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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126345361 | 12634536 | 1 | I | 20160801 | 0 | 20160808 | 20160808 | DIR | 32.00 | MON | F | N | 11.60000 | KG | 20160805 | N | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126345361 | 12634536 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | D | D | 0 | 200 | IU | 1X | ||||||
| 126345361 | 12634536 | 3 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 4 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 6 | C | IBUPROFEN. | IBUPROFEN | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 8 | C | KEPPRA | LEVETIRACETAM | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 10 | C | LEVOCARNITINE. | LEVOCARNITINE | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 12 | C | LORATADINE. | LORATADINE | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 14 | C | POLYETHYLENE GLYCOL | POLYETHYLENE GLYCOLS | 1 | 0 | ||||||||||||
| 126345361 | 12634536 | 16 | C | THIAMINE. | THIAMINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126345361 | 12634536 | 1 | Muscle tone disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126345361 | 12634536 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126345361 | 12634536 | Hypotonia | |
| 126345361 | 12634536 | Muscular weakness |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 126345361 | 12634536 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126345361 | 12634536 | 1 | 20160725 | 20160725 | 0 |