Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Thrombosis
Clinical narrative: MASSIVE AMOUNTS OF TINY BLOOD CLOTS; PSP-ELIQUIS-LASH-USA: PSP-ELIQUIS-LASH-CW2891702  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-129212 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 82 Year(s) old Male patient, enrolled in the post marketing study who received suspect product apixaban (Tablet) via Oral (5 milligram(s) 2 every 1 Day, from 01-Jan-2018) for prophylaxis stroke, lot number: unknown; suspect product covid-19 vaccine, lot number: unknown. The patient was also enrolled study. On an unknown date, the patient had thrombosis (massive amounts of tiny blood clots), which was considered serious due to the following criteria: death and medical significance. It is unknown if treatment was provided. The patient's wife reported that her husband, who used to be on apixaban, passed away. The patient received last dose of apixaban on 01-Oct-2022. The Follow up information was received from patient's wife stating that she believes the patient died from COVID vaccine. She also mentioned that patient had massive amounts of tiny blood clots. He never had problems with blood clots for all the years he was taking Eliquis. The patient had to the ER three times in one weekend. He had two EKGs and one MRI as soon as he got home received a call to return to the hospital due to him having blood clots. The patient died on 01-Oct-2022. It is unknown if an autopsy was performed. The most recent dose of drug was administered on 01-Oct-2022. The action taken with APIXABAN medication was unknown. Medical history and concurrent conditions included clot blood, fall, neck injury and atrial fibrillation. Concomitant medications were not reported. Relevant Laboratory andamp; other Diagnostic Tests on an unknown date, EKG: Diagnosed blood clots, MRI: Diagnosed blood clots. The reporter considered event thrombosis not related to apixaban. The reporter considered event thrombosis related to COVID-19 VACCINE. The following Case IDs are linked to this patient. Separate case for Covid was created. Tracking of Changes: 28-Oct-2022: Initial information was received.   BMS Comment: This patient reportedly died due to massive amounts of tiny blood clots after receiving apixaban therapy. Covid-19 vaccine is an additional suspect. Underlying thromboembolic susceptibility ascertained by the use of apixaban is a significant risk factor for the event and considered not related to suspect therapy.  Eliquis is under agreement with Bristol-Myers Squibb.  Causality Assessment: Drug: Eliquis  Event: Clot blood Per Reporter: Not Related Per Company (BMS): Not Related  Drug: COVID-19 VACCINE Event: Clot blood Per Reporter: Related Per Company (BMS): Not Related.  Follow-up (10Jul2023): This is a solicited follow-up report received from contactable reporter(s) (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-129212 (Bristol-Myers Squibb Company).  Follow up received from non health professional on 10-Jul-2023 with the following updates: The event was amended to Clot blood (previously patient died), patient's medical history, death details, suspect and narrative were updated.; Sender's Comments: BMS Comment: This patient reportedly died due to massive amounts of tiny blood clots after receiving apixaban therapy. Covid-19 vaccine is an additional suspect. Underlying thromboembolic susceptibility ascertained by the use of apixaban is a significant risk factor for the event and considered not related to suspect therapy. Pfizer comment: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported fatal event (thrombosis) cannot be excluded. Patients age and intercurrent medical condition may be confounding. Case will be reassessed upon receipt of additional information.; Reported Cause(s) of Death: Clot blood