Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: testing positive on a rapid antigen, It has been nearly a week since my symptoms rebounded and continuing to test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (testing positive on a rapid antigen, It has been nearly a week since my symptoms rebounded and continuing to test positive) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease, Migraine, Hypothyroidism and Allergy (Drug name was not reported (reaction to past drug)). Concomitant products included LEVOTHYROXINE, MESALAZINE (LIALDA), TOPIRAMATE (TROKENDI XR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced COVID-19 (testing positive on a rapid antigen, It has been nearly a week since my symptoms rebounded and continuing to test positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (testing positive on a rapid antigen, It has been nearly a week since my symptoms rebounded and continuing to test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive (rapid antigen test). On an unknown date, SARS-CoV-2 test: positive (Positive) fully clearing Covid symptoms with the course of Paxlovid.         Patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  After initially fully clearing Covid symptoms with the course of Paxlovid, patient felt congested again and tested positive on a rapid antigen test. It had been nearly a week since patient's symptoms rebounded and patient was still feeling symptoms and continuing to be positive.  Company Comment: This is a spontaneous case concerning a 46-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 7 months after receiving a dose of mRNA-1273 vaccine. The patient reported feeling of congestion again and tested positive again on a rapid antigen test after fully clearing of COVID symptoms with Nirmatrelvir/Ritonavir for 5 days. The event had not resolved at the time of the report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 7 months after receiving a dose of mRNA-1273 vaccine. The patient reported feeling of congestion again and tested positive again on a rapid antigen test after fully clearing of COVID symptoms with Nirmatrelvir/Ritonavir for 5 days. The event had not resolved at the time of the report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.