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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126899481 | 12689948 | 1 | I | 20160627 | 20160819 | 20160826 | 20160826 | EXP | DE-PFIZER INC-2016395080 | PFIZER | 0.00 | M | Y | 3.70000 | KG | 20160826 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126899481 | 12689948 | 1 | PS | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 100 MG, DAILY, 0. - 38.2. GESTATIONAL WEEK | U | 19839 | 100 | MG | |||||||
| 126899481 | 12689948 | 2 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | UNK | U | 0 | |||||||||
| 126899481 | 12689948 | 3 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | 8 MG, DAILY | U | 0 | 8 | MG | |||||||
| 126899481 | 12689948 | 4 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | 2 MG, 3X/DAY, WEEK 37+2 UNTIL DELIVERY | U | 0 | 2 | MG | TID | ||||||
| 126899481 | 12689948 | 5 | C | FEMIBION | VITAMINS | 1 | Transplacental | UNK (1.5. - 38.2. GESTATIONAL WEEK) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126899481 | 12689948 | 1 | Depression |
| 126899481 | 12689948 | 2 | Depression |
| 126899481 | 12689948 | 5 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126899481 | 12689948 | OT |
| 126899481 | 12689948 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126899481 | 12689948 | Atrial septal defect | |
| 126899481 | 12689948 | Diarrhoea | |
| 126899481 | 12689948 | Drug withdrawal syndrome neonatal | |
| 126899481 | 12689948 | Hypertonia | |
| 126899481 | 12689948 | Maternal exposure during pregnancy | |
| 126899481 | 12689948 | Myoclonus | |
| 126899481 | 12689948 | Respiratory disorder neonatal | |
| 126899481 | 12689948 | Sneezing | |
| 126899481 | 12689948 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126899481 | 12689948 | 1 | 20151003 | 20160627 | 0 | |
| 126899481 | 12689948 | 2 | 20151003 | 0 | ||
| 126899481 | 12689948 | 3 | 20160428 | 20160526 | 0 | |
| 126899481 | 12689948 | 4 | 201606 | 20160627 | 0 | |
| 126899481 | 12689948 | 5 | 20151015 | 20160627 | 0 |