SIGNIFOR,
SIGNIFOR,
FERROUS SULFATE
(+20 more)
Raw JSON (click to expand)
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],
"summary_narrativeincludeclinical": "CASE EVENT DATE: 20251007"
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"primarysource": {
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"seriousnessdeath": 2,
"seriousnessdisabling": 2,
"seriousnesshospitalization": 1,
"seriousnesslifethreatening": 2,
"seriousnessother": 2,
"source_file": "1_ADR25Q4.xml",
"transmissiondate": "2026-01-17T00:00:00",
"transmissiondateformat": "102"
}