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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126190332 | 12619033 | 2 | F | 201607 | 20160815 | 20160803 | 20160823 | EXP | US-BAXALTA-2016BLT005519 | BAXALTA | 56.16 | YR | F | Y | 0.00000 | 20160823 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126190332 | 12619033 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 125105 | SOLUTION FOR INFUSION | ||||||||||
| 126190332 | 12619033 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | 125105 | SOLUTION FOR INFUSION | |||||||||
| 126190332 | 12619033 | 3 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 35 G, 1X A MONTH | 125105 | 35 | G | SOLUTION FOR INFUSION | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126190332 | 12619033 | 1 | Primary immunodeficiency syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126190332 | 12619033 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126190332 | 12619033 | Chest injury | |
| 126190332 | 12619033 | Eye symptom | |
| 126190332 | 12619033 | Infusion site erythema | |
| 126190332 | 12619033 | Infusion site extravasation | |
| 126190332 | 12619033 | Infusion site pain | |
| 126190332 | 12619033 | Infusion site swelling | |
| 126190332 | 12619033 | Infusion site warmth | |
| 126190332 | 12619033 | Meningitis aseptic | |
| 126190332 | 12619033 | Oropharyngeal pain | |
| 126190332 | 12619033 | Pyrexia | |
| 126190332 | 12619033 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 126190332 | 12619033 | 3 | 20160715 | 0 |