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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115228905 | 11522890 | 5 | F | 20150304 | 20160726 | 20150918 | 20160802 | EXP | PHHY2015FR109354 | SANDOZ | 2.00 | MON | F | Y | 0.00000 | 20160802 | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115228905 | 11522890 | 1 | PS | VANCOMYCIN SANDOZ | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 90250 | |||||||||||
| 115228905 | 11522890 | 2 | SS | INFANRIX HEXA | DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE AND HEPATITIS B VIRUS VACCINE | 1 | Unknown | 0 | |||||||||||
| 115228905 | 11522890 | 3 | SS | RIFAMYCINE CHIBRET | RIFAMYCIN | 1 | Intraocular | 0 | |||||||||||
| 115228905 | 11522890 | 4 | SS | CAFFEINE CITRATE. | CAFFEINE CITRATE | 1 | Unknown | 0 | |||||||||||
| 115228905 | 11522890 | 5 | SS | VITAMIN K | PHYTONADIONE | 1 | Oral | 0 | |||||||||||
| 115228905 | 11522890 | 6 | SS | LASILIX | FUROSEMIDE | 1 | Unknown | 0 | |||||||||||
| 115228905 | 11522890 | 7 | SS | ALDACTONE | SPIRONOLACTONE | 1 | Unknown | 0 | |||||||||||
| 115228905 | 11522890 | 8 | SS | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 115228905 | 11522890 | 9 | SS | BRISTOPEN | OXACILLIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 115228905 | 11522890 | 10 | SS | BACTROBAN | MUPIROCINMUPIROCIN CALCIUM | 1 | Nasal | 0 | |||||||||||
| 115228905 | 11522890 | 11 | SS | TOBREX | TOBRAMYCIN | 1 | Intraocular | 0 | |||||||||||
| 115228905 | 11522890 | 12 | SS | TRIFLUCAN | FLUCONAZOLE | 1 | Unknown | 0 | |||||||||||
| 115228905 | 11522890 | 13 | SS | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | Intraocular | UNK | 0 | ||||||||||
| 115228905 | 11522890 | 14 | SS | MYDRIATICUM | TROPICAMIDE | 1 | Intraocular | UNK | 0 | ||||||||||
| 115228905 | 11522890 | 15 | SS | PREVNAR 13 | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE | 1 | Unknown | 1 DF | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115228905 | 11522890 | 1 | Staphylococcal sepsis |
| 115228905 | 11522890 | 2 | Immunisation |
| 115228905 | 11522890 | 4 | Infantile apnoea |
| 115228905 | 11522890 | 5 | Haemorrhage prophylaxis |
| 115228905 | 11522890 | 6 | Patent ductus arteriosus |
| 115228905 | 11522890 | 7 | Patent ductus arteriosus |
| 115228905 | 11522890 | 8 | Staphylococcal sepsis |
| 115228905 | 11522890 | 9 | Staphylococcal sepsis |
| 115228905 | 11522890 | 10 | Infection |
| 115228905 | 11522890 | 11 | Infection |
| 115228905 | 11522890 | 12 | Infection prophylaxis |
| 115228905 | 11522890 | 13 | Diagnostic procedure |
| 115228905 | 11522890 | 14 | Diagnostic procedure |
| 115228905 | 11522890 | 15 | Immunisation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115228905 | 11522890 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115228905 | 11522890 | Blood glucose increased | |
| 115228905 | 11522890 | Bradycardia | |
| 115228905 | 11522890 | Eye discharge | |
| 115228905 | 11522890 | Grunting | |
| 115228905 | 11522890 | Hypernatraemia | |
| 115228905 | 11522890 | Hypotonia | |
| 115228905 | 11522890 | Hypovolaemia | |
| 115228905 | 11522890 | Necrotising enterocolitis neonatal | |
| 115228905 | 11522890 | Osteopenia | |
| 115228905 | 11522890 | Pneumatosis | |
| 115228905 | 11522890 | Regurgitation | |
| 115228905 | 11522890 | Retinopathy |
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 |
|---|---|---|---|---|---|---|
| 115228905 | 11522890 | 1 | 20141225 | 20141226 | 0 | |
| 115228905 | 11522890 | 2 | 20150216 | 0 | ||
| 115228905 | 11522890 | 3 | 20141217 | 0 | ||
| 115228905 | 11522890 | 4 | 20141217 | 0 | ||
| 115228905 | 11522890 | 5 | 20141217 | 0 | ||
| 115228905 | 11522890 | 6 | 20150101 | 20150130 | 0 | |
| 115228905 | 11522890 | 7 | 20150106 | 0 | ||
| 115228905 | 11522890 | 8 | 20141225 | 20141226 | 0 | |
| 115228905 | 11522890 | 9 | 20141225 | 20150106 | 0 | |
| 115228905 | 11522890 | 11 | 20150113 | 20150121 | 0 | |
| 115228905 | 11522890 | 12 | 20141219 | 20150212 | 0 | |
| 115228905 | 11522890 | 13 | 20150222 | 0 | ||
| 115228905 | 11522890 | 14 | 20150222 | 0 | ||
| 115228905 | 11522890 | 15 | 20150216 | 0 |