Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: Anticoagulant therapy, Cardiomegaly, Chest X-ray abnormal, Circulatory collapse, Dyspnoea
Clinical narrative: No adverse event; This case is invalid due to no adverse event, as assessed by License Partner. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Information was received from a Consumer/other non health professional concerning a 59 Year(s) old Female patient, who received Suspect product APIXABAN for PE (5 milligram(s) from 12-Oct- 2021 2 every 1 Day), lot number:ACA5998P; Suspect product COVID-19 VACCINE for Product used for unknown indication (from 05-Mar-2021), lot numbers: EN5318 and EN6201. On an unknown date, the patient experienced no adverse event(no adverse event) which was considered not serious. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Medical history and concurrent conditions included Blood pressure. Concomitant medication included METOPROLOL. Relevant Laboratory & other Diagnostic Tests On an unknown date, X-RAY: Found out there are blood clots in my lungs, both lungs are full of blood clot., SCAN: Result not provided. The reporter did not provide a causal assessment for event no adverse event to product APIXABAN. The reporter did not provide a causal assessment for event no adverse event to product COVID-19 VACCINE. Tracking of Changes: 23-Jul- 2022: Initial information was received.   Follow up (29Jul2022): This is a spontaneous follow up report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Follow up received on 29-Jul-2022 with the following updates: New suspect such as COVID-19 Vaccine was added.  Follow-up (10Aug2022): This is a follow up spontaneous report from a contactable consumer. This consumer (Patient) reported in response to Non HCP letter sent which included that: Updated Information included: Patient's weight updated. Lab data captured. Dosage slider #02 added. Dosage slider #01 updated for concomitant medication "Metoprolol". Follow-up attempts are completed. No further information is expected.   Follow up (10Aug2022): This is a spontaneous follow up report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Follow up received on 10-Aug-2022 with the following updates: All the reported events were deleted as they were occurred on 12-Oct-2021 (before the start of Eliquis) and the case was made invalid as no adverse event. It was reported that the patient started to take Eliquis since 12-Oct-2021 as the patient collapsed when exercising last year. The patient was rushed to the hospital to find out that both lungs was filled with blood clots in the process of travelling to patient's heart. The patient had to have emergency surgery to keep the bloods from travelling to her heart. The patient never had a problem with blood clots until she took the Pfizer Vaccine. Hence, the case was made Invalid. BMS Comment: This patient was hospitalized due to multiple events after receiving apixaban therapy. Based on the limited information available regarding therapy dates, events onset dates, action taken with the suspect, relevant medical history, treatment given and outcome of the events, it cannot be ascertained with the reasonable possibility that the suspect could have contributed to the events thrombosis, syncope, circulatory collapse, cardiomegaly, pulmonary thrombosis and dyspnea. ELIQUIS is under agreement.