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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117048264 | 11704826 | 4 | F | 20140211 | 20160914 | 20151106 | 20160919 | EXP | US-BAYER-2015-455441 | BAYER | 50.00 | YR | A | F | Y | 99.77000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117048264 | 11704826 | 1 | PS | YASMIN | DROSPIRENONEETHINYL ESTRADIOL | 1 | UNK | Y | 21098 | FILM-COATED TABLET | |||||||||
| 117048264 | 11704826 | 2 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | 0 | |||||||||||
| 117048264 | 11704826 | 3 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 4 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 5 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 6 | C | LOVASTATIN. | LOVASTATIN | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 7 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 8 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 9 | C | LEVAQUIN | LEVOFLOXACIN | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 10 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 11 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 12 | C | COLACE | DOCUSATE SODIUM | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 13 | C | DOPAMINE | DOPAMINEDOPAMINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 14 | C | LEVOPHED | NOREPINEPHRINE BITARTRATE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 15 | C | MORPHINE | MORPHINE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 16 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 17 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 18 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 19 | C | TRIAMCINOLONE ACETONIDE. | TRIAMCINOLONE ACETONIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 20 | C | URECHOLINE | BETHANECHOL CHLORIDE | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 21 | C | MELATONIN | MELATONIN | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 22 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 117048264 | 11704826 | 23 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117048264 | 11704826 | 1 | Premenstrual syndrome |
| 117048264 | 11704826 | 2 | Sleep disorder |
| 117048264 | 11704826 | 23 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117048264 | 11704826 | DS |
| 117048264 | 11704826 | HO |
| 117048264 | 11704826 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117048264 | 11704826 | Anxiety | |
| 117048264 | 11704826 | Arthralgia | |
| 117048264 | 11704826 | Asthenia | |
| 117048264 | 11704826 | Balance disorder | |
| 117048264 | 11704826 | Brain midline shift | |
| 117048264 | 11704826 | Brain oedema | |
| 117048264 | 11704826 | Cerebral haemorrhage | |
| 117048264 | 11704826 | Cerebrovascular accident | |
| 117048264 | 11704826 | Cognitive disorder | |
| 117048264 | 11704826 | Confusional state | |
| 117048264 | 11704826 | Coordination abnormal | |
| 117048264 | 11704826 | Deep vein thrombosis | |
| 117048264 | 11704826 | Depression | |
| 117048264 | 11704826 | Disorientation | |
| 117048264 | 11704826 | Dysarthria | |
| 117048264 | 11704826 | Dysphagia | |
| 117048264 | 11704826 | Dysprosody | |
| 117048264 | 11704826 | Emotional distress | |
| 117048264 | 11704826 | Exercise tolerance decreased | |
| 117048264 | 11704826 | Facial paralysis | |
| 117048264 | 11704826 | Fear | |
| 117048264 | 11704826 | Gait disturbance | |
| 117048264 | 11704826 | Gaze palsy | |
| 117048264 | 11704826 | Grief reaction | |
| 117048264 | 11704826 | Hemiparesis | |
| 117048264 | 11704826 | Hemiplegia | |
| 117048264 | 11704826 | Hypertonia | |
| 117048264 | 11704826 | Impaired driving ability | |
| 117048264 | 11704826 | Laceration | |
| 117048264 | 11704826 | Lethargy | |
| 117048264 | 11704826 | Memory impairment | |
| 117048264 | 11704826 | Mental impairment | |
| 117048264 | 11704826 | Monoparesis | |
| 117048264 | 11704826 | Muscle spasticity | |
| 117048264 | 11704826 | Muscular weakness | |
| 117048264 | 11704826 | Neurologic neglect syndrome | |
| 117048264 | 11704826 | Pain in extremity | |
| 117048264 | 11704826 | Periarthritis | |
| 117048264 | 11704826 | Scar | |
| 117048264 | 11704826 | Speech disorder | |
| 117048264 | 11704826 | Stress | |
| 117048264 | 11704826 | Thrombophlebitis superficial | |
| 117048264 | 11704826 | Urinary retention | |
| 117048264 | 11704826 | Urinary tract infection | |
| 117048264 | 11704826 | Vascular occlusion |
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 |
|---|---|---|---|---|---|---|
| 117048264 | 11704826 | 1 | 201101 | 20140211 | 0 | |
| 117048264 | 11704826 | 2 | 2012 | 0 |