;4. National Institute for Health Research Health Protection Research Unit in Emerging and Zoonotic Infections, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Merseyside, United Kingdom;5. Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom;6. Clinical Infection Microbiology and Immunology, Institute for Infection, Veterinary and Ecological Sciences, University of Liverpool, United Kingdom;7. Brighton Collaboration, Decatur, GA, USA;8. Department of Otolaryngology, Case Western Reserve University, Cleveland, OH, USA;9. VA Northeast Ohio Healthcare System, Cleveland, OH, USA;10. University Hospitals Ear, Nose & Throat Institute, Cleveland, OH, USA |
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| Abstract: | This is a Brighton Collaboration case definition of anosmia 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 two expert reviewers prior to submission. |
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| Keywords: | Anosmia Adverse event Immunization Guidelines Case definition |
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