REVIEW AND ANALYSIS OF LOT IDENTIFIER INFORMATION DATA IN THE VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS)

Abstract

Vaccine lot identifier information reporting to the Vaccine Adverse Event Reporting System (VAERS) database is important for post-licensure product safety surveillance. VAERS-initial-report data were used to evaluate the extent of missing lot identifier information. Publicly accessible VAERS data for pneumococcal conjugate vaccine (PCV) and pneumococcal polysaccharide vaccine (PPV) were analyzed for the variables potentially associated with completeness of lot identifier information. Analysis of the data showed lot identifier information was more likely to be included in VAERS reports for PCV, serious adverse events, by publicly funded source of administrators, and by those submitted by sources other than manufacturers. PPV VAERS-initial-reports data suggested that 56.4% of this vaccine was administered to the wrong age group of children (under 2 years old). While VAERS data has many limitations it serves as a valuable tool for vaccine safety surveillance, it is important for reporters to include complete and accurate lot identification information.