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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125886071 | 12588607 | 1 | I | 20160503 | 20160725 | 20160725 | PER | US-JNJFOC-20160503900 | JANSSEN | 77.00 | YR | E | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125886071 | 12588607 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | U | U | 426870 | 19835 | 1 | DF | TABLET | QD | ||||
| 125886071 | 12588607 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | U | U | 426870 | 19835 | 1 | DF | TABLET | QD | ||||
| 125886071 | 12588607 | 3 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | Unknown | TAKEN ON AND OFF | 0 | 2 | DF | CAPLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125886071 | 12588607 | 1 | Sinus operation |
| 125886071 | 12588607 | 2 | Sinus headache |
| 125886071 | 12588607 | 3 | Headache |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125886071 | 12588607 | Drug ineffective for unapproved indication | |
| 125886071 | 12588607 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125886071 | 12588607 | 1 | 20160408 | 20160502 | 0 | |
| 125886071 | 12588607 | 2 | 20160408 | 20160502 | 0 | |
| 125886071 | 12588607 | 3 | 20160408 | 0 |