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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126599522 | 12659952 | 2 | F | 201601 | 20160816 | 20160817 | 20160824 | PER | US-SHIRE-US201609692 | SHIRE | 5.60 | YR | M | Y | 17.69000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126599522 | 12659952 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, 1X/DAY:QD | 3144586 | 21977 | 20 | MG | CAPSULE | QD | |||||
| 126599522 | 12659952 | 2 | C | FLONASE /00908302/ | MOMETASONE FUROATE | 1 | Nasal | 50 MG, 1X/DAY:QD | 0 | 50 | MG | QD | |||||||
| 126599522 | 12659952 | 3 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | 30 MG, 1X/DAY:QD | 0 | 30 | MG | TABLET | QD | ||||||
| 126599522 | 12659952 | 4 | C | CLONIDINE. | CLONIDINE | 1 | Oral | 0.1 MG, 1X/DAY:QD | 0 | .1 | MG | TABLET | QD | ||||||
| 126599522 | 12659952 | 5 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 6.25 MG, UNKNOWN | 0 | 6.25 | MG | TABLET | |||||||
| 126599522 | 12659952 | 6 | C | MULTIVITAMINS | VITAMINS | 1 | Oral | UNK, 1X/DAY:QD | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126599522 | 12659952 | 1 | Attention deficit/hyperactivity disorder |
| 126599522 | 12659952 | 2 | Seasonal allergy |
| 126599522 | 12659952 | 3 | Seasonal allergy |
| 126599522 | 12659952 | 4 | Sleep disorder |
| 126599522 | 12659952 | 5 | Sleep disorder |
| 126599522 | 12659952 | 6 | Supplementation therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126599522 | 12659952 | Aggression | |
| 126599522 | 12659952 | Anger | |
| 126599522 | 12659952 | Disturbance in attention | |
| 126599522 | 12659952 | Drug administered to patient of inappropriate age | |
| 126599522 | 12659952 | Emotional distress | |
| 126599522 | 12659952 | Frustration tolerance decreased | |
| 126599522 | 12659952 | Poor quality drug administered | |
| 126599522 | 12659952 | Product quality issue | |
| 126599522 | 12659952 | 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 |
|---|---|---|---|---|---|---|
| 126599522 | 12659952 | 1 | 201601 | 0 |