Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, COVID-19 pneumonia, SARS-CoV-2 antibody test, Vaccine induced antibody absent
Clinical narrative: Acute respiratory distress syndrome; COVID-19 pneumonia; Vaccine induced antibody absent; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress syndrome) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 70-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.      The patient's past medical history included End stage renal failure (renal transplant 6 months ago) and Renal transplant (6 months ago). Concurrent medical conditions included Diastolic heart failure and Insulin-dependent diabetes mellitus. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for Renal transplant, PREDNISONE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress syndrome) (seriousness criteria hospitalization and medically significant), COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant) and VACCINE INDUCED ANTIBODY ABSENT (Vaccine induced antibody absent). The patient was treated with CONVALESCENT PLASMA COVID-19 for ARDS and COVID-19 pneumonia, at an unspecified dose and frequency; REMDESIVIR for ARDS and COVID-19 pneumonia, at an unspecified dose and frequency and DEXAMETHASONE for ARDS and COVID-19 pneumonia, at an unspecified dose and frequency. At the time of the report, ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress syndrome), COVID-19 PNEUMONIA (COVID-19 pneumonia) and VACCINE INDUCED ANTIBODY ABSENT (Vaccine induced antibody absent) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative and negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress syndrome), COVID-19 PNEUMONIA (COVID-19 pneumonia) and VACCINE INDUCED ANTIBODY ABSENT (Vaccine induced antibody absent) to be related.    Company comment:  This literature-non-study case concerns a 70-year-old male patient with relevant medical history of end stage renal disease leading to renal transplant 6 months prior to this report, diabetes mellitus and diastolic heart failure and concurrent use of prednisone, tacrolimus and mycophenolate, who experienced serious unexpected events of acute respiratory distress syndrome and COVID-19 and non-serious unexpected event of vaccine induced antibody absent. The events occurred approximately a month after the 2nd dose of the mRNA-1273.  The rechallenge was not applicable due to occurrence after the 2nd dose. Patient's concomitant medications used for renal transplant rejection prevention are possible confounders for the events. The event of ARDS was secondary to COVID-19. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 70-year-old male patient with relevant medical history of end stage renal disease leading to renal transplant 6 months prior to this report, diabetes mellitus and diastolic heart failure and concurrent use of prednisone, tacrolimus and mycophenolate, who experienced serious unexpected events of acute respiratory distress syndrome and COVID-19 and non-serious unexpected event of vaccine induced antibody absent. The events occurred approximately a month after the 2nd dose of the mRNA-1273.  The rechallenge was not applicable due to occurrence after the 2nd dose. Patient's concomitant medications used for renal transplant rejection prevention are possible confounders for the events. The event of ARDS was secondary to COVID-19. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.