Details
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Change Request
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Resolution: Persuasive
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Highest
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US ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (FHIR)
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0.1.0
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Biomedical Research & Regulation
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ICSR Adverse Event
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Jean Duteau / Peter Bomberg : 14-0-1
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Correction
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Non-substantive
Description
It appears that in the VAERS PDF form, Item 21 allows multiple results or outcomes but AdverseEvent.seriousness does not. Assuming this is the cognate element for Item 21, is it a problem that it cannot repeat? Some of the values in the seriousness value set would see to be not mutually exclusive (for example an event could be both life threatening and requiring hospitalization. Please clarify how .seriousness should be used in cases like this.
Attachments
Issue Links
- is voted on by
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BALLOT-20919 Affirmative - Craig Newman : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted