Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: He was placed in the ICU and passed on 16Aug2021; COVID-19; High grade fever; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He was placed in the ICU and passed on 16Aug2021), COVID-19 (COVID-19) and PYREXIA (High grade fever) in a 67-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.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (COVID-19) (seriousness criteria death and life threatening), PYREXIA (High grade fever) (seriousness criterion life threatening) and DRUG INEFFECTIVE (Lack of drug effect). On 16-Aug-2021, PYREXIA (High grade fever) outcome was unknown. The patient died on 16-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: very low (Low) very low. On an unknown date, Oxygen saturation: low (Low) oxygen was not going to the blood. On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Concomitant information was not provided by reporter.  No treatment information was provided.  Patient had 1st dose of Moderna COVID-19 vaccine in last week of Jan2021 and 2nd dose was administered 28 days after.   Two weeks ago patient was diagnosed to have COVID-19 and initially had high grade fever for a few days but had to be taken to a hospital where patient was intubated because oxygen was not going to the blood and was also noted to have very low blood pressure.   Patient was placed in the ICU and passed on 16-Aug-2021.  Company comment: This is a case of COVID-19 infection with fatal outcome in a 67-year-old male who died about six months after receiving the second dose of vaccine. This report refers to a case of Drug ineffective for mRNA-1273, lot #unspecified (for the two doses). Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, 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. Based on the prolonged time since the last dose of vaccine was administered and compatibility of the event of Pyrexia with a severe COVID-19 infection, this event is assessed as unlikely related to mRNA-1273. Further information was requested.; Sender's Comments: This is a case of COVID-19 infection with fatal outcome in a 67-year-old male who died about six months after receiving the second dose of vaccine. This report refers to a case of Drug ineffective for mRNA-1273, lot #unspecified (for the two doses). Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, 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. Based on the prolonged time since the last dose of vaccine was administered and compatibility of the event of Pyrexia with a severe COVID-19 infection, this event is assessed as unlikely related to mRNA-1273. Further information was requested.; Reported Cause(s) of Death: Unknown cause of death