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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118526655 | 11852665 | 5 | F | 2015 | 20160628 | 20151218 | 20160706 | EXP | BR-ABBVIE-15K-020-1518627-00 | ABBVIE | 54.00 | YR | F | Y | 66.00000 | KG | 20160706 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118526655 | 11852665 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 49055XH01,50061XH01,57113XH03 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 118526655 | 11852665 | 2 | SS | LACRIFILM | CARBOXYMETHYLCELLULOSE SODIUM | 1 | Ophthalmic | UNKNOWN | 0 | 2 | GTT | ||||||||
| 118526655 | 11852665 | 3 | SS | LACRIFILM | CARBOXYMETHYLCELLULOSE SODIUM | 1 | UNKNOWN | 0 | |||||||||||
| 118526655 | 11852665 | 4 | C | DORIL | 2 | Oral | 0 | 2 | MG | TABLET | |||||||||
| 118526655 | 11852665 | 5 | C | DORIL | 2 | 0 | |||||||||||||
| 118526655 | 11852665 | 6 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 | 2 | MG | TABLET | QOD | |||||||
| 118526655 | 11852665 | 7 | C | RIVOTRIL | CLONAZEPAM | 1 | 0 | ||||||||||||
| 118526655 | 11852665 | 8 | C | DIPYRONE | DIPYRONE | 1 | Oral | 0 | TABLET | ||||||||||
| 118526655 | 11852665 | 9 | C | NEOPRAZOL | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 118526655 | 11852665 | 10 | C | DORALGINA | 2 | Oral | 0 | TABLET | |||||||||||
| 118526655 | 11852665 | 11 | C | DORALGINA | 2 | 0 | |||||||||||||
| 118526655 | 11852665 | 12 | C | DIAZEPAM. | DIAZEPAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118526655 | 11852665 | 1 | Psoriatic arthropathy |
| 118526655 | 11852665 | 2 | Eye irritation |
| 118526655 | 11852665 | 3 | Dry eye |
| 118526655 | 11852665 | 4 | Headache |
| 118526655 | 11852665 | 5 | Spinal pain |
| 118526655 | 11852665 | 6 | Insomnia |
| 118526655 | 11852665 | 7 | Anxiety |
| 118526655 | 11852665 | 8 | Headache |
| 118526655 | 11852665 | 9 | Gastritis |
| 118526655 | 11852665 | 10 | Migraine |
| 118526655 | 11852665 | 11 | Pain |
| 118526655 | 11852665 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118526655 | 11852665 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118526655 | 11852665 | Abdominal pain upper | |
| 118526655 | 11852665 | Anxiety | |
| 118526655 | 11852665 | Blood pressure decreased | |
| 118526655 | 11852665 | Blood triglycerides increased | |
| 118526655 | 11852665 | Dizziness | |
| 118526655 | 11852665 | Dry eye | |
| 118526655 | 11852665 | Dyspnoea | |
| 118526655 | 11852665 | Eye swelling | |
| 118526655 | 11852665 | Feeling cold | |
| 118526655 | 11852665 | Feeling hot | |
| 118526655 | 11852665 | Hallucination | |
| 118526655 | 11852665 | Heart rate increased | |
| 118526655 | 11852665 | Hypoaesthesia | |
| 118526655 | 11852665 | Inappropriate schedule of drug administration | |
| 118526655 | 11852665 | Incorrect dose administered | |
| 118526655 | 11852665 | Injection site abscess | |
| 118526655 | 11852665 | Injection site erythema | |
| 118526655 | 11852665 | Injection site haematoma | |
| 118526655 | 11852665 | Injection site mass | |
| 118526655 | 11852665 | Injection site pain | |
| 118526655 | 11852665 | Injection site pruritus | |
| 118526655 | 11852665 | Injection site warmth | |
| 118526655 | 11852665 | Insomnia | |
| 118526655 | 11852665 | Malaise | |
| 118526655 | 11852665 | Migraine | |
| 118526655 | 11852665 | Nausea | |
| 118526655 | 11852665 | Nervousness | |
| 118526655 | 11852665 | Pain in extremity | |
| 118526655 | 11852665 | Pallor | |
| 118526655 | 11852665 | Peripheral swelling | |
| 118526655 | 11852665 | Pollakiuria | |
| 118526655 | 11852665 | Pruritus | |
| 118526655 | 11852665 | Pruritus generalised | |
| 118526655 | 11852665 | Restlessness | |
| 118526655 | 11852665 | Skin irritation | |
| 118526655 | 11852665 | Sluggishness | |
| 118526655 | 11852665 | Somnolence | |
| 118526655 | 11852665 | Stress | |
| 118526655 | 11852665 | Swelling | |
| 118526655 | 11852665 | Swelling face | |
| 118526655 | 11852665 | Tongue spasm | |
| 118526655 | 11852665 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 118526655 | 11852665 | 1 | 20151001 | 0 | ||
| 118526655 | 11852665 | 4 | 2014 | 20151209 | 0 | |
| 118526655 | 11852665 | 6 | 2014 | 0 | ||
| 118526655 | 11852665 | 8 | 20151209 | 0 |