Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive test and day 4 of treatment/ Symptoms returned day 10, tested positive day 11 for 3 more days.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive test and day 4 of treatment/ Symptoms returned day 10, tested positive day 11 for 3 more days.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Drug allergy (Name of drug not reported.). Concomitant products included AMLODIPINE from 01-Mar-2022 to an unknown date for an unknown indication.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient experienced COVID-19 (Positive test and day 4 of treatment/ Symptoms returned day 10, tested positive day 11 for 3 more days.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive test and day 4 of treatment/ Symptoms returned day 10, tested positive day 11 for 3 more days.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative on day 4 after positive test and day 4 of treatment., positive Symptoms returned day 10, tested positive day 11 for 3 more days., negative Negative on RAT for 5 days post treatment., negative Negative test again day 14 so far 4 more days of negative tes and positive Negative on day 4 after positive test and day 4 of treatment..         The patient was taking any other medications within 2 weeks of starting COVID-19 treatment.  The patient had previously received a COVID-19 Vaccine.  Device Date was reported as 21-May-2022.  Company comment: This is a spontaneous case concerning a 38-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred 196 days after the third dose of mRNA-1273 vaccine administration. The event was described as recurrence of Covid-19 after treatment with Nirmatrelvir (Paxlovid). Allegedly the patient was tested negative on day 4 after positive test and day 4 of treatment with Nirmatrelvir (Paxlovid). Patient was tested negative on rapid antigen test (RAT) for 5 days post treatment. Symptoms returned day 10 and tested positive on day 11 for 3 more days. Patient was subsequently tested negative again on day 14. At the time of the report, patient had 4 more days of negative test result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 38-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred 196 days after the third dose of mRNA-1273 vaccine administration. The event was described as recurrence of Covid-19 after treatment with Nirmatrelvir (Paxlovid). Allegedly the patient was tested negative on day 4 after positive test and day 4 of treatment with Nirmatrelvir (Paxlovid). Patient was tested negative on rapid antigen test (RAT) for 5 days post treatment. Symptoms returned day 10 and tested positive on day 11 for 3 more days. Patient was subsequently tested negative again on day 14. At the time of the report, patient had 4 more days of negative test result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.