Sex: F
Vaccine: COVID19
Symptoms: Arterial thrombosis, Gangrene, Peripheral ischaemia
Clinical narrative: GANGRENE; BLOOD CLOTS/ARTERIAL THROMBOSIS; ISCHEMIC LIMB; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): BRISTOL-MYERS SQUIBB COMPANY-2022-142312 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 65 Year(s) old Female patient, who received Suspect product apixaban for prophylaxis stroke, Tablet, Oral (5 milligram(s) from Aug-2021 2 every 1 Day), lot number:Unknown. Apixaban 1 tablet by mouth twice a day. On an unknown date, the patient experienced gangrene(gangrene) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced thrombosis(she had a covid shot and got blood clots and was hospitalized 3 times with gangrene on one of her feed due to the blood clots.) 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 hypersensitivity(patient got an allergic reaction to the covid-19 vaccine and ended with blood clots) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unspecified date, patient got an allergic reaction to the COVID-19 vaccine and ended with blood clots. The status of apixaban medication is unknown. The patient mentioned while she was checking the status of her application that she had a breakdown when her husband died. She had a covid shot and got blood clots and was hospitalized 3 times with gangrene on one of her feed due to the blood clots. She started taking it (Eliquis) in August of 2021."Ae onset date is unavailable. Therapy start date: August 2021. Medical history and concurrent conditions included Latex allergy. Concomitant medications included nexium [esomeprazole magnesium trihydrate], norvasc, atorvastatin and ativan. The reporter considered event gangrene related to product apixaban. The reporter did not provide a causal assessment for events thrombosis and hypersensitivity to product apixaban. Reporter does not wish to be contacted. Tracking of Changes: 22-Nov-2022: Initial information was received.   Eliquis is under agreement with Bristol-Myers Squibb.  Follow-up (23Nov2022): This is a spontaneous follow-up report received from a contactable reporter (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): BRISTOL-MYERS SQUIBB COMPANY-2022-142312 (Bristol-Myers Squibb Company).  Follow up received on 23-Nov-2022 with the following updates: A non-serious event of allergic reaction to the COVID-19 vaccine and ended with blood clots was added to the case. Apixaban formulation, route of administration, frequency details updated.  Eliquis is under agreement with Bristol-Myers Squibb.  Follow-up (20Dec2022): This is a spontaneous follow-up report received from contactable reporter(s) (Other HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): BRISTOL-MYERS SQUIBB COMPANY-2022-142312 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 65 Year(s) old Female patient, who received Suspect product APIXABAN (Tablet) via Oral (5 milligram(s) 2 every 1 Day, from Aug-2021) for Prophylaxis stroke, lot number: Unknown; Suspect product COVID-19 VACCINE for drug use for unknown indication, lot number: Unknown. Apixaban 1 tablet by mouth twice a day. On an unknown date, the patient had gangrene (gangrene), which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the gangrene was unknown. On an unknown date, the patient had arterial thrombosis (blood clots/arterial thrombosis), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the arterial thrombosis was unknown. On an unknown date, the patient had peripheral ischaemia (ischemic limb), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the peripheral ischaemia was unknown. The patient had a covid shot and got blood clots and was hospitalized 3 times with gangrene on one of her feed due to the blood clots. The patient got an allergic reaction to the COVID-19 vaccine and ended with blood clots. The physician reported that the patient had gangrene secondary to ischemic limb arterial thrombosis secondary to COVID-VACCINE. Gangrene not caused by Eliquis. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included latex allergy. Concomitant medications included NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE], NORVASC, ATORVASTATIN and ATIVAN. The reporter considered events gangrene, arterial thrombosis and peripheral ischaemia not related to APIXABAN. The reporter considered event gangrene not related to COVID-19 VACCINE. The reporter considered events arterial thrombosis and peripheral ischaemia related to COVID-19 VACCINE. Reporter (consumer) does not wish to be contacted. Tracking of Changes: 22-Nov-2022: Initial information was received. Follow up received on 23-Nov-2022 with the following updates: A non-serious event of allergic reaction to the COVID-19 vaccine and ended with blood clots was added to the case. Apixaban formulation, route of administration, frequency details updated. Follow up received by physician on 20-Dec-2022 with the following updates: New event (ischemic limb), event blood clot was rephrased to blood clots/arterial thrombosis (arterial thrombosis), narrative information, co-suspect Covid-19 vaccine was added, event allergic reaction to COVID vaccine was removed and reporter information added.   BMS comment: This 65-year-old patient was hospitalized with gangrene, arterial thrombosis and peripheral ischemia after a COVID shot while on therapy with apixaban. Underlying thromboembolic susceptibility as ascertained by the use of apixaban for prophylaxis stroke is likely the risk factor for the reported event arterial thrombosis and which could have led to gangrene and peripheral ischemia and are considered as not related to the suspect.  Eliquis is under agreement with Bristol-Myers Squibb.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug BNT162B2 assessed as unrelated  Based on the information currently available,The casual association between the reported events and suspected drug Eliquis assessed as unrelated