Data mining runs for new or changed cases

The cumulative subset data mining runs identify new and significantly changed reports relative to prior time periods.

Data mining runs for new or changed cases consist of the following.

• One run computing new counts for all reports in VAERS.
• A second new run restricted to US-only reports.
• Six additional new runs corresponding to the following areas of interest: elderly, fatal, female, male, pediatric, and serious.

For all of the runs described in this section, the events are at the preferred term or narrow-algorithmic SMQ level of the MedDRA hierarchy.

Oracle Empirica Signal executes these runs on the Data configuration for 2D runs from the signal configuration, and names the runs in accordance with that Data configuration.

The runs use the Drug and Event variables for the 2D runs from the signal configuration as item variables.

The runs are stratified using the Stratification variables from the signal configuration.

In the descriptions that follow, the values shown in angle brackets (<>) represent values from the VAERS signal configuration.

• VAERS All new
  This data mining run computes all new or changed counts for all reports in VAERS.
• VAERS New US
  This data mining run computes all new or changed counts for reports from the United States.
• VAERS New Elderly
  This data mining run computes all new or changed counts for elderly reports.
• VAERS New Fatal
  This data mining run computes all new or changed counts for reports with a fatal outcome.
• VAERS New Female
  This data mining run computes all new or changed counts for female reports.
• VAERS New Male
  This data mining run computes all new or changed counts for male reports.
• VAERS New Pediatric
  This data mining run computes all new or changed counts for pediatric reports from the United States.
• VAERS New Serious
  This data mining run computes all new or changed counts for serious reports.