Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Rebound of symptoms/Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of symptoms/Treatment of COVID-19) in a 68-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.    Concurrent medical conditions included Drug allergy. Concomitant products included ATORVASTATIN for an unknown indication.   On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of symptoms/Treatment of COVID-19). At the time of the report, COVID-19 (Rebound of symptoms/Treatment of COVID-19) was resolving.            Patient received a 4th dose of m RNA-1273 vaccine on 5 April 2022, and he received paxlovid treatment for COVID-19 on 10 May 2022 until 14 May 2022. Rebound of COVID-19 symptoms occurred after 5 days from the last dose of his paxlovid treatment (19 May 2022). Concomitant medication reported was atorvastatin for an unknown indication. Further details on the clinical course, diagnostics, and treatments were not reported.   Company Comment: This spontaneous case concerns a 68-year-old, male patient, with a concomitant medication of atorvastatin for an unknown indication and no other relevant medical conditions reported, who experienced an unexpected, non-serious AESI COVID-19 after 44 days of vaccination with a 4th dose of mRNA-1273 vaccine. A 4-day paxlovid treatment regimen started 35 days after his vaccination with mRNA-1273 vaccine. Reportedly, rebound of COVID-19 symptoms occurred 5 days after the paxlovid treatment regimen. Event COVID-19 was reported as resolving. The natural course of the etiologic virus causing COVID-19 infection, SARS-CoV-2, may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient, with a concomitant medication of atorvastatin for an unknown indication and no other relevant medical conditions reported, who experienced an unexpected, non-serious AESI COVID-19 after 44 days of vaccination with a 4th dose of mRNA-1273 vaccine. A 4-day paxlovid treatment regimen started 35 days after his vaccination with mRNA-1273 vaccine. Reportedly, rebound of COVID-19 symptoms occurred 5 days after the paxlovid treatment regimen. Event COVID-19 was reported as resolving. The natural course of the etiologic virus causing COVID-19 infection, SARS-CoV-2, may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.