KEYWORDS:
Immunization registries/systems, VAERS, VAE ‘Alert’, Denominator data.

BACKGROUND:
The Vaccine Adverse Event Reporting System (VAERS) plays a critical role in the nation's post-marketing vaccine safety surveillance system. It serves as a focal point for collecting vaccine adverse event (VAE) reports and generates hypotheses of potential vaccine safety concerns. Kaiser Permanente’s Immunization Tracking System (KITS) currently serves about 1 million enrollees aged < 12 years and about half-a-million enrollees aged > 65 years in Southern California, and approximately the same numbers in Northern California. CDC and Southern California KITS are implementing electronic VAERS reporting, and generation of VAE ‘Alerts’ and denominator data for calculating rates.

OBJECTIVE(S):
Using KITS as a pilot project for integrating vaccine safety initiatives into Immunization Registries/Systems by enhancing VAE reporting, generating VAE ‘Alert’, and denominator data.

METHOD(S):
Staff from CDC and KITS is modifying KITS that would enable it to:
a. Collect VAERS data
b. Pre-populate VAERS from using existing data
c. Report to VAERS, electronically
d. Generate VAE ‘Alerts’ for its users, and
e. Generate vaccine/vaccine combination specific denominator data for calculating and monitoring VAE rates and trends respectively.

RESULT(S):
KITS is being modified to enable the abovementioned capabilities. System users will be educated of these new capabilities. A user survey will be conducted to evaluate acceptability/value of these. Denominator data will be used for calculating and monitoring trends for VAE rates. Findings from this pilot will be disseminated amongst immunization registries/systems.

CONCLUSIONS(S):
VAERS is committed to integrating vaccine safety in immunization systems/registries. It is expected that these capabilities will increase the accuracy, timeliness, acceptability, and sensitivity of the surveillance system. Upon successful completion of the pilot study, other immunization systems/registries will be encouraged to adopt such capabilities.

LEARNING OBJECTIVES:
The audience will understand the need for enhancing VAERS reporting, VAE ‘Alert’ generation, and denominator data, and the need for developing such capabilities.