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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125884531 | 12588453 | 1 | I | 20160613 | 20160725 | 20160725 | PER | US-JNJFOC-20160612698 | JANSSEN | 70.00 | YR | E | F | Y | 63.50000 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125884531 | 12588453 | 1 | SS | TYLENOL PM EXTRA STRENGTH | ACETAMINOPHENDIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 2 CAPLETS BED TIME | N | N | 0 | 2 | DF | TABLET | |||||
125884531 | 12588453 | 2 | PS | TYLENOL PM EXTRA STRENGTH | ACETAMINOPHENDIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 2 CAPLETS BED TIME | N | N | 999999 | 2 | DF | TABLET | |||||
125884531 | 12588453 | 3 | SS | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | Oral | N | N | 19872 | 2 | DF | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125884531 | 12588453 | 1 | Sleep disorder |
125884531 | 12588453 | 2 | Skin discomfort |
125884531 | 12588453 | 3 | Skin discomfort |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125884531 | 12588453 | Off label use | |
125884531 | 12588453 | Product use issue | |
125884531 | 12588453 | Rash pruritic |
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 |
---|---|---|---|---|---|---|
125884531 | 12588453 | 1 | 2016 | 0 | ||
125884531 | 12588453 | 2 | 2016 | 0 | ||
125884531 | 12588453 | 3 | 2016 | 0 |