Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Started Paxlovid on same day I experienced symptoms and tested positive on RAT and PCR test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Started Paxlovid on same day I experienced symptoms and tested positive on RAT and PCR test) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Allergy (Name of Drug as Reported -No). Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Apr-2022 to 21-Apr-2022 for COVID-19 treatment.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient received fourth dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced COVID-19 (Started Paxlovid on same day I experienced symptoms and tested positive on RAT and PCR test). At the time of the report, COVID-19 (Started Paxlovid on same day I experienced symptoms and tested positive on RAT and PCR test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive and positive (Positive) tested positive.         No concomitant medication was reported. It was reported that Patient started Paxlovid on same day and experienced symptoms and tested positive on RAT and PCR test. Experienced Paxlovid "rebound" Day 10. RAT cleared on Day 16. Currently experiencing long COVID symptoms 6 weeks after first symptoms. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Acupuncture was given as treatment received for the adverse event.  CC: This spontaneous case concerns a 61 year-old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred 200 days after a dose of mRNA-1273 vaccine administration, given as the third dose. The event occurred 11 days after the patient was vaccinated with a dose of Janssen COVID-19 vaccine as the fourth dose (Interchange of vaccine products). It was reported that patient started Paxlovid on same day experienced symptoms and tested positive on RAT and PCR test. Patient then experienced Paxlovid ""rebound"" Day 10. Patient tested negative for rapid antigen test on Day 16 and now currently experiencing long COVID symptoms 6 weeks after first symptoms. Patient was also treated with acupuncture for the event. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61 year-old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred 200 days after a dose of mRNA-1273 vaccine administration, given as the third dose. The event occurred 11 days after the patient was vaccinated with a dose of Janssen COVID-19 vaccine as the fourth dose (Interchange of vaccine products). It was reported that patient started Paxlovid on same day experienced symptoms and tested positive on RAT and PCR test. Patient then experienced Paxlovid ""rebound"" Day 10. Patient tested negative for rapid antigen test on Day 16 and now currently experiencing long COVID symptoms 6 weeks after first symptoms. Patient was also treated with acupuncture for the event. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.