Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Lung disorder, Myocarditis
Clinical narrative: myocarditis; did not make any antibodies to the vaccines/ tried so hard but recently he got COVID; some damage to his lungs; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDITIS (myocarditis) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome.) and Immunosuppression (auto-immune disease.). Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Eosinophilic granulomatosis with polyangiitis, PREDNISONE and RITUXIMAB for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant), COVID-19 (did not make any antibodies to the vaccines/ tried so hard but recently he got COVID) and LUNG DISORDER (some damage to his lungs). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of UNK UNK, bid(300 mg, the Nirmatrelvir and then 100mg of Ritonavir, 1 of those. At the time of the report, MYOCARDITIS (myocarditis) and LUNG DISORDER (some damage to his lungs) outcome was unknown and COVID-19 (did not make any antibodies to the vaccines/ tried so hard but recently he got COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that, recently a patient got COVID. Patient was receiving Paxlovid and it was working well for him, about within 24 hours of the first symptom and within 36 hours he was getting better.  Patient's height was 5 feet 9 inches and weight was 184 lbs.  Patient had a home test and then he also did a PCR test, results not provided. Patient also performed a laboratory tests a month ago from reporting, no results provided.  Company Comment: This is a Spontaneus case concerning a 72-year-old male patient with medical history of Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) who experienced the serious (per medically significant) expected AESI of Myocarditis which occurred on an unknown onset latency with a dose of mRNA-1273 received as the second dose for COVID-19 Vaccination. The medical history of Churg-Strauss syndrome remains as a confounding risk factor for myocarditis. Outcome was unknown. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This is a Spontaneus case concerning a 72-year-old male patient with medical history of Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) who experienced the serious (per medically significant) expected AESI of Myocarditis which occurred on an unknown onset latency with a dose of mRNA-1273 received as the second dose for COVID-19 Vaccination. The medical history of Churg-Strauss syndrome remains as a confounding risk factor for myocarditis. Outcome was unknown. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.