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      Successful mRNA COVID-19 vaccination in a patient with a history of severe polyethylene glycol anaphylaxis

      case-report

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          Abstract

          Background

          The mechanism of action behind anaphylactic reactions to the mRNA COVID-19 vaccines remains unknown, but the excipient polyethylene glycol, PEG-2000, has been implicated. Initial recommendations were made for excipient testing with PEG-3350 to help risk stratify individuals and identify an etiology. Here we present a case of a patient with a history of polyethylene glycol anaphylaxis and positive skin testing to PEG-3350, who successfully received both doses of the Pfizer-BioNTech COVID-19 mRNA vaccine in a single step with only premedication.

          Case presentation

          A 56-year-old man was referred to our clinic for assessment of his eligibility in receiving the COVID-19 vaccine given a history of anaphylaxis to PEG. He had two anaphylactic episodes: one in 2018 to methylprednisolone acetate intra-articular injection and one to oral PEG-3350 in 2020. Confirmatory skin prick testing was done in our clinic to PEG-3350 that was positive at 35 mm with appropriate positive and negative controls. Despite this he wanted to receive the PEG-containing mRNA COVID-19 vaccines and was counselled on the risks and benefits. He successfully received both doses of the Pfizer-BioNTech COVID-19 mRNA vaccine in a single step with only pre-treatment with Cetirizine 20 mg daily and Montelukast 10 mg daily for 5 days.

          Conclusions

          In conclusion, our case demonstrates that a patient with a confirmed polyethylene glycol anaphylaxis could safely receive both doses of the COVID-19 mRNA vaccines in a single step with pre-treatment. We hope that our case will further support the limited role in skin testing to PEG in the assessment of COVID-19 mRNA vaccine allergy and highlight the need for further research to elucidate the mechanism of action behind these allergic reactions.

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          Most cited references6

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          First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021

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            mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach

            The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. This has brought hope to millions of Americans in the midst of an ongoing global pandemic. The FDA EUA guidance for both vaccines is to not administer the vaccine to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) additionally advises individuals with a history of an immediate allergic reaction to a vaccine or injectable or any history of anaphylaxis be observed for 30 minutes after COVID-19 vaccination. All other individuals should be observed for 15 minutes after COVID-19 vaccination. Staff at vaccine clinics must be able to identify and manage anaphylaxis. Post–FDA EUA, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread global vaccination, allergists must offer clear guidance to individuals based on the best information available, but also in accordance with the broader recommendations of regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes drug and vaccine allergy expert opinion informed risk stratification for Allergy specialist use in conjunction with guidance of public health and regulatory authorities. The risk stratification schema guide care for (1) individuals with different allergy histories to safely receive their first mRNA COVID-19 vaccine and (2) individuals who develop a reaction to their first dose of mRNA COVID-19 vaccine.
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              Polyethylene glycol (PEG) is a cause of anaphylaxis to the Pfizer/BioNTech mRNA COVID‐19 vaccine

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                Author and article information

                Contributors
                danielh.li@mail.utoronto.ca
                Journal
                Allergy Asthma Clin Immunol
                Allergy Asthma Clin Immunol
                Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology
                BioMed Central (London )
                1710-1484
                1710-1492
                20 June 2022
                20 June 2022
                2022
                : 18
                : 57
                Affiliations
                GRID grid.17063.33, ISNI 0000 0001 2157 2938, Division of Clinical Immunology and Allergy, Department of Medicine, , University of Toronto, ; Toronto, ON Canada
                Author information
                http://orcid.org/0000-0001-5508-2961
                Article
                698
                10.1186/s13223-022-00698-8
                9208350
                35725661
                dc376f65-48bc-4ea7-9802-23a9fa8675db
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 15 January 2022
                : 8 June 2022
                Categories
                Case Report
                Custom metadata
                © The Author(s) 2022

                Immunology
                covid-19,mrna vaccine,anaphylaxis,excipient testing,polyethylene glycol
                Immunology
                covid-19, mrna vaccine, anaphylaxis, excipient testing, polyethylene glycol

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