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Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020

  • January 6, 2021

  • By Shimabukuro, Tom T.
  • Source: MMWR. Morbidity and Mortality Weekly Report ; v. 70, early release, January 6, 2021
  • Series: 1
Filetype[PDF-240.74 KB]


  • English
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    Details:

    • Personal Author:
      Shimabukuro, Tom T.
    • Corporate Authors:
    • Description:
      What is already known about this topic? Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination.

      What is added by this report? During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 Vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.

      What are the implications for public health practice? Locations administering COVID-19 vaccines should adhere to CDC guidance for use of COVID-19 vaccines, including screening recipients for Contraindications and precautions, having the necessary supplies available to manage anaphylaxis, implementing the recommended postvaccination observation periods, and immediately treating suspected cases of anaphylaxis with intramuscular injection of epinephrine.

      As of January 3, 2021, a total of 20,346,372 cases of coronaVirus disease 2019 (COVID-19) and 349,246 associated deaths have been reported in the United States Long-term sequalae of COVID-19 over the course of a lifetime currently are unknown; however, persistent symptoms and serious Complications are being reported among COVID-19 survivors, including persons who initially experience a mild acute illness.* On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, administered as 2 doses separated by 21 days. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Pfizer-BioNTech COVID-19 Vaccine (1); initial doses were recommended for health care personnel and long-term care facility residents (2). As of December 23, 2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 Vaccine had been administered in the United States, and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours (3). Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented History of allergies or allergic reactions, seven of whom had a History of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2–150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home. Of the remaining case reports that were determined not to be anaphylaxis, 86 were judged to be nonanaphylaxis allergic reactions, and 61 were considered nonallergic adverse events. Seven case reports were still under investigation. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Pfizer-BioNTech COVID-19 Vaccine during December 14–23, 2020, in the United States CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (4) and interim considerations for preparing for the potential management of anaphylaxis (5). In addition to screening for Contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the necessary supplies available to manage anaphylaxis, should implement postvaccination observation periods, and should immediately treat persons experiencing anaphylaxis signs and symptoms with intramuscular injection of epinephrine (4,5).

      Suggested citation for this article: . 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. ePub: 6 January 2021

      mm7002e1.htm?s_cid=mm7002e1_w

      /mm7002e1-H.pdf

    • Subjects:
    • Source:
      MMWR. Morbidity and Mortality Weekly Report ; v. 70, early release, January 6, 2021
    • Series:
      1
    • Document Type:
      Journal Article
    • Name as Subject:
    • Place as Subject:
      Maine
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