Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Post procedural haemorrhage, Procedural pain
Clinical narrative: BLEEDING/ THE OPERATION WAS A SUCCESS/ THE SAC AROUND MY HEART FILLED UP WITH BLOOD; NEVER HAD PAIN LIKE THAT; SHORTNESS OF BREATH; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2024-002656 (Bristol-Myers Squibb Company).  This case was received via Pfizer Inc (Reference number: PV202400000957) on 04-Jan-2024. Information was received from a Consumer/other non health professional concerning an Elderly Male patient, enrolled in the post-marketing study A solicited program in which a patient received a BMS product. : who received Suspect product APIXABAN for Product used for unknown indication, lot number:Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number:Unknown. Age of the patient was 80-84 years. On an unknown date, the patient had post procedural haemorrhage (bleeding/ the operation was a success/ the sac around my heart filled up with blood), which was considered serious due to the following criteria: life-threatening and hospitalization. It is unknown if treatment was provided. The outcome of the post procedural haemorrhage was unknown. On an unknown date, the patient had procedural pain (never had pain like that), which was considered serious due to the following criteria: life-threatening and hospitalization. It is unknown if treatment was provided. The outcome of the procedural pain was unknown. On an unknown date, the patient had dyspnoea (shortness of breath), which was considered non-serious. It is unknown if treatment was provided. The outcome of the dyspnoea was unknown. Patient was hospitalized with bleeding while taking Eliquis. Patient has also had 6 Covid vaccines and is experiencing shortness of breath. Patient stated that the operation was a success. but nipped something and what happened was the sac around his heart filled up with blood. they had to taken him to the ICU (Intensive Care Unit). Patient was there overnight. Patient stated that his last rights at three o'clock in the morning to himself. He thought he was going to die, the pain was there. He never had pain like that before. Patient stated hopefully he can come off the Eliquis. He had six Covid shots. He got out of breath, he don't like going up steps anymore. He stated it's a pain in the rear. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included operation nos. Concomitant medications were not reported. The reporter did not provide a causality assessment for events post procedural haemorrhage, procedural pain and dyspnoea to APIXABAN. The reporter did not provide a causality assessment for events post procedural haemorrhage, procedural pain and dyspnoea to COVID-19 VACCINE. Consent to contact consumer/other non health professional for follow-up information was denied. Tracking of Changes: 02-Jan-2024: Initial information was received. IB Labeling information ELIQUIS : null(null) : Not Available, ELIQUIS : null(null) : Not Available, ELIQUIS : null(null) : Not Available,  Causality assessment to Eliquis: Post procedural bleeding, Per BMS= Related; Post procedural pain, Shortness of breath, Per BMS= Not Related. Causality assessment to COVID-19 Vaccine: Post procedural bleeding, Post procedural pain, Shortness of breath, Per BMS= Not Related  BMS comment: This patient was hospitalized with post procedural hemorrhage, post procedural pain after receiving apixaban and covid-19 vaccine. Based on the anticoagulant nature of apixaban, its contributory role in the reported bleeding event post procedural hemorrhage is considered possible and not related to Covid-19 vaccine. Based on limited information regarding clinical circumstances that led to post procedural pain, it is considered not related to suspect therapy.  Eliquis is under agreement with Bristol-Myers Squibb.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information available, there was not a reasonable possibility that the events post procedural pain and shortness of breath were related to suspect drugs BNT162B2 OMI XBB.1.5 and APIXABAN. However, based on the anticoagulant nature of APIXABAN, its contributory role in the event of post procedural bleeding is considered as possible and not related to BNT162B2 OMI XBB.1.5. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.