Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: covid-19 prior to Paxlovid treatment.; patient received three doses with Pfizer / BioNTech 2 months 14 days prior to current vaccination with mRNA-1273 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment.) and INTERCHANGE OF VACCINE PRODUCTS (patient received three doses with Pfizer / BioNTech 2 months 14 days prior to current vaccination with mRNA-1273 vaccine.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EN6201 Location of injection: Arm Left) on 12-Feb-2021, Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: FD0809 Location of injection: Arm Left) on 30-Oct-2021, Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EL9262 Location of injection: Arm Left) on 25-Jan-2022 and Lisinopril (cough). Past adverse reactions to the above products included Allergy with Lisinopril; and No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE from 01-Jan-2022 to an unknown date, METOPROLOL SUCCINATE from 01-Jan-2022 to an unknown date, LOSARTAN from 01-Jan-2022 to an unknown date, CALCIUM, COLECALCIFEROL (KIRKLAND SIGNATURE CALCIUM 600MG WITH VITAMIN D3) from 01-Feb-2022 to an unknown date, CETIRIZINE HCL from 01-Jan-2022 to an unknown date, FLUCLOXACILLIN SODIUM (FLORA) from 04-May-2022 to an unknown date and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 01-Feb-2022 to an unknown date for an unknown indication.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment.) and INTERCHANGE OF VACCINE PRODUCTS (patient received three doses with Pfizer / BioNTech 2 months 14 days prior to current vaccination with mRNA-1273 vaccine.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment.) and INTERCHANGE OF VACCINE PRODUCTS (patient received three doses with Pfizer / BioNTech 2 months 14 days prior to current vaccination with mRNA-1273 vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative. On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that the patient was taking medications/products within 2 weeks of starting COVID-19 treatment. Further it was reported that patient was tested positive 5 days after completing Paxlovid treatment. Symptoms were mild but patient was concerned that patient may still be contagious and was getting conflicting advice from the doctor and the CDC over whether patient  should continue to quarantine or not. Device date was reported as 26-May-2022.  Company Comment: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 15th May to 19th May 2022 for Covid-19. After the treatment with paxlovid he was tested negative for 8 consecutive days and then tested positive and experienced mild symptoms on day 9. Patient was noted to have received three doses with Pfizer / BioNTech 2 months 14 days prior to current vaccination with mRNA-1273 vaccine (Interchange of vaccine products). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 15th May to 19th May 2022 for Covid-19. After the treatment with paxlovid he was tested negative for 8 consecutive days and then tested positive and experienced mild symptoms on day 9. Patient was noted to have received three doses with Pfizer / BioNTech 2 months 14 days prior to current vaccination with mRNA-1273 vaccine (Interchange of vaccine products). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.