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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127767411 | 12776741 | 1 | I | 20110222 | 20110721 | 20160923 | 20160923 | EXP | US-ASTRAZENECA-2016SF00951 | ASTRAZENECA | 1.00 | YR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127767411 | 12776741 | 1 | PS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 80 MG | U | U | 0 | INJECTION | |||||||
| 127767411 | 12776741 | 2 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 86 MG | U | U | 0 | INJECTION | |||||||
| 127767411 | 12776741 | 3 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 84 MG | U | U | 0 | INJECTION | |||||||
| 127767411 | 12776741 | 4 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 95 MG | U | U | 0 | INJECTION | |||||||
| 127767411 | 12776741 | 5 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 95 MG | U | U | 0 | INJECTION | |||||||
| 127767411 | 12776741 | 6 | SS | SYNAGIS | PALIVIZUMAB | 1 | Intramuscular | 92 MG | U | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127767411 | 12776741 | 1 | Antiviral prophylaxis |
| 127767411 | 12776741 | 2 | Antiviral prophylaxis |
| 127767411 | 12776741 | 3 | Antiviral prophylaxis |
| 127767411 | 12776741 | 4 | Antiviral prophylaxis |
| 127767411 | 12776741 | 5 | Antiviral prophylaxis |
| 127767411 | 12776741 | 6 | Antiviral prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127767411 | 12776741 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127767411 | 12776741 | Bronchitis | |
| 127767411 | 12776741 | Poor weight gain neonatal | |
| 127767411 | 12776741 | Respiratory syncytial virus test positive |
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 |
|---|---|---|---|---|---|---|
| 127767411 | 12776741 | 1 | 20101103 | 20101103 | 0 | |
| 127767411 | 12776741 | 2 | 20101201 | 20101201 | 0 | |
| 127767411 | 12776741 | 3 | 20101227 | 20101227 | 0 | |
| 127767411 | 12776741 | 4 | 20110125 | 20110125 | 0 | |
| 127767411 | 12776741 | 5 | 20110222 | 20110222 | 0 | |
| 127767411 | 12776741 | 6 | 20110322 | 20110322 | 0 |