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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125261753 | 12526175 | 3 | F | 201604 | 20160718 | 20160705 | 20160808 | PER | US-PFIZER INC-2016311939 | PFIZER | 88.00 | YR | F | Y | 45.00000 | KG | 20160808 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125261753 | 12526175 | 1 | PS | TIKOSYN | DOFETILIDE | 1 | Oral | 125 UG, 2X/DAY | 20931 | 125 | UG | CAPSULE, HARD | BID | ||||||
| 125261753 | 12526175 | 2 | SS | TIKOSYN | DOFETILIDE | 1 | Oral | 125 UG, 2X/DAY (8 AM AND 8 PM) | 20931 | 125 | UG | CAPSULE, HARD | BID | ||||||
| 125261753 | 12526175 | 3 | SS | TIKOSYN | DOFETILIDE | 1 | UNK | 20931 | CAPSULE, HARD | ||||||||||
| 125261753 | 12526175 | 4 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 25 MG, UNK | 0 | 25 | MG | TABLET | ||||||||
| 125261753 | 12526175 | 5 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 50 MG, DAILY (AM) | 0 | 50 | MG | TABLET | ||||||||
| 125261753 | 12526175 | 6 | C | PROLIA | DENOSUMAB | 1 | Subcutaneous | UNK (EVERY 6 MONTHS ) | 0 | INJECTION | |||||||||
| 125261753 | 12526175 | 7 | C | ASA EC | 2 | 81 MG, DAILY (PM) | 0 | 81 | MG | ||||||||||
| 125261753 | 12526175 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, AS NEEDED | 0 | 20 | MG | |||||||||
| 125261753 | 12526175 | 9 | C | TRAMADOL. | TRAMADOL | 1 | 75 MG, DAILY (50 MG AT 8 AM AND 25 MG AT 8 PM ) | 0 | 75 | MG | |||||||||
| 125261753 | 12526175 | 10 | C | TRAMADOL. | TRAMADOL | 1 | 25 MG, AS NEEDED | 0 | 25 | MG | |||||||||
| 125261753 | 12526175 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 20 MG, 1X/DAY (8 PM) | 0 | 20 | MG | QD | ||||||||
| 125261753 | 12526175 | 12 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | 20 MG, 1X/DAY (8 AM) | 0 | 20 | MG | QD | ||||||||
| 125261753 | 12526175 | 13 | C | DOXAZOSIN MESYLATE. | DOXAZOSIN MESYLATE | 1 | 2 MG, 1X/DAY (8 PM) | 0 | 2 | MG | QD | ||||||||
| 125261753 | 12526175 | 14 | C | REMERON | MIRTAZAPINE | 1 | 15 MG, 1X/DAY (8 PM) | 0 | 15 | MG | QD | ||||||||
| 125261753 | 12526175 | 15 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 1000 IU, 1X/DAY (8 PM) | 0 | 1000 | IU | QD | ||||||||
| 125261753 | 12526175 | 16 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK, AS NEEDED (IN AM) (MIXED IN WATER) | 0 | |||||||||||
| 125261753 | 12526175 | 17 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | 28 MG, UNK (M-W-F AT 8 AM) | 0 | 28 | MG | |||||||||
| 125261753 | 12526175 | 18 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | UNK (M-W-FRIDAY AM) | 0 | |||||||||||
| 125261753 | 12526175 | 19 | C | TYLENOL | ACETAMINOPHEN | 1 | 500 MG, 2X/DAY (8 AM + 8 PM) | 0 | 500 | MG | BID | ||||||||
| 125261753 | 12526175 | 20 | C | PNEUMOVAX 23 | PNEUMOCOCCAL VACCINE, POLYVALENT 23 | 1 | UNK | 0 | |||||||||||
| 125261753 | 12526175 | 21 | C | PREVNAR 13 | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE | 1 | UNK | 0 | |||||||||||
| 125261753 | 12526175 | 22 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | 100 MG, UNK (DOCUSATE SODIUM 100 MG EVERY 8 PM, AND TUES, THRUS, SAT AND SUN AT 8 AM) | 0 | 100 | MG | |||||||||
| 125261753 | 12526175 | 23 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125261753 | 12526175 | 1 | Atrial fibrillation |
| 125261753 | 12526175 | 2 | Atrial fibrillation |
| 125261753 | 12526175 | 4 | Depression |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125261753 | 12526175 | Abnormal behaviour | |
| 125261753 | 12526175 | Anxiety | |
| 125261753 | 12526175 | Confusional state | |
| 125261753 | 12526175 | Fall | |
| 125261753 | 12526175 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 125261753 | 12526175 | 1 | 20160407 | 0 | ||
| 125261753 | 12526175 | 2 | 20160606 | 0 | ||
| 125261753 | 12526175 | 3 | 20160404 | 0 | ||
| 125261753 | 12526175 | 4 | 20160531 | 0 | ||
| 125261753 | 12526175 | 6 | 201507 | 0 | ||
| 125261753 | 12526175 | 13 | 20110310 | 0 | ||
| 125261753 | 12526175 | 20 | 20141003 | 20141003 | 0 | |
| 125261753 | 12526175 | 21 | 20160315 | 20160315 | 0 |