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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125323711 | 12532371 | 1 | I | 20160624 | 20160706 | 20160706 | EXP | DE-MYLANLABS-2016M1027376 | MYLAN | 0.00 | Y | 0.00000 | 20160706 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125323711 | 12532371 | 1 | PS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Transplacental | 125 MG, QD | 77166 | 125 | MG | QD | |||||||
| 125323711 | 12532371 | 2 | C | FRAGMIN | DALTEPARIN SODIUM | 1 | Transplacental | UNK (PROBABLY COMPLETE PREGNANCY) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125323711 | 12532371 | 1 | Anxiety disorder |
| 125323711 | 12532371 | 2 | Factor V Leiden mutation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125323711 | 12532371 | CA |
| 125323711 | 12532371 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125323711 | 12532371 | Bradycardia neonatal | |
| 125323711 | 12532371 | Foetal exposure during pregnancy | |
| 125323711 | 12532371 | Haemangioma congenital | |
| 125323711 | 12532371 | Infantile apnoea | |
| 125323711 | 12532371 | Selective eating disorder |
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 |
|---|---|---|---|---|---|---|
| 125323711 | 12532371 | 1 | 20150427 | 20160124 | 0 |