Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: SARS-CoV-2 breakthrough infections; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (SARS-CoV-2 breakthrough infections) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  Concurrent medical conditions included Hypertension, Renal disease and Vasculitis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (SARS-CoV-2 breakthrough infections) (seriousness criterion hospitalization). The patient was treated with Immunotherapy (B cell depleting therapy) for COVID-19. At the time of the report, COVID-19 (SARS-CoV-2 breakthrough infections) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (SARS-CoV-2 breakthrough infections) to be related.    Treatment medications were not reported.  it was reported that COVID-19 diagnosis was made, antigen or antibody test. Patient outcome for hospitalization was he required Non-invasive ventilation or high flow oxygen devices due to COVID-19. Company comment This literature-non-study case concerns a male patient of unknown age, with medical history of hypertension, kidney disease and vasculitis, who experienced serious, unexpected event of COVID-19, which occurred on an unknown date after administration of the 2nd dose of mRNA-1273 vaccine and led to hospitalization. He required Non-invasive ventilation or high flow oxygen devices due to COVID-19. The mentioned medical history could contribute to severity in COVID-19 and lead to hospitalization. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The vaccination dates of both doses are unknown, so lack of efficacy situation cannot be evaluated.   This case was linked to MOD-2022-496442, MOD-2022-496508, MOD-2022-496509, MOD-2022-496510 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Live Follow up received by safety on 21-Apr-2022 has Email received from team and contains significant information: Reporter information (author details and additional authors), literature information  and medical history were updated. Sender's Comments: This literature-non-study case concerns a male patient of unknown age, with medical history of hypertension, kidney disease and vasculitis, who experienced serious, unexpected event of COVID-19, which occurred on an unknown date after administration of the 2nd dose of mRNA-1273 vaccine and led to hospitalization. He required Non-invasive ventilation or high flow oxygen devices due to COVID-19. The mentioned medical history could contribute to severity in COVID-19 and lead to hospitalization. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The vaccination dates of both doses are unknown, so lack of efficacy situation cannot be evaluated.