Age: 64.0
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 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Systemic sclerosis, Myopathy and Inflammatory arthritis. Concomitant products included AZATHIOPRINE and MERCAPTOPURINE (6-MP) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, 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 not reported.  Concomitant therapy included B cell depleting therapy. Patient was discharged from hospital (no ventilation reported)  Company comment: This literature non -study case that concerns a 64-year-old, female patient with concurrent medical condition of Systemic sclerosis, Myopathy, and Inflammatory arthritis, who experienced the unexpected serious AESI event of COVID -19 (seriousness criteria hospitalization) after she had been fully vaccinated with the mRNA-1273 vaccine (time interval between first and second vaccination was not provided  The patient was part of a study with SARS-CoV-2 infections with individuals with rheumatic diseases, with treatment on Azathioprine ,6-MP, BCDT. The event developed was treated at hospital and discharged with no ventilation support. 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 concurrent medical conditions were considered as risk factors for contracting of COVID-19 and could have been contributed to hospitalization in this high-risk patient. Ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-496442, MOD-2022-496508, MOD-2022-496510 (Patient Link).; Sender's Comments: This literature non -study case that concerns a 64-year-old, female patient with concurrent medical condition of Systemic sclerosis, Myopathy, and Inflammatory arthritis, who experienced the unexpected serious AESI event of COVID -19 (seriousness criteria hospitalization) after she had been fully vaccinated with the mRNA-1273 vaccine (time interval between first and second vaccination was not provided  The patient was part of a study with SARS-CoV-2 infections with individuals with rheumatic diseases, with treatment on Azathioprine ,6-MP, BCDT. The event developed was treated at hospital and discharged with no ventilation support. 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 concurrent medical conditions were considered as risk factors for contracting of COVID-19 and could have been contributed to hospitalization in this high-risk patient. Ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.