Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram, Pericarditis, SARS-CoV-2 test
Clinical narrative: COVID Disease 6 months after first Monovalent Booster; Pericarditis Diagnosis after holiday 2021/Angina and chest pain/shortness of breath/pain with breathing/palpitation; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (Pericarditis Diagnosis after Holiday 2021/Angina and chest pain/shortness of breath/pain with breathing/palpitation) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036F21A, 031L20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pericarditis (very long time ago and 1 attack about 2 years ago prior to vaccination.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PERICARDITIS (Pericarditis Diagnosis after Holiday 2021/Angina and chest pain/shortness of breath/pain with breathing/palpitation) (seriousness criterion medically significant). In May 2022, the patient experienced COVID-19 (COVID Disease 6 months after first Monovalent Booster). The patient was treated with COLCHICINE for Pericarditis, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis Diagnosis after Holiday 2021/Angina and chest pain/shortness of breath/pain with breathing/palpitation) had not resolved and COVID-19 (COVID Disease 6 months after first Monovalent Booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: Positive. On an unknown date, Electrocardiogram: Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  At first patient stated that patient was diagnosed pericarditis in 2021, but then patient remembered that patient had pericarditis a long time ago and also about 2 years ago. Patient did not remember exact dates. Patient reported that every 2 weeks sometimes after 2nd vaccine patient started having pericarditis attacks. The pericarditis symptoms included angina and chest pain, Dyspnea/shortness of breath and pain with breathing, palpitation. No syncope. It was unknown if patient had myocardial edema/cardiomyopathy/pericardial effusion/infective pericardial effusion/pericardial effusion malignant. There was no hospitalization due to pericarditis. It was reported that MD was watching the patient.After holiday 2021, the doctor prescribed Colchicine for pericarditis which really helped the pericarditis.The patient followed up with cardiologist after Holiday 2021.Cardiac lab values cardiac test and cardiac enzymes were done on an unknown date with unknown results. Troponin level was unknown.Cardiac function test abnormal was unknown. MRI of heart was not performed. Sonogram of heart was performed on unknown date with unknown result.   Company Comment: This spontaneous case concerns a 67-year-old female patient, past medical history of Pericarditis (very long time ago and 1 attack about 2 years ago prior to vaccination), who experienced expected serious (medically significant) AESI of Pericarditis which occurred on unspecified day of same month of receiving the third dose of mRNA-1273 vaccine. Patient also experienced non-serious event of COVID-19 with positive SARS-CoV-2 test after 6 months to current vaccination. The pericarditis had symptoms of angina and chest pain, shortness of breath and pain with breathing, palpitation with no syncope. It was unknown if patient had myocardial edema/cardiomyopathy/pericardial effusion/infective pericardial effusion/pericardial effusion malignant. There was no hospitalization due to pericarditis. No additional information about concomitant medications, treatment details were available. The outcome of event pericarditis had not resolved, and COVID-19 was unknown. Patient's past medical history of Pericarditis remains as confounders. The causality of the event COVID-19 was assessed as not applicable, due to lack of biologic plausibility. The event might be explained by current pandemic outbreak. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2022-681966 (Patient Link).; Sender's Comments: This spontaneous case concerns a 67-year-old female patient, past medical history of Pericarditis (very long time ago and 1 attack about 2 years ago prior to vaccination), who experienced expected serious (medically significant) AESI of Pericarditis which occurred on unspecified day of same month of receiving the third dose of mRNA-1273 vaccine. Patient also experienced non-serious event of COVID-19 with positive SARS-CoV-2 test after 6 months to current vaccination. The pericarditis had symptoms of angina and chest pain, shortness of breath and pain with breathing, palpitation with no syncope. It was unknown if patient had myocardial edema/cardiomyopathy/pericardial effusion/infective pericardial effusion/pericardial effusion malignant. There was no hospitalization due to pericarditis. No additional information about concomitant medications, treatment details were available. The outcome of event pericarditis had not resolved, and COVID-19 was unknown. Patient's past medical history of Pericarditis remains as confounders.The causality of the event COVID-19 was assessed as not applicable, due to lack of biologic plausibility. The event might be explained by current pandemic outbreak. The benefit-risk relationship of mRNA-1273 is not affected by this report.