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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124041982 | 12404198 | 2 | F | 20160505 | 20160712 | 20160525 | 20160726 | EXP | US-ALKERMES INC.-ALK-2016-001356 | ALKERMES | 54.00 | YR | F | Y | 75.28000 | KG | 20160726 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124041982 | 12404198 | 1 | PS | VIVITROL | NALTREXONE | 1 | Intramuscular | 380 MG, QMO | 380 | MG | Y | 80426 | 21897 | 380 | MG | INJECTION | |||
| 124041982 | 12404198 | 2 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | Y | 0 | |||||||||
| 124041982 | 12404198 | 3 | C | TRAMADOL. | TRAMADOL | 1 | UNK | 0 | |||||||||||
| 124041982 | 12404198 | 4 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 124041982 | 12404198 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | 0 | |||||||||||
| 124041982 | 12404198 | 6 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | 0 | |||||||||||
| 124041982 | 12404198 | 7 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124041982 | 12404198 | 1 | Alcoholism |
| 124041982 | 12404198 | 2 | Injection site reaction |
| 124041982 | 12404198 | 3 | Pain |
| 124041982 | 12404198 | 4 | Depression |
| 124041982 | 12404198 | 5 | Product used for unknown indication |
| 124041982 | 12404198 | 6 | Product used for unknown indication |
| 124041982 | 12404198 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124041982 | 12404198 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124041982 | 12404198 | Adverse drug reaction | |
| 124041982 | 12404198 | Injection site abscess | |
| 124041982 | 12404198 | Injection site erythema | |
| 124041982 | 12404198 | Injection site induration | |
| 124041982 | 12404198 | Injection site pain | |
| 124041982 | 12404198 | Injection site reaction | |
| 124041982 | 12404198 | Injection site swelling | |
| 124041982 | 12404198 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 124041982 | 12404198 | 1 | 20160415 | 20160416 | 0 | |
| 124041982 | 12404198 | 2 | 20160505 | 20160512 | 0 |