Population-Based Incidence, Severity, and Risk Factors Associated with Treated Acute-Onset COVID-19 mRNA Vaccination-Associated Hypersensitivity Reactions.

Abstract

BACKGROUND:

COVID-19 mRNA vaccination-associated acute-onset hypersensitivity reactions have caused anxiety and may be contributing to vaccine hesitancy.

OBJECTIVE:

To determine the incidence, severity, and risk factors for treated acute-onset COVID-19 mRNA vaccination-associated hypersensitivity reactions in a well-characterized population.

METHODS:

All Kaiser Permanente Southern California (KPSC) members who received COVID-19 mRNA vaccinations between December 15, 2020, and March 11, 2021, at a KPSC facility were identified and characterized, along with all treated acute-onset vaccination-associated hypersensitivity events.

RESULTS:

We identified 391,123 unique vaccine recipients (59.18% female, age 64.19 ± 17.86 years); 215,156 received 2 doses (53.54% Moderna), 157,615 only a first dose (50.13% Moderna) (1961 [1.46%] >2 weeks late getting a second dose), and 18,352 (74.43% Moderna) only a second dose. Only 104 (0.028%) (85.58% female, age 53.18 ± 15.96 years) had treated first dose events, 68 (0.030%) Moderna. Only 32 (0.014%) (93.75% female, age 57.28 ± 17.09 years) had treated second dose events, 21 (0.016%) Moderna. Only 2 (0.00033%) vaccinations resulted in anaphylaxis. Only 27 (20.77%) of those with treated first dose reactions failed to get a second dose. Only 6 of 77 (7.8%) with first dose reactions also had second dose reactions. Individuals with treated events were more likely to be female (P < .0001), younger (P < .0001), and had more pre-existing drug "allergies" (2.11 ± 2.12 vs 1.02 ± 1.41 [P < .0001] for average recipients).

CONCLUSIONS:

Treated acute-onset hypersensitivity events were mostly benign, more common with first COVID-19 mRNA vaccine doses, more likely to occur in younger females with typical risk factors associated with multiple drug intolerance syndrome, and very unlikely to be primarily immunologically mediated.

• Authors: Eric Macy, Shalin Pandya, Javed Sheikh, Amber Burnette, Jiaxiao M Shi, Joanie Chung, Nancy Gin, William Crawford, Jing Zhang
• Journal: The journal of allergy and clinical immunology. In practice (J Allergy Clin Immunol Pract) Vol. 10 Issue 3 Pg. 827-836 (03 2022) ISSN: 2213-2201 [Electronic] United States
• PMID: 34971845 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Chemical References

• COVID-19 Vaccines
• RNA, Messenger
• Vaccines, Synthetic
• mRNA Vaccines

Topics

• Adult
• Aged
• Aged, 80 and over
• Anaphylaxis (epidemiology, etiology)
• COVID-19 (epidemiology)
• COVID-19 Vaccines (adverse effects)
• Female
• Humans
• Incidence
• Male
• Middle Aged
• RNA, Messenger
• Risk Factors
• SARS-CoV-2
• Vaccination (adverse effects)
• Vaccines, Synthetic
• mRNA Vaccines