For more information: www.cdc.gov/COVID19

Anaphylaxis Following m-RNA COVID-19 

Vaccine Receipt

Thomas Clark, MD, MPH

December 19, 2020

ACIP COVID-19 Vaccines Work Group
 December 8, 2020 – UK initiated vaccination with Pfizer-BioNTech

COVID-19 vaccine

 December 9 – UK authorities confirmed 2 cases of anaphylaxis after 

vaccination 

 Prescribing information for both Pfizer-BioNTech and Moderna COVID-19 

vaccines contains information on anaphylaxis

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–

Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is a 

contraindication to vaccination

Appropriate medical treatment used to manage immediate allergic reactions must 

be immediately available in the event an acute anaphylactic reaction occurs 

following administration of the vaccine

Anaphylaxis in UK Following COVID-19 Vaccination

2
 ACIP considered anaphylaxis risk during deliberations on Pfizer-BioNTech

COVID-19 vaccine during December 11-12 meetings

 December 12 – CDC published clinical considerations for use of PfizerBioNTech COVID-19 vaccine

– Included guidance on contraindications and precautions 

(https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinicalconsiderations.html#contraindications-precautions)

CDC Guidance on Anaphylaxis Following COVID-19 

Vaccination 
 December 18*, 2020 – CDC has identified 6 case reports of anaphylaxis 

following Pfizer-BioNTech vaccine meeting Brighton Collaboration criteria for 

anaphylaxis 

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–

Cases were Brighton Collaboration levels 1 or 2 

Additional case reports have been reviewed and determined not anaphylaxis

 Cases occurred within recommended observation window and were 

promptly treated

 One case had a history of anaphylaxis following rabies vaccination

 All suspect cases were notified through VAERS or CDC notification processes

 These case reports are undergoing/will undergo clinical case review by CISA

 December 19** – 272,001 doses of vaccine have been administered

Anaphylaxis in US Following COVID-19 Vaccination

*December 18, 2020 at 2300 hrs EST

**December 19, 2020 at 0945 hrs EST
 Close coordination with FDA

 Discussions with CISA investigators, NIH, Medicine and Healthcare 

products Regulatory Agency (UK), Allergy/Immunology experts, and 

other partners

 Published Interim Considerations: Preparing for the Potential 

Management of Anaphylaxis at COVID-19 Vaccination 

Sites (https://www.cdc.gov/vaccines/covid-19/info-byproduct/pfizer/anaphylaxis-management.html)

CDC Actions Following Reports
V-safe Active Surveillance for COVID-19 Vaccines

Dec 14 Dec 15 Dec 16 Dec 17 Dec 18*

Registrants with recorded 1st dose 679 6,090 27,823 67,963 112,807

Health Impact Events** 3 50 373 1,476 3,150

Pregnancies at time of vaccination 5 29 103 286 514

*Dec 18, 5:30 pm EST

**unable to perform normal daily activities, unable to work, required care from doctor or health care professional
 Post-authorization pharmacovigilance systems have detected and 

confirmed 6 anaphylaxis cases following vaccination

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–

Notifications received have been timely

Notifications ruled out suggests systems are sensitive 

 Reinforce measures to recognize, respond, and report anaphylaxis

 Persons with anaphylaxis following COVID-19 vaccination should not 

receive additional doses of COVID-19 vaccine

 Consultation with allergy/immunology experts to provide guidance on 

evaluation of persons following anaphylaxis to COVID-19 vaccine

CDC Assessment and Further Actions
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.

Thank you