Death and Disability Reported with Cases of Vaccine Anaphylaxis Stratified by Administration Setting: An Analysis of the Vaccine Adverse Event Reporting System from 2017 to 2022

Abstract

The serious nature of post-vaccination anaphylaxis requires healthcare professionals to be adequately trained to respond to these hypersensitivity emergencies. The aim of this study was to compare outcomes reported with cases of vaccine anaphylaxis stratified by administration setting. We queried reports in the Vaccine Adverse Event Reporting System (VAERS) database from 2017 to 2022 and identified cases involving anaphylaxis with an onset within one day of vaccine administration. The primary outcome was the combined prevalence of death or disability for each setting while the secondary outcome was the prevalence of hospitalization. Adjusted (age, sex, prior history of allergy, vaccine type) odds ratios (aOR) and associated 95% confidence intervals (CI) were calculated using logistic regression analysis. A total of 2041 cases of anaphylaxis comprised the primary study cohort with representation in the sample from all 50 US states and the District of Columbia. The mean age was 43.3 ± 17.5 years, and most cases involved women (79.9%). Cases of anaphylaxis were reported after receiving a coronavirus vaccine (85.2%), influenza vaccine (5.9%), tetanus vaccine (2.2%), zoster vaccine (1.6%), measles vaccine (0.7%), and other vaccine (4.5%). Outcomes associated with reports of vaccine anaphylaxis included 35 cases of death and disability and 219 hospitalizations. Compared with all other settings, the aOR of death and disability when anaphylaxis occurred was 1.92 (95% CI, 0.86-4.54) in a medical provider's office, 0.85 (95% CI, 0.26-2.43) in a pharmacy and 1.01 (95% CI, 0.15-3.94) in a public health clinic. Compared with all other settings, the aOR of hospitalization when anaphylaxis occurred was 1.02 (95% CI, 0.71-1.47) in a medical provider's office, 1.06 (95% CI, 0.72-1.54) in a pharmacy, and 1.12 (95% CI, 0.61-1.93) in a public health clinic. An analysis of a national database across six years revealed no significant differences in the odds of death/disability and odds of hospitalization associated with post-vaccination anaphylaxis in the medical office, pharmacy, and public health clinic compared with all other settings. This study expands our understanding of the safety of immunization services and reinforces that all settings must be prepared to respond to such an emergency.

Keywords: COVID-19 vaccination; administration setting; adverse event; anaphylaxis; influenza vaccination; vaccine administration.

Figure 1

Flowchart of Inclusion Criteria and Cohort Selection.

Figure 2

Adjusted odds ratios (aOR) and 95% confidence intervals (CI) of death and disability associated with reports of post-vaccination anaphylaxis for each regression variable *. When holding other covariates constant in the regression analysis, an odds ratio greater than 1 indicates that the outcome of death and disability is more likely to occur when the variable is present. Conversely, an odds ratio less than 1 indicates that the outcome is less likely to occur when the variable is present.

Figure 3

Adjusted odds ratios (aOR) and 95% confidence intervals (CI) of hospitalization associated with reports of post-vaccination anaphylaxis for each regression variable *. When holding other covariates constant in the regression analysis, an odds ratio greater than 1 indicates that the outcome of hospitalization is more likely to occur when the variable is present. Conversely, an odds ratio less than 1 indicates that the outcome is less likely to occur when the variable is present.