Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine - United States, December 21, 2020-January 10, 2021

Abstract

As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine (1). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours (2). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1-45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020-January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (3) and interim considerations for preparing for the potential management of anaphylaxis (4).

FIGURE

Minutes from vaccine receipt to onset of anaphylaxis (A) and nonanaphylaxis allergic reactions (B) after receipt of the first dose of Moderna COVID-19 vaccine — Vaccine Adverse Events Reporting System (VAERS), United States, December 21, 2020–January 10, 2021 Abbreviation: COVID-19 = coronavirus disease 2019. * The interval from vaccine receipt to symptom onset was >30 minutes for one anaphylaxis case (45 minutes). ^† The interval from vaccine receipt to symptom onset was ≥60 minutes for three nonanaphylaxis patients who had a documented history of allergies or allergic reactions at 60, 90, and 98 minutes and for four who did not have a documented history of allergies or allergic reactions (60 minutes, 10 hours, 20 hours, and 24 hours). The interval from vaccine receipt to symptom onset was missing in two case reports, both of which documented a history of allergies or allergic reactions. Four cases of nonanaphylaxis allergic reactions with symptom onset occurring later than the day after vaccination (i.e., outside of the 0–1-day risk window) were excluded from the final analysis.