Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID-19 again testing positive on 2 tests; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID-19 again testing positive on 2 tests) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Osteoarthritis, Penicillin allergy (Penicillin), Drug allergy (Keflex), Drug allergy (Cipro) and Sulfonamide allergy (Sulfa).   On 15-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 06-May-2022 at 4:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID-19 again testing positive on 2 tests). On 13-May-2022, COVID-19 (Got COVID-19 again testing positive on 2 tests) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment. It was reported that device date was 23-May-2022.  Company comment. This spontaneous case concerns a 75  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 7 months after the third dose of mRNA-1273 vaccine (Drug ineffective was considered since the first two doses were administrated in a correct interval of time). The report stated that the patient received treatment with Paxlovid for COVID  19, and 2 weeks after she finished Paxlovid treatment, she tested positive again on two tests. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 7 months after the third dose of mRNA-1273 vaccine (Drug ineffective was considered since the first two doses were administrated in a correct interval of time). The report stated that the patient received treatment with Paxlovid for COVID  19, and 2 weeks after she finished Paxlovid treatment, she tested positive again on two tests. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.