Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).    On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive, 16 days after Paxlovid treatment.         Patient had not any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that post vaccination with Moderna vaccine, patient was treated with Paxlovid for COVID-19. On 22-MAY-2022, 16 days after Paxlovid treatment, the patient tested positive. No treatment medication given for COVID-19 post treatment with Paxlovid. Device Date : 24May2022.  Company Comment:  This is a spontaneous case concerning a 50-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, in the context of a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since the exact event onset date was not provided. Patient was given a six-day-course of Paxlovid treatment for the initial COVID-19 infection. However, sixteen days after the treatment with Paxlovid, patient tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 50-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, in the context of a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since the exact event onset date was not provided. Patient was given a six-day-course of Paxlovid treatment for the initial COVID-19 infection. However, sixteen days after the treatment with Paxlovid, patient tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.