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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887321 | 12588732 | 1 | I | 20160607 | 20160725 | 20160725 | PER | US-JNJFOC-20160606873 | JANSSEN | 0.00 | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887321 | 12588732 | 1 | PS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | N | UNKNOWN | 19872 | UNKNOWN | ||||||||
| 125887321 | 12588732 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | N | UNKNOWN | 19872 | UNKNOWN | ||||||||
| 125887321 | 12588732 | 3 | C | CELEBREX | CELECOXIB | 1 | Unknown | 200 MG PER DAY (100MG TWICE DAILY) | UNKNOWN | 0 | 100 | MG | UNSPECIFIED | BID | |||||
| 125887321 | 12588732 | 4 | C | CELEBREX | CELECOXIB | 1 | Unknown | 200 MG PER DAY (100MG TWICE DAILY) | UNKNOWN | 0 | 100 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125887321 | 12588732 | 2 | Middle ear inflammation |
| 125887321 | 12588732 | 3 | Ear infection |
| 125887321 | 12588732 | 4 | Ear infection |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125887321 | 12588732 | Drug ineffective for unapproved indication | |
| 125887321 | 12588732 | Off label use | |
| 125887321 | 12588732 | Therapeutic response unexpected |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |