Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Gene sequencing, SARS-CoV-2 test, Vaccine breakthrough infection, Viral load
Clinical narrative: Vaccine breakthrough infection; Asymptomatic SARS-CoV-2 breakthrough infection; This literature-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Breakthrough infections with multiple lineages of SARS-CoV-2 variants reveals continued risk of severe disease in immunosuppressed patients. Viruses. 2021;13(9):1743     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. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant) and ASYMPTOMATIC COVID-19 (Asymptomatic SARS-CoV-2 breakthrough infection). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown and ASYMPTOMATIC COVID-19 (Asymptomatic SARS-CoV-2 breakthrough infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Gene sequencing: 20g 20G. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Viral load: 19.5 (Positive) Viral Load (Cycle threshold) 19.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASYMPTOMATIC COVID-19 (Asymptomatic SARS-CoV-2 breakthrough infection) to be possibly related. No further causality assessment was provided for VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection).    No concomitant information were reported.  Treatment information was not provided.  Patient had documented records of completing their vaccine regimens at least 14 days prior to testing positive for COVID-19  The event of SARS-CoV-2 asymptomatic infection occurred on un unknown date, but,  more than 14 days after the second dose of Moderna COVID-19 vaccine  This literature report case concerns a 37 year-old heath-care worker female, whose medical history is not described, who experienced the unexpected serious (IME listed) event of Vaccine breakthrough infection and the non serious unexpected event of Asymptomatic SARS-CoV-2 infection.  The SARS-CoV-2 infection was due to a variant of concern from clade lineage 20G. The events occurred more than 14 days after the second dose of a complete schedule of Moderna COVID-19 vaccine administration. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report   This case was linked to MOD-2021-372518, MOD-2021-372752 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety on 03-Nov-2021 has an email with FTA received from SARA team. Reporter information, lab data are added.; Reporter's Comments: These results highlight the importance of ongoing monitoring of the spread of SARS-CoV-2 variants and the need for assessing the immune response to vaccination in immunosuppressed individuals.; Sender's Comments: This literature report case concerns a 37 year-old heath-care worker female, whose medical history is not described, who experienced the unexpected serious (IME listed) event of Vaccine breakthrough infection and the non serious unexpected event of Asymptomatic SARS-CoV-2 infection.  The SARS-CoV-2 infection was due to a variant of concern from clade lineage 20G. The events occurred more than 14 days after the second dose of a complete schedule of Moderna COVID-19 vaccine administration. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report