The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASE I F COD FOLL SEQ IMAGE EVENT DT MFR DT FDA DT REPT COD MFR NUM MFR SNDR AGE AGE COD GNDR COD E SUB WT WT COD REPT DT OCCP COD DEATH DT TO MFR CONFID REPORTER COUNTRY
4394106 4162640 F 1 4394106-3 20040517 20040618 20040630 EXP 200410400BCA BAYER PHARMACEUTICAL CORPORATION 77 YR M N 150 LBS 20040625

Drug(s) used by person

Event ID DRUG SEQ ROLE COD DRUGNAME VAL VBM ROUTE DOSE VBM DECHAL RECHAL LOT NUM EXP DT NDA NUM
4394106 1005002682 PS GAMIMUNE N 10% 1 35 MG, INTRAVENOUS; SEE IMAGE Y Y 26N3C11 20060819
4394106 1005022002 SS GAMIMUNE N 1 26N3K41 20060926
4394106 1005022003 SS GAMIMUNE N 1 26N3C11 20060819
4394106 1005022005 C GAMIMUNE N 1 26N3C11 20060819
4394106 1005022006 C METOPROLOL 2
4394106 1005022007 C L-THYROXINE 2
4394106 1005022008 C NAPROXEN 1
4394106 1005022010 C ISOSORBIDE 1
4394106 1005022012 C SERAX 1

Indications of drugs used

Event ID DRUG SEQ INDI PT
4394106 1005002682 NERVOUS SYSTEM DISORDER
4394106 1005002682 NEUROPATHY PERIPHERAL

Outcome of event

Event ID OUTC COD
4394106 LT
4394106 OT

Reactions reported

Event ID PT
4394106 BRADYCARDIA
4394106 COMA
4394106 EYE ROLLING
4394106 HYPOTENSION
4394106 INFUSION RELATED REACTION
4394106 LOSS OF CONSCIOUSNESS
4394106 PALLOR
4394106 SKIN DISCOLOURATION

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID RPSR COD
4394106 FGN
4394106 HP
4394106 OTH

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
4394106 1005002682 20040614