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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125449762 | 12544976 | 2 | F | 20150521 | 20160713 | 20160711 | 20160728 | EXP | IT-WEST-WARD PHARMACEUTICALS CORP.-IT-H14001-16-01177 | WESTWARD | POGLIANI D,POZZI A,LAUDI C,RIMOLDI L,SOGNI E,FARFAGLIA P,FIGLIOLA C,JOVANE C,ZARCONE D,CARETTA E. GENERALISED NON-CONVULSIVE STATUS EPILEPTICUS SECONDARY TO FENTANYL TOXICITY IN HAEMODIALYSIS PATIENTS:TWO CLINICAL CASE REPORTS AND REVIEW OF THE LITERATURE. G ITAL NEFROL 2016;33(3):1-11. | 82.00 | YR | F | Y | 0.00000 | 20160728 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125449762 | 12544976 | 1 | PS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 62682 | 1 | G | |||||||||
| 125449762 | 12544976 | 2 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 62682 | 500 | MG | |||||||||
| 125449762 | 12544976 | 3 | SS | FENTANYL. | FENTANYL | 1 | Transdermal | 0 | |||||||||||
| 125449762 | 12544976 | 4 | SS | FENTANYL. | FENTANYL | 1 | Transdermal | 0 | |||||||||||
| 125449762 | 12544976 | 5 | SS | FENTANYL. | FENTANYL | 1 | Oral | 0 | 100 | UG | |||||||||
| 125449762 | 12544976 | 6 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 0 | 500 | MG | |||||||||
| 125449762 | 12544976 | 7 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 0 | |||||||||||
| 125449762 | 12544976 | 8 | SS | RIFAMPICIN | RIFAMPIN | 1 | Intravenous (not otherwise specified) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125449762 | 12544976 | 1 | Staphylococcal infection |
| 125449762 | 12544976 | 3 | Ischaemic limb pain |
| 125449762 | 12544976 | 6 | Staphylococcal infection |
| 125449762 | 12544976 | 8 | Staphylococcal infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125449762 | 12544976 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125449762 | 12544976 | Altered state of consciousness | |
| 125449762 | 12544976 | Drug interaction | |
| 125449762 | 12544976 | Hallucination | |
| 125449762 | 12544976 | Somnolence | |
| 125449762 | 12544976 | Status epilepticus | |
| 125449762 | 12544976 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125449762 | 12544976 | 1 | 20150521 | 20150521 | 0 | |
| 125449762 | 12544976 | 2 | 20150522 | 0 | ||
| 125449762 | 12544976 | 3 | 20150521 | 20150527 | 0 | |
| 125449762 | 12544976 | 4 | 20150528 | 20150602 | 0 | |
| 125449762 | 12544976 | 5 | 20150602 | 20150602 | 0 | |
| 125449762 | 12544976 | 6 | 20150521 | 20150521 | 0 | |
| 125449762 | 12544976 | 7 | 20150522 | 0 | ||
| 125449762 | 12544976 | 8 | 20150521 | 0 |