Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 Breakthrough infection; This non-study case was reported in a article and describes the occurrence of BREAKTHROUGH COVID-19 (COVID-19 Breakthrough infection) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  REFERENCE: Clinical characteristics and outcomes of COVID-19 breakthrough infections among vaccinated patients with systemic autoimmune rheumatic diseases.     Concurrent medical conditions included Rheumatoid arthritis-associated interstitial lung disease. Concomitant products included RITUXIMAB for Rheumatoid arthritis-associated interstitial lung disease.   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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BREAKTHROUGH COVID-19 (COVID-19 Breakthrough infection) (seriousness criteria death and hospitalization). The patient was treated with REMDESIVIR at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. The reported cause of death was covid-19 breakthrough infection. It is unknown if an autopsy was performed. Related    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.   Patient age was reported as 65-84. Patient was on mechanical ventilation. Patient was not asymptomatic and symptoms were not reported in electronic record. The patient was treated with glucocorticoids. This study was conducted from 30 January 2020 and 30 July 2021. From this, breakthrough infections were identified in fully vaccinated patients, defined as a positive test more than equal to 14 days after the final vaccine dose. Time from last B cell depletion before vaccination to first vaccine dose were 35 days. Author stated the most common 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 DMARD 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 belonged to patient 12 from table 1.  Company comment: This non-study case concerns an elderly patient of unknown gender with medical history of Rheumatoid arthritis-associated interstitial lung disease, who experienced the unexpected serious (death and hospitalization) fetal event of COVID 19. The event occurred approximately 78 days after the second dose of mRNA-1273. The patient had SARS-CoV-2 test positive. Patient was treated with REMDESIVIR at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency and placed on mechanical ventilation. The reported cause of death was covid-19 breakthrough infection. It is unknown if an autopsy was performed. No further information about the events was provided. Patient's medical history and elderly age are confounders for fatal outcome. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-681232, US-MODERNATX, INC.-MOD-2022-681229, US-MODERNATX, INC.-MOD-2022-681234, US-MODERNATX, INC.-MOD-2022-680389 (E2B Linked Report).; Sender's Comments: This non-study case concerns an elderly patient of unknown gender with medical history of Rheumatoid arthritis-associated interstitial lung disease, who experienced the unexpected serious (death and hospitalization) fetal event of COVID 19. The event occurred approximately 78 days after the second dose of mRNA-1273. The patient had SARS-CoV-2 test positive. Patient was treated with REMDESIVIR at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency and placed on mechanical ventilation. The reported cause of death was covid-19 breakthrough infection. It is unknown if an autopsy was performed. No further information about the events was provided. Patient's medical history and elderly age are confounders for fatal outcome. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-681229:25-44 YO US-MODERNATX, INC.-MOD-2022-681234:25-44 YO US-MODERNATX, INC.-MOD-2022-681232:25-44 YO US-MODERNATX, INC.-MOD-2022-680389:45-64 YO; Reported Cause(s) of Death: COVID-19 Breakthrough infection