Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ COVID symptoms returned in full after 10 days completing the antiviral regimen. I tested positive for COVID for the 2nd time.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/ COVID symptoms returned in full after 10 days completing the antiviral regimen. I tested positive for COVID for the 2nd time.) in a 69-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 treatment.    The patient's past medical history included Heart disease, unspecified. Previously administered products included for Drug use for unknown indication: ZOCOR. Past adverse reactions to the above products included Allergy with ZOCOR. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], DESIPRAMINE and METOPROLOL TARTRATE for an unknown indication.   On 26-Feb-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021 at 12:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19/ COVID symptoms returned in full after 10 days completing the antiviral regimen. I tested positive for COVID for the 2nd time.). At the time of the report, COVID-19 (COVID-19/ COVID symptoms returned in full after 10 days completing the antiviral regimen. I tested positive for COVID for the 2nd time.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID for the 2nd time. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications within 2 weeks of starting COVID-19 treatment.  The patient received Paxlovid as treatment drug for initial COVID-19 diagnosis. The patient did not receive any treatment drug for the event COVID-19 recurrent.  Company Comment:This spontaneous case concerns a 69-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred after receiving an unknown dose number of mRNA-1273 vaccine. Patient completed the primary vaccination with mRNA-1273 with the last dose taken approximately 8 months prior to the current dose. It was reported that patient developed COVID-19 (with a positive SARS-CoV-2 test) on unspecified date and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for 6 days.  He recovered from COVID-19 but noted recurrence of symptoms 10 days after completion of anti-viral therapy. He also re-tested positive for COVID-19. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred after receiving an unknown dose number of mRNA-1273 vaccine. Patient completed the primary vaccination with mRNA-1273 with the last dose taken approximately 8 months prior to the current dose. It was reported that patient developed COVID-19 (with a positive SARS-CoV-2 test) on unspecified date and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for 6 days.  He recovered from COVID-19 but noted recurrence of symptoms 10 days after completion of anti-viral therapy. He also re-tested positive for COVID-19. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.