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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115107533 | 11510753 | 3 | F | 20141227 | 20160726 | 20150915 | 20160803 | EXP | FR-PFIZER INC-2015302806 | PFIZER | 4.00 | WK | M | Y | 0.68000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115107533 | 11510753 | 1 | PS | ALDACTONE | SPIRONOLACTONE | 1 | UNK | 12151 | FILM-COATED TABLET | ||||||||||
| 115107533 | 11510753 | 2 | SS | IBUPROFEN. | IBUPROFEN | 1 | 10 MG/KG, UNK | 18989 | 10 | MG/KG | |||||||||
| 115107533 | 11510753 | 3 | SS | IBUPROFEN. | IBUPROFEN | 1 | 5 MG/KG, UNK | 18989 | 5 | MG/KG | |||||||||
| 115107533 | 11510753 | 4 | SS | RIFAMYCINE CHIBRET | RIFAMYCIN | 1 | Intraocular | UNK | 0 | ||||||||||
| 115107533 | 11510753 | 5 | SS | CAFEINE COOPER | CAFFEINE | 1 | UNK | 0 | |||||||||||
| 115107533 | 11510753 | 6 | SS | PULMICORT TURBUHALER | BUDESONIDE | 1 | Respiratory (inhalation) | 0.25 MG, IN 12 HOURS | 0 | .25 | MG | ||||||||
| 115107533 | 11510753 | 7 | SS | CELESTENE /00008501/ | BETAMETHASONE | 1 | Intravenous (not otherwise specified) | 0.25 MG/KG, DAILY | 0 | .25 | MG/KG | ||||||||
| 115107533 | 11510753 | 8 | SS | CELESTENE /00008501/ | BETAMETHASONE | 1 | Intravenous (not otherwise specified) | 0.063 MG/KG, DAILY | 0 | .063 | MG/KG | ||||||||
| 115107533 | 11510753 | 9 | SS | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 115107533 | 11510753 | 10 | SS | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | UNK | 0 | ||||||||||
| 115107533 | 11510753 | 11 | SS | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | Intraocular | UNK | U | 0 | |||||||||
| 115107533 | 11510753 | 12 | SS | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 115107533 | 11510753 | 13 | SS | MYDRIATICUM | TROPICAMIDE | 1 | Intraocular | UNK | 0 | ||||||||||
| 115107533 | 11510753 | 14 | SS | MYDRIATICUM | TROPICAMIDE | 1 | UNK | 0 | |||||||||||
| 115107533 | 11510753 | 15 | SS | FERROSTRANE | SODIUM FEREDETATE | 1 | Oral | 2 MG/KG, DAILY | 0 | 2 | MG/KG | ||||||||
| 115107533 | 11510753 | 16 | SS | FERROSTRANE | SODIUM FEREDETATE | 1 | Oral | 3 MG/KG, DAILY | 0 | 3 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115107533 | 11510753 | 1 | Bronchopulmonary dysplasia |
| 115107533 | 11510753 | 2 | Patent ductus arteriosus |
| 115107533 | 11510753 | 4 | Infection prophylaxis |
| 115107533 | 11510753 | 5 | Infantile apnoea |
| 115107533 | 11510753 | 6 | Bronchopulmonary dysplasia |
| 115107533 | 11510753 | 7 | Bronchopulmonary dysplasia |
| 115107533 | 11510753 | 9 | Regurgitation |
| 115107533 | 11510753 | 10 | Regurgitation |
| 115107533 | 11510753 | 11 | Diagnostic procedure |
| 115107533 | 11510753 | 13 | Diagnostic procedure |
| 115107533 | 11510753 | 15 | Anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115107533 | 11510753 | OT |
| 115107533 | 11510753 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115107533 | 11510753 | Atelectasis neonatal | |
| 115107533 | 11510753 | Necrotising enterocolitis neonatal | |
| 115107533 | 11510753 | Serratia infection | |
| 115107533 | 11510753 | Staphylococcus 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 |
|---|---|---|---|---|---|---|
| 115107533 | 11510753 | 1 | 20141217 | 20150116 | 0 | |
| 115107533 | 11510753 | 2 | 20141124 | 20141124 | 0 | |
| 115107533 | 11510753 | 3 | 20141125 | 20141129 | 0 | |
| 115107533 | 11510753 | 4 | 20141123 | 0 | ||
| 115107533 | 11510753 | 5 | 20141123 | 20150124 | 0 | |
| 115107533 | 11510753 | 6 | 20141217 | 20141222 | 0 | |
| 115107533 | 11510753 | 7 | 20141221 | 20141222 | 0 | |
| 115107533 | 11510753 | 8 | 20141223 | 20141223 | 0 | |
| 115107533 | 11510753 | 9 | 20141229 | 20150106 | 0 | |
| 115107533 | 11510753 | 10 | 20150106 | 20150117 | 0 | |
| 115107533 | 11510753 | 11 | 20150106 | 20150106 | 0 | |
| 115107533 | 11510753 | 12 | 20150120 | 20150120 | 0 | |
| 115107533 | 11510753 | 13 | 20150106 | 20150106 | 0 | |
| 115107533 | 11510753 | 14 | 20150120 | 20150120 | 0 | |
| 115107533 | 11510753 | 15 | 20150110 | 20150114 | 0 | |
| 115107533 | 11510753 | 16 | 20150114 | 20150116 | 0 |