Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19
Clinical narrative: COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE.  No Medical History information was reported.   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 COVID-19 (COVID-19) (seriousness criteria death and hospitalization). The reported cause of death was covid-19. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body mass index: 34.3.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Patient was not severly immunocompromised. Months after vaccination prior to hospitalization was 4 months. Patient did not receive booster dose. The primary aim was to describe the characteristics of fully vaccinated persons admitted with COVID-19. A retrospective review of all patients admitted with COVID-19 was conducted between 15 July and 31 August 2021. Patients were considered fully vaccinated if symptom onset or positive SARS-CoV-2 testing was at least 14 days after their final dose. Patients were identified using the electronic heath record by extracting all patients with a positive SARS-CoV-2 test during the study time period, or if they had an active COVID-19 designation by the AHN infection prevention department for patients diagnosed outside the health system. Patients were included if they had COVID-19 during their hospitalization.  Of the 19 patients with in-hospital death due to COVID-19, 5 were severely immunosuppressed. Of the other 14 patients, 11 were =65 years of age and all had numerous comorbidities. Most (89.2percent) fully vaccinated patients hospitalized with symptomatic COVID-19 were greater than or equal to years old and/or severely immunosuppressed. VE against hospitalization, need for ICU care, mechanical ventilation, and in-hospital mortality for the entire cohort was estimated to be 84.5 percent, 85.1percent, 86.6 percent, and 83.1 percent, respectively. Vaccination was found to be greater than 91 percent protective against hospitalization for all age groups under 70. 128 fully vaccinated patients hospitalized with COVID-19 prior to booster vaccines were reviewed and found that 27 percent were asymptomatic, 52 percent required ICU care, and 15 percent died due to COVID-19. Most (89.2 percent) fully vaccinated patients with symptomatic COVID-19 were =65 years old and/or severely immunosuppressed.  Company Comment: This literature-non-study case report concerns a 70-year-old male patient with medical history of Chronic lung disease, who experienced serious (due to hospitalization and fatal outcome) unexpected event of COVID-19. The event occurred after the patient had received first and second dose of the mRNA-1273 vaccine. Reportedly, the patient was hospitalized due to COVID-19 4 months after the received the second dose of the vaccine. Time interval between vaccination with the first and with the second dose (vaccination schedule) was not provided. As reported, the patient died due to COVID-19. It was confirmed that the patient was not severely immunosuppressed, however, the patient's elderly age and underlying chronic lung disease are considered as significant confounding factors which could contribute to unfavorable (fatal) outcome in this patient. The authors reported that mRNA-1273 showed overall significant efficacy when it comes to hospitalization, intensive care unit admission, need for mechanical ventilation or hospital mortality due to COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-677463 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2022: Live significant follow-up received by safety on 23-Nov-2022 has email with full text article and  contains significant information. Reporter information, literature information, patient details, medical history, product, event details and seriousness was updated.; Sender's Comments: This literature-non-study case report concerns a 70-year-old male patient with medical history of Chronic lung disease, who experienced serious (due to hospitalization and fatal outcome) unexpected event of COVID-19. The event occurred after the patient had received first and second dose of the mRNA-1273 vaccine. Reportedly, the patient was hospitalized due to COVID-19 4 months after the received the second dose of the vaccine. Time interval between vaccination with the first and with the second dose (vaccination schedule) was not provided. As reported, the patient died due to COVID-19. It was confirmed that the patient was not severely immunosuppressed, however, the patient's elderly age and underlying chronic lung disease are considered as significant confounding factors which could contribute to unfavorable (fatal) outcome in this patient. The authors reported that mRNA-1273 showed overall significant efficacy when it comes to hospitalization, intensive care unit admission, need for mechanical ventilation or hospital mortality due to COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-677463:81 patient; Reported Cause(s) of Death: COVID-19