Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested "positive for Covid on 5/19"; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (tested "positive for Covid on 5/19") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032f21a, 016m20a and 013l20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy (unknown drug). Concomitant products included METOPROLOL from an unknown date to 19-May-2022 for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested "positive for Covid on 5/19"). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested "positive for Covid on 5/19") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 27-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment Patient previously received a COVID-19 Vaccine It was reported that tested negative on 27-May-2022 after paxlovid treatment and symptoms were resolved. No treatment medications were reported by the reporter. Device Date was 30-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with relevant medical history of hypertension, who experienced the unexpected non-serious AESI of COVID-19 that occurred 6 months and 15 days after the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test positive was reported positive. Patient took Paxlovid for 5 days as treatment regimen. Symptoms resolved and tested negative after completion of treatment. Nine days (from event onset) patient reported severe runny nose as large amounts clear sinus drainage. The medical history of hypertension could be considered as a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgment; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with relevant medical history of hypertension, who experienced the unexpected non-serious AESI of COVID-19 that occurred 6 months and 15 days after the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test positive was reported positive. Patient took Paxlovid for 5 days as treatment regimen. Symptoms resolved and tested negative after completion of treatment. Nine days (from event onset) patient reported severe runny nose as large amounts clear sinus drainage. The medical history of hypertension could be considered as a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgment