Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough infection (Positive SARS-CoV-2 Test Result); This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough infection (Positive SARS-CoV-2 Test Result)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   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 (Breakthrough infection (Positive SARS-CoV-2 Test Result)) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to BREAKTHROUGH COVID-19. At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough infection (Positive SARS-CoV-2 Test Result)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported  This report describes outcomes of household contact tracing during 29 Jan - 2 July 2021, where fully vaccinated patients with COVID-19 were the index case in the household.  The median interval from receipt of the most recent dose of each vaccine to diagnosis was 64 days.  Vaccinated persons who developed symptoms less than 2 weeks after receipt of their most recent vaccine dose were considered not fully vaccinated for the analysis and asymptomatic fully vaccinated persons with laboratory-confirmed COVID-19 in the 180 days before specimen collection were excluded.  Partially vaccinated patients were defined as patients who received at least 1 dose of vaccine but were not fully vaccinated. Fully vaccinated patients were defined as patients who had received a second mRNA vaccine dose or a single-dose viral vector vaccine =14 days from symptom onset or collection of a positive specimen. In addition, no transmissions were found among tested contacts who had received Moderna (n = 7).  It was reported that one patient who had received Moderna vaccine was hospitalized. Company comment: This is a literature non study case concerning a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected and serious (due to hospitalization) event of BREAKTHROUGH COVID-19. The vaccination date with the first and the second dose of mRNA-1273 vaccine and the event´s onset date were not provided; hence, latency could not be properly assessed. A positive SARS-CoV-2 test was performed on an unknown date. No further patient specific information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-668883 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2022: Follow up received by safety on 03-Nov-2022 has Email with full text article and contains significant information: Reporter information, literature information, lab data and event details were updated.; Sender's Comments: This is a literature non study case concerning a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected and serious (due to hospitalization) event of BREAKTHROUGH COVID-19. The vaccination date with the first and the second dose of mRNA-1273 vaccine and the event´s onset date were not provided; hence, latency could not be properly assessed. A positive SARS-CoV-2 test was performed on an unknown date. No further patient specific information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-668883:38 fully vaccinated patients had breakthrough infection