Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested negative for 4 straight days. On fifth day nasal congestion returned/ Took a COVID test and positive again.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested negative for 4 straight days. On fifth day nasal congestion returned/ Took a COVID test and positive again.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested negative for 4 straight days. On fifth day nasal congestion returned/ Took a COVID test and positive again.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested negative for 4 straight days. On fifth day nasal congestion returned/ Took a COVID test and positive again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2022, SARS-CoV-2 test: negative (Negative) negative for 4 straight days. On 31-May-2022, SARS-CoV-2 test: negative (Negative) negative for 4 straight days. On 01-Jun-2022, SARS-CoV-2 test: negative (Negative) negative for 4 straight days. On 02-Jun-2022, SARS-CoV-2 test: positive again (Positive) positive again time: 18:00. In June 2022, SARS-CoV-2 test: negative (Negative) negative for 4 straight days.         The patient was not taking other medications or products within 2 weeks of staring COVID-19 treatment.  The patient after 5 days of anti-viral treatment, felt much better and tested negative for 4 straight days. On fifth day nasal congestion returned, the patient simply thought had bad allergies, but allergy medications did not help. The patient underwent a COVID test and tested positive again. The device date 03-Jun-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine (Primary doses - unknown). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 4 days, however 1 day later, the patient had tested positive again for COVID-19. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine (Primary doses - unknown). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 4 days, however 1 day later, the patient had tested positive again for COVID-19. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.