Anaphylaxis to SARS-CoV-2 Vaccines in the Setting of a Nationwide Passive Epidemiological Surveillance Program

J Clin Immunol. 2022 Nov;42(8):1593-1599. doi: 10.1007/s10875-022-01350-1. Epub 2022 Aug 17.

Abstract

Background: Information on anaphylaxis among recipients of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains scarce.

Objective: To identify the observed incidence of anaphylaxis in recipients of different anti-SARS-CoV-2 vaccines.

Methods: A nationwide observational study among recipients of 61,414,803 doses of seven different anti-SARS-CoV-2 vaccines, describing the incidence and characteristics of adult patients (age ≥ 18 years) who developed anaphylaxis as an adverse event following immunization (AEFI) against SARS-CoV-2 vaccines between December 24, 2020, and October 15, 2021, in Mexico.

Results: Sixty-six patients developed anaphylaxis as an AEFI, for an overall observed incidence of 1.07 cases per 1,000,000 (95% CI 0.84-1.37) administered doses. Eighty-six percent of the patients were female, consistent with previous reports of AEFI to COVID-19 vaccines. mRNA-based vaccine recipients had the highest frequency of anaphylaxis, followed by adenovirus-vectored vaccines and inactivated virus recipients, with an observed incidence of 2.5, 0.7, and 0.2 cases per 1,000,000 doses administered, respectively. Only 46% of the patients received correct treatment with epinephrine as the first-line treatment through the appropriate route and dose. We detected one case of anaphylactic reaction-related death occurring 5 min following immunization with ChAdOx1 nCov-19 for a mortality rate of 1.5% among those who developed this AEFI.

Conclusions: In our population, anaphylactic reactions were infrequent. Our study provides further evidence supporting the security of these newly developed vaccines.

Keywords: Anaphylaxis; COVID-19 vaccines; SARS-CoV-2 vaccines; Vaccine anaphylaxis; Vaccine safety.

Publication types

  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Anaphylaxis* / chemically induced
  • Anaphylaxis* / epidemiology
  • COVID-19 Vaccines* / adverse effects
  • COVID-19* / epidemiology
  • COVID-19* / prevention & control
  • ChAdOx1 nCoV-19 / adverse effects
  • Female
  • Humans
  • Male
  • Mexico / epidemiology
  • SARS-CoV-2

Substances

  • ChAdOx1 nCoV-19
  • COVID-19 Vaccines