Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid rebound with nasal congestion and fatigue; COVID-19 treated with Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid rebound with nasal congestion and fatigue) and COVID-19 (COVID-19 treated with Paxlovid) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21a) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    The patient's past medical history included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.   On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In April 2022, the patient experienced COVID-19 (COVID-19 treated with Paxlovid). On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid rebound with nasal congestion and fatigue). At the time of the report, COVID-19 (Covid rebound with nasal congestion and fatigue) had not resolved and COVID-19 (COVID-19 treated with Paxlovid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) Antigen test positive. On an unknown date, SARS-CoV-2 test: negative (Negative) previous negative test.       Patient experienced COVID-19 rebound with nasal congestion and fatigue. Antigen test was positive after previous negative test and disappearance of symptoms. No treatment was taken by the patient.  Company Comment:  This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 (described as COVID-19 treated with Paxlovid) and COVID-19 recurrent (described as rebound COVID-19 with nasal congestion and fatigue), which occurred after receiving a dose of mRNA-1273 as fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). On the same month after mRNA-1273 vaccination, patient had COVID-19 and was treated with Paxlovid for 5 days. However, 7 days after Paxlovid treatment, patient reportedly re-contracted COVID-19 infection associated with nasal congestion and fatigue (28 days post-vaccination), which was supported by a positive SARS-CoV-2 test. Outcome of the event COVID-19 was unknown, while the event COVID-19 recurrent was not yet resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 (described as COVID-19 treated with Paxlovid) and COVID-19 recurrent (described as rebound COVID-19 with nasal congestion and fatigue), which occurred after receiving a dose of mRNA-1273 as fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). On the same month after mRNA-1273 vaccination, patient had COVID-19 and was treated with Paxlovid for 5 days. However, 7 days after Paxlovid treatment, patient reportedly re-contracted COVID-19 infection associated with nasal congestion and fatigue (28 days post-vaccination), which was supported by a positive SARS-CoV-2 test. Outcome of the event COVID-19 was unknown, while the event COVID-19 recurrent was not yet resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.