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

Rüggeberg, Jens U.; Gold, Michael; Bayas, JM; Blum, Michael D.; Bonhoeffer, Jan; Friedlander, Sheila Fallon; Brito, Glacus de Souza; Heininger, Ulrich; Imoukhuede, Babatunde; Khamesipour, Ali; Erlewyn-Lajeunesse, Michel; Martín, Susana María Ramírez; Mäkelä, Mika J.; Nell, Patricia; Pool, Vitali; Simpson, Nick

doi:10.1016/j.vaccine.2007.02.064

Cited by 352 publications

(307 citation statements)

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“…The criteria used to define anaphylaxis will affect the results. In this study, we used the criteria of NIAID/FAAN and the case definition of Brighton Collaboration [10,11]. However, since these criteria correspond to the criteria for anaphylaxis recently suggested by the World Allergy Organization [17], our results would not have been altered if the latter criteria had been used.…”

Section: Resultsmentioning

confidence: 99%

“…The clinical data associated to the reports have been evaluated according to NIAID/FAAN criteria [6] and the case definition of Brighton Collaboration [10,11]. We have assigned each case to one of three levels of decreasing probability using a clinical check-list based on recommendations of the Brighton Collaboration, thus obtaining two groups of patients: one group (anaphylaxis) with high, moderate and low probability of anaphylaxis and the other group (severe allergic reactions) that did not fulfill the criteria of anaphylaxis.…”

Section: Identification Of Casesmentioning

confidence: 99%

“…Gastrointestinal symptoms are considered, by definition, minor criteria: diarrhea, abdominal pain, nausea, vomiting (see ref. [10])…”

Section: Foodmentioning

confidence: 99%

“…This procedure may help to decrease the variability of the assessment of severity of the reactions by health professionals. According to Brighton Collaboration's criteria, three levels of diagnostic probability are easily obtained by combining major and minor criteria [10,11]. The clinical check-list of signs and symptoms related to the various organs potentially involved in anaphylaxis that was developed by Brighton Collaboration is much more detailed compared to the symptoms reported in the clinical criteria for diagnosing anaphylaxis by the NIAID/FAAN Symposium.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Incidence of food anaphylaxis in Piemonte region (Italy): data from registry of Center for Severe Allergic Reactions

et al. 2013

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There are wide differences in estimated incidence and prevalence of anaphylaxis because of the absence, until recently, of a universal consensus on the definition of anaphylaxis and the different source of collected data. We aimed to estimate the incidence of food anaphylaxis based on the database of Piemonte Region (Italy) Reference Center for Severe Allergic Reactions. All cases of severe food allergic reactions reported in 2010 were studied. Clinical data associated to the reports were evaluated according to National Institute of Allergy and Infectious Disease and Food Allergy and Anaphylaxis Network diagnostic criteria of anaphylaxis. 75 % of the 778 cases were classified as food anaphylaxis (incidence of 13/100,000 personyears, ranging from 9.9 in adults to 29/100,000 person-years in children). Nuts were the most frequent foods causing anaphylaxis. Milk and eggs were responsible for anaphylaxis more often in children, while peach, vegetables and crustaceans were in adults. Cardiovascular symptoms were more frequent in adults. Gastrointestinal involvement was more frequent in children. A high prevalence of respiratory allergic comorbidities was observed. Food is an important cause of anaphylaxis, particularly in subjects with respiratory allergic comorbidities. Children and adults differ in triggers and clinical presentation of anaphylaxis.Keywords: Anaphylaxis, Food allergy, Epidemiology, Allergy Introduction Population-based studies estimate the incidence of anaphylaxis in western countries to be in the range of 4-50 per 100,000 person-years [1, 2], with a true lifetime prevalence in the range of 0.05-2 % [3]. Foods are reported to be the most important trigger of anaphylaxis, being responsible for 33.2-56 % of all anaphylaxis cases [4]. The other two principal triggers of anaphylaxis are insect stings and drugs [1,5]. The relative contribution of each of these triggers to anaphylaxis may differ according to the study design, study population, or geographic area. The wide differences in the estimated incidences and prevalences of anaphylaxis are the direct result of the absence, until recently, of a universal consensus on the definition of anaphylaxis and the different source of collected data. For this reason in 2005 the National Institute of Allergy and Infectious Disease (NIAID) and the Food Allergy and Anaphylaxis Network (FAAN) developed a very useful preliminary definition, based on diagnostic criteria [6]. The symposium defined anaphylaxis as: "a serious allergic reaction that is rapid in onset and may cause death". Clinically, involvement of at least two organs (skin or mucosal tissue, cardiovascular apparatus, breathing apparatus, gastrointestinal tract) is required, or a sudden reduced blood pressure along with a temporal relationship (generally minutes) to a potential causative agent. A problematic issue with this definition, which may explain the under-reporting or misreporting of anaphylaxis cases, is the failure to agree among health care providers on the severity threshold for classi...

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Section: Resultsmentioning

confidence: 99%

Section: Identification Of Casesmentioning

confidence: 99%

“…Gastrointestinal symptoms are considered, by definition, minor criteria: diarrhea, abdominal pain, nausea, vomiting (see ref. [10])…”

Section: Foodmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Incidence of food anaphylaxis in Piemonte region (Italy): data from registry of Center for Severe Allergic Reactions

et al. 2013

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“…A validated illness possibly indicative of a hypersensitivity reaction was defined by a report of signs or symptoms consistent with urticaria, hives, wheezing, respiratory collapse, hypotension, angioedema, or anaphylaxis that were not known to have onset prior to vaccination. For validated illnesses possibly indicative of a hypersensitivity reaction, medical record review was also conducted to determine whether the event could be confirmed to have met the Brighton Collaboration case definition of anaphylaxis [4]. …”

Section: Methodsmentioning

confidence: 99%

Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study

Jackson

Belongia

et al. 2009

BMC Infect Dis

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BackgroundLocal reactions are the most commonly reported adverse events following tetanus and diphtheria toxoid (Td) vaccine and the risk of local reactions may increase with number of prior Td vaccinations.MethodsTo estimate the risk of medically attended local reactions following Td vaccination in adolescents and young adults we conducted a six-year retrospective cohort study assessing 436,828 Td vaccinations given to persons 9 through 25 years of age in the Vaccine Safety Datalink population from 1999 through 2004.ResultsOverall, the estimated risk of a medically attended local reaction was 3.6 events per 10,000 Td vaccinations. The lowest risk (2.8 events per 10,000 vaccinations) was found in the 11 to 15 year old age group. In comparison with that group, the event risks were significantly higher in both the 9 to 10 and 21 to 25 year old age groups. The risk of a local reaction was significantly higher in persons who had received another tetanus and diphtheria toxoid containing vaccine (TDCV) in the previous five years (incidence rate ratio, 2.9; 95% confidence interval, 1.2 to 7.2). Twenty-eight percent of persons with a local reaction to Td vaccine were prescribed antibiotics.ConclusionMedically attended local reactions were uncommon following Td vaccination. The risk of those reactions varied by age and by prior receipt of TDCVs. These findings provide a point of reference for future evaluations of the safety profile of newer vaccines containing tetanus or diphtheria toxoid.

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Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

Slade

Leidel²,

Vellozzi³

et al. 2009

JAMA

402

178

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N JUNE 8, 2006, THE FOOD and Drug Administration (FDA) licensed the quadrivalent human papillomavirus recombinant vaccine (qHPV) (Gardasil; Merck & Co, Inc, Whitehouse Station, New Jersey) for females aged 9 to 26 years to prevent infection with genital human papillomavirus (HPV) types 6, 11, 16, and 18. 1 Later that month, the Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination of females aged 11 to 12 years with 3 doses of qHPV and catch-up vaccination for females aged 13 to 26 years. Doses are administered intramuscularly on a schedule of 0, 2, and 6 months. 2 The viruses HPV-16 and HPV-18 can cause cervical cancer, other anogenital cancers, and precancerous or dysplastic lesions and are responsible for about 70% of cervical cancers worldwide. 3 The viruses HPV-6 and HPV-11 are the most common causes of genital warts. Prior to licensure, clinical trials were conducted in more than 21 000 women. Vaccination with qHPV was 90% to 100% effective in preventing precancerous cervical, vaginal, and vulvar lesions and genital warts caused by infection with the relevant HPV types (6, 11, 16, or 18) in women aged 15 to 26 years who were uninfected prior to vaccination. 4,5 Additional immunogenicity and safety studies in 9-to 15-year-See also pp 781 and 795.

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

Cited by 352 publications

References 28 publications

Incidence of food anaphylaxis in Piemonte region (Italy): data from registry of Center for Severe Allergic Reactions

Incidence of food anaphylaxis in Piemonte region (Italy): data from registry of Center for Severe Allergic Reactions

Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study

Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

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