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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127395811 | 12739581 | 1 | I | 20160723 | 0 | 20160913 | 20160913 | DIR | US-FDA-350445 | FDA-CTU | 44.00 | YR | F | N | 64.80000 | KG | 20160913 | Y | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127395811 | 12739581 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Subcutaneous | N | D | C4098C3 | 0 | ||||||||
| 127395811 | 12739581 | 2 | C | ATIVAN | LORAZEPAM | 1 | 0 | ||||||||||||
| 127395811 | 12739581 | 4 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127395811 | 12739581 | 1 | Skin wrinkling |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127395811 | 12739581 | HO |
| 127395811 | 12739581 | OT |
| 127395811 | 12739581 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127395811 | 12739581 | Affective disorder | |
| 127395811 | 12739581 | Angina pectoris | |
| 127395811 | 12739581 | Anxiety | |
| 127395811 | 12739581 | Depressed mood | |
| 127395811 | 12739581 | Diarrhoea | |
| 127395811 | 12739581 | Dysphonia | |
| 127395811 | 12739581 | Dyspnoea | |
| 127395811 | 12739581 | Feeling abnormal | |
| 127395811 | 12739581 | Feeling drunk | |
| 127395811 | 12739581 | Head discomfort | |
| 127395811 | 12739581 | Hypoaesthesia oral | |
| 127395811 | 12739581 | Malaise | |
| 127395811 | 12739581 | Muscular weakness | |
| 127395811 | 12739581 | Palpitations | |
| 127395811 | 12739581 | Speech disorder | |
| 127395811 | 12739581 | Vision blurred | |
| 127395811 | 12739581 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 127395811 | 12739581 | 1 | 20160723 | 0 |