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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126783712 | 12678371 | 2 | F | 2009 | 20160907 | 20160823 | 20160919 | EXP | US-SHIRE-US201610461 | SHIRE | 41.40 | YR | F | Y | 68.27000 | KG | 20160919 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126783712 | 12678371 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 70 MG, 1X/DAY:QD | 21977 | 70 | MG | CAPSULE | QD | ||||||
| 126783712 | 12678371 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, UNKNOWN | 21977 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126783712 | 12678371 | 1 | Narcolepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126783712 | 12678371 | HO |
| 126783712 | 12678371 | OT |
| 126783712 | 12678371 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126783712 | 12678371 | Activities of daily living impaired | |
| 126783712 | 12678371 | Amnesia | |
| 126783712 | 12678371 | Atrial fibrillation | |
| 126783712 | 12678371 | Autoimmune hepatitis | |
| 126783712 | 12678371 | Basedow's disease | |
| 126783712 | 12678371 | Blood thyroid stimulating hormone increased | |
| 126783712 | 12678371 | Brain injury | |
| 126783712 | 12678371 | Cardiac failure congestive | |
| 126783712 | 12678371 | Cerebral haematoma | |
| 126783712 | 12678371 | Condition aggravated | |
| 126783712 | 12678371 | Depression | |
| 126783712 | 12678371 | Disability | |
| 126783712 | 12678371 | Drug dose omission | |
| 126783712 | 12678371 | Fatigue | |
| 126783712 | 12678371 | Feeling abnormal | |
| 126783712 | 12678371 | General symptom | |
| 126783712 | 12678371 | Hypertension | |
| 126783712 | 12678371 | Hypoaesthesia | |
| 126783712 | 12678371 | Intervertebral disc protrusion | |
| 126783712 | 12678371 | Logorrhoea | |
| 126783712 | 12678371 | Menopause | |
| 126783712 | 12678371 | Paralysis | |
| 126783712 | 12678371 | Peripheral venous disease | |
| 126783712 | 12678371 | Physical assault | |
| 126783712 | 12678371 | Post-traumatic stress disorder | |
| 126783712 | 12678371 | Product quality issue | |
| 126783712 | 12678371 | Product tampering | |
| 126783712 | 12678371 | Product use issue | |
| 126783712 | 12678371 | Spinal column stenosis | |
| 126783712 | 12678371 | Sudden onset of sleep | |
| 126783712 | 12678371 | Thyroid cancer | |
| 126783712 | 12678371 | Thyroid disorder | |
| 126783712 | 12678371 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126783712 | 12678371 | 1 | 2010 | 0 | ||
| 126783712 | 12678371 | 2 | 2009 | 2010 | 0 |