Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive after feeling fine for a week; patient received dose with Janssen Vaccine 6 months 26 days prior to current vaccination; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive after feeling fine for a week) and INTERCHANGE OF VACCINE PRODUCTS (patient received dose with Janssen Vaccine 6 months 26 days prior to current vaccination) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032f21a) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Janssen Vaccine (Dose Number: 1, Batch/Lot No: 042a21a, Location of injection: Arm Left and Vaccine Administration Time: 03:00 PM) on 31-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen Vaccine. Concurrent medical conditions included Drug allergy.   On 26-Oct-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Tested positive after feeling fine for a week) and INTERCHANGE OF VACCINE PRODUCTS (patient received dose with Janssen Vaccine 6 months 26 days prior to current vaccination). At the time of the report, COVID-19 (Tested positive after feeling fine for a week) was resolving and INTERCHANGE OF VACCINE PRODUCTS (patient received dose with Janssen Vaccine 6 months 26 days prior to current vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient tested positive after feeling fine for a week.  Company comment: This spontaneous case concerns a 55-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Tested positive after feeling fine for a week) which occurred on unspecified day after a dose of mRNA-1273 vaccine (Dose number not specified). SARS-CoV-2 test was positive as on 27-May-2022. patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment on 17-May-2022.It was noted that patient received dose with Janssen Vaccin 6 months 26 days   prior to current vaccination (Interchange of vaccine products). Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 55-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Tested positive after feeling fine for a week) which occurred on unspecified day after a dose of mRNA-1273 vaccine (Dose number not specified). SARS-CoV-2 test was positive as on 27-May-2022. patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment on 17-May-2022.It was noted that patient received dose with Janssen Vaccin 6 months 26 days   prior to current vaccination (Interchange of vaccine products). Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.