Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach


Matthew Greenhawt
Timothy E Dribin
Elissa M Abrams
Marcus Shaker
Derek K Chu
David B K Golden
Cem Akin
Akterini Anagnostou
Faisal ALMuhizi
Waleed Alqurashi
Peter Arkwright
James L Baldwin
Aleena Banerji
Philippe Bégin
Moshe Ben-Shoshan
Jonathan Bernstein
Theresa A Bingemann
Carsten Bindslev-Jensen
Kim Blumenthal
Aideen Byrne
Julia Cahill
Scott Cameron
Dianne Campbell
Ronna Campbell
Michael Cavender
Edmond S Chan
Sharon Chinthrajah
Pasquale Comberiati
Jacqueline J Eastman
Anne K Ellis
David M Fleischer
Adam Fox
Pamela A Frischmeyer-Guerrerio
Remi Gagnon
Lene H Garvey
Mitchell H Grayson
Ghislaine Annie Clarisse Isabwe
Nicholas Hartog
David Hendron
Caroline C Horner
Johnathan O'B Hourihane
Edward Iglesia
Manstein Kan
Blanka Kaplan
Constance H Katelaris
Harold Kim
John M Kelso
David A Khan
David Lang
Dennis Ledford
Michael Levin
Jay A Lieberman
Richard Loh
Douglas P Mack
Bruce Mazer
Ketan Mody
Gisele Mosnaim
Daniel Munblit
S Shahzad Mustafa
Anil Nanda
Richard Nathan
John Oppenheimer
Iris M Otani
Miguel Park
Ruby Pawankar
Kirsten P Perrett
Jonny Peter
Elizabeth J Phillips
Matthieu Picard
Mitchell Pitlick
Allison Ramsey, Rochester Regional Health System
Trine Holm Rasmussen
Melinda M Rathkopf
Hari Reddy
Kara Robertson
Pablo Rodriguez Del Rio
Stephen Sample
Ajay Sheshadri
Javed Sheik
Sayantani B Sindher
Jonathan M Spergel
Cosby A Stone
David Stukus
Mimi L K Tang
James M Tracy
Paul J Turner
Timothy K Vander Leek
Dana V Wallace
Julie Wang
Susan Wasserman
David Weldon
Anna R Wolfson
Margitta Worm
Mona-Rita Yacoub


Allergy and Immunology

Document Type


Publication Title

The Journal of Allergy and Clinical Immunology


This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against > 15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

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Publication Date


Medical Subject Headings

Humans; COVID-19 Vaccines; GRADE Approach; Consensus; Vaccine Excipients; COVID-19; Hypersensitivity, Immediate; Anaphylaxis; Excipients

PubMed ID