Age: 38.0
Sex: F
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 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Lung disease, Diabetes, Neuromuscular disorder NOS and SLE. Concomitant products included BELIMUMAB and MYCOPHENOLIC ACID for Systemic lupus erythematosus.   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.    Treatment medications were not reported. The patient did not required supplemental oxygen.  Company comment:  This literature case concerns a 38-year-old female patient with medical history of Lung disease, Diabetes, Neuromuscular disorder and Systemic lupus erythematosus, who developed serious unexpected event of special interest - COVID-19, after she 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, however, it was confirmed that the patient did not require 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 concomitant use of Belimumab and Mycophenolic acid 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-2022-496509, MOD-2022-496510 (Patient Link).; Sender's Comments: This literature case concerns a 38-year-old female patient with medical history of Lung disease, Diabetes, Neuromuscular disorder and Systemic lupus erythematosus, who developed serious unexpected event of special interest - COVID-19, after she 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, however, it was confirmed that the patient did not require 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 concomitant use of Belimumab and Mycophenolic acid 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.