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[...]for those very rare patients who have been identified as being allergic to PEG, this history would be a contraindication to receiving the vaccine. [...]as with all vaccines, the EUAs indicate that appropriate treatment required to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration. [...]the vaccines should be administered in a setting where patients can be observed after vaccination. [15] The Centers for Disease Control and Prevention (CDC) in the United States has proposed less restrictive guidance indicating that patients with a history of a severe allergic reaction due to any cause be observed for 30 min after vaccination, while all others should be observed for 15 min [16]. A history of food, pet, insect, venom, environmental, latex, etc., allergies, history of allergy to oral medications (including the oral equivalent of an injectable medication) and non-serious allergy to vaccines or other injectables (e.g., no

This is a Brighton Collaboration case definition of the term “Sensorineural Hearing Loss” to be utilized in the evaluation of adverse events following immunization. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for Lassa Fever and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and define levels of diagnostic certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network.

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.

The Brighton Collaboration (BC) has formulated a number of case definitions which have primarily been applied to adverse events of special interest in the context of vaccine safety surveillance. This is a revision of the 2007 BC case definition for anaphylaxis. Recently, the BC definition has been widely used for evaluating reports of suspected anaphylaxis following COVID-19 vaccination. This has led to debate about the performance of the BC definition in comparison with those from the US National Institute of Allergy and Infectious Disease/Food Allergy Anaphylaxis Network (NIAID/FAAN) and the World Allergy Organization (WAO). BC convened an expert working group to revise the case definition based on their usual process of literature review and expert consensus. This manuscript presents the outcome of this process and proposes a revised case definition for anaphylaxis. Major and minor criteria have been re-evaluated with an emphasis on the reporting of observable clinical signs, rather than subjective symptoms, and a clearer approach to the ascertainment of levels of certainty is provided. The BC case definition has also been aligned with other contemporary and international case definitions for anaphylaxis.

The most serious form of type I or IgE-mediated hypersensitivity reaction is anaphylaxis. A standardized case definition of anaphylaxis as an adverse event after immunization has been developed. Such reactions to vaccines, including influenza vaccine, are rare but potentially life-threatening. Until recently, all influenza vaccines were manufactured in eggs. Residual egg protein in the vaccines was thought to pose a risk to egg-allergic vaccine recipients. However, a large number of recent studies have demonstrated that egg-allergic recipients are no more likely than those without egg allergy to suffer such reactions. Published guidelines have been updated to recommend that patients with egg allergy receive annual influenza vaccination. Any patient who has an anaphylactic reaction to influenza vaccine should be carefully evaluated by an allergist for guidance on subsequent immunization.

•The rate of reported hypersensitivity reactions following 2009 H1N1 vaccine was 10.8 per million.•The rates of hypersensitivity reactions were equal for 3 manufacturers of vaccine, but higher following live vaccine.•Females of childbearing age had higher rates of allergic reactions than males, but equal rates in other ages.•Epinephrine was underutilized for treatment of anaphylaxis following influenza vaccination. Hypersensitivity disorders following vaccinations are a cause for concern. To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines. A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines. US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010. Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event. Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 698 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine. Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males. Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions.

The preparation of recombinant hepatitis B vaccines involves using cellular cultures of Saccharomyces cerevisiae, otherwise known as baker's yeast. Prior to vaccine licensure, clinical trials were performed to address whether residual yeast proteins in the vaccines could induce anaphylaxis, including testing for IgE anti-yeast antibody levels. 1–2% of subjects had anti-yeast IgE antibodies before immunization, but demonstrated no significant rise in IgE after HBV. We searched reports in the Vaccine Adverse Event Reporting System (VAERS) for those that mentioned a history of allergy to yeast and then reviewed the adverse events described in these reports for potential anaphylactic reactions. Probable anaphylaxis was defined as the presence of one or more dermatologic symptoms and one or more respiratory, gastrointestinal, or cardiovascular symptoms with onset within 4 h of Hepatitis B vaccination. Possible anaphylaxis was defined in one of two ways: (1) cases that described dermatologic or respiratory symptoms (but not both) occurring within 4 h of vaccination; or (2) cases that described one or more dermatologic and/or respiratory symptoms occurring 4–12 h post vaccination. Among the 107 reports of pre-existing “yeast allergies,” 11 reports described probable or possible anaphylaxis after HBV. Four additional cases were described after other vaccines. The majority of vaccinees who met the case definitions and had a history of yeast allergies were female, ages ranged from 10 to 64, and symptom onset ranged from 15 min to 5 h after vaccination. No deaths were reported. The small number of reports to VAERS may be partly due to health care professionals observing current contraindications by not vaccinating yeast sensitive individuals. Nevertheless, yeast associated anaphylaxis after HBV in sensitized patients appears to be a rare event.

Children with allergic or atopic diseases require immunization just like non-atopic children. However, vaccination of such children requires some special considerations and precautions. Children may be allergic to specific vaccine constituents such as gelatin or egg. Children who have suffered an apparent allergic reaction to a vaccine should be evaluated by an allergist to determine the culprit allergen and to make recommendations regarding future vaccination. In rare circumstances, certain vaccines may cause acute exacerbations of allergic diseases, but the contention that vaccination causes allergic disease is not substantiated by any available evidence.

Vaccine products currently licensed in the US and other countries are marketed in vials and syringes that may contain natural latex allergens. Little scientific information exists regarding the safety of vaccination of latex-allergic individuals. A review of data within the Vaccine Adverse Event Reporting System (VAERS), a large registry of reported possible vaccine adverse reactions was conducted. A search of the database, which contains >160,000 vaccine adverse event reports, revealed only 28 cases of possible immediate-type hypersensitivity reactions in vaccine recipients with a history of allergy to latex. Given the large number of immunizations administered every year in the US, the reported risk of allergic reactions possibly due to latex contamination of vaccines appears to be very small.