Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Allergy. Concomitant products included BUSPIRONE and DICLOFENAC for an unknown indication. On 29-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid). At the time of the report, COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) "rebound" antigen-positive infection.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Pfizer had permission to contact patient about this report. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Patient experienced rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid. No treatment medication were reported. Paxlovid Device Date : 24May2022  Company comment: This is a spontaneous case concerning a 70-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) which occurred 1 month 22 days after a dose of mRNA-1273vaccine(dose number not specified). SARS-CoV-2 test was positive (Positive) "rebound" antigen-positive infection as on 21-May-2022.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 is a spontaneous case concerning a 70-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) which occurred 1 month 22 days after a dose of mRNA-1273vaccine(dose number not specified). SARS-CoV-2 test was positive (Positive) "rebound" antigen-positive infection as on 21-May-2022.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.