KEYWORDS:
Vaccine safety, VAERS, data, smallpox vaccine
BACKGROUND:
The National Immunization Program (NIP) was charged with closely monitoring smallpox vaccine safety. NIP developed a smallpox data mart with data tables stored in SAS format. Data collected in this data mart included data from the Pre-Event Vaccination System (PVS); Active Surveillance; the Clinical Response Team; and the Vaccine Adverse Event Reporting System (VAERS). The PVS allowed collection of denominator data and the data mart included tables for redacted patient vaccination records; take responses; patient history; and vaccine batch use/tracking.
OBJECTIVE:
Identify lessons learned, benefits and next steps of registry linkages with immunization safety surveillance systems.
METHOD:
A Pre-Event Vaccination Number (PVN) assigned to each unique vaccination event linked the data tables, ‘followed’ a vaccination through time, and through the various data systems. VAERS was modified to allow manual entry of the PVN as the PVN could not automatically be pulled from the PVS. The PVN was initially missing on 48% of VAERS reports requiring additional effort to update the PVN, facilitating a virtual ‘linkage’ in the analytical data mart.
RESULT:
Approximately 60% of VAERS reports had assigned PVN after follow up. The NIP data mart served as a ‘one stop shopping’ location from which data could be linked and merged from the multiple data collection systems for the purposes of analyses and report generation. Reports produced ranged from internal QA reports to official reports disseminated to various Public Health entities providing smallpox vaccinations, and covered a number of areas including vaccinators per grantee; evaluation of examiniers per grantee; batch usage/wastage evaluation; and various VAERS summary reports.
CONCLUSION:
The experiences with smallpox vaccination monitoring demonstrates the importance for registries to be fully electronically linked to immunization safety surveillance systems and to have collection-system level integration. Denominator data available from such systems are essential for calculating adverse event reporting rates.
LEARNING OBJECTIVES:
Participants will:
1. List 2 components of the smallpox vaccination safety surveillance data systems.
2. State at least 1 benefit of connecting Safety Surveillance Systems with Registries.
Handout (.ppt format, 1103.0 kb)
Back to Connecting the Vaccine Safety Efforts and Immunization Information Systems: A Health Partnership
Back to The 2003 Immunization Registry Conference (October 27-29, 2003)