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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126804031 | 12680403 | 1 | I | 20160816 | 20160824 | 20160824 | EXP | US-GLAXOSMITHKLINE-US2016GSK121750 | GLAXOSMITHKLINE | 0.00 | F | Y | 0.00000 | 20160824 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126804031 | 12680403 | 1 | PS | POTIGA | EZOGABINE | 1 | 250 MG, TID | U | 22345 | 250 | MG | TID | |||||||
| 126804031 | 12680403 | 2 | SS | POTIGA | EZOGABINE | 1 | 250 MG, TID | U | 22345 | 250 | MG | TID | |||||||
| 126804031 | 12680403 | 3 | SS | Morphine | MORPHINE | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 4 | SS | TORADOL | KETOROLAC TROMETHAMINE | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 5 | SS | CECLOR | CEFACLOR | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 6 | SS | DURICEF | CEFADROXIL | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 7 | SS | NEURONTIN | GABAPENTIN | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 8 | SS | TOPAMAX | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 9 | SS | LIDOCAINE. | LIDOCAINE | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 10 | SS | TRAMADOL. | TRAMADOL | 1 | U | 0 | |||||||||||
| 126804031 | 12680403 | 11 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 12 | C | VALIUM | DIAZEPAM | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 13 | C | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 14 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 15 | C | LASIX | FUROSEMIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 16 | C | VITAMIN B2 | RIBOFLAVIN | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 17 | C | HYDROCODONE | HYDROCODONE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 18 | C | STADOL | BUTORPHANOL TARTRATE | 1 | 0 | NASAL SPRAY | |||||||||||
| 126804031 | 12680403 | 19 | C | LORTAB (ACETAMINOPHEN + HYDROCODONE) | 2 | 0 | |||||||||||||
| 126804031 | 12680403 | 20 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 21 | C | LIDODERM | LIDOCAINE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 22 | C | COLACE | DOCUSATE SODIUM | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 23 | C | PEPCID | FAMOTIDINE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 24 | C | CLEOCIN | CLINDAMYCIN PHOSPHATE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 25 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 26 | C | MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 27 | C | ALUMINUM HYDROXIDE+MAGNESIUM HYDROXIDE+SIMETHICONE | 2 | 0 | |||||||||||||
| 126804031 | 12680403 | 28 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 29 | C | CATAPRES | CLONIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 30 | C | CLARITIN | LORATADINE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 31 | C | Cepacol lozenge | 2 | 0 | LOZENGE | ||||||||||||
| 126804031 | 12680403 | 32 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126804031 | 12680403 | 33 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126804031 | 12680403 | 1 | Seizure |
| 126804031 | 12680403 | 3 | Product used for unknown indication |
| 126804031 | 12680403 | 4 | Product used for unknown indication |
| 126804031 | 12680403 | 5 | Product used for unknown indication |
| 126804031 | 12680403 | 6 | Product used for unknown indication |
| 126804031 | 12680403 | 8 | Product used for unknown indication |
| 126804031 | 12680403 | 9 | Product used for unknown indication |
| 126804031 | 12680403 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126804031 | 12680403 | HO |
| 126804031 | 12680403 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126804031 | 12680403 | Arthrodesis | |
| 126804031 | 12680403 | Back pain | |
| 126804031 | 12680403 | Burning sensation | |
| 126804031 | 12680403 | Discomfort | |
| 126804031 | 12680403 | Drain placement | |
| 126804031 | 12680403 | Drug hypersensitivity | |
| 126804031 | 12680403 | Endocrine disorder | |
| 126804031 | 12680403 | Foraminotomy | |
| 126804031 | 12680403 | Grip strength decreased | |
| 126804031 | 12680403 | Hypoaesthesia | |
| 126804031 | 12680403 | Immune system disorder | |
| 126804031 | 12680403 | Injury | |
| 126804031 | 12680403 | Intervertebral disc protrusion | |
| 126804031 | 12680403 | Medical device implantation | |
| 126804031 | 12680403 | Muscle spasms | |
| 126804031 | 12680403 | Muscular weakness | |
| 126804031 | 12680403 | Neck pain | |
| 126804031 | 12680403 | Nerve block | |
| 126804031 | 12680403 | Nerve compression | |
| 126804031 | 12680403 | Nervous system disorder | |
| 126804031 | 12680403 | Pain in extremity | |
| 126804031 | 12680403 | Procedural nausea | |
| 126804031 | 12680403 | Procedural vomiting | |
| 126804031 | 12680403 | Pruritus | |
| 126804031 | 12680403 | Pseudarthrosis | |
| 126804031 | 12680403 | Rash | |
| 126804031 | 12680403 | Reflex test abnormal | |
| 126804031 | 12680403 | Respiratory arrest | |
| 126804031 | 12680403 | Sensory loss | |
| 126804031 | 12680403 | Spinal decompression | |
| 126804031 | 12680403 | Spinal laminectomy | |
| 126804031 | 12680403 | Spinal pain | |
| 126804031 | 12680403 | Tenderness | |
| 126804031 | 12680403 | Visual acuity reduced |
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 |
|---|---|---|---|---|---|---|
| 126804031 | 12680403 | 1 | 20130708 | 0 | ||
| 126804031 | 12680403 | 2 | 20140121 | 0 |