Sex: F
Vaccine: COVID19, UNK
Symptoms: Diabetes mellitus, Thrombosis, Weight, Weight decreased
Clinical narrative: SHE IS ALSO DIABETIC; PATIENT STATED THAT SHE HAS LOST ABOUT 30LBS THIS YEAR AND EATS VERY LITTLE AND HAS A SPECIAL DIET; SHE DEVELOPED BLOOD CLOTS IN OCTOBER LAST YEAR AFTER GETTING THE COVID-19  VACCINE IN SEPTEMBER 2022; PSP-ELIQUIS-LASH-USA: PSP-ELIQUIS-LASH-CW2891702  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-2023-099290 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 79 Year(s) old Female patient, enrolled in the post-marketing study PSP-Eliquis-Lash-CW2891702: PSP-ELIQUIS-LASH-USA who received Suspect product APIXABAN (from 31-Aug-2022) for PRODUCT USED FOR UNKNOWN INDICATION, lot number: Unknown; Suspect product COVID-19 VACCINE (from Sep-2022) for COVID-19 IMMUNIZATION, lot number:Unknown. In Oct-2022, the patient had thrombosis (she developed blood clots in october last year after getting the covid-19 vaccine in september 2022), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the thrombosis was unknown. In 2023, the patient had weight decreased (patient stated that she has lost about 30lbs this year and eats very little and has a special diet), which was considered non-serious. It is unknown if treatment was provided. The outcome of the weight decreased was unknown. On an unknown date, the patient had diabetes mellitus (she is also diabetic), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the diabetes mellitus was unknown. Patient stated that she has lost about 30lbs this year and eats very little and has a special diet. She also mentioned being on disability. She developed blood clots in October last year after getting the COVID-19 vaccine in September 2022. She is also diabetic. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Concomitant medications were not reported. Relevant Laboratory and other Diagnostic Tests In 2023, WEIGHT: she has lost about 30lbs this year.. The reporter considered events thrombosis and weight decreased not related to APIXABAN. The reporter did not provide a causality assessment for event diabetes mellitus to APIXABAN. The reporter considered event thrombosis related to COVID-19 VACCINE. The reporter did not provide a causality assessment for events diabetes mellitus and weight decreased to COVID-19 VACCINE. The following Case IDs are linked to this patient: 2023-099583. Tracking of Changes: 13-Jul-2023: Initial information was received.  The reporter's assessment of the causal relationship of "she is also diabetic" with the suspect product(s) apixaban was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's assessment of the causal relationship of "she is also diabetic" and "patient stated that she has lost about 30lbs this year and eats very little and has a special diet" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  ELIQUIS is under agreement with Bristol-Myers Squibb.; Sender's Comments: Bristol-Myers Squibb Comment: This 79-year-old patient had thrombosis and had diabetes after receiving apixaban and covid-19 vaccine. Elderly age is a significant risk factor for increased thromboembolic susceptibility, hence reported event thrombosis is considered not related to suspect therapy. Based on the etiopathogenesis, diabetes is considered not related to suspect therapy. Pfizer comment: Based on the information provided in this case and considering a plausible drug-event temporal association, the company concurs with LP BMS that, there is a not a reasonable possibility that the reported events are related to BNT162b2 (COMIRNATY)  administration. There is limited information provided. This case will be reassessed should additional 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.