Background
COVID-19 mRNA vaccination-associated acute-onset hypersensitivity reactions have caused anxiety and may be contributing to vaccine hesitancy.
Objective
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 12-15-2020 and 3-11-2021 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) [1,961 (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 6/77 (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 preexisting drug “allergies” (2.11 ± 2.12 versus 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.