Age: 78.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Aortic valve incompetence, Cardiac failure
Clinical narrative: pericarditis/was not able to climb the steps/fluid in the lungs; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (pericarditis/was not able to climb the steps/fluid in the lungs) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high, High cholesterol (treated with Repatha (statins)), Eosinophilic esophagitis, Aortic stenosis (transvascular aortic valve replacement, which was performed on 2019) since 2019, Cardiac failure (Cardiac operation was performed as surgical procedure) and Aortic valve incompetence (Cardiac operation was performed as surgical procedure). Concomitant products included EVOLOCUMAB (REPATHA) for High cholesterol, COLCHICINE, PREDNISONE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and RIVAROXABAN (XARELTO) for an unknown indication.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (COVID-19). In February 2023, the patient experienced PERICARDITIS (pericarditis/was not able to climb the steps/fluid in the lungs) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (pericarditis/was not able to climb the steps/fluid in the lungs) had resolved and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had no symptoms before the surgery. Then, after the surgery, before being diagnosed with pericarditis, he had fluid in the lungs and he was not able to climb the steps. It was serious. The doctors said that the causes for the pericarditis were the open heart surgery, (since they opened up his pericardium), and the blood thinner (xarelto).   No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 78-year-old male patient with concurrent medical history of Aortic stenosis (transvascular aortic valve replacement, which was performed on 2019), High blood pressure, High cholesterol and Eosinophilic esophagitis. He also had concurrent ongoing medical conditions of Cardiac failure and Aortic valve incompetence. The patient experienced the serious (per medically significant) expected event of Pericarditis which occurred on Feb-2023 with an unknown onset latency after a dose of mRNA-1273 BIVALENT.222 which was received on the 2022 as a booster after other three doses of mRNA-1273 vaccine. It was described by the reporter that 2 years after the fist aortic valve replacement in 2019 he experienced Cardiac failure and Aortic valve incompetence for which it was planned a cardiac surgery for valve replacement which was performed on the 30-Jan-2023; right after the surgery on Feb-2023 the patient experienced signs and symptoms of not been able to climb the steps and fluid in the lungs for which then it was diagnosed with pericarditis.  It was also reported that before that surgery the patient had no symptoms of pericarditis and that the doctors attributed the causes for the pericarditis to the open heart surgery and use of blood thinner RIVAROXABAN (XARELTO). Considering the strong confounders of temporal associated open heart surgery which involves pericardium with the use of rivaroxaban which is also known to increase risk of haemorrhagic pericarditis, as probable causes of pericarditis and latency between vaccine dose and the event, company causality for event of Pericarditis is assessed as not related to mRNA-1273 BIVALENT.222. Treatment information was not provided. The benefit-risk relationship of mRNA-1273 BIVALENT.222 is not affected by this report.  This case was linked to MOD-2023-724012 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 78-year-old male patient with concurrent medical history of Aortic stenosis (transvascular aortic valve replacement, which was performed on 2019), High blood pressure, High cholesterol and Eosinophilic esophagitis. He also had concurrent ongoing medical conditions of Cardiac failure and Aortic valve incompetence. The patient experienced the serious (per medically significant) expected event of Pericarditis which occurred on Feb-2023 with an unknown onset latency after a dose of mRNA-1273 BIVALENT.222 which was received on the 2022 as a booster after other three doses of mRNA-1273 vaccine. It was described by the reporter that 2 years after the fist aortic valve replacement in 2019 he experienced Cardiac failure and Aortic valve incompetence for which it was planned a cardiac surgery for valve replacement which was performed on the 30-Jan-2023; right after the surgery on Feb-2023 the patient experienced signs and symptoms of not been able to climb the steps and fluid in the lungs for which then it was diagnosed with pericarditis.  It was also reported that before that surgery the patient had no symptoms of pericarditis and that the doctors attributed the causes for the pericarditis to the open heart surgery and use of blood thinner RIVAROXABAN (XARELTO). Considering the strong confounders of temporal associated open heart surgery which involves pericardium with the use of rivaroxaban which is also known to increase risk of haemorrhagic pericarditis, as probable causes of pericarditis and latency between vaccine dose and the event, company causality for event of Pericarditis is assessed as not related to mRNA-1273 BIVALENT.222. Treatment information was not provided. The benefit-risk relationship of mRNA-1273 BIVALENT.222 is not affected by this report.