Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough infection of COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough infection of COVID-19) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       The patient's past medical history included COVID-19. Concurrent medical conditions included Dermatomyositis. Concomitant products included AZATHIOPRINE and RITUXIMAB for Dermatomyositis.   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 BREAKTHROUGH COVID-19 (Breakthrough infection of COVID-19) (seriousness criterion hospitalization). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency and AZITHROMYCIN for COVID-19, at an unspecified dose and frequency. At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough infection of COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This study was conducted from 30 January 2020 and 30 July 2021. From this cohort, breakthrough infections were identified in fully vaccinated patients, defined as a positive test more than equal to 14 days after the final vaccine dose. This case belonged to patient 1 from table 1. Patient age range was reported as 45-64 years. Time from last B cell depletion before vaccination to first vaccine dose was 99 days. The patient also was treated with glucocorticoids. Patient had no asymptomatic infection. Patient was hospitalized and required supplemental oxygen therapy. The patient did not decease. Author stated the most common systemic autoimmune rheumatic diseases (SARD) treatments at the time of vaccination included those associated with blunted antibody responses to SARS-CoV-2 vaccination. These findings suggested that the blunted SARS-CoV-2 antibody response following COVID-19 vaccination in certain disease-modifying anti-rheumatic drugs (DMARDs) users may be associated with an increased risk of breakthrough infections that may be severe and even fatal. SARS-CoV-2 antibody testing was not available for all patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-681229, US-MODERNATX, INC.-MOD-2022-681232, US-MODERNATX, INC.-MOD-2022-681233, US-MODERNATX, INC.-MOD-2022-681234 (Linked Report).  Company comment:This literature-non-study case concerns an adult patient of unknown gender with medical history of Dermatomyositis that was treated with azathioprine and rituximab, who experienced the unexpected serious (due to hospitalization) event of Breakthrough COVID-19. The event occurred 16 days days after the second dose (final dose) of mRNA-1273. The patient was treated with remdesivir and azithromycin, at an unspecified dose and frequency, as well as with unspecified glucocorticoids. The patient also need supplemental oxygen therapy. No further information about the event was provided and the outcome remained unknown. As the authors suggested, the patient's underlying rheumatic disease treated with disease-modifying anti-rheumatic drugs might be associated with an increased risk of breakthrough infections that might be severe in such patients. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Follow up received by safety on 30-Nov-2022 has email with full text article received and contains significant information: Reporter information and literature information was updated, medical history was added, lab data was added, product information was updated, event seriousness was updated.; Sender's Comments: This literature-non-study case concerns an adult patient of unknown gender with medical history of Dermatomyositis that was treated with azathioprine and rituximab, who experienced the unexpected serious (due to hospitalization) event of Breakthrough COVID-19. The event occurred 16 days days after the second dose (final dose) of mRNA-1273. The patient was treated with remdesivir and azithromycin, at an unspecified dose and frequency, as well as with unspecified glucocorticoids. The patient also need supplemental oxygen therapy. No further information about the event was provided and the outcome remained unknown. As the authors suggested, the patient's underlying rheumatic disease treated with disease-modifying anti-rheumatic drugs might be associated with an increased risk of breakthrough infections that might be severe in such patients. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-681233:65-84 YO US-MODERNATX, INC.-MOD-2022-681234:25-44 YO US-MODERNATX, INC.-MOD-2022-681229:25-44 YO US-MODERNATX, INC.-MOD-2022-681232:25-44 YO