Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatic necrosis, Myelodysplastic syndrome, Pleural effusion, Pneumonia
Clinical narrative: pleural effusion; peritoneal effusion/Patient has minimal fluid in the lung area. Patient got an abdominal peritoneal fluid.; preleukemia/ Each of the biopsy show know cancer. The abnormal T cell are inhibiting the production of red blood cell/ anemic; pneumonia/Patient had 3 chest cap; cardiac arrest; Patient got some necrosis showing in his liver; had a ripple effect after his first Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYELODYSPLASTIC SYNDROME (preleukemia/ Each of the biopsy show know cancer. The abnormal T cell are inhibiting the production of red blood cell/ anemic), PNEUMONIA (pneumonia/Patient had 3 chest cap), CARDIAC ARREST (cardiac arrest), PLEURAL EFFUSION (pleural effusion), ASCITES (peritoneal effusion/Patient has minimal fluid in the lung area. Patient got an abdominal peritoneal fluid.) and HEPATIC NECROSIS (Patient got some necrosis showing in his liver) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L2BA, 016M20A, 939904 and 855822A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Patient had no allergies.  Patient did have medical history before receiving the vaccine.  Concurrent medical conditions included Social alcohol drinker.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2022, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-May-2023, received sixth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYELODYSPLASTIC SYNDROME (preleukemia/ Each of the biopsy show know cancer. The abnormal T cell are inhibiting the production of red blood cell/ anemic) (seriousness criteria hospitalization, medically significant and life threatening), PNEUMONIA (pneumonia/Patient had 3 chest cap) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), PLEURAL EFFUSION (pleural effusion) (seriousness criteria hospitalization and life threatening), ASCITES (peritoneal effusion/Patient has minimal fluid in the lung area. Patient got an abdominal peritoneal fluid.) (seriousness criteria hospitalization, medically significant and life threatening), HEPATIC NECROSIS (Patient got some necrosis showing in his liver) (seriousness criterion medically significant) and CONDITION AGGRAVATED (had a ripple effect after his first Moderna vaccine). The patient was hospitalized for 10 days due to CARDIAC ARREST. The patient was treated with CICLOSPORIN (CYCLOSPORINE) at an unspecified dose and frequency; DARBEPOETIN ALFA (ARANESP) at a dose of for 3 months and METHOTREXATE at a dose of for 3 months. At the time of the report, MYELODYSPLASTIC SYNDROME (preleukemia/ Each of the biopsy show know cancer. The abnormal T cell are inhibiting the production of red blood cell/ anemic), PNEUMONIA (pneumonia/Patient had 3 chest cap), CARDIAC ARREST (cardiac arrest), PLEURAL EFFUSION (pleural effusion), HEPATIC NECROSIS (Patient got some necrosis showing in his liver) and CONDITION AGGRAVATED (had a ripple effect after his first Moderna vaccine) outcome was unknown and ASCITES (peritoneal effusion/Patient has minimal fluid in the lung area. Patient got an abdominal peritoneal fluid.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2023, Haemoglobin: hemoglobin last Thursday was 6.8.. On an unknown date, Biopsy bone: Had 4 bone biopsies. Each of the biopsy showed non cancerous T cell, that are inhibiting the production of red blood cell..         No concomitant medications were reported. It was reported that the patient has not had any problem before the vaccine. He was extremely anemic when he went for his routine physical exam. They found non-cancerous T cell in this bone marrow. He went to the emergency room and his heart stoped. He had a cardiac arrest. He spent 10 days in ICU. He had a variety of issues in March 2022. This started 6 months ago, he was dealing with lung and liver process. He was stable cardiac and pulmonary wise. His anemia persisted. They try 4 other drugs. In the last year he had 70 transfusions. All this started after the 1st dose of the Moderna vaccine. While patient was in ICU for the pneumonia, he develops a pleural effusion. Patient's brother believes this could be the residual of the pneumonia. Every two-week patient had his abdomen tap. About 3 to 5 liter of fluids was removed from his abdomen. Last week it was 5 liters. Patient continued to accumulate fluid. His abdominal tap had been going on for months. Before they did not know where the fluid was coming from. Now, they were saying from his liver. Patient heart and lung were fine but still had the abnormal T cell.  Company comment: This is a Spontaneous case reported by a consumer, concerning an 80-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to life-threatening, hospitalization and medically significant) events of Myelodysplastic syndrome, Pneumonia, Cardiac arrest and Ascites, the unexpected and serious (due to hospitalization and medically significant) event of Pleural effusion, and the unexpected and serious (due to medically significant) AESI of Hepatic necrosis, which occurred on an unknown date after the first dose of mRNA-1273 vaccine. Second, third and fourth doses against COVID-19 were administered with mRNA-1273, and fifth and sixth with Pfizer vaccine, which remains as a co-suspect product. As reported, patient was extremely anemic when he went for his routine physical exam. Non-cancerous T cells were found in his bone marrow. He was diagnosed with preleukemia and was prescribed cyclosporine. He got pneumonia and went to the emergency room where his heart stopped. He spent 10 days in intensive care unit, where he developed pleural and peritoneal effusion. His liver had necrosis. Since then, 3 to 5 liters of fluid are removed from patient´s abdomen. Last hemoglobin was 6.8. In the last year patient had 70 transfusions. He had 4 bone biopsies. Each of the biopsies showed no cancer. The abnormal T cells are inhibiting the production of red blood cell. Patient was prescribed Cyclosporine, Darbepoetin alfa and Methotrexate. At the time of the report, Myelodysplastic syndrome, Pneumonia, Cardiac arrest, Pleural effusion, Hepatic necrosis and Condition aggravated outcome was unknown, and Ascites had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an 80-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to life-threatening, hospitalization and medically significant) events of Myelodysplastic syndrome, Pneumonia, Cardiac arrest and Ascites, the unexpected and serious (due to hospitalization and medically significant) event of Pleural effusion, and the unexpected and serious (due to medically significant) AESI of Hepatic necrosis, which occurred on an unknown date after the first dose of mRNA-1273 vaccine. Second, third and fourth doses against COVID-19 were administered with mRNA-1273, and fifth and sixth with Pfizer vaccine, which remains as a co-suspect product. As reported, patient was extremely anemic when he went for his routine physical exam. Non-cancerous T cells were found in his bone marrow. He was diagnosed with preleukemia and was prescribed cyclosporine. He got pneumonia and went to the emergency room where his heart stopped. He spent 10 days in intensive care unit, where he developed pleural and peritoneal effusion. His liver had necrosis. Since then, 3 to 5 liters of fluid are removed from patient´s abdomen. Last hemoglobin was 6.8. In the last year patient had 70 transfusions. He had 4 bone biopsies. Each of the biopsies showed no cancer. The abnormal T cells are inhibiting the production of red blood cell. Patient was prescribed Cyclosporine, Darbepoetin alfa and Methotrexate. At the time of the report, Myelodysplastic syndrome, Pneumonia, Cardiac arrest, Pleural effusion, Hepatic necrosis and Condition aggravated outcome was unknown, and Ascites had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.