Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Somnolence
Clinical narrative: MILD STROKE; TOO TIRED; VERY SLEEPY; 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-2022-129830.  Information was received from a Consumer/other non health professional concerning a 80 Year(s) old Female patient, who received Suspect product APIXABAN for Blood clots in lungs, Oral (5 milligram(s) 2 every 1 Day), lot number:1909418; Suspect product PFIZER BIONTECH COVID-19 VACCINE for Product used for unknown indication, lot number:Unknown; Suspect product XANAX for Product used for unknown indication, lot number:Unknown. On an unknown date, the patient experienced cerebrovascular accident(mild stroke) which was considered serious due to medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced fatigue(too tired) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced somnolence(very sleepy) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of PFIZER BIONTECH COVID-19 VACCINE medication is unknown. XANAX was discontinued. Concomitant medications included SYNTHROID, BUSPIRONE and REPATHA. The reporter did not provide a causal assessment for events cerebrovascular accident, fatigue and somnolence to product APIXABAN. The reporter considered event cerebrovascular accident related to product PFIZER BIONTECH COVID-19 VACCINE. The reporter did not provide a causal assessment for events fatigue and somnolence to product PFIZER BIONTECH COVID-19 VACCINE. The reporter did not provide a causal assessment for events cerebrovascular accident, fatigue and somnolence to product XANAX. The caller reported that about two years ago she was put on Eliquis for a blood clot. The caller stated that she was on Eliquis for that clot for about six months. The caller reported that in Mar2022 she developed major blood clots in her lungs. The caller stated that she was put back on Eliquis and told she would have to stay on it the rest of her life. The caller stated that about five months later she got the Pfizer covid shot. The caller stated a week later she had a mild stroke. The caller stated that she thought maybe the shot may have been the reason for the stroke since she was already on Eliquis. The caller reported that she has been anxious all her life and since the blood clots in March and her husband being sick, she has had more anxiety. The caller stated she was put on Xanax, but that made her too tired and very sleepy. The caller stated that the Xanax was discontinued, and she was prescribed Buspirone 5mg. The caller stated that she will start that medication today. The caller reported that she has taken multiple cholesterol medications, but none of them have worked. The caller stated that she will start Repatha this Sunday. The caller reported that she has been on Synthroid for over twenty years as well. The caller stated that she did have trouble at times remembering information regarding her experience. Follow-up not performed, Reporter does not wish to be contacted for follow-up The following Case IDs are linked to this patient: BMS-2020-066042 and 2022-129337. Tracking of Changes: 28-Oct-2022: Initial information was received.  Eliquis is under agreement with Regulatory Authority.; Sender's Comments: RA comment: This 80-year-old patient had cerebrovascular accident after receiving apixaban. Elderly age is a risk factor for the reported event and is considered not related to apixaban.