Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: SARS-CoV-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (SARS-CoV-2 infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Lung disease, Hypertension, Cardiovascular disease, unspecified, Renal disease, Anti-neutrophil cytoplasmic antibody positive vasculitis and B-cell depletion therapy.   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, received second 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 (SARS-CoV-2 infection) (seriousness criterion hospitalization). At the time of the report, COVID-19 (SARS-CoV-2 infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (SARS-CoV-2 infection) to be related.    The patient was on B cell depleting therapy at the time of vaccination.  The patient required supplemental oxygen therapy due to COVID-19..  Company comment:  This literature case concerns a 66-year-old male patient with medical history of Lung disease, Hypertension, Cardiovascular disease, unspecified, Kidney disease and Anti-neutrophil cytoplasmic antibody positive vasculitis, who developed serious unexpected event of special interest - COVID-19, after he had been fully vaccinated with the mRNA-1273 vaccine (time interval between first and second vaccination was not provided). The precise temporal relationship between the event occurrence and vaccine administration was not provided. The reported event required hospitalization and it was confirmed that the patient required supplemental oxygen therapy due to event. The outcome of the reported event remained unknown and no additional details regarding the clinical course of the event were disclosed at the time of this report. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The patient's underlying medical history and B cell depleting therapy are considered as risk factors for development of COVID-19 and could have been contributed to hospitalization in this high-risk patient. The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-496442, MOD-2022-496508, MOD-2022-496509 (Patient Link).; Sender's Comments: This literature case concerns a 66-year-old male patient with medical history of Lung disease, Hypertension, Cardiovascular disease, unspecified, Kidney disease and Anti-neutrophil cytoplasmic antibody positive vasculitis, who developed serious unexpected event of special interest - COVID-19, after he had been fully vaccinated with the mRNA-1273 vaccine (time interval between first and second vaccination was not provided). The precise temporal relationship between the event occurrence and vaccine administration was not provided. The reported event required hospitalization and it was confirmed that the patient required supplemental oxygen therapy due to event. The outcome of the reported event remained unknown and no additional details regarding the clinical course of the event were disclosed at the time of this report. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The patient's underlying medical history and B cell depleting therapy are considered as risk factors for development of COVID-19 and could have been contributed to hospitalization in this high-risk patient. The benefit risk relationship of mRNA-1273 is not affected by this report.