Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19 infection; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (Breakthrough COVID-19 infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Congestive heart failure, Lung disease and Type 2 diabetes mellitus.   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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Breakthrough COVID-19 infection) (seriousness criteria death and hospitalization). The reported cause of death was breakthrough covid-19 infection. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Breakthrough COVID-19 infection) to be possibly related.    Patient was in Intensive care unit (ICU) and critical in covid-19 severity provided with Non-invasive positive pressure ventilation support.   Patient was treated with immunosuppressive agent.  Company Comment: This literature-study case concerns a 65-year-old female patient with relevant medical history of congestive heart failure, lung disease and type 2 diabetes and concurrent use of immunosuppressive agents, who experienced serious unexpected event of special interest (RA) COVID-19. The event occurred after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273) however, the exact time to onset was not provided. The patient was admitted to the ICU due to critical COVID-19 with non-invasive positive pressure ventilation support. The patient passed away due to the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received by safety on 16-Nov-2021 included an Email with RA received from RA team and does not contain any new information; Sender's Comments: This literature-study case concerns a 65-year-old female patient with relevant medical history of congestive heart failure, lung disease and type 2 diabetes and concurrent use of immunosuppressive agents, who experienced serious unexpected event of special interest (RA) COVID-19. The event occurred after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273) however, the exact time to onset was not provided. The patient was admitted to the ICU due to critical COVID-19 with non-invasive positive pressure ventilation support. The patient passed away due to the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Reported Cause(s) of Death: Breakthrough COVID-19 infection