These release notes describe VAERS Interactive Signal Management for use with Oracle Empirica Signal version 9.x with VAERS data 20180430 or later.

The Oracle Empirica Signal software is a web-based analysis environment for generating statistical scores for combinations of products (vaccines) and events in a vaccines safety database, and for detecting unexpected associations of vaccines and events (signals).

If your organization subscribes to Oracle Empirica Topics for Signal Management Cloud Service and Oracle Empirica Signal WHO UMC VAERS Extract Cloud Service, you can employ the Signal Management feature in Oracle Empirica Signal on VAERS data. If your organization has not used VAERS Signal Management before, contact Oracle Support to enable the feature in your environment. The feature facilitates ongoing monitoring of safety signals by enabling users to perform statistical analyses on successive releases of the data.

A scripted form of VAERS Signal Management was originally released in 2010. In scripted VAERS Signal Management, monthly refreshes are initiated by running shell scripts on the server. Scripted VAERS Signal Management can be used with Oracle Empirica Signal versions 7.3.x and above.

Interactive Signal Management allows configuring and refreshing Signal Management from the user interface rather than using scripts. This release also makes use of the configurable alerts feature introduced in Oracle Empirica Signal 9.0.

VAERS Interactive Signal Management requires VAERS data 20180430 or later but can be used with any 9.x release of Oracle Empirica Signal. R and RGPS package must be installed on Empirica Signal application server and RGPS must be configured in Empirica Signal.

For more information on a monthly VAERS data release, please refer to the VAERS Data Release Notes.pdf file distributed with the release. That document describes the preparation of VAERS data for use with Oracle Empirica Signal, including Oracle tables and table views, record counts, duplicate removal, standard data configurations, and a complete data mining table schema.