Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Was treated with Paxlovid on day 1 of Covid infection with active symptoms and positive test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Was treated with Paxlovid on day 1 of Covid infection with active symptoms and positive test) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin).    On 25-Oct-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Was treated with Paxlovid on day 1 of Covid infection with active symptoms and positive test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-Apr-2022 to 29-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Chest tightness, at an unspecified dose and frequency. At the time of the report, COVID-19 (Was treated with Paxlovid on day 1 of Covid infection with active symptoms and positive test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Events respiratory symptoms, wheezing, illness, fatigue are subsumed under the event Covid-19. Patient was taking unknown other medication/Product within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Patient was treated with Paxlovid on day 1 of Covid infection with active symptoms and positive test. Device date was reported as 31-May-2022. It was reported that Physician prescribed Medrol steroid pack to relive chest tightness.  Company comment: This is a spontaneous case concerning a 73-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 182 days after the third dose of mRNA-1273 vaccine administration. The event was described as, patient experienced Covid-19 and was treated with Nirmatrelvir + Ritonavir (Paxlovid) on day 1 of Covid-19 for 5 days. Patient was reported to have active symptoms and positive test result. However, 2 days from the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient became ill again with upper respiratory symptoms, chest wheezing and fatigue. Patient was prescribed with Methylprednisolone (Medrol). No other information surrounding the event was reported. The outcome of the event was reported as resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine 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, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 182 days after the third dose of mRNA-1273 vaccine administration. The event was described as, patient experienced Covid-19 and was treated with Nirmatrelvir + Ritonavir (Paxlovid) on day 1 of Covid-19 for 5 days. Patient was reported to have active symptoms and positive test result. However, 2 days from the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient became ill again with upper respiratory symptoms, chest wheezing and fatigue. Patient was prescribed with Methylprednisolone (Medrol). No other information surrounding the event was reported. The outcome of the event was reported as resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.