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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126202771 | 12620277 | 1 | I | 20160714 | 20160801 | 20160803 | 20160803 | PER | US-BAXALTA-2016BLT005638 | BAXALTA | 66.42 | YR | F | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126202771 | 12620277 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 5 G, 1X A WEEK | U | 125105 | 5 | G | SOLUTION FOR INFUSION | /wk | |||||
| 126202771 | 12620277 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 12.5 G, 1X A WEEK | U | 125105 | 12.5 | G | SOLUTION FOR INFUSION | /wk | |||||
| 126202771 | 12620277 | 3 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 25 MG, UNK | 0 | 25 | MG | |||||||||
| 126202771 | 12620277 | 4 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 50 MG, UNK | 0 | 50 | MG | |||||||||
| 126202771 | 12620277 | 5 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126202771 | 12620277 | 1 | Primary immunodeficiency syndrome |
| 126202771 | 12620277 | 2 | Immunodeficiency common variable |
| 126202771 | 12620277 | 3 | Premedication |
| 126202771 | 12620277 | 5 | Premedication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126202771 | 12620277 | Blood pressure increased | |
| 126202771 | 12620277 | Chest discomfort | |
| 126202771 | 12620277 | Dizziness | |
| 126202771 | 12620277 | Headache | |
| 126202771 | 12620277 | Myalgia | |
| 126202771 | 12620277 | Nausea | |
| 126202771 | 12620277 | Pruritus | |
| 126202771 | 12620277 | Pyrexia | |
| 126202771 | 12620277 | Throat tightness |
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 |
|---|---|---|---|---|---|---|
| 126202771 | 12620277 | 1 | 20160720 | 20160720 | 0 | |
| 126202771 | 12620277 | 2 | 201607 | 201607 | 0 | |
| 126202771 | 12620277 | 3 | 20160714 | 20160714 | 0 | |
| 126202771 | 12620277 | 4 | 20160720 | 20160720 | 0 |