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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115361763 | 11536176 | 3 | F | 20150316 | 20160726 | 20150922 | 20160801 | EXP | FR-GLAXOSMITHKLINE-FR2015GSK132788 | GLAXOSMITHKLINE | 2.97 | MON | F | Y | 0.00000 | 20160801 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115361763 | 11536176 | 1 | SS | INFANRIX HEXA | DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE AND HEPATITIS B VIRUS VACCINE | 1 | 0 | SOLUTION FOR INJECTION | |||||||||||
| 115361763 | 11536176 | 2 | SS | INFANRIX HEXA | DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE AND HEPATITIS B VIRUS VACCINE | 1 | 0 | SOLUTION FOR INJECTION | |||||||||||
| 115361763 | 11536176 | 3 | PS | BACTROBAN | MUPIROCINMUPIROCIN CALCIUM | 1 | Nasal | UNK | 50591 | ||||||||||
| 115361763 | 11536176 | 4 | SS | VITAMIN K | PHYTONADIONE | 1 | Oral | UNK | 0 | ||||||||||
| 115361763 | 11536176 | 5 | SS | Lasilix | FUROSEMIDE | 1 | UNK | U | 0 | ||||||||||
| 115361763 | 11536176 | 6 | SS | ALDACTONE | SPIRONOLACTONE | 1 | UNK | 0 | |||||||||||
| 115361763 | 11536176 | 7 | SS | CEFOTAXIME SODIUM | CEFOTAXIME SODIUM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 115361763 | 11536176 | 8 | SS | VANCOMYCINE SANDOZ | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 115361763 | 11536176 | 9 | SS | Bristopen | OXACILLIN SODIUM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 115361763 | 11536176 | 10 | SS | RIFAMYCINE CHIBRET | RIFAMYCIN | 1 | Ophthalmic | UNK | 0 | EYE DROPS | |||||||||
| 115361763 | 11536176 | 11 | SS | TOBREX | TOBRAMYCIN | 1 | Ophthalmic | UNK | 0 | EYE DROPS | |||||||||
| 115361763 | 11536176 | 12 | SS | Triflucan | FLUCONAZOLE | 1 | UNK | 0 | |||||||||||
| 115361763 | 11536176 | 13 | SS | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | Ophthalmic | UNK | 0 | ||||||||||
| 115361763 | 11536176 | 14 | SS | MYDRIATICUM | TROPICAMIDE | 1 | Ophthalmic | UNK | 0 | ||||||||||
| 115361763 | 11536176 | 15 | SS | PREVNAR 13 | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE | 1 | 1 DF, UNK | 0 | |||||||||||
| 115361763 | 11536176 | 16 | SS | PREVNAR 13 | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE | 1 | 1 DF, UNK | 0 | |||||||||||
| 115361763 | 11536176 | 17 | SS | CAFEINE | CAFFEINE | 1 | UNK | 0 | |||||||||||
| 115361763 | 11536176 | 18 | C | ALDOMET | METHYLDOPA | 1 | Intra-uterine | 0 | |||||||||||
| 115361763 | 11536176 | 19 | C | LOXEN | NICARDIPINE HYDROCHLORIDE | 1 | Intra-uterine | 0 | |||||||||||
| 115361763 | 11536176 | 20 | C | CUROSURF | PORACTANT ALFA | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115361763 | 11536176 | 1 | Prophylaxis |
| 115361763 | 11536176 | 2 | Prophylaxis |
| 115361763 | 11536176 | 3 | Infection |
| 115361763 | 11536176 | 5 | Patent ductus arteriosus |
| 115361763 | 11536176 | 6 | Patent ductus arteriosus |
| 115361763 | 11536176 | 7 | Staphylococcal sepsis |
| 115361763 | 11536176 | 8 | Staphylococcal sepsis |
| 115361763 | 11536176 | 9 | Staphylococcal sepsis |
| 115361763 | 11536176 | 10 | Prophylaxis |
| 115361763 | 11536176 | 11 | Infection |
| 115361763 | 11536176 | 12 | Infection prophylaxis |
| 115361763 | 11536176 | 13 | Diagnostic procedure |
| 115361763 | 11536176 | 14 | Diagnostic procedure |
| 115361763 | 11536176 | 15 | Prophylaxis |
| 115361763 | 11536176 | 16 | Prophylaxis |
| 115361763 | 11536176 | 17 | Infantile apnoea |
| 115361763 | 11536176 | 18 | Hypertension |
| 115361763 | 11536176 | 19 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115361763 | 11536176 | HO |
| 115361763 | 11536176 | DE |
| 115361763 | 11536176 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115361763 | 11536176 | Inappropriate schedule of drug administration | |
| 115361763 | 11536176 | Necrotising enterocolitis neonatal |
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 |
|---|---|---|---|---|---|---|
| 115361763 | 11536176 | 1 | 20150216 | 20150216 | 0 | |
| 115361763 | 11536176 | 2 | 20150316 | 20150316 | 0 | |
| 115361763 | 11536176 | 3 | 20150103 | 20150308 | 0 | |
| 115361763 | 11536176 | 4 | 20141217 | 2015 | 0 | |
| 115361763 | 11536176 | 5 | 20150101 | 20150130 | 0 | |
| 115361763 | 11536176 | 6 | 20150106 | 2015 | 0 | |
| 115361763 | 11536176 | 7 | 20141225 | 20141226 | 0 | |
| 115361763 | 11536176 | 8 | 20141225 | 20141226 | 0 | |
| 115361763 | 11536176 | 9 | 20141225 | 20150106 | 0 | |
| 115361763 | 11536176 | 10 | 20141217 | 20150112 | 0 | |
| 115361763 | 11536176 | 11 | 20150113 | 20150121 | 0 | |
| 115361763 | 11536176 | 12 | 20141219 | 20150212 | 0 | |
| 115361763 | 11536176 | 13 | 20150222 | 20150317 | 0 | |
| 115361763 | 11536176 | 14 | 20150222 | 20150317 | 0 | |
| 115361763 | 11536176 | 15 | 20150216 | 0 | ||
| 115361763 | 11536176 | 16 | 20150316 | 0 | ||
| 115361763 | 11536176 | 17 | 20141217 | 0 | ||
| 115361763 | 11536176 | 20 | 20141216 | 0 |