Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac tamponade, Echocardiogram, Pericarditis, SARS-CoV-2 test
Clinical narrative: Cardiac tamponade; Pericarditis; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC TAMPONADE (Cardiac tamponade) and PERICARDITIS (Pericarditis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). On 04-Sep-2021, the patient experienced CARDIAC TAMPONADE (Cardiac tamponade) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 17 days due to CARDIAC TAMPONADE. The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and COLCHICINE at a dose of 1 dosage form. At the time of the report, CARDIAC TAMPONADE (Cardiac tamponade) and PERICARDITIS (Pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) cardiac tamponade. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and medication were reported. patient had shortness of breath 2 months after getting the 2nd dose of the Moderna Covid-19 vaccine which later developed into pericarditis.  She went to the emergency room on 31-Aug-2021 and was told that she had fluid around her heart but was sent home with the diagnosis of pericarditis but without any medication.  She always had low grade fever and it got worse on 04-Sep-2021. They went to another emergency room where an echocardiogram was done and revealed cardiac tamponade.  A pericardial widow was done on 04-Sep-2021 and VATS on 05-Sep-2021. She stayed in the hospital for 17 days. symptoms started about 20 days after 2nd dose.  Company Comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history who experienced serious unexpected event of cardiac tamponade and serious expected event of pericarditis. The events occurred approximately 4 months after the second dose of the Moderna COVID-19 vaccine. Rechallenge was unknown.  Reportedly, the patient complained of tiredness, fatigue, as well as shortness of breath and fever. The patient went to the ER due to the events and they've diagnosed her with pericarditis with pericardial effusion. The patient was discharged home without any treatment. The patient's condition got worse 4 days later and echocardiogram showed cardiac tamponade. The patient had pericardial window and VATS as a corrective treatment and was hospitalized for 17 days. The benefit-risk relationship of product is not affected by this report; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history who experienced serious unexpected event of cardiac tamponade and serious expected event of pericarditis. The events occurred approximately 4 months after the second dose of the Moderna COVID-19 vaccine. Rechallenge was unknown.  Reportedly, the patient complained of tiredness, fatigue, as well as shortness of breath and fever. The patient went to the ER due to the events and they've diagnosed her with pericarditis with pericardial effusion. The patient was discharged home without any treatment. The patient's condition got worse 4 days later and echocardiogram showed cardiac tamponade. The patient had pericardial window and VATS as a corrective treatment and was hospitalized for 17 days. The benefit-risk relationship of product is not affected by this report