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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127744021 | 12774402 | 1 | I | 20160909 | 20160923 | 20160923 | PER | US-JNJFOC-20160910588 | JOHNSON AND JOHNSON | 9.00 | DEC | E | F | Y | 56.25000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127744021 | 12774402 | 1 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 471351;467858 | 0 | 10 | MG | TABLET | QD | |||||
| 127744021 | 12774402 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 471351;467858 | 0 | 10 | MG | TABLET | QD | |||||
| 127744021 | 12774402 | 3 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 1/2 TABLET | N | 471351;467858 | 0 | 5 | MG | TABLET | QD | ||||
| 127744021 | 12774402 | 4 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 1/2 TABLET | N | 471351;467858 | 0 | 5 | MG | TABLET | QD | ||||
| 127744021 | 12774402 | 5 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 471351;467858 | 0 | 10 | MG | TABLET | QD | |||||
| 127744021 | 12774402 | 6 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 471351;467858 | 0 | 10 | MG | TABLET | QD | |||||
| 127744021 | 12774402 | 7 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 1/2 TABLET | N | 471351;467858 | 0 | 5 | MG | TABLET | QD | ||||
| 127744021 | 12774402 | 8 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 471351;467858 | 19835 | 10 | MG | TABLET | QD | |||||
| 127744021 | 12774402 | 9 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 471351;467858 | 19835 | 10 | MG | TABLET | QD | |||||
| 127744021 | 12774402 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | YEARS | D | 0 | 88 | MG | UNSPECIFIED | ||||||
| 127744021 | 12774402 | 11 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | Unknown | 3-4 YEARS | D | 0 | 120 | MG | UNSPECIFIED | ||||||
| 127744021 | 12774402 | 12 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | D | 0 | 1 | DF | UNSPECIFIED | |||||||
| 127744021 | 12774402 | 13 | C | ALL OTHER THERAPEUTIC PRODUCTS | UNSPECIFIED INGREDIENT | 1 | Unknown | EVERY OTHER DAY FOR 6 MONTHS | D | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127744021 | 12774402 | 1 | Lacrimation increased |
| 127744021 | 12774402 | 2 | Lacrimation increased |
| 127744021 | 12774402 | 3 | Lacrimation increased |
| 127744021 | 12774402 | 4 | Rhinorrhoea |
| 127744021 | 12774402 | 5 | Rhinorrhoea |
| 127744021 | 12774402 | 6 | Rhinorrhoea |
| 127744021 | 12774402 | 7 | Cough |
| 127744021 | 12774402 | 8 | Cough |
| 127744021 | 12774402 | 9 | Cough |
| 127744021 | 12774402 | 10 | Thyroid disorder |
| 127744021 | 12774402 | 11 | Atrial fibrillation |
| 127744021 | 12774402 | 12 | Nutritional supplementation |
| 127744021 | 12774402 | 13 | Cataract |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127744021 | 12774402 | Lethargy | |
| 127744021 | 12774402 | Off label use | |
| 127744021 | 12774402 | Product packaging issue | |
| 127744021 | 12774402 | Product use issue | |
| 127744021 | 12774402 | Somnolence | |
| 127744021 | 12774402 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 127744021 | 12774402 | 1 | 2016 | 2016 | 0 | |
| 127744021 | 12774402 | 2 | 2016 | 0 | ||
| 127744021 | 12774402 | 3 | 2016 | 0 | ||
| 127744021 | 12774402 | 4 | 2016 | 0 | ||
| 127744021 | 12774402 | 5 | 2016 | 0 | ||
| 127744021 | 12774402 | 6 | 2016 | 2016 | 0 | |
| 127744021 | 12774402 | 7 | 2016 | 0 | ||
| 127744021 | 12774402 | 8 | 2016 | 0 | ||
| 127744021 | 12774402 | 9 | 2016 | 2016 | 0 |