# FAERS & VAERS Reconciliation

Vault can generate _Case_ listings to identify cases that are present in the FAERS or VAERS database and missing from Safety.

## About FAERS and VAERS Reconciliation

Case linking and reconciliation reports help synchronize your pharmacovigilance (PV) database (Safety) with external databases, such as the FDA Adverse Event Reporting System (<a href="/en/gr/752950/#faers">FAERS</a>) and Vaccine Adverse Event Reporting System (<a href="/en/gr/752950/#vaers">VAERS</a>). This process allows case data that was analyzed in external databases to be included in signal detection.

The reconciliation reports compare cases between Safety and the FAERS or VAERS database to ensure that applicable cases sent to the FDA from sources other than Safety also exist in your Safety Vault. To complete this comparison, Vault performs case linking, which links _Cases_ in your Safety Vault with cases in FAERS and VAERS. If any cases are missing from your Safety Vault, you can [generate a _Workbench Report_][1] to identify them in a _Case_ listing.

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      <p><strong>Note</strong>: As of May 8, 2025, VAERS data includes all submitted reports for a given patient, vaccine, and dose, instead of just the initial report. However, the VAERS reconciliation report will use only the initial report that was submitted.</p>
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## Prerequisites

You must have a <a href="/en/gr/752926/">Veeva Safety Workbench</a> license to use this feature. After obtaining a license, your Admin must <a href="/en/gr/23647/#assign">assign</a> you to the _Workbench Management_ security profile.

## Generate Case Listings

To reconcile cases between Safety and FAERS or VAERS, you can generate _Case_ listings from: 
* [_Workbench Report Sets_][2]
* [Ad-hoc _Workbench Reports_][3]

### Generate Case Listings from Workbench Report Sets

_Workbench Report Sets_ use the following _Workbench Report Definitions_ to generate _Case_ listings for reconciliation:
* _FAERS Case Reconciliation Summary (Excludes Cases found in Safety Database)_
* _VAERS Case Reconciliation Summary (Excludes Cases found in Safety Database)_

These report definitions are managed by Veeva and cannot be edited. To generate _Case_ listings for reconciliation:
1. <a href="/en/gr/826869/">Create</a> a _Workbench Report Set_ and add one of the above definitions.
2. FAERS and VAERS reconciliation report definitions include predefined filters. Enter filter values according to your business needs using the following guidance:
    * For FAERS reconciliation reports, you must enter the following filter values in lowercase:
      * _Substance Name_
      * _Brand Name_
      * _Generic Name_
    * For VAERS reconciliation reports:
      * You must enter the following filter values in uppercase:
        * _Vaccine Name_
        * _Manufacturer_
        * _Vaccine Type Code_
      * You must enter the _Manufacturer_ filter value exactly how it appears in the VAERS database.
      * If you enter a _Vaccine Type Code_ filter value, this value must match the Vaccine Code as published in the <a class="external-link " href="https://vaers.hhs.gov/docs/VAERSDataUseGuide_en_March2025.pdf" target="_blank" rel="noopener">VAERS Data Use Guide<i class="fa fa-external-link" aria-hidden="true"></i></a>.
3. <a href="/en/gr/860561/#generate-reports-from-report-definitions-on-workbench-report-sets">Generate</a> reports from the _Workbench Report Set_. We recommend generating reports from _Workbench Report Sets_ as opposed to standalone _Workbench Report Definitions_ so these reports can be <a href="/en/gr/860557/#schedule-workbench-report-sets">automatically scheduled</a>.

### Generate Case Listings from Workbench Reports

You can run ad-hoc _Workbench Reports_ to generate _Case_ listings for reconciliation. To do this, <a href="/en/gr/752963/#properties">set up</a> a _Workbench Report_ using the following safety views and then <a href="/en/gr/752975/">run</a> the report:
* _Signal FAERS - Case Listing Principal View_
* _Signal VAERS - Case Listing Principal View_

## How Vault Performs Reconciliation

When you generate _Case_ listings for reconciliation, Vault queries the FAERS or VAERS database for matching cases. For Vault to link a FAERS or VAERS case with a Safety _Case_, the following criteria must be met for:

**FAERS**
* The FAERS case receipt date (receiptdate) matches a Safety _Case_ _New Info Date_.
* One (1) of the following matches must be found:
  * The FAERS case number (safetyreportid) matches any _Case Identifier (Reference Number)_ of a Safety _Case_.
  * The FAERS case company number (companynumb) or authority number (authoritynumb) matches one (1) of the following on a Safety _Case_:
    * _Worldwide UID_ (WWUID)
    * _UID_
    * _External System UID_
    * _Case_ _Identifier (Reference Number)_

**VAERS**
* One (1) of the following matches must be found:
  * The VAERS case number (vaers_id) matches any _Case Identifier (Reference Number)_ of a Safety _Case_.
  * The VAERS case company number (splttype) matches one (1) of the following on a Safety _Case_:
      * _Worldwide UID_ (WWUID)
      * _UID_
      * _External System UID_
      * _Case_ _Identifier (Reference Number)_

Matching is case-sensitive, for example, a WWUID of _US-001-01USA001_ will not match a case company number of _us-001-01usa001_.

After Vault generates a _Case_ listing for reconciliation, you can review this output.

[1]: #generate-case-listings
[2]: #generate-case-listings-from-workbench-report-sets
[3]: #generate-case-listings-from-workbench-reports