Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient developed symptoms of COVID on 5/8/22, tested positive on 5/10/22; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient developed symptoms of COVID on 5/8/22, tested positive on 5/10/22) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Microscopic polyangiitis, Hepatic fibrosis, Thrombocytopenia, Drug allergy (Cipro) and Drug allergy (Sulfa).    On 14-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Patient developed symptoms of COVID on 5/8/22, tested positive on 5/10/22). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 10-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 22-May-2022, COVID-19 (Patient developed symptoms of COVID on 5/8/22, tested positive on 5/10/22) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 19-May-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 medications were reported. It was reported that patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received COVID-19 treatment. The event reported was Patient developed symptoms of COVID on 08-May-22, tested positive on 10-May-22 and was prescribed Paxlovid (renal dose). He completed the course of Paxlovid on 16-May-22 and symptoms were improving. Then on 19-May-2022 his symptoms returned, increased cough and congestion,and rapid antigen covid was positive. He was treated with another course of Paxlovid on 5/20 and symptoms started improving again 22-May-22 with Device date as 26-May-2022.  Company comment: This spontaneous case concerns an elderly male patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 3 months after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Symptoms started on 8-May and tested positive for COVID 19 on 10-May. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 16-May. Symptoms of increased cough and congestion recurred on 19-May, and he again tested positive for COVID 19 by rapid antigen test. Patient was treated with another course of Paxlovid. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 3 months after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Symptoms started on 8-May and tested positive for COVID 19 on 10-May. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 16-May. Symptoms of increased cough and congestion recurred on 19-May, and he again tested positive for COVID 19 by rapid antigen test. Patient was treated with another course of Paxlovid. The benefit-risk relationship of mRNA-1273 is not affected by this report.