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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126680291 | 12668029 | 1 | I | 20160710 | 20160810 | 20160819 | 20160819 | EXP | FR-MYLANLABS-2016M1034531 | MYLAN | 0.00 | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126680291 | 12668029 | 1 | SS | PIPERACILLIN,TAZOBACTAM MYLAN | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 3 G, QD | 69 | G | U | 0 | 3 | G | QD | ||||
| 126680291 | 12668029 | 2 | SS | VANCOMYCIN MYLAN 500 MG, POWDER FOR SOLUTION FOR INFUSION | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 2500 MG, QD | 60000 | MG | U | 0 | 2500 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | |||
| 126680291 | 12668029 | 3 | PS | HYDROXYZINE MYLAN 25 MG, COMPRIM? PELLICUL? S?CABLE | HYDROXYZINE HYDROCHLORIDE | 1 | Oral | 25 MG, QD | 25 | MG | 91176 | 25 | MG | TABLET | QD | ||||
| 126680291 | 12668029 | 4 | SS | ALPRAZOLAM MYLAN 0.25 MG, COMPRIM? S?CABLE | ALPRAZOLAM | 1 | Oral | 0.25 MG, QD | 0 | .25 | MG | TABLET | QD | ||||||
| 126680291 | 12668029 | 5 | SS | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | 4000 IU, QD | 80000 | IU | U | 0 | 4000 | IU | QD | ||||
| 126680291 | 12668029 | 6 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 500 MG, TID | 24000 | MG | U | 0 | 500 | MG | TID | ||||
| 126680291 | 12668029 | 7 | SS | IOMERON | IOMEPROL | 1 | Intravenous (not otherwise specified) | 80 ML, UNK | 0 | 80 | ML | SOLUTION FOR INJECTION | |||||||
| 126680291 | 12668029 | 8 | SS | IMOVANE | ZOPICLONE | 1 | Oral | 7.5 MG, QD | 180.363998 | MG | U | 0 | 7.5 | MG | FILM-COATED TABLET | QD | |||
| 126680291 | 12668029 | 9 | SS | SKENAN | MORPHINE SULFATE | 1 | Oral | 40 MG, QD | 960 | MG | U | 0 | 40 | MG | QD | ||||
| 126680291 | 12668029 | 10 | SS | SOMATULINE LP | LANREOTIDE ACETATE | 1 | Intramuscular | 30 MG, QD | 30 | MG | 0 | 30 | MG | POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION | QD | ||||
| 126680291 | 12668029 | 11 | SS | PARACETAMOL B. BRAUN | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 1 G, PRN | 0 | 1 | G | ||||||||
| 126680291 | 12668029 | 12 | SS | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 40 MG, QD | 960 | MG | U | 0 | 40 | MG | GASTRO-RESISTANT TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126680291 | 12668029 | 1 | Liver abscess |
| 126680291 | 12668029 | 2 | Liver abscess |
| 126680291 | 12668029 | 3 | Procedural anxiety |
| 126680291 | 12668029 | 4 | Procedural anxiety |
| 126680291 | 12668029 | 5 | Thrombosis prophylaxis |
| 126680291 | 12668029 | 6 | Liver abscess |
| 126680291 | 12668029 | 7 | Computerised tomogram |
| 126680291 | 12668029 | 8 | Product used for unknown indication |
| 126680291 | 12668029 | 9 | Analgesic therapy |
| 126680291 | 12668029 | 10 | Product used for unknown indication |
| 126680291 | 12668029 | 11 | Analgesic therapy |
| 126680291 | 12668029 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126680291 | 12668029 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126680291 | 12668029 | Drug reaction with eosinophilia and systemic symptoms | |
| 126680291 | 12668029 | Toxic skin eruption |
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 |
|---|---|---|---|---|---|---|
| 126680291 | 12668029 | 1 | 20160618 | 20160715 | 0 | |
| 126680291 | 12668029 | 2 | 20160617 | 20160718 | 0 | |
| 126680291 | 12668029 | 3 | 20160618 | 20160618 | 0 | |
| 126680291 | 12668029 | 4 | 20160618 | 20160618 | 0 | |
| 126680291 | 12668029 | 5 | 20160621 | 20160715 | 0 | |
| 126680291 | 12668029 | 6 | 20160625 | 20160710 | 0 | |
| 126680291 | 12668029 | 7 | 20160629 | 20160629 | 0 | |
| 126680291 | 12668029 | 8 | 20160617 | 20160719 | 0 | |
| 126680291 | 12668029 | 9 | 20160617 | 20160723 | 0 | |
| 126680291 | 12668029 | 10 | 20160629 | 20160629 | 0 | |
| 126680291 | 12668029 | 11 | 20160618 | 20160704 | 0 | |
| 126680291 | 12668029 | 12 | 20160617 | 20160719 | 0 |