Age: 67.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Computerised tomogram, Gait disturbance, Ischaemic stroke, Nuclear magnetic resonance imaging, Thrombosis
Clinical narrative: This spontaneous report was received from the patient's husband and concerns a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient started therapy with JANUMET 50/1000 tablets, per oral route, for an unknown indication (dose, frequency, lot number and expiration date were not reported). On an unknown date, the patient run out of her JANUMET 50/1000mg medication, because she was trying to order a prescription refill from the pharmacy for the last several weeks, before she was able to get some JANUMET 50/1000 samples from her physician in the interim, however she would run out the samples too in about 4 or 5 days. No adverse event was reported. Follow-up information was received on 02-AUG-2018, from both, the patient and her husband. The patient would be currently 69 years old at the time of this report. The patient's concurrent conditions included high blood pressure. The patient's concomitant medication included glipizide. The patient had no drug reactions/allergies. On an unknown date, about 4 to 5 years ago, the patient started therapy with JANUMET (50/1000 mg/twice a day) oral tablets for diabetes. On an unknown date (reported as a few weeks ago), the patient had a small stroke that only affected her walking ability. Then, on an unspecified date, the patient sought medical attention and was admitted overnight. It was reported that the patient developed a blood clot. On unknown date, computerized axial tomography (CAT scan) and magnetic resonance imaging (MRI) were performed; results were not provided. Unspecified treatment was given for the adverse events. Therapy with JANUMET was continued. At the reporting time, the patient was recovering from cerebrovascular accident, gait disturbance and thrombosis. The reporter did not provide the causality assessment between the aforementioned events and therapy with JANUMET. Upon internal review the events cerebrovascular accident and thrombosis were considered to be medically significant. Follow up information has been received from the physician on 28-AUG-2018. The patient was reported to be a non-pregnant, who was reported to be of 69 year old also reported as of age "70". The patient had no known drug allergies. It was reported that patient smokes cigarette every day and never used smokeless tobacco. The patient's concurrent conditions included anxiety, dyspepsia and pain. The patient's past therapies included pneumococcal 13 valent conjugate (01-Jan-2008). It was reported that on an unspecified date in 2015 (previously reported as 2013), the patient started therapy with JANUMET for type 2 diabetes mellitus. Other suspect therapies included PNEUMOVAX 23 (on 16-SEP-2015 at 10.28 hours whose route and dose were not reported for prophylaxis), VACCIN TD (on 29-AUG-2014 whose route and dose were not reported for prophylaxis) and influenza virus vaccine (unspecified) first dose 16-SEP-2015 at 10:28 hours, second dose on 09-NOV-2016 at 00:08 hours, third dose on 15-NOV-2017 at 13:03 hours whose route and dose were not reported for prophylaxis). The patient's concomitant medications included Concomitant therapies included aspirin, LIPITOR, TUMS, cholecalciferol, CARDIZEM, ADVIL, MOTRIN, lorazepam, COZAAR, MAG OX, vitamins (unspecified), PRILOSEC, ULTRAM and GLUCOTROL XL. On 18-JUN-2014, the patient had undergone purified protein derivative (PPD) test whose results were not reported. On an unspecified in July 2018, the patient developed ischemic cerebrovascular accident (ischemic stroke, previously reported as cerebrovascular accident) which had led to the hospital admission. During the admission within 24 hours, the patient's vital signs noted to be blood pressure 120/80 (units not reported), height 1.676 m (5'8"), body weight 78.5 kg (172 LB), body mass index 27.92 kg/m2. The reporter did not provide the causal relationship of adverse events with the aforementioned suspect therapies. Upon internal review the event ischemic stroke (previously reported as cerebrovascular accident) was considered to be medically significant.