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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125643332 | 12564333 | 2 | F | 2016 | 20160719 | 20160718 | 20160722 | PER | US-SHIRE-US201607752 | SHIRE | 26.86 | YR | F | Y | 74.83000 | KG | 20160722 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125643332 | 12564333 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 21977 | 30 | MG | CAPSULE | QD | ||||||
| 125643332 | 12564333 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 2X/DAY:BID (30 MG IN THE AM, 30 MG A FEW HOURS LATER) | 21977 | 30 | MG | CAPSULE | BID | ||||||
| 125643332 | 12564333 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, 1X/DAY:QD | 3139686 | 21977 | 60 | MG | CAPSULE | QD | |||||
| 125643332 | 12564333 | 4 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | TWO 25 OR 50 MG PILLS, UNKNOWN | U | U | 0 | ||||||||
| 125643332 | 12564333 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | 5 MG, UNKNOWN (ON THE DAYS SHE WOKE UP LATE) | 0 | 5 | MG | ||||||||
| 125643332 | 12564333 | 6 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0.05 MG, AS REQ'D | 0 | .05 | MG | TABLET | |||||||
| 125643332 | 12564333 | 7 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 100 MG, 1X/DAY:QD | 0 | 100 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125643332 | 12564333 | 1 | Attention deficit/hyperactivity disorder |
| 125643332 | 12564333 | 4 | Product used for unknown indication |
| 125643332 | 12564333 | 5 | Sleep disorder |
| 125643332 | 12564333 | 6 | Anxiety |
| 125643332 | 12564333 | 7 | Routine health maintenance |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125643332 | 12564333 | Decreased appetite | |
| 125643332 | 12564333 | Disturbance in attention | |
| 125643332 | 12564333 | Drug ineffective | |
| 125643332 | 12564333 | Feeling abnormal | |
| 125643332 | 12564333 | Inappropriate schedule of drug administration | |
| 125643332 | 12564333 | Insomnia | |
| 125643332 | 12564333 | Paranoia | |
| 125643332 | 12564333 | Product quality issue | |
| 125643332 | 12564333 | Psychomotor hyperactivity | |
| 125643332 | 12564333 | Sneezing | |
| 125643332 | 12564333 | Therapeutic response increased |
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 |
|---|---|---|---|---|---|---|
| 125643332 | 12564333 | 1 | 201601 | 2016 | 0 | |
| 125643332 | 12564333 | 2 | 2016 | 2016 | 0 | |
| 125643332 | 12564333 | 3 | 2016 | 0 | ||
| 125643332 | 12564333 | 4 | 20160621 | 20160621 | 0 | |
| 125643332 | 12564333 | 5 | 2016 | 0 | ||
| 125643332 | 12564333 | 6 | 201601 | 0 | ||
| 125643332 | 12564333 | 7 | 201601 | 0 |