Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Glycosylated haemoglobin, Haematemesis, Red blood cell count, Red blood cell count increased
Clinical narrative: CATARACTS REMOVED LAST YEAR; SHE HAS ARTHRITIS; HER HANDS BROKE OUT, THE PARAMEDICS TOLD HER THEY WERE BURNS AND THAT SHE DID NOT HAVE CALLUSES ON HER HANDS/SKIN HAD PEELED; VOMITED BLOOD IN THE SINK; SHE COULD NOT WALK; SHE IS EXPERIENCING EXTREMELY HIGH RED BLOOD CELL LEVELS/RED BLOOD CELLS ARE TOO HIGH; HEART VALVE ISSUES; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2024-152221 (BRISTOL-MYERS SQUIBB COMPANY).  Information was received from a Consumer or other non health professional concerning a 71 Year(s) old Female patient, who received Suspect product APIXABAN (Tablet) via Oral ( 5 milligram(s) 2 every 1 Day, from unknown start date ) for Product used for unknown indication, lot number: Unknown;; Suspect product COVID-19 VACCINE from unknown start date ) for corona virus, lot number: Unknown;. Patient received APIXABAN with Strength: 5mg. The patient was first approved for Eliquis on 02-Oct-2023. In Jun-2018, the patient had cardiac valve disease (heart valve issues), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the cardiac valve disease was unknown. In Jun-2024, the patient had red blood cell count increased (she is experiencing extremely high red blood cell levels/red blood cells are too high), which was considered non-serious. It is unknown if treatment was provided. The outcome of the red blood cell count increased was unknown. On an unknown date, the patient had gait inability (she could not walk), which met the following seriousness criteria: disability. It is unknown if treatment was provided. The outcome of the gait inability was unknown. On an unknown date, the patient had haematemesis (vomited blood in the sink), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The haematemesis resolved. On an unknown date, the patient had cataract (cataracts removed last year), which met the following seriousness criteria: medical significance. Treatment included cataracts removed. The outcome of the cataract was unknown. On an unknown date, the patient had skin exfoliation (her hands broke out, the paramedics told her they were burns and that she did not have calluses on her hands/skin had peeled), which was considered non-serious. It is unknown if treatment was provided. The outcome of the skin exfoliation was unknown. On an unknown date, the patient had arthritis (she has arthritis), which was considered non-serious. It is unknown if treatment was provided. The outcome of the arthritis was unknown. The caller reported she needs the side effects of Eliquis mailed to her because she may be allergic to it. She now must go to a hematologist and that she only takes three medications a day. The caller reported she is not like others who take sixteen pills a day. she is very regular with taking her medication. She must see a hematologist because her red blood cells are too high and that this could cause brain damage. The caller reported she has arthritis. She took a blood pressure medication for four years and her hands broke out. The caller reported that the paramedics told her they were burns and that she did not have calluses on her hands. The caller reported she needed to go to a dermatologist and that afternoon she had an appointment with a dermatologist. The dermatologist scraped and told her to immediately stop the blood pressure medication that she was allergic to it. she had a reaction to her blood pressure medication and her skin had peeled. The caller reported when she had taken statins and cholesterol medications, after three days she could not walk. The caller reported that it builds up in her system and then she has an allergy and has side effects. The caller reported this occurs with Vitamin D and Vitamin B12 as well. She has heart valve issues that were diagnosed in Jun-2018 and as of Jun-2022 it was the same as four years prior. She had cataracts removed last year. The caller reported she has worn glasses since she was age but now she has twenty twenty visions. She has taken Eliquis for years. The caller reported she stays away from people with coronavirus coming out again. She received a shot for the corona virus when it first came out a couple of years ago, and seven days after the shot she got up to the go to the restroom around midnight and vomited blood in the sink. The caller reported she was allergic to the shot, but the next morning she was fine. The caller reported that she could be allergic to Eliquis, but that Eliquis is not a bad drug. She reported her primary HCP has faxed over her last two blood draws to the hematologist and that she and her HCP are staying on top it. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included blood pressure, cholesterol, cataracts removed, eyeglasses wearer and covid-19 vaccination. Concomitant medications included ATENOLOL and DIURETIC [HYDROCHLOROTHIAZIDE]. Concomitant medication included Amatolt (spelling not verified). PAF reported the patient said she is on 3 but not sure of names. Relevant Laboratory & other Diagnostic Tests In Jun-2024, RED BLOOD CELL COUNT: too high. On an unknown date, A1C TEST: Not Provided, CHOLESTEROL: Not Provided, BLOOD TEST/BLOOD DRAWS: Not Provided. The reporter did not provide a causality assessment for events cardiac valve disease, gait inability, haematemesis, cataract, red blood cell count increased, skin exfoliation and arthritis to APIXABAN. The reporter did not provide a causality assessment for events cardiac valve disease, gait inability, haematemesis, cataract, red blood cell count increased, skin exfoliation and arthritis to COVID-19 VACCINE. Tracking of Changes: 24-Sep-2024: Initial information was received.  Bristol-Myers Squibb Comment: This elderly aged patient had heart valve issues, she could not walk, vomited blood in the sink and her cataracts removed last year while on apixaban therapy. COVID- 19 vaccine is also a co- suspect. Based on the anticoagulant action of the suspect, the reported vomiting blood in the sink is considered as related to apixaban therapy and not related to COVID-19 vac. Considering the nature of the events and also in lack of biological plausibility, the reported events heart valve issues, disability to walk and cataract removal are considered as not related to apixaban therapy and COVID- 19 vac.  Eliquis is under agreement with BRISTOL-MYERS SQUIBB.