Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had took three shots, a booster and all for COVID-19 and is positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had took three shots, a booster and all for COVID-19 and is positive for COVID-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002B21A and 013A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 3 dosage form twice a day. In July 2022, the patient experienced COVID-19 (had took three shots, a booster and all for COVID-19 and is positive for COVID-19). At the time of the report, COVID-19 (had took three shots, a booster and all for COVID-19 and is positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The ethnicity was reported. No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns 80 years old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. On an unknown date, SARS-CoV-2 test was Positive. It was reported that patient received co-suspect NIRMATRELVIR, RITONAVIR (PAXLOVID) on unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 80 years old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. On an unknown date, SARS-CoV-2 test was Positive. It was reported that patient received co-suspect NIRMATRELVIR, RITONAVIR (PAXLOVID) on unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.