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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124162864 | 12416286 | 4 | F | 201605 | 20160720 | 20160530 | 20160726 | PER | US-PFIZER INC-2016276582 | PFIZER | 63.00 | YR | F | Y | 80.00000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124162864 | 12416286 | 1 | PS | PREMPRO | ESTROGENS, CONJUGATEDMEDROXYPROGESTERONE ACETATE | 1 | Oral | 0.625 MG/0.5 MG, 1X/DAY | 20527 | TABLET | QD | ||||||||
| 124162864 | 12416286 | 2 | C | TRIAMTERENE. | TRIAMTERENE | 1 | UNK | 0 | |||||||||||
| 124162864 | 12416286 | 3 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 10 MG, 1X/DAY | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124162864 | 12416286 | 1 | Menopausal symptoms |
| 124162864 | 12416286 | 2 | Fluid retention |
| 124162864 | 12416286 | 3 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124162864 | 12416286 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124162864 | 12416286 | Abdominal distension | |
| 124162864 | 12416286 | Body temperature fluctuation | |
| 124162864 | 12416286 | Fatigue | |
| 124162864 | 12416286 | Flatulence | |
| 124162864 | 12416286 | Insomnia | |
| 124162864 | 12416286 | Malaise | |
| 124162864 | 12416286 | Pre-existing condition improved | |
| 124162864 | 12416286 | Skin texture abnormal | |
| 124162864 | 12416286 | Therapeutic response unexpected | |
| 124162864 | 12416286 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 124162864 | 12416286 | 3 | 2011 | 0 |