EVAERS Elements For Patient Race 1 & 2, Rejected On Submission (Doc ID 2035966.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

 On Applications Oracle Life Sciences Argus Safety : Version 8..0

Issue with the eVAERS elements patientrace1 & patientrace2.

Get an error in the acknowledgement:

Per the FDA guidelines, UNK, MSK or OTH are valid null flavours.

However, this error is received when transmitting UNK for both Patient Race 1 and 2

Customized the code to transmit OTH if the value is not available and submitted a new file. OTH also resulted in same error.

it was observed that the information is not present for the Race field, we are able to see 'NI' being transmitted as CODE and not as null flavour in the HL7 file.

Similarly when null flavours like UNK and OTH are sent, they are being sent as code instead of null flavour.

Cause

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