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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126250131 | 12625013 | 1 | I | 20160719 | 20160629 | 20160805 | 20160805 | EXP | US-BAXALTA-2016BLT004708 | BAXALTA | 20.22 | YR | F | Y | 61.20000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126250131 | 12625013 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 60 G, 2X A WEEK | Y | 125105 | 60 | G | SOLUTION FOR INFUSION | BIW | |||||
| 126250131 | 12625013 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Y | 125105 | SOLUTION FOR INFUSION | ||||||||||
| 126250131 | 12625013 | 3 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 126250131 | 12625013 | 4 | C | GAMUNEX | HUMAN IMMUNOGLOBULIN G | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126250131 | 12625013 | 1 | Primary immunodeficiency syndrome |
| 126250131 | 12625013 | 2 | Secondary immunodeficiency |
| 126250131 | 12625013 | 3 | Product used for unknown indication |
| 126250131 | 12625013 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126250131 | 12625013 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126250131 | 12625013 | Arthralgia | |
| 126250131 | 12625013 | Chest discomfort | |
| 126250131 | 12625013 | Drug hypersensitivity | |
| 126250131 | 12625013 | Hypoaesthesia | |
| 126250131 | 12625013 | Meningitis aseptic | |
| 126250131 | 12625013 | Paraesthesia | |
| 126250131 | 12625013 | 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 |
|---|---|---|---|---|---|---|
| 126250131 | 12625013 | 1 | 20160718 | 0 | ||
| 126250131 | 12625013 | 3 | 20160724 | 20160725 | 0 |