Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive again after Paxlovid therapy, symptomatic; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive again after Paxlovid therapy, symptomatic) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer / BioNTech (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Time: 12:00 PM) on 18-Mar-2021, Pfizer / BioNTech (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Time: 02:00 PM) on 08-Apr-2021, Pfizer / BioNTech (Dose Number: 3 , Batch/Lot No: FF2587  and Location of injection: Right arm) on 20-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy. Concomitant products included ATHLETIC GREENS from 01-Sep-2020 to 01-Jun-2022 for an unknown indication.    On 04-May-2022 at 9:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive again after Paxlovid therapy, symptomatic). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive again after Paxlovid therapy, symptomatic) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: positive (Positive) positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was treated with Paxlovid for 5 days.  Device date was reported as 01-Jun-2022.  Company comment  This spontaneous case reported by a patient, concerns a 59-year-old male patient with no relevant medical history reported, who experienced the unexpected non seriou of COVID-19 (Tested positive again after Paxlovid therapy, symptomatic) about 14 days after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) From 18 May to 23 May 2022 for 6 days for covid 19 treatment. SARS-CoV-2 test was positive on 18 May 2022. It became negative on 23 May after Paxlovid Treatment and again became positive 5 days after stopping Paxlovid on 28 May 2022. Patient received primary 2 doses with Pfizer vaccines about 1 year ago and the 3 dose also with Pfizer vaccine about 6 months prior to 4 dose with Moderna, with no adverse events reported for Pfizer vaccines. Interchange of vaccine products was noted. 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 59-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious of COVID-19 (Tested positive again after Paxlovid therapy, symptomatic) about 14 days after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) From 18 May to 23 May 2022 for 6 days for covid 19 treatment. SARS-CoV-2 test was positive on 18 May 2022. It became negative on 23 May after Paxlovid Treatment and again became positive 5 days after stopping Paxlovid on 28 May 2022. Patient received primary 2 doses with Pfizer vaccines about 1 year ago and the 3 dose also with Pfizer vaccine about 6 months prior to 4 dose with Moderna, with no adverse events reported for Pfizer vaccines. Interchange of vaccine products was noted. The event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement