Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; Patient tested positive on rapid antigen; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) and COVID-19 (Patient tested positive on rapid antigen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Penicillin allergy, Latex allergy and Pollen allergy. Concomitant products included LEVOTHYROXINE, BUPROPION, COD LIVER OIL [COD-LIVER OIL], LAMOTRIGINE, FEXOFENADINE, LISINOPRIL, PANTOPRAZOLE and SEMAGLUTIDE for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced COVID-19 (Patient tested positive on rapid antigen). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) and COVID-19 (Patient tested positive on rapid antigen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-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.   It was reported that the patient tested positive after stopping Paxlovid on 16-May-2022 and had recurrence of COVID illness symptoms and actually felt worse this time. Vitals were stable and patient was referred for antibody infusion on the day of reporting. The device date was reported as 25-May-2022.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 5-6 months after the third dose of mRNA-1273 vaccine administration. The event was described as, on unknown date patient experienced Covid-19. Approximately 181 days patient took Nirmatrelvir + Ritonavir (Paxlovid). Approximately 5 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient experienced recurrence of Covid-19 symptoms reported as felt worse. Patient was tested positive on rapid antigen approximately 8 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid). Patient was referred for antibody infusion. No other information surrounding the event was reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 5-6 months after the third dose of mRNA-1273 vaccine administration. The event was described as, on unknown date patient experienced Covid-19. Approximately 181 days patient took Nirmatrelvir + Ritonavir (Paxlovid). Approximately 5 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient experienced recurrence of Covid-19 symptoms reported as felt worse. Patient was tested positive on rapid antigen approximately 8 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid). Patient was referred for antibody infusion. No other information surrounding the event was reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.