Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cardiac failure, Dizziness, Feeling abnormal, Malaise
Clinical narrative: HEART FAILURE; FELT REALLY BAD; DIZZY; OFF BALANCED; FELT SICK; This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-096508).  Information was received from a Consumer/other non health professional concerning a 63 Year(s) old Female patient, enrolled in the post-marketing study: who received Suspect product APIXABAN for Product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for Vaccination, lot number:Unknown. On an unknown date, the patient had cardiac failure (heart failure), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the cardiac failure was unknown. On an unknown date, the patient had feeling abnormal (felt really bad), which was considered non-serious. It is unknown if treatment was provided. The outcome of the feeling abnormal was unknown. On an unknown date, the patient had dizziness (dizzy), which was considered non-serious. It is unknown if treatment was provided. The outcome of the dizziness was unknown. On an unknown date, the patient had balance disorder (off balanced), which was considered non-serious. It is unknown if treatment was provided. The outcome of the balance disorder was unknown. On an unknown date, the patient had malaise (felt sick), which was considered non-serious. It is unknown if treatment was provided. The outcome of the malaise was unknown. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Patient stated she had a bad reaction to the Pfizer covid vaccine. She stated it killed her heart. She felt really bad; dizzy; off balanced; felt sick for about 3 weeks and now has heart failure. Concomitant medications were not reported. The reporter considered events cardiac failure, feeling abnormal, dizziness, balance disorder and malaise not related to APIXABAN. The reporter considered events cardiac failure, feeling abnormal, dizziness, balance disorder and malaise related to COVID-19 VACCINE. Tracking of Changes: 07-Jul-2023: Initial information was received.  Eliquis is under agreement; Sender's Comments: Comment: This patient had cardiac failure while on apixaban therapy along with COVID- 19 vaccine. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspects, treatment given and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban/ COVID- 19 vaccine could have contributed to the event heart failure. Pfizer comment: Based on potential temporal association, a contributory role of COVID-19 VACCINE.to the events of cardiac failure, feeling abnormal, dizziness, balance disorder and malaise cannot be excluded. The case will be reassessed once more information become 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.