Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 treated with Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 treated with Paxlovid) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Diabetic and Allergy NOS (Unspecified drug). Concomitant products included METFORMIN from 01-May-2022 to 19-May-2022 for an unknown indication.   On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2021, the patient experienced COVID-19 (COVID-19 treated with Paxlovid). At the time of the report, COVID-19 (COVID-19 treated with Paxlovid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: negative (Negative) tested negative. On 18-May-2022, SARS-CoV-2 test: positive (Positive) came back positive.         The patient was taking other medications or products within 2 weeks of staring COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient tested negative on 15-May-2022. On 18-May-2022 was started to get a bit stuffy and thought it was normal allergies but underwent a test and it came back positive. The device date 19-May-2022. Treatment received information reported as no.  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 (reported as COVID-19 and COVID-19 recurrent), which occurred after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). The initial episode of COVID-19 occurred approximately less than a month after the fourth dose, while the event COVID-19 recurrent occurred approximately 1 month post-vaccination. One day after treatment of Paxlovid for the initial COVID-19 infection, patient had a negative SARS-CoV-2 test. Three days after, patient started to feel stuffy and tested positive for COVID-19. Patient reported that the event COVID-19 recurrent was resolving. 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 (reported as COVID-19 and COVID-19 recurrent), which occurred after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). The initial episode of COVID-19 occurred approximately less than a month after the fourth dose, while the event COVID-19 recurrent occurred approximately 1 month post-vaccination. One day after treatment of Paxlovid for the initial COVID-19 infection, patient had a negative SARS-CoV-2 test. Three days after, patient started to feel stuffy and tested positive for COVID-19. Patient reported that the event COVID-19 recurrent was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.