Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Febrile neutropenia, Haemoglobin, Liver function test, Lymphocyte count, Neutrophil count
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of CARDIAC ARREST (Cardiac arrest), SEPTIC SHOCK (Septic shock), ENTEROCOCCAL INFECTION (high-grade vancomycin-resistant enterococcal infection), CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection), APLASTIC ANAEMIA (Severe aplastic anemia), PNEUMONIA (Pneumonia) and FEBRILE NEUTROPENIA (Recurrent neutropenic fever) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death, hospitalization prolonged and medically significant), SEPTIC SHOCK (Septic shock) (seriousness criteria death, hospitalization prolonged and medically significant), ENTEROCOCCAL INFECTION (high-grade vancomycin-resistant enterococcal infection) (seriousness criteria death, hospitalization prolonged and medically significant), CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) (seriousness criteria death, hospitalization prolonged and medically significant), APLASTIC ANAEMIA (Severe aplastic anemia) (seriousness criteria hospitalization prolonged and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant) and FEBRILE NEUTROPENIA (Recurrent neutropenic fever) (seriousness criteria hospitalization and medically significant). The patient was treated with CYCLOSPORINE for Immunosuppression, at an unspecified dose and frequency; ANTITHYMOCYTE IMMUNOGLOBULIN for Immunosuppression, at an unspecified dose and frequency; ELTROMBOPAG for Immunosuppression, at an unspecified dose and frequency and PREDNISONE for Immunosuppression, at an unspecified dose and frequency. The patient died on an unknown date. The reported cause of death was Cardiac arrest and Septic shock. It is unknown if an autopsy was performed. At the time of death, APLASTIC ANAEMIA (Severe aplastic anemia), PNEUMONIA (Pneumonia) and FEBRILE NEUTROPENIA (Recurrent neutropenic fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy bone marrow: very severe aplastic anaemia very severe aplastic anemia with severely hypocellular bone marrow. On an unknown date, Haemoglobin: 8.0 g/dl 8.0 g/dL. On an unknown date, Liver function test: normal (normal) Normal. On an unknown date, Lymphocyte count: 1.1x10^3/microl 1.1x10^3/microL and 93% 93%. On an unknown date, Neutrophil count: 0x10^3/microl 0x10^3/microL and 3% 3%. On an unknown date, Platelet count: 1 x10^3/mm^3 1 x10^3/mm^3 and platelets continued to downtrend platelets continued to downtrend despite platelet transfusions and steroids. On an unknown date, Renal function test: normal (normal) Normal. On an unknown date, White blood cell count: 1.2 x10^3/mm^3 1.2 x10^3/mm^3. For mRNA-1273 (Spikevax) (Unknown), the reporter considered CARDIAC ARREST (Cardiac arrest), SEPTIC SHOCK (Septic shock), ENTEROCOCCAL INFECTION (high-grade vancomycin-resistant enterococcal infection), CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection), APLASTIC ANAEMIA (Severe aplastic anemia), PNEUMONIA (Pneumonia) and FEBRILE NEUTROPENIA (Recurrent neutropenic fever) to be related. Laboratory test included immature platelet fraction with result as 0.7 percent. Patient presented to the emergency department with complaints of easy bruising and worsening epistaxis after receiving severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Moderna mRNA vaccination. He had no personal or family history of hematological conditions. He had bruises in various stages involving the upper and lower extremities. On treatment, patient was discharged but was readmitted to the hospital secondary to recurrent neutropenic fever and pneumonia. He had high-grade vancomycin-resistant enterococcal infection and Clostridium difficile infection leading to septic shock and succumbing to cardiac arrest. Author concluded that this case demonstrates the possibility of very severe aplastic anemia following SARS-CoV-2 mRNA vaccination and clinicians need to be aware of this rare but serious side effect. No concomitant medications were reported. Company comment: This literature non-study case concerns a 60-year-old male patient, with no reported medical history, who experienced the serious (fatal, hospitalization, MS), unexpected events of Cardiac Arrest, Septic shock, Enterococcal infection, and Clostridium Difficile Infection and serious (hospitalization, MS) unexpected events of Aplastic Anemia, Febrile Neutropenia and Pneumonia. On unknown date after receiving the second dose of mRNA 1273 COVID-19 vaccine, patient presented to the hospital due to easy bruising and epistaxis. Onset latency of events were unknown as dates of vaccine and events were not provided. On examination, patient had bruises in the upper and lower extremities. Laboratory data revealed low count of white blood cell, hemoglobin, and platelet, Bone marrow biopsy revealed very severe aplastic anemia with severely hypocellular bone marrow. Patient was given platelet transfusion, immunosuppressive therapy with cyclosporine, anti-thymocyte globulin, eltrombopag and prednisone. The patient was discharged, but readmitted due to neutropenic fever and pneumonia. He had vancomycin-resistant enterococcal infection and Clostridium difficile infection leading to septic shock and finally Cardiac Arrest which led to Death of patient. It was unknown if an autopsy was done. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Sender's Comments: This literature non-study case concerns a 60-year-old male patient, with no reported medical history, who experienced the serious (fatal, hospitalization, MS), unexpected events of Cardiac Arrest, Septic shock, Enterococcal infection, and Clostridium Difficile Infection and serious (hospitalization, MS) unexpected events of Aplastic Anemia, Febrile Neutropenia and Pneumonia. On unknown date after receiving the second dose of mRNA 1273 COVID-19 vaccine, patient presented to the hospital due to easy bruising and epistaxis. Onset latency of events were unknown as dates of vaccine and events were not provided. On examination, patient had bruises in the upper and lower extremities. Laboratory data revealed low count of white blood cell, hemoglobin, and platelet, Bone marrow biopsy revealed very severe aplastic anemia with severely hypocellular bone marrow. Patient was given platelet transfusion, immunosuppressive therapy with cyclosporine, anti-thymocyte globulin, eltrombopag and prednisone. The patient was discharged, but readmitted due to neutropenic fever and pneumonia. He had vancomycin-resistant enterococcal infection and Clostridium difficile infection leading to septic shock and finally Cardiac Arrest which led to Death of patient. It was unknown if an autopsy was done. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Reported Cause(s) of Death: Cardiac arrest; Septic Shock.