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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Vaccine Safety: Anaphylaxis and COVID-19 Vaccinations

The CDC Advisory Committee on Immunization Practices has issued interim recommendations for the Pfizer-BioNTech and Moderna COVID-19 vaccines for prevention of COVID-19 in the US. Anaphylaxis is a severe, life-threatening allergic reaction which occurs rarely after vaccination and has been reported with the Pfizer-BioNTech COVID-19 vaccine.1,2

During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System (VAERS) 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. Appropriate medical treatment for severe allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of an mRNA COVID-19 vaccine.1,2

Medications and Supplies for Assessing and Managing Anaphylaxis3

The following should be available at all sites, at a minimum.

  • Epinephrine prefilled syringe or autoinjector (>3 doses)
  • Blood pressure cuff
  • Timing device to assess pulse
  • H1 antihistamine (e.g., diphenhydramine)
  • Stethoscope

Contraindications and Precautions2

CDC considers a history of the following to be a contraindication to vaccination with both COVID-19 vaccines:

  • Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or its components
  • Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or its components (including polyethylene glycol [PEG])*
  • Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

*These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist-immunologist and determined that the person can safely receive the vaccine.

CDC considers a history of any immediate allergic reaction to any other vaccine or injectable therapy as a precaution but not a contraindication to vaccination for both COVID-19 vaccines.

As described in the Indian Health Manual, report all significant or unusual Adverse Vaccine Events (AVE) to the VAERS program.

Instructions for reporting are located on the IHS Pharmacovigilance website.

References

  1. CDC MMWR. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020 Exit Disclaimer: You Are Leaving www.ihs.gov . January 6, 2021.
  2. CDC ACIP. Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States Exit Disclaimer: You Are Leaving www.ihs.gov . December 30, 2020.
  3. CDC ACIP. Interim Considerations: Preparing for the Potential Management of Anaphylaxis After COVID-19 Vaccination Exit Disclaimer: You Are Leaving www.ihs.gov . Accessed January 3, 2021.
  4. CDC Clinical Outreach and Communication Activity Webinar. Update on Allergic Reactions, Contraindications, and PrecautionsExit Disclaimer: You Are Leaving www.ihs.gov . December 30, 2020.