Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: newly positive antigen test 7 days after completion of Paxlovid/recurrent sx consistent with Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (newly positive antigen test 7 days after completion of Paxlovid/recurrent sx consistent with Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (newly positive antigen test 7 days after completion of Paxlovid/recurrent sx consistent with Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 07-May-2022 to 11-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (newly positive antigen test 7 days after completion of Paxlovid/recurrent sx consistent with Covid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, Patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 vaccine.   Patient had a newly positive antigen test 7 days after completion of Paxlovid.  Device Date was mentioned as 18-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown age and sex with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 6 months after receiving the third dose of mRNA-1273 vaccine. No information was provided regarding the first two doses of COVID 19 vaccination. Patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid). However, patient developed recurrent symptoms and a new positive COVID-19 antigen test a week after treatment completion. The associated clinical manifestations of COVID-19, date of the initial diagnosis of COVID-19 and date of the initial COVID-19 test were not provided in this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and sex with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 6 months after receiving the third dose of mRNA-1273 vaccine. No information was provided regarding the first two doses of COVID 19 vaccination. Patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid). However, patient developed recurrent symptoms and a new positive COVID-19 antigen test a week after treatment completion. The associated clinical manifestations of COVID-19, date of the initial diagnosis of COVID-19 and date of the initial COVID-19 test were not provided in this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.