Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphopenia, Oxygen saturation, Pyrexia, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: covid-19 infection; SOB; Cough; Bilateral lung infiltrate; Fever; vaccination failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This case describes the occurrence of COVID-19 (covid-19 infection), DYSPNOEA (SOB), COUGH (Cough), LUNG INFILTRATION (Bilateral lung infiltrate) and PYREXIA (Fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Concurrent medical conditions included Kidney transplant (11.35 years from  transplant), Pancreatic transplant (11.35 years from  transplant) and Diabetes mellitus (Cause for organ transplants). Concomitant products included BELATACEPT, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 infection) (seriousness criterion hospitalization prolonged), DYSPNOEA (SOB) (seriousness criterion hospitalization prolonged), COUGH (Cough) (seriousness criterion hospitalization prolonged), LUNG INFILTRATION (Bilateral lung infiltrate) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization prolonged) and VACCINATION FAILURE (vaccination failure). The patient was hospitalized for 11 days due to COUGH, COVID-19, DYSPNOEA, LUNG INFILTRATION and PYREXIA. At the time of the report, COVID-19 (covid-19 infection), DYSPNOEA (SOB), COUGH (Cough), LUNG INFILTRATION (Bilateral lung infiltrate), PYREXIA (Fever) and VACCINATION FAILURE (vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: >0.3mg/ml (abnormal) >0.3mg/ml. On an unknown date, Lymphopenia: <900/mcl (abnormal) <900/mcL. On an unknown date, Oxygen saturation: <92% (abnormal) Hypoxia. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients were comparable to those of solid organ transplant patients (SOTs) who had COVID-19 infection and have not been vaccinated. Antinucleocapside antibody at COVID-19 diagnosis was also negative.  Treatment for COVID-19 was with Bamlanivimab (MAB1), Remdesivir, Dexamethasone, Convalescent Plasma and Tocilizumab. Patient's concomitant medication Mycophenolate Mofetil (immunosuppression therapy) was withheld during hospitalization. Patient was discharge on 2 liters of oxygen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However the patient's concurrent medical conditions of Kidney transplant, Pancreatic transplant, Diabetes mellitus and use of immunosuppressants remains a risk factor.   Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However the patient's concurrent medical conditions of Kidney transplant, Pancreatic transplant, Diabetes mellitus and use of immunosuppressants remains a risk factor.