Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004rZia, 010MZOA and 014MYOA) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Sulfonamide allergy. Concomitant products included AIRBORNE from 15-May-2022 to 24-May-2022, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) from 14-May-2022 to 24-May-2022 and COLECALCIFEROL (VITAMIN D 3) from 15-May-2022 to 24-May-2022 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 22-May-2022 at 1:50 PM, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving.            The patient had rebound Covid, faint positive evening day 10, on day 11 the patient had mild symptoms included congestion and back pain. Treatment drug was not provided.  Company comment This spontaneous case reported by a patient, concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious of Covid 19 infection about 6 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (paxlovid) starting on 14-May-2022 for covid 19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported.  On 22-May-2022, the patient again experienced COVID-19. The patient had a rebound Covid 19, with a faint positive test on day 10 of treatment with Paxlovid and on the next day the patient had mild symptoms including congestion and back pain. It was reported that the patient had the 2 primary doses with Moderna vaccines at an interval of 1 month with the last dose taken about 08 months prior to the 3 dose. Treatment for the event was not provided. The event was resolving. 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 39-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious  of Covid 19 infection about 6 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (paxlovid) starting on 14-May-2022 for covid 19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported.  On 22-May-2022, the patient again experienced COVID-19. The patient had a rebound Covid 19, with a faint positive test on day 10 of treatment with Paxlovid and on the next day the patient had mild symptoms including congestion and back pain. It was reported that the patient had the 2 primary doses with Moderna vaccines at an interval of 1 month with the last dose taken about 08 months prior to the 3 dose. Treatment for the event was not provided. The event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.