Anaphylaxis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

• Published in: Vaccine 2007-08, Vol.25 (31), p.5675-5684
• Main Authors: Rüggeberg, Jens U, Gold, Michael S, Bayas, José-Maria, Blum, Michael D, Bonhoeffer, Jan, Friedlander, Sheila, de Souza Brito, Glacus, Heininger, Ulrich, Imoukhuede, Babatunde, Khamesipour, Ali, Erlewyn-Lajeunesse, Michel, Martin, Susana, Mäkelä, Mika, Nell, Patricia, Pool, Vitali, Simpson, Nick
• Format: Article
• Language: English
• Subjects: Adverse Drug Reaction Reporting Systems - standards; Adverse event; Allergies; Allergy and Immunology; Anaphylaxis; Case definition; Data collection; Data Collection - statistics & numerical data; Data Interpretation, Statistical; Guidelines; Humans; Immunization; Immunization - adverse effects; International organizations; Laboratories; Public health; Safety; Studies; Terminology as Topic
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2007.02.064

Methods for the development of the case definition and guidelines for data collection, analysis, and presentation for anaphylaxis as an adverse event following immunization Following the process described in the overview paper [21] as well as on the Brighton Collaboration Website http://www.brightoncollaboration.org/internet/en/index/process.html, the Brighton Collaboration Anaphylaxis Working Group was formed in 2003 and included members of clinical and academic, but also public health and industry background. The term anaphylaxis has been used in some contexts primarily to denote an immunological principle (i.e., type I reaction according to Coombs/Gel) while in other contexts it has been reserved to denote the life-threatening character of a clinical event, thus implying a degree of clinical severity.\n) * recession * cyanosis * grunting * dermatologic or mucosal * generalized pruritus without skin rash * generalized prickle sensation * localized injection site urticaria * red and itchy eyes