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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121010533 | 12101053 | 3 | F | 20160206 | 20160808 | 20160222 | 20160823 | PER | US-PFIZER INC-2016078138 | PFIZER | 60.00 | YR | F | Y | 59.00000 | KG | 20160823 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121010533 | 12101053 | 1 | PS | PREMARIN | ESTROGENS, CONJUGATED | 1 | Vaginal | 0.5 MG, SINGLE | Y | L94943 | 20216 | .5 | MG | VAGINAL CREAM | |||||
| 121010533 | 12101053 | 2 | SS | PREMARIN | ESTROGENS, CONJUGATED | 1 | Vaginal | 0.5 G, 2X/WEEK | Y | 20216 | .5 | G | VAGINAL CREAM | BIW | |||||
| 121010533 | 12101053 | 3 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | UNK, DAILY (108 MCG/ACT 2 PUFFS) | 0 | |||||||||||
| 121010533 | 12101053 | 4 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK UNK, AS NEEDED (50 MCG/ACT 1 SPRAY, 1 SPRAY IN EACH NOSTRIL ONCE A DAY) | 0 | |||||||||||
| 121010533 | 12101053 | 5 | C | CETIRIZINE HCL | CETIRIZINE HYDROCHLORIDE | 1 | 10 MG, DAILY | 0 | 10 | MG | CAPSULE | ||||||||
| 121010533 | 12101053 | 6 | C | CETIRIZINE HCL | CETIRIZINE HYDROCHLORIDE | 1 | (CAPSULE AS NEEDED ONCE A DAY)10 MG, AS NEEDED | 0 | 10 | MG | CAPSULE | ||||||||
| 121010533 | 12101053 | 7 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | UNK (90 MCG/ACTUATION AEROSOL INHALER) | 0 | ||||||||||
| 121010533 | 12101053 | 8 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK, AS NEEDED (108 (90 BASE) MCG/ACT, 2 PUFFS AS NEEDED EVERY 4 HRS) | 0 | |||||||||||
| 121010533 | 12101053 | 9 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 3 ML, 3X/DAY, (2.5 MG/3 ML) 0.08% NEBULIZATION SOLUTION | 0 | 3 | ML | NEBULISER SOLUTION | TID | ||||||
| 121010533 | 12101053 | 10 | C | HALCION | TRIAZOLAM | 1 | 0.25 MG, AS NEEDED (1 TABLET AT BEDTIME AS NEEDED ONCE A DAY) | 0 | .25 | MG | TABLET | ||||||||
| 121010533 | 12101053 | 11 | C | CALCIUM +D3 | CALCIUMCHOLECALCIFEROL | 1 | UNK (CALCIUM 1200+ D3 600-40-500 MG-MG) | 0 | PROLONGED-RELEASE TABLET | ||||||||||
| 121010533 | 12101053 | 12 | C | METROGEL VAGINAL | METRONIDAZOLE | 1 | Vaginal | UNK UNK, DAILY (INSERT 1 APPLICATOR(S) FULL EVERY DAY BY VAGINAL ROUTE FOR 5 DAYS) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121010533 | 12101053 | 1 | Vulvovaginal dryness |
| 121010533 | 12101053 | 2 | Vaginal inflammation |
| 121010533 | 12101053 | 3 | Asthma |
| 121010533 | 12101053 | 4 | Drug hypersensitivity |
| 121010533 | 12101053 | 5 | Drug hypersensitivity |
| 121010533 | 12101053 | 7 | Asthma |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121010533 | 12101053 | Dermatitis contact | |
| 121010533 | 12101053 | Drug hypersensitivity | |
| 121010533 | 12101053 | Vaginal discharge | |
| 121010533 | 12101053 | Vaginal infection | |
| 121010533 | 12101053 | Vulvovaginal burning sensation | |
| 121010533 | 12101053 | Vulvovaginal discomfort | |
| 121010533 | 12101053 | Vulvovaginitis |
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 |
|---|---|---|---|---|---|---|
| 121010533 | 12101053 | 1 | 20160206 | 20160206 | 0 | |
| 121010533 | 12101053 | 2 | 20160205 | 0 |