Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: Blood test, Cardiomegaly, Chest discomfort, Chest pain, Computerised tomogram coronary artery
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party (RA). The reporter is the patient. Other Case identifier(s): -Regulatory Authority COMPANY-2022-080423 (RA Company).  This case was received via {BP} Pfizer Inc (Reference number: 202201004765) on 23-Jul-2022. Information was received from a Consumer/other non health professional concerning a 59 Year(s) old Female patient, who received Suspect product APIXABAN for Product used for unknown indication (5 milligram(s) 2 every 1 Day), lot number: Unknown. On an unknown date, the patient experienced thrombosis(i developed a blood clot and i was hospitalized) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included She had to have emergency surgeries because blood clot was trying to get into my heart.. The outcome of the event is unknown. On an unknown date, the patient experienced syncope(i was fainting and that's why i had shortness of breath) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced circulatory collapse(i collapsed, almost died) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced cardiomegaly(my heart is slightly enlarged) which was considered serious due to hospitalization. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced pulmonary thrombosis (blood clots in my lungs) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced dyspnea(I was fainting and that's why I had shortness of breath) which was considered serious due to hospitalization. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced chest pain(i had chest pain or whatever I was going to die) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced sluggishness(i was getting sluggish and I started having tightness in my chest) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced chest discomfort(I was getting sluggish and i started having tightness in my chest) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced fatigue(I couldn't make back up to the stairs, i was so exhausted like my heart beating out of my chest, having like a heart attack) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN 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 events thrombosis, syncope, circulatory collapse, cardiomegaly, pulmonary thrombosis, dyspnea, chest pain, sluggishness, chest discomfort and fatigue to product APIXABAN. Tracking of Changes: 23-Jul-2022: Initial information was received.   Eliquis is under agreement with RA  Follow up (29Jul2022): This is a spontaneous follow up report received from contactable reporter(s) (Consumer or other non HCP) from License Party (Regulatory Authority Company). Other Case identifier(s): -Regulatory Authority COMPANY-2022-080423 (Regulatory Authority Company). Information was received from a Consumer/other non health professional concerning a 59 Year(s) old Female patient, who received Suspect product APIXABAN for Product used for unknown indication (5 milligram(s) 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 thrombosis(i developed a blood clot and i was hospitalized) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included She had to have emergency surgeries because blood clot was trying to get into my heart.. The outcome of the event is unknown. On an unknown date, the patient experienced circulatory collapse(i collapsed, almost died) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced cardiomegaly(my heart is slightly enlarged) which was considered serious due to hospitalization. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced syncope(i was fainting and that's why i had shortness of breath) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced dyspnea(i was fainting and that's why i had shortness of breath) which was considered serious due to hospitalization. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced pulmonary thrombosis(blood clots in my lungs) which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced chest pain(i had chest pain or whatever i was going to die) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced sluggishness(i was getting sluggish and i started having tightness in my chest) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced chest discomfort(i was getting sluggish and i started having tightness in my chest) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced fatigue(i couldn't make back up to the stairs, i was so exhausted like my heart beating out of my chest, having like a heart attack) which was considered not serious. 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. 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 events thrombosis, circulatory collapse, cardiomegaly, syncope, dyspnea, pulmonary thrombosis, chest pain, sluggishness, chest discomfort and fatigue to product APIXABAN. The reporter did not provide a causal assessment for events thrombosis, circulatory collapse, cardiomegaly, syncope, dyspnea, pulmonary thrombosis, chest pain, sluggishness, chest discomfort and fatigue to product COVID-19 VACCINE. Tracking of Changes: 23-Jul-2022: Initial information was received. Follow up received on 29-Jul-2022 with the following updates: New suspect such as COVID-19 Vaccine was added. ELIQUIS is under agreement with Regulatory Authority. Sender's Comments: 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.