Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Scan myocardial perfusion, Syncope
Clinical narrative: 5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot; pericarditis; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot) and PERICARDITIS (pericarditis) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Local reaction (local reaction around eyes from eye drops.). Family history included Heart disorder. Concurrent medical conditions included Hypertension and Drug allergy (Thiomersal drug allergy). Concomitant products included METOPROLOL TARTRATE (METOPROLOL XL) and VALSARTAN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced SYNCOPE (5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2022 due to SYNCOPE. At the time of the report, SYNCOPE (5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot) and PERICARDITIS (pericarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan myocardial perfusion: had a nuclear stress test done the previous fall that they passed with flying colors.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not reported clearly.  Patient was taking a statin.  Patient had coughing, shortness of breath, fluid around their heart and fluid retention.   Patient received third dose in Dec2021 or Jan2022. Then in Mar/Apr2022 patient developed a diagnosis of pericarditis.  Patient started coughing and could not figure out why. Patient thought he had a respiratory issue. The coughing continued for a number of weeks and caller experienced shortness of breath going upstairs.  5 to 6 months after the stress test, patient passed out a few times, a case of syncope from coughing a lot.  Patient had fluid around heart and fluid retention. Patient was diagnosed with inflammation in the pericardium and tried to treat it with anti-inflammatory drugs that did not work.  Patient had a pericardiectomy. Patient current age was 71 years. Company comment This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced the serious (due to medically significant) expected, event of pericarditis and the serious (due to medically significant and hospitalization) unexpected (expected according to Fact Sheet and insert), event of syncope, which occurred about 3-4 months after the third dose of mRNA-1273 vaccine. It was reported that Patient had coughing, shortness of breath, fluid around their heart and fluid retention. Patient thought he had a respiratory issue. The coughing continued for a few weeks, and he experienced shortness of breath going upstairs. The patient developed a diagnosis of pericarditis. 5 to 6 months after the stress test, patient passed out a few times, a case of syncope from coughing a lot. Patient had fluid around heart and fluid retention. Patient was diagnosed with inflammation in the pericardium and tried to treat it with anti-inflammatory drugs that did not work. He had a pericardiectomy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.