Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: TWO BLOOD CLOTS;  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-2022-095485.  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; apixaban (ELIQUIS). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "TWO BLOOD CLOTS". The action taken for apixaban was unknown. It was unknown if therapeutic measures were taken as a result of thrombosis.  Additional information: Information was received from a Consumer/other non health professional concerning a 76 Year(s) old Male 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 experienced thrombosis(two blood clots) which was considered serious due to medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. The patient reported that he developed 2 blood clots after taking the Covid-19 vaccine. Concomitant medications were not reported. The reporter considered event thrombosis not related to product APIXABAN. The reporter did not provide a causal assessment for event thrombosis to product COVID-19 VACCINE.   Comment: This patient had thrombosis after receiving apixaban therapy. Based on the limited information regarding thrombosis event details with relevant medical history, therapy details and indication, it cannot be ascertained with reasonable possibility that apixaban contributed to the reported event.  Causality Assessment for Clot blood for COVID-19 VACCINE per reporter was not reported, per company was related. The reporter's assessment of the causal relationship of "two blood clots" with the suspect product(s) BNT162b2 and 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.  Eliquis is under agreement with company.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Pfizer comment: The available information does not provide compelling evidence to implicate the suspect drugs with the reported event. The event thrombosis most likely was due to underlying medical conditions. The case will be reassessed when 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.