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COVID-19 Management

How Common are Anaphylaxis and Allergic Reactions Following Pfizer-BioNTech COVID-19 Vaccination?

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BACKGROUND AND PURPOSE:

  • As of December 23, 2020, over 1.8 million first-doses of Pfizer-BioNTech’s COVID-19 vaccine had been administered in the US
  • The CDC COVID-19 Response Team (MMWR, 2021) report on cases of allergic reactions, including anaphylaxis, associated with first-dose vaccination

METHODS:

  • Data sources
    • Vaccine Adverse Event Reporting System (VAERS)
  • Population
    • Initial vaccination was suggested for front-line healthcare workers and long-term care facility residents

RESULTS:

  • Initial vaccinations: 1,893,360 first doses
    • 0.2% (n=4393) had associated adverse events
  • Allergic reactions: 175 events
    • Anaphylaxis: 21 events
    • The overall anaphylaxis rate is 11.1 per million doses administered
  • 17 of these events took place in persons with a documented history of allergic reactions
    • 7 of these persons had a history of anaphylaxis
  • The median interval from vaccine receipt to symptom onset was 13 minutes (range 2 to 150 minutes)
  • Among the 20 patients with follow-up information available, all recovered
  • Of the non-anaphylaxis case reports
    • 86 were judged to be non-anaphylaxis allergic reactions
    • 61 were considered nonallergic adverse events

CONCLUSION:

  • Anaphylaxis is a rare event after initial vaccination with Pfizer-BioNTech’s COVID-19 vaccine (approximately 11 per million)
  • Limitations include
    • Passive reporting system which could lead to underreporting
    • Major media attention which could lead to heightened awareness and lower threshold for early treatment of suspected cases (overreporting)
  • Currently, the CDC recommends vaccine providers
    • Screen for contraindications before administering the vaccine
    • Have on hand supplies needed to manage anaphylaxis, should it occur
    • Implement post-vaccination observation periods
    • Immediately treat persons who exhibit signs of anaphylaxis with intramuscular injection of epinephrine

Learn More – Primary Sources:

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020

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Related ObG Topics:

Safety and Efficacy of AstraZeneca Oxford’s COVID-19 Vaccine
Safety and Efficacy Data of BNT162b2 COVID-19 Vaccine
The Moderna Vaccine: Study Results Presented to ACIP CDC Committee

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