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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124164773 | 12416477 | 3 | F | 201605 | 20160725 | 20160530 | 20160728 | EXP | US-PFIZER INC-2016276677 | PFIZER | 81.00 | YR | F | Y | 53.00000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124164773 | 12416477 | 1 | PS | PREMARIN | ESTROGENS, CONJUGATED | 1 | Vaginal | 1X/DAY (SHE THINKS SHE WAS USING 0.5 GRAMS OR LESS) | Y | L99441 | 20216 | VAGINAL CREAM | QD | ||||||
| 124164773 | 12416477 | 2 | SS | PREMARIN | ESTROGENS, CONJUGATED | 1 | UNK | Y | L9941 | 20216 | VAGINAL CREAM | ||||||||
| 124164773 | 12416477 | 3 | C | CLOTRIMAZOLE BETAMETHASONE | 2 | 1 DF (1 APPLICATION), DAILY | 306345 | 0 | 1 | DF | |||||||||
| 124164773 | 12416477 | 4 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 2.5 %, 1X/DAY | 30 | PCT | 0 | 2.5 | PCT | QD | ||||||
| 124164773 | 12416477 | 5 | C | CLOBETASOL | CLOBETASOL | 1 | .05 %, 2X/DAY | 0 | CREAM | BID | |||||||||
| 124164773 | 12416477 | 6 | C | FLUOCINONIDE. | FLUOCINONIDE | 1 | UNK UNK, 2X/DAY | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124164773 | 12416477 | 1 | Atrophic vulvovaginitis |
| 124164773 | 12416477 | 2 | Pruritus genital |
| 124164773 | 12416477 | 3 | Vulvovaginal discomfort |
| 124164773 | 12416477 | 4 | Vulvovaginal discomfort |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124164773 | 12416477 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124164773 | 12416477 | Condition aggravated | |
| 124164773 | 12416477 | Rash | |
| 124164773 | 12416477 | Rash erythematous | |
| 124164773 | 12416477 | Rash macular | |
| 124164773 | 12416477 | Rash pruritic | |
| 124164773 | 12416477 | Vulvovaginal discomfort |
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 |
|---|---|---|---|---|---|---|
| 124164773 | 12416477 | 1 | 20160523 | 20160524 | 0 | |
| 124164773 | 12416477 | 3 | 20160512 | 20160524 | 0 | |
| 124164773 | 12416477 | 4 | 20160512 | 20160523 | 0 | |
| 124164773 | 12416477 | 5 | 20160719 | 0 |