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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127982061 | 12798206 | 1 | I | 20160922 | 0 | 20160930 | 20160930 | DIR | FDA-CTU | 49.00 | YR | F | N | 0.00000 | 20160929 | N | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127982061 | 12798206 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 200 UNITS, Q3MONTHS | Y | D | C4009C3 | 20181031 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127982061 | 12798206 | 1 | Migraine |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127982061 | 12798206 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127982061 | 12798206 | Asthenia | |
| 127982061 | 12798206 | Blood pressure decreased | |
| 127982061 | 12798206 | Eye pain | |
| 127982061 | 12798206 | Heart rate decreased | |
| 127982061 | 12798206 | Musculoskeletal stiffness | |
| 127982061 | 12798206 | Pyrexia | |
| 127982061 | 12798206 | Vision blurred | |
| 127982061 | 12798206 | White blood cell count increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 127982061 | 12798206 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127982061 | 12798206 | 1 | 20150214 | 0 |