Vaccine anaphylaxis

Vaccine 25 (2007) 5675–5684

Anaphylaxis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data
Jens U. R¨ ggeberg a,b , Michael S. Gold c , Jos´ -Maria Bayas d , Michael D. Blum e , u e f , Sheila Friedlander g , Glacus de Souza Brito h , Ulrich Heininger f,∗ , Jan Bonhoeffer Babatunde Imoukhuede i , Ali Khamesipour j , MichelErlewyn-Lajeunesse k , Susana Martin l , Mika M¨ kel¨ m , Patricia Nell n,1 , Vitali Pool o,2 , Nick Simpson p a a The Brighton Collaboration Anaphylaxis Working Group3
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P¨ diatrische Infektiologie, Universit¨ tskinderklinik D¨ sseldorf, Germany a a u b St. Georges Hospital Medical School, London, UK South Australian Immunisation Coordination Unit, University of Adelaide, Australia d Hospital Clinic iProvincial de Barcelona, Barcelona, Spain e Wyeth Research, Collegeville, PA, USA f University Children’s Hospital, Basel, Switzerland g University of California San Diego Medical Center, La Jolla, USA h Sao Paulo State University, Sao Paulo, Brazil i MRC Fajara, Banjul, The Gambia j Tehran University of Medical Sciences, Tehran, Iran k University of Bristol, Bristol, UK l EAP Santa Hortensia, Area 2,Madrid, Spain m University Central Hospital Helsinki, Finland n Airforce Reserve Command, United States Air Force, Sturgeon Bay, WI, USA o Centers for Disease Control and Prevention, Atlanta, GA, USA p John Curtin School of Medical Research, Canberra, Australia Available online 12 March 2007

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Keywords: Anaphylaxis; Adverse event; Immunization; Guidelines; Case definition

1. Preamble 1.1.Need for developing case definitions and guidelines for data collection, analysis, and presentation for anaphylaxis as an adverse event following immunization Anaphylaxis is an acute hypersensitivity reaction with multi-organ-system involvement that can present as, or rapidly progress to, a severe life-threatening reaction. It may occur following exposure to allergens from a variety of sourcesincluding food, aeroallergens, insect venom, drugs, and immunizations [1–4]. Anaphylaxis is triggered by the binding of allergen to specific immunoglobulin E (IgE). It implies previous exposure and sensitization to the triggering substance or a cross reactive allergen. When an allergen binds to the IgE receptors on

DOI of original article:10.1016/j.vaccine.2007.02.063. Disclaimer: The findings,opinions, and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant’s organization (e.g., government, university, or corporation). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily represent the viewsof the Centers for Disease Control and Prevention. ∗ Corresponding author at: Centers for Disease Control and Prevention, Atlanta, GA, USA. Tel.: +1 404 639 8073. E-mail address: secretariat@brightoncollaboration.org (U. Heininger). 1 Retired., 2 Vitali Pool is currently employed by Ely Lilly, Indianapolis, IN, USA. 3 Brighton Collaboration homepage: http://www.brightoncollaboration.org/0264-410X/$ – see front matter. Published by Elsevier Ltd. doi:10.1016/j.vaccine.2007.02.064

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the surface of mast cells and basophils this results in cellular activation and degranulation. These cells release preformed mediators such as histamine and tryptase that elicit the signs and symptoms of anaphylaxis. This mechanism is also knownas the Type 1 immediate hypersensitivity reaction in the Gel and Coombs classification [1,3]. “Anaphylactoid” reactions are clinically indistinguishable, but differ from anaphylaxis by their immune mechanism, being characterized by mast cell activation due to a range of chemical or physical triggers independently of IgE. This mechanism is less well understood. As distinction between anaphylaxis...