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Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine

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

On December 11, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, administered as 2 doses separated by 21 days.1 Shortly after, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use.2 Following implementation of vaccination, reports of anaphylaxis after the first dose of the Pfizer-BioNTech COVID-19 vaccine emerged.3 Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours.4

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Article Information

Corresponding Author: Tom Shimabukuro, MD, MPH, MBA, Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30329 (ayv6@cdc.gov).

Published Online: January 21, 2021. doi:10.1001/jama.2021.0600

Conflict of Interest Disclosures: None reported.

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of CDC or FDA. Mention of a product or company name is for identification purposes only and does not constitute endorsement by CDC or FDA.

Additional Contributions: We thank investigators from the CDC COVID-19 Response Team; the FDA Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research; and the Clinical Immunization Safety Assessment Project.

References
1.
FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Revised January 2021. Accessed January 17, 2021. https://www.fda.gov/media/144413/download
2.
Oliver  SE , Gargano  JW , Marin  M ,  et al.  The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 Vaccine—United States, December 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(50):1922-1924. doi:10.15585/mmwr.mm6950e2 PubMedGoogle ScholarCrossref
3.
 Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine—United States, December 14–23, 2020.   MMWR Morb Mortal Wkly Rep. Published January 6, 2021. doi:10.15585/mmwr.mm7002e1Google Scholar
4.
McNeil  MM , DeStefano  F .  Vaccine-associated hypersensitivity.   J Allergy Clin Immunol. 2018;141(2):463-472. doi:10.1016/j.jaci.2017.12.971 PubMedGoogle ScholarCrossref
5.
Shimabukuro  TT , Nguyen  M , Martin  D , DeStefano  F .  Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).   Vaccine. 2015;33(36):4398-4405. PubMedGoogle ScholarCrossref
6.
Rüggeberg  JU , Gold  MS , Bayas  JM ,  et al.  Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data.   Vaccine. 2007;25(31):5675-5684. doi:10.1016/j.vaccine.2007.02.064 PubMedGoogle ScholarCrossref
7.
Rossen  LM , Branum  AM , Ahmad  FB ,  et al.  Excess deaths associated with COVID-19, by age and race and ethnicity—United States, January 26–October 3, 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(42):1522-1527. doi:10.15585/mmwr.mm6942e2 PubMedGoogle ScholarCrossref
8.
CDC. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Updated January 6, 2021. Accessed January 17, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
9.
CDC. Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination. Updated December 31, 2020. Accessed January 18, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html
10.
Vaccine Adverse Event Reporting System: report an adverse event to VAERS. Accessed January 18, 2021. https://vaers.hhs.gov/reportevent.html
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