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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887751 | 12588775 | 1 | I | 20160613 | 20160725 | 20160725 | PER | US-JNJFOC-20160612771 | JANSSEN | 67.00 | YR | E | F | Y | 68.04000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887751 | 12588775 | 1 | PS | TYLENOL 8 HR ARTHRITIS PAIN | ACETAMINOPHEN | 1 | Oral | N | 1392072 | 19872 | CAPLET | ||||||||
| 125887751 | 12588775 | 2 | SS | TYLENOL 8 HR ARTHRITIS PAIN | ACETAMINOPHEN | 1 | Oral | IN THE MORNING. | N | 1392072 | 19872 | CAPLET | |||||||
| 125887751 | 12588775 | 3 | SS | TYLENOL PM EXTRA STRENGTH | ACETAMINOPHENDIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | TAKING AT NIGHT BEFORE BED. | N | HMC206 | 0 | CAPLET | |||||||
| 125887751 | 12588775 | 4 | SS | TYLENOL PM EXTRA STRENGTH | ACETAMINOPHENDIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | TAKING AT NIGHT BEFORE BED. | N | HMC206 | 999999 | CAPLET | |||||||
| 125887751 | 12588775 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125887751 | 12588775 | 6 | C | ALL OTHER THERAPEUTIC PRODUCTS | UNSPECIFIED INGREDIENT | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125887751 | 12588775 | 2 | Analgesic therapy |
| 125887751 | 12588775 | 3 | Analgesic therapy |
| 125887751 | 12588775 | 4 | Sleep disorder |
| 125887751 | 12588775 | 5 | Product used for unknown indication |
| 125887751 | 12588775 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125887751 | 12588775 | Incorrect dose administered | |
| 125887751 | 12588775 | Product packaging issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |