Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Batch/Lot No: Unknown. Unable to locate or read the details Location of injection: Arm Right Vaccine Administration Time: 01:00 PM) on 20-Jan-2021 and Pfizer / BioNTech (Batch/Lot No: Unknown. Unable to locate or read the details Location of injection: Arm Right Vaccine Administration Time: 01:00 PM) on 17-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Overweight, Anxiety and Drug allergy.   On 17-Dec-2021 at 1:00 PM, the patient received 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 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (COVID-19) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was provided.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Paxlovid rebound 3 days after completing treatment. Zero symptoms after treatment. 3 days later runny nose, congestion, fever, fatigue, sore throat, and sneezing. Device Date was reported as : 27May2022.  Company Comment: This is a spontaneous case concerning a 41-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 6 days and symptoms resolved. 3 days after completing the treatment, the patient reported to have runny nose, congestion, fever, fatigue, sore throat and sneezing. The event had not resolved at the time of the report. Interchange of vaccine products was also reported as the patient received primary doses of other COVID-19 vaccine (Pfizer/Biontech) with the last Pfizer/Biontech administered approximately 10 months prior to the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 41-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 6 days and symptoms resolved. 3 days after completing the treatment, the patient reported to have runny nose, congestion, fever, fatigue, sore throat and sneezing. The event had not resolved at the time of the report. Interchange of vaccine products was also reported as the patient received primary doses of other COVID-19 vaccine (Pfizer/Biontech) with the last Pfizer/Biontech administered approximately 10 months prior to the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.