Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: Positive COVID Antigen test, flu l ke symptoms,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID Antigen test, flu l ke symptoms,) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J212A, 048F21A and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 14-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022 at 1:00 PM, 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 (Positive COVID Antigen test, flu l ke symptoms,). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 31-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive COVID Antigen test, flu l ke symptoms,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-1 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Device date was reported as 04-Jun-2022. Company Comment:  This spontaneous case reported by a patient, concerns a 75-year-old male patient with medical history of Allergy, doses of mRNA-1273 vaccine on 8/14 and 9/12, 2021 and 2/2, 2022 who experienced the unexpected non serious AESI event of Covid 19 infection unknown days after receiving 3rd. dose of mRNA-1273 vaccine in the covid 19 vaccination series.  It was reported that the patient was treated with Paxlovid starting on 25-May to 31-May-2022 for covid-19 treatment.  Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported.  On an unknown date, the patient experienced COVID-19 (Positive COVID Antigen test, Treatment for the event was not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case reported by a patient, concerns a 75-year-old male patient with medical history of Allergy, doses of mRNA-1273 vaccine on 8/14 and 9/12, 2021 and 2/2, 2022 who experienced the unexpected non serious AESI event of Covid 19 infection unknown days after receiving 3rd. dose of mRNA-1273 vaccine in the covid 19 vaccination series.  It was reported that the patient was treated with Paxlovid starting on 25-May to 31-May-2022 for covid-19 treatment.  Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported.  On an unknown date, the patient experienced COVID-19 (Positive COVID Antigen test, Treatment for the event was not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.