Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Headache, runny nose, congestion, slight fever,fatigue. Negative covid test followed by a positive covidtest 12 hours later.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Headache, runny nose, congestion, slight fever,fatigue. Negative covid test followed by a positive covidtest 12 hours later.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).   On 01-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021 at 4:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Headache, runny nose, congestion, slight fever,fatigue. Negative covid test followed by a positive covidtest 12 hours later.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-May-2022 to 01-Jun-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Headache, runny nose, congestion, slight fever,fatigue. Negative covid test followed by a positive covidtest 12 hours later.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient took other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 28th May 2022 to 1st June 2022 for 5 days. COVID-19 test done on an unknown date was positive. Patient reported covid symptoms, a negative covid test followed by a positive covid test after 12 hours. No further details on clinical course, other lab test results were reported. Patient had received 1st and 2nd dose of vaccination at an interval of 29 days. The current pandemic situation of COVID 19 may remain as confounder. 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 concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 28th May 2022 to 1st June 2022 for 5 days. COVID-19 test done on an unknown date was positive. Patient reported covid symptoms, a negative covid test followed by a positive covid test after 12 hours. No further details on clinical course, other lab test results were reported. Patient had received 1st and 2nd dose of vaccination at an interval of 29 days. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.