Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of efficacy; Unknown cause of death; This literature-non-study case was reported in a literature article and describes the occurrence of DEATH (Unknown cause of death) and COVID-19 (COVID-19) in a 66-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 Kidney transplant. Concomitant products included CICLOSPORIN (CYCLOSPORIN) and MYCOPHENOLATE MOFETIL for Immunosuppression.   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 DEATH (Unknown cause of death) (seriousness criteria death and medically significant), COVID-19 (COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with CASIRIVIMAB;IMDEVIMAB for COVID-19, at an unspecified dose and frequency. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COVID-19 (COVID-19) had resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) 63 days from second dose.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) to be possibly related and DEATH (Unknown cause of death) to be not related.    The patient received the first dose of the vaccine after 28 months from the time of transplant.  After 62 days from receiving the second dose of the vaccine, the patient developed symptoms of shortness of breath and fatigue, for which the SARS-COV-2 test was conducted the next day. The patient was hospitalized and received casirivimab and imdevimab but did not require to get admitted to the ICU or require mechanical ventilation.  There were no previous transplant except for the kidney transplant.  The patient was discharged to home without oxygen supplement.  None of the patients had anti-SARS-CoV-2 spike protein antibody checked after vaccination or disease and the viruses were not sequenced.  On follow up after 30 days, it was known that the patient was dead. However, it was reported that patient recovered from COVID-19 and death was unrelated.  Company Comment: this is a case of lack of effect, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Regarding AE "death" the assessment was: unlikely related, based on reporter causality, the long latency between vaccination dates and death (more than 62 days), and because the patient had other concomitant medical conditions that could be potentially confounders (immunosupressive therapy, transplant)   This case was linked to MOD-2021-313024, MOD-2021-313114, MOD-2021-313115 (Patient Link).; Sender's Comments: this is a case of lack of effect, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Regarding AE "death" the assessment was: unlikely related, based on reporter causality, the long latency between vaccination dates and death (more than 62 days), and because the patient had other concomitant medical conditions that could be potentially confounders (immunosupressive therapy, transplant); Reported Cause(s) of Death: Unknown cause of death