Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation

• Published in: Vaccine Vol. 22; no. 5-6; pp. 575 - 585
• Main Authors: Rothstein, Edward, Kohl, Katrin S, Ball, Leslie, Halperin, Scott A, Halsey, Neal, Hammer, Sandra Jo, Heath, Paul T, Hennig, Renald, Kleppinger, Cynthia, Labadie, Jerry, Varricchio, Frederick, Vermeer, Patricia, Walop, Wikke
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 26.01.2004; Elsevier Limited
• Subjects: Adverse Drug Reaction Reporting Systems - standards; Clinical trials; Collaboration; Data Collection - statistics & numerical data; Data Interpretation, Statistical; Histology; Humans; Immunization; Immunization - adverse effects; Injections; Injections - adverse effects; Skin Diseases - etiology; Skin Diseases - pathology; Studies; Terminology as Topic; Vaccines
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2003.09.005

The Working Group concluded that the paucity of information on onset [5], duration [2,11,37], and size of nodules at injection site in the published literature precludes including this information in the case definition. [...]because the definition itself defines a clinical entity without inference of a causal relation to a given exposure, the time interval between immunization and onset of the event cannot be part of the definition itself, but should be assessed as described in the Guidelines. Use of guidelines for data collection, analysis, and presentation Many variables and uncertainties affect both the definition and the diagnosis of nodule at injection site. [...]the Brighton Collaboration Local Reactions Working Group has attempted to establish useful and practical guidelines directed at standardizing collection, analysis, and presentation of data on nodule at injection site in the setting of clinical trials, surveillance, and retrospective epidemiologic studies of vaccine safety.