Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive for Omicron/tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 after completing more than 14 days of second dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1A and 036AZ1A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced COVID-19 (Tested positive for Omicron/tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 after completing more than 14 days of second dose). The patient was treated with MOLNUPIRAVIR (oral) for COVID-19, at a dose of 400 milligram twice a day. At the time of the report, COVID-19 (Tested positive for Omicron/tested positive for COVID-19) had resolved and DRUG INEFFECTIVE (Tested positive for COVID-19 after completing more than 14 days of second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test positive: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test negative: negative (Negative) tested negative for COVID-19. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Patient heard that booster shots should be held for 90 days after antiviral treatments. Patient was recovered and does not have any symptoms, and was tested negative for COVID-19. Company comment: This is a spontaneous case concerning a 44-year-old male patient with no reported medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 9 months after the administration of second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. According to the genomic test, he had the Omicron variant. The patient was treated with Molpunavir (oral) 400 mg twice a day for 5 days. At the time of the report COVID-19 had resolved. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: Company comment: This is a spontaneous case concerning a 44-year-old male patient with no reported medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 9 months after the administration of second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. According to the genomic test, he had the Omicron variant. The patient was treated with Molpunavir (oral) 400 mg twice a day for 5 days. At the time of the report COVID-19 had resolved. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.