Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; ELIQUIS DID NOT HELP; 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-2023-177565.  Information was received from a Consumer/other non health professional concerning a 72 Year(s) old Male patient, who received Suspect product APIXABAN (Tablet) via Oral (5 milligram(s) 2 every 1 Day) for Product used for unknown indication, lot number: Unknown. Strength: 5mg In Oct-2023, the patient died, which was considered serious due to the following criteria: death and medical significance. It is unknown if treatment was provided. The reporter stated that the patient had passed away on Oct-2023 and stated that the patient was on medication when he passed away. The patient enrolled on 24-jan-2023. The patient died in Oct-2023. It is unknown if an autopsy was performed. The action taken with APIXABAN medication was not applicable. Concomitant medications were not reported. The reporter did not provide a causality assessment for event death to APIXABAN. Tracking of Changes: 05-Dec-2023: Initial information was received  ELIQUIS is under agreement.  Follow-up (21May2024): This is a spontaneous follow-up report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-177565.  Information was received from a Consumer or other non health professional concerning a 72 Year(s) old Male patient, who received Suspect product APIXABAN (Tablet) via Oral (5 milligram(s) 2 every 1 Day) for Blood clots in both lungs, lot number: Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number: Unknown. Strength of Apixaban was 5mg. On an unknown date, the patient had pulmonary embolism (pulmonary embolism), which was considered serious due to the following criteria: death and medical significance. It is unknown if treatment was provided. On an unknown date, the patient had drug ineffective (Eliquis did not help), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the drug ineffective was unknown. The reporter stated that the patient had passed away on Oct-2023 and stated that the patient was on medication when he passed away. The patient enrolled on 24-Jan-2023. Reporter stated that her husband had a blood clot in his leg in the mid-nineties. He was diagnosed with Lupus clotting factor and put on Warfarin. He received two doses of the Covid Vaccine, then got the first booster at the pharmacy and two or three months after the booster, I took him to the Emergency room where they discovered blood clots in both lungs. The doctor told to patient that he should not have developed blood clots while on Warfarin and put him on Eliquis. After a few months on Eliquis, he awoke in severe distress. Reporter called the paramedics, and by the time they arrived, he was dead. His death certificate listed the cause of death as pulmonary embolism and cardiac arrest. Reporter believed that the booster killed him. Too bad the Eliquis did not help. The patient died in Oct-2023. The reported cause of death was cardiac arrest. It is unknown if an autopsy was performed. 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 clot in his leg (in the mid-nineties), lupus clotting factor and blood clots in both lungs. Past therapy included WARFARIN. Concomitant medications were not reported. The reporter considered event pulmonary embolism not related to APIXABAN. The reporter did not provide a causality assessment for event drug ineffective to APIXABAN. The reporter considered event pulmonary embolism related to COVID-19 VACCINE. The reporter did not provide a causality assessment for event drug ineffective to COVID-19 VACCINE. Tracking of Changes: 05-Dec-2023: Initial information was received. Follow up received on 21-May-2024 from a non-health professional with the following updates: Consent to contact updated, death details updated, product attributes updated for Apixaban and new suspect Covid-19 vaccine was added, event attributes and new events added, medical history updated, past therapy updated and narrative updated.  Evaluation Comment: This 72-year-old patient had drug ineffectiveness and died due to pulmonary embolism after receiving therapy with apixaban and COVID-19 vaccine. Drug ineffective is inherent to the nature of pharmacotherapy; hence, it considered as not related to the suspect therapy. Underlying blood clots in both lungs and medical history of blood clot in leg, lupus clotting factor are risk factors for the reported event in this elderly patient and considered not related to the suspect therapy.  Eliquis is under agreement .; Sender's Comments: Based on the limited information, there is no reasonable possibility that the reported events were related to COVID-19 Vaccine - Manufacturer Unknown or ELIQUIS. The events are more likely intercurrent conditions.; Reported Cause(s) of Death: Pulmonary embolism; Cardiac arrest