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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126181201 | 12618120 | 1 | I | 20160726 | 20160803 | 20160803 | PER | US-JNJFOC-20160725569 | JANSSEN | 0.00 | F | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126181201 | 12618120 | 1 | PS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 126181201 | 12618120 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 126181201 | 12618120 | 3 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | TABLET | ||||||||
| 126181201 | 12618120 | 4 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | TABLET | ||||||||
| 126181201 | 12618120 | 5 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||||
| 126181201 | 12618120 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 40 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126181201 | 12618120 | 2 | Premedication |
| 126181201 | 12618120 | 4 | Premedication |
| 126181201 | 12618120 | 5 | Product used for unknown indication |
| 126181201 | 12618120 | 6 | Premedication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126181201 | 12618120 | Off label use | |
| 126181201 | 12618120 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 126181201 | 12618120 | 5 | 20160608 | 0 |