Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of Covid symptoms on days 9/10/11 following the day of symptom onset, positive test and initiation of treatment with paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of Covid symptoms on days 9/10/11 following the day of symptom onset, positive test and initiation of treatment with paxlovid) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006121b) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Obesity and Drug allergy (Name of Drug as Reported- No). Concomitant products included BUPROPION from 30-Jan-2021 to an unknown date for an unknown indication.    On 16-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced COVID-19 (Rebound of Covid symptoms on days 9/10/11 following the day of symptom onset, positive test and initiation of treatment with paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-Apr-2022 to 06-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound of Covid symptoms on days 9/10/11 following the day of symptom onset, positive test and initiation of treatment with paxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine.  Company Comment:  This is a spontaneous case concerning a 50-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 rebound of COVID-19 symptoms on multiple days following the positive test and treatment with Paxlovid), which occurred 1 month and 21 days after receiving a dose of mRNA-1273 as fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient underwent SARS-CoV-2 test with positive result on an unknown date. Patient was treated with Paxlovid for COVID-19 for 7 days, however patient reported that there is a rebound of COVID-19 symptoms. Patient reported that the event COVID-19 was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 50-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 rebound of COVID-19 symptoms on multiple days following the positive test and treatment with Paxlovid), which occurred 1 month and 21 days after receiving a dose of mRNA-1273 as fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient underwent SARS-CoV-2 test with positive result on an unknown date. Patient was treated with Paxlovid for COVID-19 for 7 days, however patient reported that there is a rebound of COVID-19 symptoms. Patient reported that the event COVID-19 was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.