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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1039538410 | 10395384 | 10 | F | 20140417 | 20160729 | 20140820 | 20160808 | EXP | US-ROCHE-1391370 | ROCHE | 0.00 | DY | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1039538410 | 10395384 | 1 | PS | Omalizumab | OMALIZUMAB | 1 | Transplacental | 103976 | |||||||||||
| 1039538410 | 10395384 | 2 | SS | Omalizumab | OMALIZUMAB | 1 | Transmammary | 103976 | |||||||||||
| 1039538410 | 10395384 | 3 | C | AMOXIL | AMOXICILLIN | 1 | 0 | ||||||||||||
| 1039538410 | 10395384 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | 0 | ||||||||||||
| 1039538410 | 10395384 | 5 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1039538410 | 10395384 | 1 | Product used for unknown indication |
| 1039538410 | 10395384 | 4 | Pyrexia |
| 1039538410 | 10395384 | 5 | Hypersensitivity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1039538410 | 10395384 | CA |
| 1039538410 | 10395384 | HO |
| 1039538410 | 10395384 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1039538410 | 10395384 | Bronchiolitis | |
| 1039538410 | 10395384 | Bronchospasm | |
| 1039538410 | 10395384 | Conjunctivitis | |
| 1039538410 | 10395384 | Cryptorchism | |
| 1039538410 | 10395384 | Ear infection | |
| 1039538410 | 10395384 | Exposure during breast feeding | |
| 1039538410 | 10395384 | Foetal exposure during pregnancy | |
| 1039538410 | 10395384 | Gastrooesophageal reflux disease | |
| 1039538410 | 10395384 | Inguinal hernia | |
| 1039538410 | 10395384 | Jaundice neonatal | |
| 1039538410 | 10395384 | Penis disorder | |
| 1039538410 | 10395384 | Tooth injury | |
| 1039538410 | 10395384 | Umbilical granuloma | |
| 1039538410 | 10395384 | Upper respiratory tract infection | |
| 1039538410 | 10395384 | Urticaria chronic | |
| 1039538410 | 10395384 | Viral infection | |
| 1039538410 | 10395384 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 1039538410 | 10395384 | 1 | 201011 | 0 |