With the 26R1 release, users can run Signal Calculations, create Statistical Data, and run signal alerts on Vaccine Adverse Event Reporting System (VAERS) data. After you have configured this feature, see the following resources for next steps:
- Configure Signal Calculation Objects to configure calculations for the VAERS data source
- Manage Signal Product Profiles to configure Signal Product Identifiers for each Signal Product Profile associated with VAERS calculations
- Configure and Assign Default Workbench Dashboard
- Signal Detection Overview
26R3 Update: Include Additional VAERS Data
With the 26R3 release, Veeva supports ingesting additional VAERS data from the FDA. See (26R3) Configure Including Additional VAERS Data to configure your Vault for the updated feature.
Activate the VAERS Data Source
To activate the VAERS data source:
- Navigate to Business Admin > Objects > Signal Source Data.
- From the All Actions menu next to VAERS, select Change State to Active.
- Select the VAERS data source.
- Select the Edit icon.
- In the Signal Source field, select Regulatory Database.
- Select Save.
Update Data Source VQL on Workbench View Object
To update the criteria VQL for the Data Source field on the Workbench View object:
- Navigate to Admin > Configuration > Objects > Workbench View > Fields > Data Source.
- Select Edit.
- In the Criteria VQL field, update the reference constraint to
api_name__v CONTAINS ('fda_faers__v', 'fda_vaers__v', 'ema_evdas_ermr__v'). - Select Save.
Copy & Update VAERS Views
To copy and update VAERS safety views:
- Navigate to Business Admin > Objects > Workbench Views.
- Use the table below to copy VAERS safety views so you can customize them according to your business needs.
- On each custom VAERS view, ensure the Data Source field is set to VAERS and update dependent views and SQL as needed.
| Safety View | API Name |
|---|---|
| Sample_VAERS – All Product-Event Combinations Principal | sample_vaers_all_pec_principal__c |
| Sample_VAERS Interval Filter View | sample_vaers_fv_interval__c |
| Sample_VAERS Cumulative Filter View | sample_vaers_fv_cumulative__c |
| Sample_VAERS New Counts | sample_vaers_new_counts__c |
| Sample_VAERS Cumulative Counts | sample_vaers_cumulative_counts__c |
| Sample_VAERS EBGM - Age Group, Gender, Receipt Year Strata | sample_vaers_ebgm_ag_sex_ryr__c |
| Sample_VAERS Case Series - New Counts | sample_vaers_case_series_new_counts__c |
| Sample_VAERS Case Series - Cumulative Counts | sample_vaers_case_series_cumulative_counts__c |
Configure Views & Default Workbench Dashboard
To analyze your VAERS data in Workbench Reports and Workbench Dashboards:
- Configure a Principal View that queries VAERS data. You can use the provided VAERS views for reference. Ensure the Data Source is set to VAERS.
- Configure Signal Views as needed for analysis. Ensure the Data Source is set to VAERS.
- Enable Case series on the VAERS Principal View.
- Create a Workbench Dashboard for VAERS.
- In Business Admin > Objects > Signal Data Source > VAERS, set the Default Workbench Dashboard to the created VAERS dashboard.
Note: To use Workbench Reports and Workbench Dashboards, you must obtain a Veeva Safety Workbench license.
(26R3) Configure Including Additional VAERS Data
To run Signal Calculations and create Statistical Data records for the additional data ingested from VAERS, update the SQL in the appropriate VAERS safety view with a default Workbench Dashboard to include the additional VAERS fields. This ensures Vault considers these fields when returning cases.