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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125546232 | 12554623 | 2 | F | 201607 | 20160721 | 20160713 | 20160804 | PER | US-SHIRE-US201608708 | SHIRE | 74.08 | YR | F | Y | 64.40000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125546232 | 12554623 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | Y | Y | 21977 | 30 | MG | CAPSULE | QD | ||||
| 125546232 | 12554623 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, UNKNOWN (TOOK 2/3 OF THE MEDICATION) | Y | Y | 21977 | CAPSULE | |||||||
| 125546232 | 12554623 | 3 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | 10 MG, 2X/DAY:BID | 0 | 10 | MG | BID | |||||||
| 125546232 | 12554623 | 4 | C | VALIUM | DIAZEPAM | 1 | Oral | 2 MG, AS REQ'D | 0 | 2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125546232 | 12554623 | 1 | Attention deficit/hyperactivity disorder |
| 125546232 | 12554623 | 3 | Attention deficit/hyperactivity disorder |
| 125546232 | 12554623 | 4 | Sleep disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125546232 | 12554623 | Agitation | Agitation |
| 125546232 | 12554623 | Discomfort | |
| 125546232 | 12554623 | Feeling abnormal | |
| 125546232 | 12554623 | Incorrect dosage administered | |
| 125546232 | 12554623 | Psychomotor hyperactivity | |
| 125546232 | 12554623 | Tension | |
| 125546232 | 12554623 | Therapeutic response unexpected | |
| 125546232 | 12554623 | Treatment noncompliance | |
| 125546232 | 12554623 | Wrong technique in product usage process |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125546232 | 12554623 | 1 | 20160709 | 0 | ||
| 125546232 | 12554623 | 2 | 20160721 | 20160721 | 0 |