Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initail COVID-19 after vaccination/ feeling worse than original COVID19 disease, rapid antigen still positive after 10 days; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Initail COVID-19 after vaccination/ feeling worse than original COVID19 disease, rapid antigen still positive after 10 days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 011A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Hypertension, Osteopenia, Polymyalgia rheumatica, Vertigo, Drug allergy (Celebrex), Drug allergy (dextromethorphan) and Allergy to antibiotic (Tetracyclines). Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) from 19-May-2022 to an unknown date and BENZONATATE from 19-May-2022 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Initail COVID-19 after vaccination/ feeling worse than original COVID19 disease, rapid antigen still positive after 10 days). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initail COVID-19 after vaccination/ feeling worse than original COVID19 disease, rapid antigen still positive after 10 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) still positive after 10 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was feeling worse than original COVID19 disease, rapid antigen still + after 10days of treatment. Device Date was reported as 25-May-2022.  Company Comment: This is a spontaneous case concerning a 78-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 7 months after receiving the third dose of mRNA-1273 Vaccine. As reported, patient received treatment Paxlovid for COVID-19. Patient felt worse and had positive test after 10 days, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 7 months after receiving the third dose of mRNA-1273 Vaccine. As reported, patient received treatment Paxlovid for COVID-19. Patient felt worse and had positive test after 10 days, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.