Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood loss anaemia, Cardiac valve disease, Cardiac valve vegetation, Colonoscopy, Computerised tomogram
Clinical narrative: BLOOD CLOT; BLEEDING; ANEMIA SECONDARY TO BLEEDING; VEGETATIONS ON THE VALVES; HEART VALVES NOT FUNCTIONING; WEIGHT LOSS; LEG SWELLING; This spontaneous report received from a consumer concerned a 76 year old female. The patient's weight was not reported and height was 60 inches. The patient's concurrent conditions included: peripheral neuropathy (not diabetic neuropathy), non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient never ever had cardiac problem and cardiac disease history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on MAR-2022 or APR-2022 (exact date unknown) for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2022, the patient was in hospital in cardiac wing considered in life threatening condition. Patient's all 4 valves were not functioning properly at all; the aortic valve was the worst (tricuspid valve). Doctors said its very rare all valve to be affected and not functioning, there was vegetations on the valves and there was blood clot. Patient was bleeding, the type of the bleeding was not determined yet, they had done CAT scan (computed axial tomography) and MRI (magnetic resonance imaging) Colonoscopy, to determine where the bleeding was coming from and they didn't know yet. Patient was in the hospital for over 2 weeks, the doctors were considering transfer to other hospital, they considered infectious disease and ruled that out. The patient didn't feel sick but she was sick and they were saying its life threating, hemoglobin kept dropping and she was considered now anemic (anemia secondary to bleeding). Patient was receiving a lot of blood transfusion one unit, two units and so. Doctors considering possibly a blood thinner, the patient might be possibly bleeding anally, the blood thinner considered was xarelto. The cardiologist and the gastro-neurologist were stomped, they had not determined the cause of bleeding, considering the test with the camera. Patient lost a lot of weight (she lost about 20 LB) and there was leg swelling and she was on Lasix for life. Patient considered class 4 very high risk anesthesia, not advisable. Doctors were considering a transfer to cardiac specialist surgeon and gave two units of blood, doctors were coming out and in from the room, CAT scan showed no cancer. Laboratory data (dates unspecified) included: CAT scan not reported, No cancer, Colonoscopy not reported, Haemoglobin kept dropping, and Weight lost 20LB. Treatment medications (dates unspecified) included: furosemide, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, bleeding, heart valves not functioning, weight loss, leg swelling, anemia secondary to bleeding and vegetations on the valves was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20220761614-covid-19 vaccine ad26.cov2.s- blood clot,bleeding, anemia secondary to bleeding, vegetations on the valves ,heart valves not functioning, weight loss, leg swelling. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.