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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127768691 | 12776869 | 1 | I | 20100203 | 20160923 | 20160923 | EXP | US-ASTRAZENECA-2016SF01096 | ASTRAZENECA | 0.00 | M | Y | 0.00000 | 20160923 | MD | DE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127768691 | 12776869 | 1 | PS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 110.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 110 | MG | INJECTION | |||||
| 127768691 | 12776869 | 2 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 110.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 110 | MG | INJECTION | |||||
| 127768691 | 12776869 | 3 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 110.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 110 | MG | INJECTION | |||||
| 127768691 | 12776869 | 4 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 65.3MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 65.3 | MG | INJECTION | |||||
| 127768691 | 12776869 | 5 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 65.3MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 65.3 | MG | INJECTION | |||||
| 127768691 | 12776869 | 6 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 65.3MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 65.3 | MG | INJECTION | |||||
| 127768691 | 12776869 | 7 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 78.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 78 | MG | INJECTION | |||||
| 127768691 | 12776869 | 8 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 78.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 78 | MG | INJECTION | |||||
| 127768691 | 12776869 | 9 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 78.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 78 | MG | INJECTION | |||||
| 127768691 | 12776869 | 10 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 84.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 84 | MG | INJECTION | |||||
| 127768691 | 12776869 | 11 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 84.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 84 | MG | INJECTION | |||||
| 127768691 | 12776869 | 12 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 84.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 84 | MG | INJECTION | |||||
| 127768691 | 12776869 | 13 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 90.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 90 | MG | INJECTION | |||||
| 127768691 | 12776869 | 14 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 90.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 90 | MG | INJECTION | |||||
| 127768691 | 12776869 | 15 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 90.0MG ONCE/SINGLE ADMINISTRATION | U | U | 0 | 90 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127768691 | 12776869 | 1 | Bronchopulmonary dysplasia |
| 127768691 | 12776869 | 2 | Antiviral prophylaxis |
| 127768691 | 12776869 | 3 | Premature baby |
| 127768691 | 12776869 | 4 | Bronchopulmonary dysplasia |
| 127768691 | 12776869 | 5 | Antiviral prophylaxis |
| 127768691 | 12776869 | 6 | Premature baby |
| 127768691 | 12776869 | 7 | Bronchopulmonary dysplasia |
| 127768691 | 12776869 | 8 | Antiviral prophylaxis |
| 127768691 | 12776869 | 9 | Premature baby |
| 127768691 | 12776869 | 10 | Bronchopulmonary dysplasia |
| 127768691 | 12776869 | 11 | Antiviral prophylaxis |
| 127768691 | 12776869 | 12 | Premature baby |
| 127768691 | 12776869 | 13 | Bronchopulmonary dysplasia |
| 127768691 | 12776869 | 14 | Antiviral prophylaxis |
| 127768691 | 12776869 | 15 | Premature baby |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127768691 | 12776869 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127768691 | 12776869 | Bronchitis | |
| 127768691 | 12776869 | Nosocomial 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 |
|---|---|---|---|---|---|---|
| 127768691 | 12776869 | 1 | 20080310 | 20080310 | 0 | |
| 127768691 | 12776869 | 2 | 20080310 | 20080310 | 0 | |
| 127768691 | 12776869 | 3 | 20080310 | 20080310 | 0 | |
| 127768691 | 12776869 | 4 | 20080919 | 20080919 | 0 | |
| 127768691 | 12776869 | 5 | 20080919 | 20080919 | 0 | |
| 127768691 | 12776869 | 6 | 20080919 | 20080919 | 0 | |
| 127768691 | 12776869 | 7 | 20081016 | 20081016 | 0 | |
| 127768691 | 12776869 | 8 | 20081016 | 20081016 | 0 | |
| 127768691 | 12776869 | 9 | 20081016 | 20081016 | 0 | |
| 127768691 | 12776869 | 10 | 20081113 | 20081113 | 0 | |
| 127768691 | 12776869 | 11 | 20081113 | 20081113 | 0 | |
| 127768691 | 12776869 | 12 | 20081113 | 20081113 | 0 | |
| 127768691 | 12776869 | 13 | 20081217 | 20081217 | 0 | |
| 127768691 | 12776869 | 14 | 20081217 | 20081217 | 0 | |
| 127768691 | 12776869 | 15 | 20081217 | 20081217 | 0 |