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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126192381 | 12619238 | 1 | I | 2016 | 20160715 | 20160803 | 20160803 | PER | US-SHIRE-US201608919 | SHIRE | 9.81 | YR | F | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126192381 | 12619238 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, OTHER (HALF CONTENTS IN AM AND HALF CONTENTS IN PM) | 3139745 | 21977 | 60 | MG | CAPSULE | ||||||
| 126192381 | 12619238 | 2 | C | MULTIVITAMIN /07504101/ | VITAMINS | 1 | Oral | UNK, 1X/DAY:QD | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126192381 | 12619238 | 1 | Attention deficit/hyperactivity disorder |
| 126192381 | 12619238 | 2 | Vitamin supplementation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126192381 | 12619238 | Defiant behaviour | |
| 126192381 | 12619238 | Depressed mood | |
| 126192381 | 12619238 | Disturbance in attention | |
| 126192381 | 12619238 | Drug ineffective | |
| 126192381 | 12619238 | Dysgraphia | |
| 126192381 | 12619238 | Inappropriate schedule of drug administration | |
| 126192381 | 12619238 | Mood altered | |
| 126192381 | 12619238 | Product quality issue | |
| 126192381 | 12619238 | Restlessness | |
| 126192381 | 12619238 | Tic | |
| 126192381 | 12619238 | 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
| no results found |