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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125893211 | 12589321 | 1 | I | 20160626 | 20160629 | 20160725 | 20160725 | PER | US-JNJFOC-20160700387 | JANSSEN | 55.00 | YR | A | F | Y | 74.84000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125893211 | 12589321 | 1 | PS | MOTRIN INFANTS | IBUPROFEN | 1 | Oral | N | FHB4V00 | 20603 | DROPS | ||||||||
| 125893211 | 12589321 | 2 | SS | MOTRIN INFANTS | IBUPROFEN | 1 | Oral | SMALL DOSE, JUST ONCE | N | FHB4V00 | 20603 | DROPS | |||||||
| 125893211 | 12589321 | 3 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125893211 | 12589321 | 4 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125893211 | 12589321 | 2 | Product used for unknown indication |
| 125893211 | 12589321 | 3 | Pain |
| 125893211 | 12589321 | 4 | Fibromyalgia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125893211 | 12589321 | Drug administered to patient of inappropriate age | |
| 125893211 | 12589321 | Off label use | |
| 125893211 | 12589321 | Product use issue | |
| 125893211 | 12589321 | Throat irritation |
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 |
|---|---|---|---|---|---|---|
| 125893211 | 12589321 | 2 | 20160626 | 20160626 | 0 |