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VACCAT EVAERS Validation Error On Downgrade Report When Vaccine Product Deleted (Doc ID 2741609.1)

Last updated on DECEMBER 04, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.3 and later
Information in this document applies to any platform.


 Is there a work-around/solution for an eVAERS downgrade report error?

An Initial eVAERS report was successfully submitted to FDA CBER with an Influenza Vaccine product (License type: Marketed Vaccine).
During the addition of case follow-up the Vaccine product was deleted and replaced with a "Not Otherwise Specified" Drug Product. Due to this product change the case no longer meets the reporting rule to CBER for the vaccine product and a downgrade was scheduled for the vaccine reporting rule.

Following are exact steps to reproduce the issue:
1. Create a new case with a vaccine product.
2. On the product tab enter Facility Type as "Unknown"
3. Schedule, generate and submit an eVAERS report and mark it as submitted from an auto-schedule rule.
4. Delete the vaccine product and replace it with a drug product.
5. Auto schedule new reports and observe a downgrade schedules for the vaccine product.
6. The downgrade report is unable to generate and results in an error message related to the VACCAT E2B field.

Error message:

In earlier versions of the case with the Influenza vaccine product the Facility Type field was set to "Unknown". It is not possible to enter that info now under a drug product.

Does the SQL need to be modified to account for this (ex. if NULL defaults to 'UNK")?
Is there an alternative front-end fix to meet regulatory requirements?





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