Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Treatment noncompliance
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-062230. Information was received from a Consumer/other non-health professional concerning a 72 Year(s) old Female patient, who received Suspect product apixaban (Tablet) via Oral (5 milligram(s) 2 every 1 Day, from Dec-2019) for prophylaxis stroke, lot number: Unknown; Suspect product COVID-19 VACCINE (from Nov-2021) for covid-19 immunization, lot number: Unknown.  On an unknown date, Patient was splitting her apixaban 5 mg tablets in half and taking apixaban 2.5 mg twice daily because of financial issues. Caller taking lower dose than prescribed due to financial constraints.  On an unknown date, the patient had fall (caller stated that she has fallen quite a few times, she fell as a result of the nausea), which met the following seriousness criteria: hospitalization. It is unknown if treatment was provided. The outcome of the fall was unknown.  On an unknown date, the patient had arthropathy (caller stated that she has fallen quite a few times and that these falls have weakened her joints), which met the following seriousness criteria: hospitalization. Treatment included she takes over-the-counter supplements: Move Free Ultra: contains hyaluronic acid, boron, cartilage.  Multivitamin containing Vitamin K, "twice as much Vitamin K as Centrum Silver vitamins". The outcome of the arthropathy was unknown.  On an unknown date, the patient had nausea (caller provided that she received the covid19 vaccine around November 2021 and was nauseous from the vaccine), which met the following seriousness criteria: hospitalization. It is unknown if treatment was provided. The outcome of the nausea was unknown.  On an unknown date, the patient had presyncope (physician stated that she had had a vasovagal reaction), which met the following seriousness criteria: hospitalization. It is unknown if treatment was provided. The outcome of the presyncope was unknown.  On an unknown date, the patient had benign neoplasm (caller stated that the mri revealed a tumor that was defined to be benign), which met the following seriousness criteria: hospitalization. It is unknown if treatment was provided. The outcome of the benign neoplasm was unknown.  On an unknown date, the patient had meibomian gland dysfunction (caller stated that she recently completed a course of antibiotic cephalexin for a plugged up oil gland in the eye), which met the following seriousness criteria: hospitalization. Treatment included antibiotic cephalexin. The outcome of the meibomian gland dysfunction was unknown.  On an unknown date, the patient had treatment noncompliance (patient was splitting her apixaban 5 mg tablets in half and taking apixaban 2.5 mg twice daily because of financial issues. caller taking lower dose than prescribed due to financial constraints), which was considered non-serious. It is unknown if treatment was provided. The outcome of the treatment noncompliance was unknown. Caller stated that she has questions about some over-the-counter medications that she takes along with the apixaban and she wants to check to see if any interactions are possible between them. Informed caller that I could check for her, but that she needs to also make her physician aware of all of the over-the-counter medications that she takes so that the physician can apply his/her judgment as well. Caller provided that she has been taking the apixaban since December 2019. Caller stated that she takes apixaban 5 mg twice daily. Caller provided that one supplement that she takes is for joints and that her dermatologist encouraged her to take a supplement that contains cartilage for patient's joints. Caller stated that she has fallen quite a few times and that these falls have weakened her joints. Caller provided that she received the COVID19 vaccine around November 2021 and was nauseous from the vaccine. Caller stated that she fell as a result of the nausea and that her physician stated that she had had a Vasovagal reaction. Caller stated that she was hospitalized at this time and had to undergo an MRI since she takes apixaban and the physician had to evaluate whether there was any intracranial bleeding. Caller stated that the MRI revealed a tumor that was defined to be benign. Hospitalization was in November 2021. Caller stated that she recently completed a course of antibiotic cephalexin for a "plugged up oil gland in the eye."  The action taken with apixaban medication was unknown.  The action taken with COVID-19 VACCINE medication was unknown. Concomitant medication included DULCOLAX [BISACODYL].  Relevant Laboratory and other Diagnostic Tests. On an unknown date, MRI: Caller stated that the MRI revealed a tumor that was defined to be benign.  The reporter did not provide a causality assessment for events fall, arthropathy, nausea, presyncope, benign neoplasm, meibomian gland dysfunction and treatment noncompliance to apixaban.  The reporter did not provide a causality assessment for events fall, arthropathy, presyncope, benign neoplasm, meibomian gland dysfunction and treatment noncompliance to COVID-19 VACCINE.  The reporter considered event nausea related to COVID-19 VACCINE.  Tracking of Changes: 26-Apr-2023: Initial information was received.   Eliquis is under agreement with BRISTOL-MYERS SQUIBB.; Sender's Comments: BMS Comment: This 72-year-old patient had multiple events while on apixaban therapy. Covid-19 vaccine is an additional suspect. In the absence of information pertaining to definitive diagnosis and diagnostic test results to rule out alternative etiologies, it cannot be ascertained with reasonable possibility that the suspect therapy caused or contributed to the events, vasovagal reaction and nausea. Fall occurred secondary to nausea. Repeated falls most likely lead to the weakened joints. Elderly age is a significant risk factor for meibomian gland dysfunction and fall. Benign neoplasm had a neoplastic etiopathogenesis for which anticoagulant-natured apixaban or covid-19 vaccine would be unlikely to contribute due to the absence of biological plausibility. Hence, the reported events are assessed as not related to suspect therapy.