Allergic reactions and adverse events associated with administration of mRNA-based vaccines. A health-care system experience

Abstract

Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (EHCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 EHCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The EHCPs self-reported adverse reactions to a centralized COVID-19 command center (CCC). The CCC screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to the CCC, 113 were identified as requiring consideration by a panel of three (American Board of Allergy and Immunology) ABAI-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 EHCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the ECHPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.

The risk of anaphylaxis behind authorized COVID-19 vaccines: a meta-analysis

“…However, a report from Ontario in period between December 13, 2020 and March 6, 2021 noted anaphylaxis cases the rates of 32.7 and 38.0 per million doses administered of mRNA-1273 and BNT162b2, respectively [ 41 ]. Among health care providers from Baylor Scott and White Health from Texas, which were vaccinated with first dose, only 3 persons had anaphylaxis what corresponds to 0.01% of vaccinated medical staff members [ 42 ]. In overall, in U.S. after first month of vaccination in period between December 14, 2020 and January 13, 2021, 4.5 per million cases of anaphylaxis after doses administered of both mRNA vaccines have been reported [ 43 ].…”

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management

“…Another observational study of 28,544 employees and health care providers receiving a first dose of a mRNA-based vaccine in the period between December 15, 2020, and March 8, 2021, reported 1253 vaccine-related adverse reactions. For 113 subjects, the experts required further evaluation before receiving the second dose, since three persons reported symptoms that were judged to be consistent with anaphylaxis [20].…”

Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review

“…Only 41 studies met our inclusion criteria 22,61–100 ; these consisted of 18 case series/reports, 18 cohort studies without control groups, and 4 cohort studies with control groups, one of which was a double‐blinded randomized clinical trial. The last study, Kaplan et al, 79 contained both a cohort analysis and a case series.…”

“…Anaphylaxis was also more common in women, with 76 of the case series being female. Cohort studies, such as Arroliga et al 91 and Klein et al 90 also reported that the vast majority of anaphylactic cases occurred in females. Moreover, they suggested that this difference in adverse events could be due to genetic differences, hormonal influences, environmental or immunological variance between men and women.…”

“…For example, Klein et al 90 reported a rate of 5.1 per million doses and 4.8 per million doses for the Pfizer/BioNTech and Moderna vaccines, respectively, noting that they were comparable. However, Arroliga et al 91 noted an increased risk of anaphylaxis following administration of the Pfizer/BioNTech vaccine compared to Moderna, citing rates of 11.1 per million and 2.5 per million, respectively. For the AstraZeneca vaccine, most cases developed within the first 30 minutes after administration.…”