COVID-19 Vaccine Allergy Case Registry (VACR)
In December 2020, the first vaccinations for COVID-19 completed phase III trials. Regulatory agencies around the world began to approve the vaccinations for emergency use as a clinical prevention measure to address the continued COVID-19 global pandemic.
The Food and Drug Administration (FDA) approved the Pfizer-BioNTech under emergency use authorization (EUA) in the Unites States (US) on December 11, 2020.1,2 On December 18, 2020, the FDA issued an EUA for the second vaccine, the Moderna COVID-19 Vaccine.3,4 It is expected several others will also receive EUAs in the next few months (for example, Johnson & Johnson/Ad26.COV2.S Vaccine, COVID-19 Vaccine AstraZeneca).
Severe allergic reactions to vaccines are typically extremely rare and are estimated to occur at very low rates. However, on the first day of vaccine administration in the United Kingdom, two immediate allergic reactions to the Pfizer-BioNTech COVID-19 vaccine were reported. Other reports followed as vaccinations continued for both Pfizer-BioNTech and Moderna COVID-19 vaccines.5,6
As the US and countries worldwide continues to expand the immunization programs against COVID-19 it is essential to capture information about potential COVID-19 vaccine hypersensitivity reactions.
About the Project
We have created the COVID-19 Vaccine Allergy Case Registry as a community-wide effort to collect and share case reports on COVID-19 hypersensitivity reactions. We are collecting potential cases of severe hypersensitivity reactions, including anaphylaxis, to COVID-19 vaccine. These case reports are collected from health care professionals who wish to share their reports of vaccine hypersensitivity.
The case report form is designed in an online survey format and will take approximately 10 to 20 minutes to complete. Patient health identifiers such as name or date of birth will not be collected. Only de-identified information will be collected. The information will be kept strictly confidential.
Data will be stored on a secure server at Massachusetts General Hospital, USA, a teaching hospital of the Harvard University Medical School. The information is only shared with health care professionals and researchers for managing and improving patient care for patients and for expansion of the current limited knowledge on COVID-19 vaccine allergy.
This study has been reviewed by the Mass General Brigham (MGB) institutional review board.
The success of this collaborative effort depends on active participation and accuracy and reliability of the information provided. This registry is for healthcare professionals. Even if you have already submitted your case to a journal, please enter a summary of the case here so we can get an accurate understanding of the range of hypersensitivity and allergic reactions from COVID-19 vaccination.
Thank you for participating in this community-wide effort to better understand the prevalence and symptoms resulting from vaccination.
 U.S. Food and Drug Administration Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine (https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine
 Press Release: Pfizer and Biontech celebrate historic first authorization in the U.S. of vaccine to prevent COVID-19 (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-celebrate-historic-first-authorization)
 U.S. Food and Drug Administration Emergency Use Authorization for Moderna COVID-19 Vaccine (https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine)
 Press Release: Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S. (https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us)
 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. Published January 6, 2021. doi:10.15585/mmwr.mm7002e1
 Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep. ePub: 22 January 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7004e1external icon.