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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113124673 | 11312467 | 3 | F | 20090312 | 20160510 | 20150727 | 20160819 | EXP | DK-DKMA-EFO12234 | PHHY2015DK085963 | SANDOZ | 14.91 | YR | F | Y | 51.00000 | KG | 20160819 | LW | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113124673 | 11312467 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | U | 77713 | ||||||||||
| 113124673 | 11312467 | 2 | SS | GARDASIL | HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT | 1 | Intramuscular | 1 DF, UNK | U | 0 | 1 | DF | |||||||
| 113124673 | 11312467 | 3 | C | DOGMATIL | SULPIRIDE | 1 | Unknown | U | 0 | ||||||||||
| 113124673 | 11312467 | 4 | C | ELVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 113124673 | 11312467 | 5 | C | TRUXAL | CHLORPROTHIXENE | 1 | Unknown | U | 0 | ||||||||||
| 113124673 | 11312467 | 6 | C | FLUOXETIN | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113124673 | 11312467 | 1 | Anxiety |
| 113124673 | 11312467 | 2 | Human papilloma virus immunisation |
| 113124673 | 11312467 | 3 | Depressive symptom |
| 113124673 | 11312467 | 4 | Product used for unknown indication |
| 113124673 | 11312467 | 5 | Product used for unknown indication |
| 113124673 | 11312467 | 6 | Depressive symptom |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113124673 | 11312467 | DS |
| 113124673 | 11312467 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113124673 | 11312467 | Anxiety | |
| 113124673 | 11312467 | Chest pain | |
| 113124673 | 11312467 | Confusional state | |
| 113124673 | 11312467 | Cystitis | |
| 113124673 | 11312467 | Decreased immune responsiveness | |
| 113124673 | 11312467 | Disorganised speech | |
| 113124673 | 11312467 | Disturbance in attention | |
| 113124673 | 11312467 | Dizziness | |
| 113124673 | 11312467 | Drug hypersensitivity | |
| 113124673 | 11312467 | Fatigue | |
| 113124673 | 11312467 | Feeling cold | |
| 113124673 | 11312467 | Gastric pH decreased | |
| 113124673 | 11312467 | Headache | |
| 113124673 | 11312467 | Heart rate increased | |
| 113124673 | 11312467 | Hyperaesthesia | |
| 113124673 | 11312467 | Hypotension | |
| 113124673 | 11312467 | Infection | |
| 113124673 | 11312467 | Insomnia | |
| 113124673 | 11312467 | Learning disorder | |
| 113124673 | 11312467 | Malaise | |
| 113124673 | 11312467 | Memory impairment | |
| 113124673 | 11312467 | Muscle tightness | |
| 113124673 | 11312467 | Muscular weakness | |
| 113124673 | 11312467 | Nasal congestion | |
| 113124673 | 11312467 | Oropharyngeal pain | |
| 113124673 | 11312467 | Palpitations | |
| 113124673 | 11312467 | Peripheral coldness | |
| 113124673 | 11312467 | Photophobia | |
| 113124673 | 11312467 | Pyrexia | |
| 113124673 | 11312467 | Rash | |
| 113124673 | 11312467 | Stress | |
| 113124673 | 11312467 | Urticaria | |
| 113124673 | 11312467 | Vitamin D deficiency |
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 |
|---|---|---|---|---|---|---|
| 113124673 | 11312467 | 2 | 20081022 | 20090414 | 0 | |
| 113124673 | 11312467 | 6 | 2012 | 2013 | 0 |