Abscess at injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

• Published in: Vaccine Vol. 25; no. 31; pp. 5821 - 5838
• Main Authors: Kohl, Katrin S, Ball, Leslie, Gidudu, Jane, Hammer, Sandra Jo, Halperin, Scott, Heath, Paul, Hennig, Renald, Labadie, Jerry, Rothstein, Edward, Schuind, Anne, Varricchio, Frederick, Walop, Wikke
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01-08-2007; Elsevier Limited
• Subjects: Abscess; Abscess - etiology; Abscess - pathology; Adverse Drug Reaction Reporting Systems - standards; Adverse event; Allergy and Immunology; Case definition; Collaboration; Data Collection - statistics & numerical data; Data Interpretation, Statistical; Guidelines; Guidelines as Topic; Humans; Immunization; Immunization - adverse effects; Injection; Injections - adverse effects; Public health; Safety; Vaccines; Adverse event; Immunization; Case definition; Abscess; Guidelines
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2007.04.057

[...]the Working Group recognized that the distinction between abscesses of infectious etiology and sterile abscesses could not always be made on the basis of clinical symptoms.\ng., passive or active surveillance), the characteristics of the surveillance system (e.g., population served, mode of report solicitation), and the search strategy in surveillance databases; The trial profile, indicating participant flow during a study, including drop-outs and withdrawals, to indicate the size and nature of the respective groups under investigation; Comparison group(s), if used for analysis; Whether the day of immunization was considered "day one" or "day zero" in the analysis; Whether the date of onset (see Footnote 8) and/or the date of first observation (see Footnote 9) and/or the date of diagnosis (see Footnote 10) was used for analysis; and Use of this Brighton Collaboration case definition for an abscess at the injection site in the abstract or methods section of a publication.19Use of this document should preferably be referenced by referring to the link on the Brighton Collaboration website (http://www.brightoncollaboration.org). [...]we would like to thank the members of the WHO/CIOMS Working Group on Vaccine Pharmacovigilance (http://www.cioms.ch/frame_current_programme.htm) for the review of, constructive comments on, and endorsement of this document.