VACCAT EVAERS Validation Error On Downgrade Report When Vaccine Product Deleted
(Doc ID 2741609.1)
Last updated on FEBRUARY 08, 2021
Applies to:Oracle 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.
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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