Acute intraocular inflammation: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

This is a new Brighton Collaboration (BC) case definition of acute intraocular inflammation (aIOI) which includes one or more of: anterior uveitis, intermediate uveitis, posterior uveitis, panuveitis, retinal vasculitis, and neuroretinitis. It is intended for use in vaccine safety studies including clinical trials throughout the vaccine life cycle, background incidence studies, causality assessment hypothesis testing studies and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. It is not intended to guide clinical management. The case definition was developed by a group of subject matter and BC process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI) funded Safety Platform for Evaluation of vACcines (SPEAC). The BC case definition includes a scoping review of literature and expert consensus used to define levels of diagnostic certainty for aIOI and provide specific guidelines for related data collection and analysis. The document underwent peer review by vaccine safety stakeholders to ensure case definition usability and applicability as well as aIOI experts for scientific integrity.