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Acute Allergic Reactions to mRNA COVID-19 Vaccines

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

Anaphylaxis to the mRNA COVID-19 vaccines is currently estimated to occur in 2.5 to 11.1 cases per 1 million doses, largely in individuals with a history of allergy.1 Allergic concerns contribute to vaccine hesitancy; we investigated acute allergic reaction incidence after more than 60 000 mRNA COVID-19 vaccine administrations.

We prospectively studied Mass General Brigham (MGB) employees who received their first dose of an mRNA COVID-19 vaccine (12/16/2020-2/12/2021, with follow-up through 2/18/2021) (eMethods in the Supplement). For 3 days after vaccination, employees completed symptom surveys through a multipronged approach including email, text message, phone, and smartphone application links. Acute allergic reaction symptoms solicited included itching, rash, hives, swelling, and/or respiratory symptoms (eAppendix in the Supplement).

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Article Information

Corresponding Author: Kimberly G. Blumenthal, MD, MSc, The Mongan Institute, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA 02114 (kblumenthal@mgh.harvard.edu).

Accepted for Publication: March 2, 2021.

Published Online: March 8, 2021. doi:10.1001/jama.2021.3976

Author Contributions: Dr Blumenthal had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Landman and Wickner are co–senior authors.

Concept and design: Blumenthal, Robinson, Camargo, Banerji, Landman, Wickner.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Blumenthal.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Blumenthal.

Obtained funding: Blumenthal.

Administrative, technical, or material support: Blumenthal, Banerji, Landman, Wickner.

Supervision: Blumenthal, Shenoy, Landman, Wickner.

Conflict of Interest Disclosures: Dr Blumenthal reported receiving grants from the American Academy of Allergy Asthma and Immunology (AAAAI) Foundation, CRICO, and Massachusetts General Hospital outside the submitted work. Dr Camargo reported receiving grants from the National Institutes of Health (NIH) outside the submitted work. Dr Landman reported receiving personal fees from Abbott Medical Device Cybersecurity Council outside the submitted work. Dr Wickner reported receiving grants from CRICO outside the submitted work. No other disclosures were reported.

Funding/Support: This work was supported by NIH grant K01 AI125631 and the Massachusetts General Hospital Department of Medicine Transformative Scholar Program. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or Massachusetts General Hospital.

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.

Additional Contributions: We thank many colleagues in the Mass General Brigham health system for the design and implementation of the COVID-19 vaccination program, including Dean M. Hashimoto, MD, Paul D. Biddinger, MD, Thomas D. Sequist, MD, MPH, Upeka Samarakoon, MS, PhD, MPH, Rajesh Patel, MD, MPH, Leeann Ouimet, MBA, Allen Judd, AB, Anna R. Wolfson, MD, Rebecca Saff, MD, PhD, Aidan A. Long, MD, Lily Li, MD, Tanya M. Laidlaw, MD, David I. Hong, MD, Anna M. Feldweg, MD, Katrin Stinson, MPH, Amanda J. Centi, PhD, Lynn Simpson, MPH, Nahal Beik, PharmD, BCPS, Christian M. Mancini, BS, Amelia S. Cogan, MPH, and Aubree E. McMahon, BA. We thank Xiaoqing Fu, MS, for assistance with data analysis. No compensation was received by any of these individuals.

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Sampson  HA , Muñoz-Furlong  A , Campbell  RL ,  et al.  Second symposium on the definition and management of anaphylaxis: summary report—Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Symposium.   J Allergy Clin Immunol. 2006;117(2):391-397. doi:10.1016/j.jaci.2005.12.1303PubMedGoogle ScholarCrossref
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Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
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  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

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