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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104029355 | 10402935 | 5 | F | 201111 | 20160728 | 20140822 | 20160804 | PER | US-BAYER-2014-125402 | BAYER | 33.00 | YR | A | F | Y | 83.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104029355 | 10402935 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | N | TU00B12 | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | |||||
| 104029355 | 10402935 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | N | 21225 | INTRAUTERINE DELIVERY SYSTEM | ||||||||||
| 104029355 | 10402935 | 3 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 104029355 | 10402935 | 4 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | 0 | |||||||||||
| 104029355 | 10402935 | 5 | C | LOESTRIN NOS | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | 0 | ||||||||||||
| 104029355 | 10402935 | 6 | C | POTASSIUM | POTASSIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104029355 | 10402935 | 1 | Contraception |
| 104029355 | 10402935 | 2 | Menorrhagia |
| 104029355 | 10402935 | 3 | Depression |
| 104029355 | 10402935 | 4 | Obsessive-compulsive disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104029355 | 10402935 | OT |
| 104029355 | 10402935 | LT |
| 104029355 | 10402935 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104029355 | 10402935 | Abdominal pain | |
| 104029355 | 10402935 | Anhedonia | |
| 104029355 | 10402935 | Anxiety | |
| 104029355 | 10402935 | Depression | |
| 104029355 | 10402935 | Device difficult to use | |
| 104029355 | 10402935 | Device dislocation | |
| 104029355 | 10402935 | Device issue | |
| 104029355 | 10402935 | Drug ineffective | |
| 104029355 | 10402935 | Dyspareunia | |
| 104029355 | 10402935 | Emotional distress | |
| 104029355 | 10402935 | General physical health deterioration | |
| 104029355 | 10402935 | Infection | |
| 104029355 | 10402935 | Injury | |
| 104029355 | 10402935 | Menorrhagia | |
| 104029355 | 10402935 | Pregnancy with contraceptive device | |
| 104029355 | 10402935 | Uterine perforation |
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 |
|---|---|---|---|---|---|---|
| 104029355 | 10402935 | 1 | 20111018 | 20120228 | 0 | |
| 104029355 | 10402935 | 3 | 2006 | 0 | ||
| 104029355 | 10402935 | 4 | 2011 | 0 |