Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram, Pericarditis
Clinical narrative: Pericarditis attack about 5 months after 2nd Primary vaccine/angina/chest pain/shortness of breath/pain with breathing/palpitation; has a history of Pericarditis and she thinks that it got worst after vaccination/Pericarditis got worst 5 months after 2nd Primary vaccine; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (Pericarditis attack about 5 months after 2nd Primary vaccine/angina/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. 038A21A and 031L20A) 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. In September 2021, the patient experienced PERICARDITIS (Pericarditis attack about 5 months after 2nd Primary vaccine/angina/chest pain/shortness of breath/pain with breathing/palpitation) (seriousness criterion medically significant) and CONDITION AGGRAVATED (has a history of Pericarditis and she thinks that it got worst after vaccination/Pericarditis got worst 5 months after 2nd Primary vaccine). At the time of the report, PERICARDITIS (Pericarditis attack about 5 months after 2nd Primary vaccine/angina/chest pain/shortness of breath/pain with breathing/palpitation) and CONDITION AGGRAVATED (has a history of Pericarditis and she thinks that it got worst after vaccination/Pericarditis got worst 5 months after 2nd Primary vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Abnormal.         COMPANY COMMENT:  This spontaneous case concerns a 67-year-old, female patient with a relevant history of pericarditis, who experienced the expected serious (medically significant) event Pericarditis (AESI), which occurred approximately 6 months after receiving a second dose of mRNA-1273 vaccine. Patient had a previous attack about 2 years ago prior to vaccination (Condition aggravated).  It was reported that the patient started having pericarditis attacks every 2 weeks since the 2nd vaccination, which was described as, angina/chest pain, shortness of breath and pain with breathing, and palpitation. Electrocardiogram showed abnormal results. Echocardiogram was done but results were not provided. Patient was treated with colchicine. Underlying history of pericarditis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-681978 (Patient Link).; Reporter's Comments: Concomitant medication list was not provided. Patient reported that patient had a history of pericarditis. At first patient stated that patient was diagnosed in 2021, but then patient remembered that patient had pericarditis a long time ago and also about 2 years ago. Patient does 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, 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 thanksgiving 2021, the doctor prescribed Colchicine for pericarditis which really helped the pericarditis. The patient followed up with cardiologist after thanksgiving 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.; Sender's Comments: This spontaneous case concerns a 67-year-old, female patient with a relevant history of pericarditis, who experienced the expected serious (medically significant) event Pericarditis (AESI), which occurred approximately 6 months after receiving a second dose of mRNA-1273 vaccine. Patient had a previous attack about 2 years ago prior to vaccination (Condition aggravated).  It was reported that the patient started having pericarditis attacks every 2 weeks since the 2nd vaccination, which was described as, angina/chest pain, shortness of breath and pain with breathing, and palpitation. Electrocardiogram showed abnormal results. Echocardiogram was done but results were not provided. Patient was treated with colchicine. Underlying history of pericarditis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.