Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Neuropathy peripheral, Product dose omission issue, Protein urine present, Stress
Clinical narrative: NEUROPATHY IN FEET; URINE WAS VERY FOAMY; MEMORY HAS BEEN HAVING TROUBLE FOR ABOUT TWO YEARS; STRESS; ARTHRITIS IN HANDS, FEET AND BACK; ELIQUIS FOR BLOOD CLOTTING DISORDER; PROTEIN LEVELS WERE VERY HIGH (URINE); MISSED ONE DOSE OF REVLIMID; BONE CANCER; BLOOD CANCER; 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-2022-055896.  Information was received from a Consumer/other non health professional concerning a 53 Year(s) old Male patient, who received Suspect product APIXABAN for Blood clotting disorder, Tablet (from 2018 2 every 1 Day), lot number:Unknown; Suspect product LENALIDOMIDE for Product used for unknown indication, Tablet (20 milligram(s) from 03Jun2022 14 every 21 Day), lot number:Unknown; Suspect product COVID-19 VACCINE for COVID-19 immunization, lot number:Unknown. On Feb2022, the patient experienced bone cancer(bone cancer) which was considered serious due to medical significance. The outcome of the event is unknown. On Feb2022, the patient experienced haematological malignancy(blood cancer) which was considered serious due to medical significance. The outcome of the event is unknown. On 04Jun2022, the patient experienced product dose omission issue(missed one dose of revlimid) which was considered not serious. The outcome of the event is unknown.On an unknown date, the patient experienced neuropathy peripheral(neuropathy in feet) which was considered serious due to medical significance. The outcome of the event is unknown. On an unknown date, the patient experienced urine abnormality(urine was very foamy) which was considered not serious. The outcome of the event is unknown. On an unknown date, the patient experienced memory impairment(memory has been having trouble for about two years) which was considered not serious. The outcome of the event is unknown. On an unknown date, the patient experienced stress(stress) which was considered not serious. Treatment included Vyvanse (blue pill). The outcome of the event is unknown. On an unknown date, the patient experienced arthritis(arthritis in hands, feet and back) which was considered not serious. The outcome of the event is unknown. On an unknown date, the patient experienced protein urine present(protein levels were very high (urine)) which was considered not serious. The outcome of the event is unknown. On an unknown date, the patient experienced intentional product use issue(eliquis for blood clotting disorder) which was considered not serious. The outcome of the event is unknown. The patient explained that he had a blood clotting disorder that causes him to develop clots all over his body. He said he first used generic warfarin (confirmed he did not use brand Coumadin). He said when he took warfarin, he used to drink alcohol, but he does not anymore. He said that his levels would get out of range, and he had internal bleeding and had to get vitamin K to stop it. He said that the doctor changed him to Eliquis for better control in 2018. He said he loved Eliquis because it was so easy to take and does not require any labs. He said that he has had three Covid vaccines including the primary series and one booster. He said he had labs done prior to the first dose and between doses and then after the booster. He said his labs were normal until after the booster. After the booster he urinated and the toilet looked like it was filled with soap, and his urine was very foamy. He drank more fluids and flushed and urinated again and had the same foam. His doctor sent him for labs and found that his protein levels were very high and sent him to the blood specialist. The specialist said he had one bad cell and the others were good. They told him he had blood and bone cancer, but he did not know the real name of it. They monitored him for a few months and then started him on Revlimid on 03Jun2022. He was taking Revlimid 20 mg tablet, daily for 14 days and a 7-day break. The doctor would not say if the cancer was caused by the Covid vaccines, but the consumer thinks it was. The patient was not at home and did not have access to his full list of medications, or the lot/expiration dates of the Revlimid or Eliquis. He said his memory has been having trouble for about two years and his doctor said it was stress and not the Alzheimer's that runs in his family. He had trouble with recall and remembering names of people, medications and birthdates. He said he missed one dose of Revlimid on 04 Jun 2022 and his doctor told him to take it at the end. He planned to ask the doctor today, what that means to be sure he takes it when his doctor wants him to. He had a follow up appointment today for labs and to see the doctor. The patient said that he was not sure of all the medications he was taking and was not sure if maybe one of it was steroid or not. He said he feels like he was taking a steroid because he had much less pain today. He said that he normally had very bad arthritis in his hands, feet and back, but today (09Jun2022) he woke up and had no pain. He said he used to walk like he was a cripple bent over but now he could run today and had more energy since the pain was not wearing him out. He said his knuckles were usually swollen and sore but today he could bend all of them except his thumb. He said he had neuropathy in his feet, and they usually sting, and he did not like wearing socks or shoes, but today he can walk without pain. He said in the past when he took steroids for his knees and also once for a bronchial infection that his arthritis felt better. He was not sure if he was taking one currently. He said he also gets some shot but he does not know what. The status of APIXABAN medication is unknown. The status of LENALIDOMIDE medication is unknown. Medical history and concurrent conditions included Asthma, Attention deficit hyperactivity disorder, Alcoholic (not continuing) and Bronchial infection. Family history of Alzheimer's. Concomitant medication included ZOLOFT. Stomach medication starts with D, a shot. Relevant Laboratory & other Diagnostic Tests On an unknown date, LAB TEST: Normal, prior to the first dose Covid vaccine, LAB TEST: Normal, between doses of Covid vaccine, LAB TEST: Abnormal, after the booster, URINALYSIS: Protein levels were very high. The reporter did not provide a causal assessment for events bone cancer, haematological malignancy, neuropathy peripheral, product dose omission issue, urine abnormality, memory impairment, stress, arthritis, protein urine present and intentional product use issue to product APIXABAN. The reporter did not provide a causal assessment for events bone cancer, haematological malignancy, neuropathy peripheral, product dose omission issue, urine abnormality, memory impairment, stress, arthritis, protein urine present and intentional product use issue to product LENALIDOMIDE. The reporter considered events bone cancer and haematological malignancy related to product COVID-19 VACCINE. The reporter did not provide a causal assessment for events neuropathy peripheral, product dose omission issue, urine abnormality, memory impairment, stress, arthritis, protein urine present and intentional product use issue to product COVID-19 VACCINE. Tracking of Changes: 08Jun2022: Initial information was received.  Company Comment: This patient had multiple events after receiving apixaban therapy along with lenalidomide. Patient also got vaccinated for COVID- 19. Based on the limited information available regarding the circumstances leading to these events, diagnostic workups, action taken with the suspects and outcome of the events, it cannot be ascertained with the reasonable possibility that the suspects could have contributed to the events bone cancer, blood cancer and peripheral neuropathy.  Eliquis is under agreement with Company.; Sender's Comments: Company Comment: This patient had multiple events after receiving apixaban therapy along with lenalidomide. Patient also got vaccinated for COVID- 19. Based on the limited information available regarding the circumstances leading to these events, diagnostic workups, action taken with the suspects and outcome of the events, it cannot be ascertained with the reasonable possibility that the suspects could have contributed to the events bone cancer, blood cancer and peripheral neuropathy.  Pfizer company comment:  Based on the information provided by the reporter, it appears unlikely that subject product BNT162B2 vaccine contributed to the events.  The reported events may likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.