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      International Consensus (ICON): allergic reactions to vaccines

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          Abstract

          Background

          Routine immunization, one of the most effective public health interventions, has effectively reduced death and morbidity due to a variety of infectious diseases. However, allergic reactions to vaccines occur very rarely and can be life threatening. Given the large numbers of vaccines administered worldwide, there is a need for an international consensus regarding the evaluation and management of allergic reactions to vaccines.

          Methods

          Following a review of the literature, and with the active participation of representatives from the World Allergy Organization (WAO), the European Academy of Allergy and Clinical Immunology (EAACI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI), the final committee was formed with the purpose of having members who represented a wide-range of countries, had previously worked on vaccine safety, and included both allergist/immunologists as well as vaccinologists.

          Results

          Consensus was reached on a variety of topics, including: definition of immediate allergic reactions, including anaphylaxis, approaches to distinguish association from causality, approaches to patients with a history of an allergic reaction to a previous vaccine, and approaches to patients with a history of an allergic reaction to components of vaccines.

          Conclusions

          This document provides comprehensive and internationally accepted guidelines and access to on-line documents to help practitioners around the world identify allergic reactions following immunization. It also provides a framework for the evaluation and further management of patients who present either following an allergic reaction to a vaccine or with a history of allergy to a component of vaccines.

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          Most cited references133

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          The diagnosis and management of anaphylaxis practice parameter: 2010 update.

          These parameters were developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. The AAAAI and the ACAAI have jointly accepted responsibility for establishing "The Diagnosis and Management of Anaphylaxis Practice Parameter: 2010 Update." This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. Because this document incorporated the efforts of many participants, no single individual, including those who served on the Joint Task Force, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, or the Joint Council of Allergy, Asthma and Immunology. These parameters are not designed for use by pharmaceutical companies in drug promotion. Copyright (c) 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
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            A revised nomenclature for allergy. An EAACI position statement from the EAACI nomenclature task force.

            This report has been prepared by an EAACI task force representing the five EAACI Sections and the EAACI Executive Committee composed of specialists that reflect the broad opinion on allergy expressed by various clinical and basic specialties dealing with allergy. The aim of this report is to propose a revised nomenclature for allergic and related reactions that can be used independently of target organ or patient age group. The nomenclature is based on the present knowledge of the mechanisms which initiate and mediate allergic reactions. However, the intention has not been to revise the nomenclature of nonallergic hypersensitivity.
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              Lessons for management of anaphylaxis from a study of fatal reactions.

              The unpredictability of anaphylactic reactions and the need for immediate, often improvised treatment will make controlled trials impracticable; other means must therefore be used to determine optimal management. This study aimed to investigate the circumstances leading to fatal anaphylaxis. A register was established including all fatal anaphylactic reactions in the UK since 1992 that could be traced from the certified cause of death. Data obtained from other sources suggested that deaths certified as due to anaphylaxis underestimate the true incidence. Details of the previous medical history, the reaction and necropsy were sought for all cases. Approximately half the 20 fatal reactions recorded each year in the UK were iatrogenic, and a quarter each due to food or insect venom. All fatal reactions thought to have been due to food caused difficulty breathing that in 86% led to respiratory arrest; shock was more common in iatrogenic and venom reactions. The median time to respiratory or cardiac arrest was 30 min for foods, 15 min for venom and 5 min for iatrogenic reactions. Twenty-eight per cent of fatal cases were resuscitated but died 3 h-30 days later, mostly from hypoxic brain damage. Adrenaline (epinephrine) was used in treatment of 62% of fatal reactions but before arrest in only 14%. Immediate recognition of anaphylaxis, early use of adrenaline, inhaled beta agonists and other measures are crucial for successful treatment. Nevertheless, a few reactions will be fatal whatever treatment is given; optimal management of anaphylaxis is therefore avoidance of the cause whenever this is possible. Predictable cross-reactivity between the cause of the fatal reaction and that of previous reactions had been overlooked. Adrenaline overdose caused at least three deaths and must be avoided. Kit for self-treatment had proved unhelpful for a variety of reasons; its success depends on selection of appropriate medication, ease of use and good training.
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                Author and article information

                Contributors
                stephen.dreskin@ucdenver.edu
                nhalsey1@jhu.edu
                kelso.john@scrippshealth.org
                rwood@jhmi.edu
                donna.hummell@vanderbilt.edu
                kathryn.edwards@vanderbilt.edu
                Caubet719@hotmail.com
                renata.engler@gmail.com
                michael.gold@adelaide.edu.au
                claude.ponvert@orange.fr
                pascal.demoly@inserm.fr
                sanchezbmario@gmail.com
                muraro@centroallergiealimentari.eu
                li.james@mayo.edu
                menachem@rottem.net
                Journal
                World Allergy Organ J
                World Allergy Organ J
                The World Allergy Organization Journal
                BioMed Central (London )
                1939-4551
                16 September 2016
                16 September 2016
                2016
                : 9
                : 1
                : 32
                Affiliations
                [1 ]Division of Allergy and Clinical Immunology, Department of Medicine, University of Colorado Denver School of Medicine, Aurora, CO USA
                [2 ]Institute for Vaccine Safety, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD USA
                [3 ]Division of Allergy, Asthma, and Immunology, Scripps Clinic, San Diego, CA USA
                [4 ]The Division of Pediatric Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD USA
                [5 ]Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN USA
                [6 ]Division of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN USA
                [7 ]Department of Pediatrics, University Hospitals of Geneva and Medical School, University of Geneva, Geneva, Switzerland
                [8 ]Department of Medicine and Pediatrics, Uniformed Services University of the Health Sciences, Allergy-Immunology-Immunization, Walter Reed National Military Medical Center, Bethesda, MD USA
                [9 ]Disipline of Paediatrics, School of Medicine, University of Adelaide, Adelaide, South Australia Australia
                [10 ]Department Paediatrics, Pulmonology and Allergy service, Necker-Enfants Malades Hospital, 149 rue de Sèvres, 75015 Paris, France
                [11 ]Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve - University Hospital of Montpellier, 34295 Montpellier cedex 05 – FRANCE and Sorbonne Universités, UPMC Paris 06, UMR-S 1136 INSERM, IPLESP, Equipe EPAR, 75013 Paris, France
                [12 ]Allergy and Clinical Immunology Department, Centro Médico Docente La Trinidad, Caracas, Venezuela
                [13 ]Food Allergy Referral Centre Department of Women and Child health, University of Padua, Padua, Italy
                [14 ]Division of Allergic Diseases, Mayo Clinic, Rochester, MN USA
                [15 ]Allergy Asthma and Immunology, Emek Medical Center, Afula, and the Rappaport Faculty of Medicine, Technion- Israel Institute of Technology, Haifa, Israel
                [16 ]Allergy-Immunology Division, Children’s Mercy Hospital and the University of Missouri-Kansas City School of Medicine, Kansas City, MO USA
                Article
                120
                10.1186/s40413-016-0120-5
                5026780
                27679682
                0da56fb6-a6f9-4188-96f9-12ba23204e40
                © Dreskin et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 15 April 2016
                : 10 August 2016
                Categories
                Consensus Document
                Custom metadata
                © The Author(s) 2016

                Immunology
                allergy,allergic reactions,anaphylaxis,causality,components,international,consensus,vaccine
                Immunology
                allergy, allergic reactions, anaphylaxis, causality, components, international, consensus, vaccine

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