Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Infection, SARS-CoV-2 test
Clinical narrative: Breakthrough infection; COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of INFECTION (Breakthrough infection) and COVID-19 (COVID-19 infection) in a 6-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Liver transplantation (Time since liver transplantation was mentioned as >10 years.) and Mechanical ventilation. Concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL (MMF) for Immunosuppression.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Breakthrough infection) (seriousness criteria death and hospitalization). an unknown date, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion hospitalization). The patient died on an unknown date. The reported cause of death was breakthrough infection. It is unknown if an autopsy was performed. At the time of death, COVID-19 (COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: confirmed covid-19 (Positive) Laboratory confirmed COVID 19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFECTION (Breakthrough infection) and COVID-19 (COVID-19 infection) to be related.    No treatment medications were reported.  Patient age was mentioned as 50-59 years. This fatal regulatory case concerns an 6 decades-year-old male patient with medical history of  Liver transplantation (Time since liver transplantation was mentioned as >10 years) and Mechanical ventilation, concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL (MMF) for Immunosuppression who experienced the serious unexpected events of  INFECTION and COVID-19 (AESI). SARS-CoV-2 test Laboratory confirmed covid-19 (Positive)  The events occurred unknown days after 1st dose of mRNA-1273 vaccine  The patient death on unknown date, reported cause of death was breakthrough infection.  It is Unknown if Autopsy was performed The medical history and concomitant medications remains as confounders. The benefit-risk relationship of drug is not affected by this report Terms and onset dates were captured as provided  The case was assessed as serious by the Regulatory Authority´s report due to Death   This case was linked to MOD-2022-551365, MOD-2022-551368, MOD-2022-551369, MOD-2022-553577.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live significant follow up received by safety on 28-April-2022 included an Email with Agency received from team contains significant information includes author address details, citation details, concomitants medications, onset latency, hospitalization details.; Sender's Comments: This fatal regulatory case concerns an 6 decades-year-old male patient with medical history of  Liver transplantation (Time since liver transplantation was mentioned as >10 years) and Mechanical ventilation, concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL (MMF) for Immunosuppression who experienced the serious unexpected events of  INFECTION and COVID-19 (AESI). SARS-CoV-2 test Laboratory confirmed covid-19 (Positive)  The events occurred unknown days after 1st dose of mRNA-1273 vaccine  The patient death on unknown date, reported cause of death was breakthrough infection.  It is Unknown if Autopsy was performed The medical history and concomitant medications remains as confounders. The benefit-risk relationship of drug is not affected by this report Terms and onset dates were captured as provided  The case was assessed as serious by the Regulatory Authority´s report due to Death; Reported Cause(s) of Death: Breakthrough infection