Who Is Unlikely to Report Adverse Events Following Immunizations to the Vaccine Adverse Event Reporting System (VAERS)?

Background:
The nation's post-marketing safety surveillance system for vaccines (VAERS) was established, in part, to address reporting requirements of the National Childhood Vaccine Injury Act of 1986. Healthcare provider (HCP) awareness of and reporting to VAERS is therefore particularly important.

Objectives:
The primary objective of this study was to examine U.S. HCP knowledge and practices in identifying and reporting adverse events following immunization (AEFI).

Methods:
A stratified, nationally representative random sample of U.S. office-based HCP across 3 occupational categories (physicians, mid-level providers [physician assistants and advanced practice nurses] and nurses) and 3 primary care practice areas (pediatrics, family medicine and internal medicine) were surveyed utilizing standardized design methodology. We performed a logistic regression analysis to determine variables most commonly associated with a HCP not reporting AEFI to VAERS.

Results:
A total of 2,808 surveys were mailed with 1,602 completed for a 57.1% response rate. The percentage of HCP aware of VAERS (73%) varied by occupation and practice area. About 40% of HCP had identified at least one AEFI but only 18% of these indicated that they had ever reported to VAERS. More serious events were more likely to be reported. Factors associated with HCP not reporting AEFIs included: HCP not familiar versus very familiar with filing a paper VAERS report (OR=20.5, p<0.0001), primary practice area internal medicine/OB/GYN/other versus pediatrics (OR=3.4, p=0.0002), and HCP working in a solo versus group practice setting (OR= 2.0, p=0.02).

Conclusions:
As the number of recommended vaccines increases, HCP awareness of and reporting of AEFI, is critical to assuring the safety of U.S. licensed vaccines. Specific educational interventions targeted to HCPs likely to see AEFIs but not currently reporting may improve vaccine safety reporting practices.