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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126271001 | 12627100 | 1 | I | 20160229 | 20160803 | 20160805 | 20160805 | EXP | NO-NOMAADVRE-PASRAPP-2016-0002358 | NO-ALLERGAN-1664773US | ALLERGAN | 66.00 | YR | M | Y | 77.00000 | KG | 20160805 | OT | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126271001 | 12627100 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | UNK UNITS, SINGLE | 103000 | POWDER FOR INJECTION | QD | ||||||||
| 126271001 | 12627100 | 2 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | UNK UNITS SINGLE | 103000 | POWDER FOR INJECTION | QD | ||||||||
| 126271001 | 12627100 | 3 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 100 MG DAILY | U | 0 | 100 | MG | TABLET | QD | |||||
| 126271001 | 12627100 | 4 | C | CLARITIN | LORATADINE | 1 | 10 MG DAILY | U | 0 | 10 | MG | TABLET | QD | ||||||
| 126271001 | 12627100 | 5 | C | RHINOCORT | BUDESONIDE | 1 | Respiratory (inhalation) | 100 MICROGRAMS EVERY OTHER DAY | U | 0 | 100 | UG | NASAL SPRAY, SUSPENSION | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126271001 | 12627100 | 1 | Salivary hypersecretion |
| 126271001 | 12627100 | 3 | Heart rate |
| 126271001 | 12627100 | 4 | Hypersensitivity |
| 126271001 | 12627100 | 5 | Hypersensitivity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126271001 | 12627100 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126271001 | 12627100 | Death | |
| 126271001 | 12627100 | General physical health deterioration | |
| 126271001 | 12627100 | Hallucination | |
| 126271001 | 12627100 | Lip swelling | |
| 126271001 | 12627100 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 126271001 | 12627100 | 1 | 20160226 | 20160226 | 0 | |
| 126271001 | 12627100 | 2 | 20160209 | 20160209 | 0 | |
| 126271001 | 12627100 | 3 | 20160229 | 0 |