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What is the association between self-reported history of high-risk allergy and allergic reactions after messenger RNA (mRNA) COVID-19 vaccination?
In this cohort study of 52 998 health care employees, self-reported high-risk allergy history was associated with an increased risk of self-reported allergic reactions after mRNA COVID-19 vaccination. Most of the reported allergy symptoms, however, did not impede the completion of the 2-dose vaccine protocol.
This finding suggests that the mRNA COVID-19 vaccines are safe to receive for eligible individuals.
Allergic history in individuals with confirmed anaphylaxis to a messenger RNA (mRNA) COVID-19 vaccine is common. However, the risk factors for allergy symptoms after receiving the vaccine are unknown.
To assess the association between self-reported history of high-risk allergy and self-reported allergic reactions after mRNA COVID-19 vaccination of health care employees.
Design, Setting, and Participants
This cohort study obtained demographic, medical, and vaccine administration data of employees of Mass General Brigham from the institutional electronic health record. Employees who received at least 1 dose of an mRNA COVID-19 vaccine between December 14, 2020, and February 1, 2021, and who completed at least 1 postvaccination symptom survey in the 3 days after vaccination were included.
Self-reported history of high-risk allergy, defined as a previous severe allergic reaction to a vaccine, an injectable medication, or other allergen.
Main Outcomes and Measures
The primary outcome was 1 or more self-reported allergic reactions in the first 3 days after dose 1 or dose 2 of an mRNA COVID-19 vaccine. Multivariable log binomial regression was used to assess the association between allergic reactions and high-risk allergy status.
A total of 52 998 health care employees (mean [SD] age, 42  years; 38 167 women [72.0%]) were included in the cohort, of whom 51 706 (97.6%) received 2 doses of an mRNA COVID-19 vaccine and 474 (0.9%) reported a history of high-risk allergy. Individuals with vs without a history of high-risk allergy reported more allergic reactions after receiving dose 1 or 2 of the vaccine (11.6% [n = 55] vs 4.7% [n = 2461]). In the adjusted model, a history of high-risk allergy was associated with an increased risk of allergic reactions (adjusted relative risk [aRR], 2.46; 95% CI, 1.92-3.16), with risk being highest for hives (aRR, 3.81; 95% CI, 2.33-6.22) and angioedema (aRR, 4.36; 95% CI, 2.52-7.54).
Conclusions and Relevance
This cohort study found that self-reported history of high-risk allergy was associated with an increased risk of self-reported allergic reactions within 3 days of mRNA COVID-19 vaccination. However, reported allergy symptoms did not impede the completion of the 2-dose vaccine protocol among a cohort of eligible health care employees, supporting the overall safety of mRNA COVID-19 vaccine.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: August 21, 2021.
Published: October 26, 2021. doi:10.1001/jamanetworkopen.2021.31034
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Li L et al. JAMA Network Open.
Corresponding Author: Kimberly G. Blumenthal, MD, MSc, The Mongan Institute, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA 02114 (email@example.com).
Author Contributions: Drs Li and Blumenthal had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Li, Robinson, Hashimoto, Banerji, Zhang, Blumenthal.
Acquisition, analysis, or interpretation of data: Li, Robinson, Patel, Landman, Fu, Shenoy, Hashimoto, Banerji, Wickner, Samarakoon, Mancini, Blumenthal.
Drafting of the manuscript: Li, Patel, Mancini, Blumenthal.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Li, Fu, Mancini, Zhang.
Obtained funding: Blumenthal.
Administrative, technical, or material support: Patel, Landman, Shenoy, Hashimoto, Banerji, Samarakoon, Mancini, Blumenthal.
Supervision: Banerji, Blumenthal.
Conflict of Interest Disclosures: Dr Robinson reported receiving personal fees from Viatris outside the submitted work. Dr Landman reported receiving personal fees from Abbott (as a former member of the Abbott Medical Device Cybersecurity Council) outside the submitted work. Dr Shenoy reported receiving personal fees from Vertex Pharmaceuticals outside the submitted work. Dr Hashimoto reported serving as the chief medical officer of the Workplace Health and Wellness Division at Mass General Brigham. Dr Wickner reported being an employee at CVS Health and Brigham and Women's Hospital. No other disclosures were reported.
Funding/Support: Dr Li was supported by grant T32AI007306 from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Dr Robinson was supported by the Executive Committee on Research Population Health Sciences Fellowship Award from Massachusetts General Hospital. Dr Blumenthal was supported by grant K01 AI125631 from the NIAID/NIH and by the Massachusetts General Hospital Department of Medicine Transformative Scholar Program.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The views expressed herein are those of the authors and do not reflect the official policy or position of the NIH or Mass General Brigham.
Additional Contributions: We thank the following colleagues at the Mass General Brigham health system for the design and implementation of the COVID-19 vaccination program: Paul Biddinger, MD; Thomas D. Sequist, MD, MPH; Anna R. Wolfson, MD; Rebecca Saff, MD, PhD; Aidan A. Long, MD; Tanya Laidlaw, MD; David Hong, MD; Anna Feldweg, MD; Katrin Stinson, MPH; Amanda J. Centi, PhD; Lynn Simpson, MPH; Nahal Beik, PharmD, BCPS; Amelia S. Cogan, MPH; and Aubree E. McMahon, BA. These individuals received no additional compensation, outside of their usual salary, for their contributions.
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