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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120060375 | 12006037 | 5 | F | 20160111 | 20160720 | 20160205 | 20160728 | EXP | AU-ALEXION PHARMACEUTICALS INC-A201600548 | ALEXION | 24.98 | YR | F | Y | 120.00000 | KG | 20160728 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120060375 | 12006037 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 120060375 | 12006037 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 120060375 | 12006037 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 120060375 | 12006037 | 4 | SS | MENVEO | NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENNEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENNEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTI | 1 | Intramuscular | SINGLE | 0 | QD | |||||||||
| 120060375 | 12006037 | 5 | SS | MENVEO | NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENNEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENNEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTI | 1 | Intramuscular | UNK, SINGLE | 0 | QD | |||||||||
| 120060375 | 12006037 | 6 | C | PENICILLIN /00000901/ | PENICILLIN G | 1 | Unknown | 0 | |||||||||||
| 120060375 | 12006037 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120060375 | 12006037 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 120060375 | 12006037 | 4 | Immunisation |
| 120060375 | 12006037 | 6 | Product used for unknown indication |
| 120060375 | 12006037 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120060375 | 12006037 | HO |
| 120060375 | 12006037 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120060375 | 12006037 | Blood bilirubin increased | |
| 120060375 | 12006037 | Exposure during pregnancy | |
| 120060375 | 12006037 | Hyperhidrosis | |
| 120060375 | 12006037 | Incorrect dose administered | |
| 120060375 | 12006037 | Influenza like illness | |
| 120060375 | 12006037 | Vaccination site erythema | |
| 120060375 | 12006037 | Vaccination site pain | |
| 120060375 | 12006037 | Vaccination site swelling |
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 |
|---|---|---|---|---|---|---|
| 120060375 | 12006037 | 1 | 20090805 | 20090826 | 0 | |
| 120060375 | 12006037 | 2 | 20090902 | 0 | ||
| 120060375 | 12006037 | 4 | 20130729 | 20130729 | 0 | |
| 120060375 | 12006037 | 5 | 20160111 | 20160111 | 0 |