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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118040372 | 11804037 | 2 | F | 20150913 | 20160712 | 20151204 | 20160725 | EXP | US-JNJFOC-20151200319 | JOHNSON AND JOHNSON | 0.00 | DY | N | Y | 2.06000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118040372 | 11804037 | 1 | PS | STELARA | USTEKINUMAB | 1 | Transplacental | N | 125261 | 90 | MG | SOLUTION FOR INJECTION | /month | ||||||
| 118040372 | 11804037 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Transplacental | N | 0 | 1 | DF | TABLET | BID | ||||||
| 118040372 | 11804037 | 3 | SS | TYLENOL | ACETAMINOPHEN | 1 | Transplacental | N | 19872 | 1 | DF | TABLET | TID | ||||||
| 118040372 | 11804037 | 4 | SS | ESTRADIOL. | ESTRADIOL | 1 | Transplacental | N | 0 | PATCH | |||||||||
| 118040372 | 11804037 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 9 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 17 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 35 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 30 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 8 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 12 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 7 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 13 | SS | PREDNISONE. | PREDNISONE | 1 | Transplacental | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 118040372 | 11804037 | 14 | SS | TUMS | CALCIUM CARBONATE | 1 | Transplacental | 0 | 1 | DF | TABLET | ||||||||
| 118040372 | 11804037 | 15 | SS | CRINONE | PROGESTERONE | 1 | Transplacental | 0 | GEL | ||||||||||
| 118040372 | 11804037 | 16 | SS | PROGESTERONE. | PROGESTERONE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118040372 | 11804037 | 17 | SS | ESTRADIOL. | ESTRADIOL | 1 | Transplacental | 0 | 2 | MG | UNSPECIFIED | QD | |||||||
| 118040372 | 11804037 | 18 | C | BIOTIN | BIOTIN | 1 | Transplacental | 0 | 1000 | MG | UNSPECIFIED | QD | |||||||
| 118040372 | 11804037 | 19 | C | CALCIUM | CALCIUM | 1 | Transplacental | 0 | 1200 | MG | UNSPECIFIED | QD | |||||||
| 118040372 | 11804037 | 20 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Transplacental | 0 | 2000 | MG | UNSPECIFIED | QD | |||||||
| 118040372 | 11804037 | 21 | C | FOLIC ACID. | FOLIC ACID | 1 | Transplacental | 0 | 1 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118040372 | 11804037 | 1 | Crohn's disease |
| 118040372 | 11804037 | 2 | Headache |
| 118040372 | 11804037 | 3 | Headache |
| 118040372 | 11804037 | 4 | In vitro fertilisation |
| 118040372 | 11804037 | 5 | Crohn's disease |
| 118040372 | 11804037 | 6 | Crohn's disease |
| 118040372 | 11804037 | 7 | Crohn's disease |
| 118040372 | 11804037 | 8 | Crohn's disease |
| 118040372 | 11804037 | 9 | Crohn's disease |
| 118040372 | 11804037 | 10 | Crohn's disease |
| 118040372 | 11804037 | 11 | Crohn's disease |
| 118040372 | 11804037 | 12 | Crohn's disease |
| 118040372 | 11804037 | 13 | Crohn's disease |
| 118040372 | 11804037 | 14 | Dyspepsia |
| 118040372 | 11804037 | 15 | In vitro fertilisation |
| 118040372 | 11804037 | 16 | In vitro fertilisation |
| 118040372 | 11804037 | 17 | In vitro fertilisation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118040372 | 11804037 | OT |
| 118040372 | 11804037 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118040372 | 11804037 | Atrial septal defect | |
| 118040372 | 11804037 | Foetal exposure during pregnancy | |
| 118040372 | 11804037 | Haemangioma | |
| 118040372 | 11804037 | Premature baby | |
| 118040372 | 11804037 | Ventricular septal defect |
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 |
|---|---|---|---|---|---|---|
| 118040372 | 11804037 | 1 | 20130215 | 20150701 | 0 | |
| 118040372 | 11804037 | 2 | 20150430 | 20150903 | 0 | |
| 118040372 | 11804037 | 3 | 20150109 | 20150420 | 0 | |
| 118040372 | 11804037 | 4 | 20150116 | 20150410 | 0 | |
| 118040372 | 11804037 | 5 | 20150409 | 20150415 | 0 | |
| 118040372 | 11804037 | 6 | 20150802 | 20150913 | 0 | |
| 118040372 | 11804037 | 7 | 20150531 | 20150801 | 0 | |
| 118040372 | 11804037 | 8 | 20150523 | 20150530 | 0 | |
| 118040372 | 11804037 | 9 | 20150508 | 20150522 | 0 | |
| 118040372 | 11804037 | 10 | 20150109 | 20150408 | 0 | |
| 118040372 | 11804037 | 11 | 20150416 | 20150422 | 0 | |
| 118040372 | 11804037 | 12 | 20150423 | 20150429 | 0 | |
| 118040372 | 11804037 | 13 | 20150430 | 20150507 | 0 | |
| 118040372 | 11804037 | 14 | 20150430 | 20150903 | 0 | |
| 118040372 | 11804037 | 17 | 20150116 | 20150410 | 0 | |
| 118040372 | 11804037 | 18 | 20150109 | 20150913 | 0 | |
| 118040372 | 11804037 | 19 | 20150109 | 20150913 | 0 | |
| 118040372 | 11804037 | 20 | 20150109 | 20150913 | 0 | |
| 118040372 | 11804037 | 21 | 20150109 | 20150913 | 0 |