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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125217811 | 12521781 | 1 | I | 20160331 | 20160527 | 20160701 | 20160701 | EXP | DE-ABBVIE-16P-062-1641802-00 | ABBVIE | 1.16 | YR | F | Y | 9.00000 | KG | 20160701 | MD | COUNTRY NOT SPECIFIED | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125217811 | 12521781 | 1 | PS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | UNKNOWN | 0 | 115 | MG | INJECTION | |||||||
| 125217811 | 12521781 | 2 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | UNKNOWN | 0 | 125 | MG | INJECTION | |||||||
| 125217811 | 12521781 | 3 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | UNKNOWN | 0 | 135 | MG | INJECTION | |||||||
| 125217811 | 12521781 | 4 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | UNKNOWN | 0 | 140 | MG | INJECTION | |||||||
| 125217811 | 12521781 | 5 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | UNKNOWN | 0 | 145 | MG | INJECTION | |||||||
| 125217811 | 12521781 | 6 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | UNKNOWN | 0 | 150 | MG | INJECTION | |||||||
| 125217811 | 12521781 | 7 | C | SILDENAFIL. | SILDENAFIL | 1 | Unknown | 0 | 12.5 | MG | TID | ||||||||
| 125217811 | 12521781 | 8 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 0 | 20 | MG | QD | ||||||||
| 125217811 | 12521781 | 9 | C | OMEPRAZOL | OMEPRAZOLE | 1 | Unknown | 0 | 5 | MG | QD | ||||||||
| 125217811 | 12521781 | 10 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Unknown | 0 | |||||||||||
| 125217811 | 12521781 | 11 | C | SALBUTAMOL | ALBUTEROL | 1 | Respiratory (inhalation) | 3 DROPS IN 2 L SODIUM CHLORIDE 0.9% | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125217811 | 12521781 | 1 | Premature baby |
| 125217811 | 12521781 | 7 | Product used for unknown indication |
| 125217811 | 12521781 | 8 | Product used for unknown indication |
| 125217811 | 12521781 | 9 | Product used for unknown indication |
| 125217811 | 12521781 | 10 | Product used for unknown indication |
| 125217811 | 12521781 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125217811 | 12521781 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125217811 | 12521781 | Bronchitis | |
| 125217811 | 12521781 | Dyspnoea | |
| 125217811 | 12521781 | General physical health deterioration | |
| 125217811 | 12521781 | Obstruction | |
| 125217811 | 12521781 | Oxygen consumption increased | |
| 125217811 | 12521781 | Pneumonia | |
| 125217811 | 12521781 | Respiratory disorder | |
| 125217811 | 12521781 | Respiratory fatigue | |
| 125217811 | 12521781 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 125217811 | 12521781 | 1 | 20151001 | 20151001 | 0 | |
| 125217811 | 12521781 | 2 | 20151102 | 20151102 | 0 | |
| 125217811 | 12521781 | 3 | 20151214 | 20151214 | 0 | |
| 125217811 | 12521781 | 4 | 20160121 | 20160121 | 0 | |
| 125217811 | 12521781 | 5 | 20160309 | 20160309 | 0 | |
| 125217811 | 12521781 | 6 | 20160414 | 20160414 | 0 |