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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116165555 | 11616555 | 5 | F | 20140303 | 20160725 | 20151009 | 20160801 | EXP | PHHY2014CA039580 | SANDOZ | 41.02 | YR | F | Y | 0.00000 | 20160801 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116165555 | 11616555 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW | U | 0 | 300 | MG | QOW | ||||||
| 116165555 | 11616555 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 3 | PS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 81127 | |||||||||
| 116165555 | 11616555 | 4 | SS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | U | 81127 | |||||||||||
| 116165555 | 11616555 | 5 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 6 | C | TECTA | PANTOPRAZOLE MAGNESIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 7 | C | NAPROXEN. | NAPROXEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 8 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 9 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 11 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116165555 | 11616555 | 12 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116165555 | 11616555 | 1 | Chronic spontaneous urticaria |
| 116165555 | 11616555 | 2 | Asthma |
| 116165555 | 11616555 | 3 | Rubber sensitivity |
| 116165555 | 11616555 | 4 | Anaphylactic reaction |
| 116165555 | 11616555 | 5 | Product used for unknown indication |
| 116165555 | 11616555 | 6 | Product used for unknown indication |
| 116165555 | 11616555 | 7 | Product used for unknown indication |
| 116165555 | 11616555 | 8 | Product used for unknown indication |
| 116165555 | 11616555 | 9 | Product used for unknown indication |
| 116165555 | 11616555 | 10 | Product used for unknown indication |
| 116165555 | 11616555 | 11 | Product used for unknown indication |
| 116165555 | 11616555 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116165555 | 11616555 | OT |
| 116165555 | 11616555 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116165555 | 11616555 | Anaphylactic reaction | |
| 116165555 | 11616555 | Asthma | |
| 116165555 | 11616555 | Blood immunoglobulin E increased | |
| 116165555 | 11616555 | Blood potassium decreased | |
| 116165555 | 11616555 | Blood pressure decreased | |
| 116165555 | 11616555 | Cellulitis | |
| 116165555 | 11616555 | Decreased activity | |
| 116165555 | 11616555 | Decreased appetite | |
| 116165555 | 11616555 | Disease progression | |
| 116165555 | 11616555 | Drug hypersensitivity | |
| 116165555 | 11616555 | Dysgeusia | |
| 116165555 | 11616555 | Feeding disorder | |
| 116165555 | 11616555 | Flushing | |
| 116165555 | 11616555 | Food allergy | |
| 116165555 | 11616555 | Hyperaesthesia | |
| 116165555 | 11616555 | Malaise | |
| 116165555 | 11616555 | Mast cell activation syndrome | |
| 116165555 | 11616555 | Mechanical urticaria | |
| 116165555 | 11616555 | Mouth ulceration | |
| 116165555 | 11616555 | Multiple allergies | |
| 116165555 | 11616555 | Oral pain | |
| 116165555 | 11616555 | Rubber sensitivity | |
| 116165555 | 11616555 | Smoke sensitivity |
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 |
|---|---|---|---|---|---|---|
| 116165555 | 11616555 | 1 | 20130110 | 0 | ||
| 116165555 | 11616555 | 2 | 20150422 | 0 |