Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID asymptomatic; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (Positive for COVID asymptomatic) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neutropenia and Microcephaly (Microcephaly neutropenia). Concurrent medical conditions included Drug allergy (Extremely sensitive to medications), Soy allergy (soy sauce), Behcet's syndrome (Bechet syndrome (autoimmune)), Legal blindness (Legally blind), Learning disorder (Non-verbal), Kidney failure and Rheumatoid arthritis (Rheumatory arthritis). Concomitant products included ADALIMUMAB (HUMIRA) for Autoimmune disorder NOS, METRONIDAZOLE (METRO [METRONIDAZOLE]) for an unknown indication.   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. In April 2020, the patient experienced ASYMPTOMATIC COVID-19 (Positive for COVID asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (Positive for COVID asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) Positive. In April 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant also included booster shot.  In April 2021, the patient was possibly positive for COVID asymptomatic and outcome was unknown.  No treatment medications were reported.  Company Comment: This is a regulatory case concerning a 46-year-old male patient with medical history of Behcet's syndrome and Kidney failure, who experienced the unexpected non-serious adverse event of special interest, Asymptomatic COVID-19 which occurred on an unknown date and interval (vaccination date not provided) after receiving a dose of mRNA-1273 Vaccine. SARS-CoV-2 test yielded positive result, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Behcet's syndrome and Kidney failure remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-523037 (Patient Link).; Sender's Comments: This is a regulatory case concerning a 46-year-old male patient with medical history of Behcet's syndrome and Kidney failure, who experienced the unexpected non-serious adverse event of special interest, Asymptomatic COVID-19 which occurred on an unknown date and interval (vaccination date not provided) after receiving a dose of mRNA-1273 Vaccine. SARS-CoV-2 test yielded positive result, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Behcet's syndrome and Kidney failure remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.