Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (COVID-19 breakthrough infection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.   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. In 2021, the patient experienced BREAKTHROUGH COVID-19 (COVID-19 breakthrough infection) (seriousness criterion hospitalization). At the time of the report, BREAKTHROUGH COVID-19 (COVID-19 breakthrough infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) confirmed infection.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  This retrospective study was conducted for patients admitted to the hospital between 26-Aug-2021 to 8-Sep-2021 with a positive SARS CoV-2 reverse transcription polymerase chain reaction-confirmed infection who were fully vaccinated against COVID-19. All patients had chest imaging performed (either radiography, CT, or a combination of both). Chest radiographs and CTs were assessed and scored on admission and on follow up to determine the extent and type of pulmonary involvement. Charts of 60 hospitalized patients that tested positive for SARS-CoV-2 were reviewed for a prior history of COVID-19 vaccination. Eight such patients were identified and included for analysis (mean age, 54 years; range 34-81 years; four women). Patients received either two doses of Pfizer-BioNTech (n = 6), two doses of Moderna (n = 1), or one dose of Johnson and Johnson (n = 1). Five patients were immunosuppressed at the time of presentation, and six reported respiratory symptoms. Most of the patients had normal radiographs (4 of 7 patients). The most common chest CT findings were ground glass opacities (3 of 5 patients), with mild to moderate severity scores (average, 51; range 8-88). Two patients required intensive care unit admission. However, no patients died and all were either discharged or were on room air without residual respiratory symptoms by the end of the study period.  Authors concluded that in hospitalized patients with COVID-19 breakthrough illness, normal to mild or moderately positive imaging findings were observed.  Company comment: This is a literature non-study case concerning a 56-year-old female patient, with no medical history reported, who was fully vaccinated and experienced the unexpected and serious (hospitalization) event of COVID-19 breakthrough infection after the mRNA-1273 vaccination. Dates were not reported; hence, latency could not be properly assessed. A positive SARSCoV-2 reverse transcription polymerase chain reaction confirmed the infection. Chest imaging was performed but studies were not disclosed. No further clinical information was available for medical review.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a literature non-study case concerning a 56-year-old female patient, with no medical history reported, who was fully vaccinated and experienced the unexpected and serious (hospitalization) event of COVID-19 breakthrough infection after the mRNA-1273 vaccination. Dates were not reported; hence, latency could not be properly assessed. A positive SARSCoV-2 reverse transcription polymerase chain reaction confirmed the infection. Chest imaging was performed but studies were not disclosed. No further clinical information was available for medical review.  The benefit-risk relationship of mRNA-1273 is not affected by this report.