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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126695452 | 12669545 | 2 | F | 20150226 | 20160822 | 20160819 | 20160826 | EXP | US-JNJFOC-20150908220 | JANSSEN | 0.00 | YR | F | Y | 2.72000 | KG | 20160826 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126695452 | 12669545 | 1 | PS | EVIPLERA | EMTRICITABINERILPIVIRINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | N | KNHF | 0 | 1 | DF | TABLET | QD | |||||
| 126695452 | 12669545 | 2 | SS | DARUNAVIR | DARUNAVIR | 1 | Transplacental | N | KNHF | 21976 | 1 | DF | TABLETS | QD | |||||
| 126695452 | 12669545 | 3 | SS | DIFLUCAN | FLUCONAZOLE | 1 | Transplacental | 0 | 150 | MG | UNSPECIFIED | ||||||||
| 126695452 | 12669545 | 4 | SS | MACROBID | NITROFURANTOINNITROFURANTOIN MONOHYDRATE | 1 | Transplacental | 0 | 100 | MG | UNSPECIFIED | BID | |||||||
| 126695452 | 12669545 | 5 | SS | FLUVIRIN NOS | INFLUENZA VIRUS VACCINE | 1 | Transplacental | 0 | .5 | ML | UNSPECIFIED | ||||||||
| 126695452 | 12669545 | 6 | SS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Transplacental | 0 | 300 | MG | TABLET | BID | |||||||
| 126695452 | 12669545 | 7 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 0 | 8 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126695452 | 12669545 | 1 | HIV infection |
| 126695452 | 12669545 | 2 | Infection prophylaxis |
| 126695452 | 12669545 | 3 | Product used for unknown indication |
| 126695452 | 12669545 | 4 | Product used for unknown indication |
| 126695452 | 12669545 | 5 | Immunisation |
| 126695452 | 12669545 | 6 | Product used for unknown indication |
| 126695452 | 12669545 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126695452 | 12669545 | OT |
| 126695452 | 12669545 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126695452 | 12669545 | Foetal exposure during pregnancy | |
| 126695452 | 12669545 | 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 |
|---|---|---|---|---|---|---|
| 126695452 | 12669545 | 1 | 20150226 | 20150811 | 0 | |
| 126695452 | 12669545 | 2 | 20150427 | 20150811 | 0 | |
| 126695452 | 12669545 | 3 | 20150226 | 20150319 | 0 | |
| 126695452 | 12669545 | 4 | 20150220 | 20150226 | 0 | |
| 126695452 | 12669545 | 5 | 20150319 | 20150319 | 0 | |
| 126695452 | 12669545 | 6 | 20150226 | 20150811 | 0 | |
| 126695452 | 12669545 | 7 | 20150226 | 20150730 | 0 |