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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121137203 | 12113720 | 3 | F | 20160211 | 20160907 | 20160225 | 20160916 | EXP | US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-00297 | WESTWARD | 5.91 | YR | F | Y | 16.34000 | KG | 20160916 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121137203 | 12113720 | 1 | PS | AMOXICILLIN. | AMOXICILLIN | 1 | Oral | Y | 65325 | 10 | ML | BID | |||||||
| 121137203 | 12113720 | 2 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | 0 | 5 | MG | QD | ||||||||
| 121137203 | 12113720 | 3 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121137203 | 12113720 | 1 | Ear infection |
| 121137203 | 12113720 | 2 | Product used for unknown indication |
| 121137203 | 12113720 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121137203 | 12113720 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121137203 | 12113720 | Drug dose omission | |
| 121137203 | 12113720 | Drug hypersensitivity | |
| 121137203 | 12113720 | Lip haemorrhage | |
| 121137203 | 12113720 | Lip swelling | |
| 121137203 | 12113720 | Oral mucosal blistering | |
| 121137203 | 12113720 | Oral mucosal erythema | |
| 121137203 | 12113720 | Scab | |
| 121137203 | 12113720 | Screaming | |
| 121137203 | 12113720 | Stomatitis | |
| 121137203 | 12113720 | Tongue blistering | |
| 121137203 | 12113720 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 121137203 | 12113720 | 1 | 20160211 | 20160212 | 0 |