Safety Rates Drug Report: adverse events in 2016 Q3 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

Person who experienced the adverse event (patient)

Event ID	CASEID	CASEVERSION	I F COD	EVENT DT	MFR DT	INIT FDA DT	FDA DT	REPT COD	AUTH NUM	MFR NUM	MFR SNDR	LIT REF	AGE	AGE COD	AGE GRP	GNDR COD	E SUB	WT	WT COD	REPT DT	TO MFR	OCCP COD	REPORTER COUNTRY	OCCR COUNTRY
127879381	12787938	1	I	20160504	0	20160928	20160928	DIR			FDA-CTU		68.00	YR		M	N	85.50000	KG	20160720	N	PH	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127879381	12787938	1	PS	AMOXICILLIN.	AMOXICILLIN	1	Oral				D	D			0	2000	MG		1X
127879381	12787938	2	SS	LIDOCAINE.	LIDOCAINE	1	Intravenous (not otherwise specified)				D	D			0	3.4	ML		1X

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127879381	12787938	1	Antibiotic therapy
127879381	12787938	2	Anaesthesia

Outcome of event

Reactions reported

Event ID	CASEID	PT
127879381	12787938	Anaphylactic reaction
127879381	12787938	Hypotension
127879381	12787938	Pruritus
127879381	12787938	Rash

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

Event ID	CASEID	RPSR COD
127879381	12787938	HP

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT	DUR	DUR COD
127879381	12787938	1	20160504	20160504	0
127879381	12787938	2	20160504	20160504	0