Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Re-tested Covid positive on antigen testing; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Re-tested Covid positive on antigen testing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: COVID 19 vaccine (Dose Number: 1 Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID 19 vaccine. Concurrent medical conditions included GERD and Drug allergy (unknown historical drug).   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 experienced COVID-19 (Re-tested Covid positive on antigen testing). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 21-Apr-2022 to 25-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Re-tested Covid positive on antigen testing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-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.   No concomitant medications was provided by the reporter. It was unknown whether the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.    Reported return of URI symptoms approximately 5 days after completing Paxlovid treatment and re-tested Covid positive on antigen testing on 01-May-2022.  OTC cold meds treatment was received for the adverse event. Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of onset of the event was not specified in respect to the administration of second and third dose of mRNA-1273, hence latency could not be assessed. The interval between the second and third dose is approximately 7 months, there was no information provided regarding the first dose. The patient was started on Paxlovid treatment regimen on April 21-25, 2022, however it has been reported that the upper respiratory tract infection symptoms occurred after 5 days of treatment, the patient had a positive SARS-CoV-2 test on May 1, 2022. Details of concomitant medications, medical history and clinical course were not provided. 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 gender with no relevant medical history, who experienced the unexpected, non-serious  of COVID-19. The exact date of onset of the event was not specified in respect to the administration of second and third dose of mRNA-1273, hence latency could not be assessed. The interval between the second and third dose is approximately 7 months, there was no information provided regarding the first dose. The patient was started on Paxlovid treatment regimen on April 21-25, 2022, however it has been reported that the upper respiratory tract infection symptoms occurred after 5 days of treatment, the patient had a positive SARS-CoV-2 test on May 1, 2022. Details of concomitant medications, medical history and clinical course were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.