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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125063782 | 12506378 | 2 | F | 20150602 | 20160704 | 20160628 | 20160707 | EXP | IT-FRESENIUS KABI-FK201603910 | FRESENIUS KABI | 82.00 | YR | F | Y | 0.00000 | 20160707 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125063782 | 12506378 | 1 | PS | VANCOMYCIN (MANUFACTURER UNKNOWN) | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 62663 | 1 | G | UNKNOWN | ||||||
| 125063782 | 12506378 | 2 | SS | VANCOMYCIN (MANUFACTURER UNKNOWN) | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 62663 | UNKNOWN | ||||||||
| 125063782 | 12506378 | 3 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 0 | 500 | MG | UNKNOWN | ||||||||
| 125063782 | 12506378 | 4 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 0 | UNKNOWN | QD | |||||||||
| 125063782 | 12506378 | 5 | SS | FENTANYL. | FENTANYL | 1 | Transdermal | 0 | 600 | UG | PATCH | QD | |||||||
| 125063782 | 12506378 | 6 | SS | FENTANYL. | FENTANYL | 1 | Transdermal | 0 | 288 | UG | PATCH | QD | |||||||
| 125063782 | 12506378 | 7 | SS | FENTANYL. | FENTANYL | 1 | Oral | 0 | 100 | UG | TABLET | ||||||||
| 125063782 | 12506378 | 8 | SS | RIFAMPICIN | RIFAMPIN | 1 | Intravenous (not otherwise specified) | 0 | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125063782 | 12506378 | 1 | Staphylococcal infection |
| 125063782 | 12506378 | 3 | Staphylococcal infection |
| 125063782 | 12506378 | 5 | Ischaemic limb pain |
| 125063782 | 12506378 | 8 | Staphylococcal infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125063782 | 12506378 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125063782 | 12506378 | Altered state of consciousness | |
| 125063782 | 12506378 | Drug interaction | |
| 125063782 | 12506378 | Hallucination | |
| 125063782 | 12506378 | Prescribed overdose | |
| 125063782 | 12506378 | Somnolence | |
| 125063782 | 12506378 | Status epilepticus | |
| 125063782 | 12506378 | 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 |
|---|---|---|---|---|---|---|
| 125063782 | 12506378 | 1 | 20160521 | 20150521 | 0 | |
| 125063782 | 12506378 | 2 | 20150522 | 0 | ||
| 125063782 | 12506378 | 3 | 20150521 | 20150521 | 0 | |
| 125063782 | 12506378 | 4 | 20150522 | 0 | ||
| 125063782 | 12506378 | 5 | 20150528 | 20150602 | 0 | |
| 125063782 | 12506378 | 6 | 20150521 | 20150527 | 0 | |
| 125063782 | 12506378 | 7 | 20150602 | 20150602 | 0 | |
| 125063782 | 12506378 | 8 | 20150521 | 0 |