Sensorineural hearing loss (SNHL) as an adverse event following immunization (AEFI): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Yi-Chun Carol Liu; Titus Ibekwe; John M Kelso; Nicola P Klein; Nathan Shehu; Wendy Steuerwald; Satinder Aneja; Matthew Z Dudley; Robert Garry; Flor M Munoz; Brighton Collaboration SNHL Working Group

doi:10.1016/j.vaccine.2020.05.019

Sensorineural hearing loss (SNHL) as an adverse event following immunization (AEFI): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine. 2020 Jun 19;38(30):4717-4731. doi: 10.1016/j.vaccine.2020.05.019. Epub 2020 May 15.

Affiliations

¹ Department of Otorhinolaryngology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
² Department of Otorhinolaryngology, University of Abuja, Nigeria.
³ Division of Allergy, Asthma and Immunology, Scripps Clinic, San Diego, CA, USA.
⁴ Kaiser Permanente Vaccine Study Center, Oakland, CA, USA.
⁵ Department of Pediatric Infectious Diseases, Jos University, Nigeria.
⁶ Department of Audiology, Phoenix Children's Hospital, Phoenix, AZ, USA.
⁷ Department of Pediatrics, School of Medical Sciences and Research, Sharda University, Gr Noida, India.
⁸ Department of International Health, and Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.
⁹ Tulane University, Louisiana, USA.
¹⁰ Department of Pediatrics, Section of Infectious Diseases, and Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA. Electronic address: bc-coordinator@taskforce.org.

PMID: 32418788
DOI: 10.1016/j.vaccine.2020.05.019

Abstract

This is a Brighton Collaboration case definition of the term "Sensorineural Hearing Loss" 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 Lassa Fever and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and define levels of diagnostic certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network.

Keywords: Adverse event; Adverse event following immunization (AEFI); Adverse event of special interest (AESI); Case definition; Guidelines; Hearing loss (HL); Immunization; Sensorineural hearing loss (SNHL); Vaccines.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adverse Drug Reaction Reporting Systems
Data Collection
Hearing Loss, Sensorineural*
Humans
Immunization / adverse effects
Vaccines*

Substances

Vaccines