Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Echocardiogram, Pericarditis, SARS-CoV-2 test
Clinical narrative: Acute Pericarditis; SARS-CoV-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (Acute Pericarditis) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:    The patient's past medical history included SARS-CoV-2 infection (Early 2020) in 2020. Concurrent medical conditions included Tachycardia (Persistent). Concomitant products included METOPROLOL TARTRATE for Tachycardia.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Acute Pericarditis) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection). The patient was treated with IBUPROFEN at a dose of high dose; INDOMETHACIN [INDOMETACIN] at an unspecified dose and frequency; COLCHICINE at an unspecified dose and frequency; PANTOPRAZOLE at an unspecified dose and frequency; RILONACEPT (subcutaneous) for Recurrent pericarditis, at a dose of 320 milligram and RILONACEPT (subcutaneous) ongoing since an unknown date for Recurrent pericarditis, at a dose of 160 milligram once a week. At the time of the report, PERICARDITIS (Acute Pericarditis) had resolved and COVID-19 (SARS-CoV-2 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: showed a small pericardial effusion and enhancement of the pericardium. On an unknown date, SARS-CoV-2 test: (Positive) three months later diagnosed, acute symptomatic.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had progressively worsening sharp chest pain aggravated by supine positioning, fatigue, and intermittent low-grade fever two weeks after a booster dose of the mRNA-1273 vaccine. Acute pericarditis was diagnosed.  Four months later, the patient presented with similar symptoms and echocardiography results following SARS-CoV-2 infection. The patient returned after two weeks and reported his symptoms were unchanged. Standard treatment was ineffective despite a good previous response.  The patient was treated with Rilonacept. Three months later the patient was diagnosed with PCR-confirmed acute symptomatic SARS-CoV-2 infection. The patient continued to take rilonacept weekly and at a follow-up eight weeks after recovering, the patient reported no recurrence of pericarditis symptoms.  Authors concluded that this case showed that rilonacept was an effective treatment for SARS-CoV-2 and mRNA vaccine-associated pericarditis, and implies that cytokine dysregulation was a significant contributor to its pathogenesis. Furthermore, the case suggests that rilonacept might prevent recurrence of pericarditis in a susceptible individual acutely diagnosed with SARS-CoV-2.  Company Comment: This is a literature non-study case concerning a 35-year-old, male patient with reported past medical history of SARS-CoV-2 infection in early 2020 and concurrent medical condition of persistent tachycardia (controlled with metoprolol tartate), who experienced the serious (due to medically significant) expected event Acute Pericarditis and the non-serious unexpected event SARS-CoV-2 infection. The event Acute Pericarditis occurred 2 weeks after receiving the booster dose of mRNA-1273 vaccine. The event SARS-CoV-2 infection occurred 3 months after receiving the booster dose of mRNA-1273 vaccine. The patient presented complaining of progressively worsening sharp chest pain aggravated by supine positioning, fatigue, and intermittent low-grade fever two weeks after a booster dose of the mRNA-1273 vaccine. Acute pericarditis was diagnosed and was treated successfully with high dose ibuprofen. Four months later, the patient presented with similar symptoms and echocardiography results following SARS-CoV-2 infection. He was prescribed with indomethacin, colchicine, pantoprazole. The patient returned after two weeks and reported his symptoms were unchanged. Hence, the patient was treated with Rilonacept. Three months later the patient was diagnosed with PCR-confirmed acute symptomatic SARS-CoV-2 infection. The patient continued to take rilonacept weekly and at a follow-up eight weeks after recovering, the patient reported no recurrence of pericarditis symptoms. Relevant diagnostic tests performed included: Echocardiogram that showed a small pericardial effusion and enhancement of the pericardium, and positive SARS-CoV-2 test three months later. At the time of the report, outcome of Acute Pericarditis was reported as resolved and outcome of event SARS-CoV-2 infection was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2023: Live follow up received by safety on 30-Mar-2023 has email with full text article that contains significant information: Reporter information and literature information; Sender's Comments: Company Comment: This is a literature non-study case concerning a 35-year-old, male patient with reported past medical history of SARS-CoV-2 infection in early 2020 and concurrent medical condition of persistent tachycardia (controlled with metoprolol tartate), who experienced the serious (due to medically significant) expected event Acute Pericarditis and the non-serious unexpected event SARS-CoV-2 infection. The event Acute Pericarditis occurred 2 weeks after receiving the booster dose of mRNA-1273 vaccine. The event SARS-CoV-2 infection occurred 3 months after receiving the booster dose of mRNA-1273 vaccine. The patient presented complaining of progressively worsening sharp chest pain aggravated by supine positioning, fatigue, and intermittent low-grade fever two weeks after a booster dose of the mRNA-1273 vaccine. Acute pericarditis was diagnosed and was treated successfully with high dose ibuprofen. Four months later, the patient presented with similar symptoms and echocardiography results following SARS-CoV-2 infection. He was prescribed with indomethacin, colchicine, pantoprazole. The patient returned after two weeks and reported his symptoms were unchanged. Hence, the patient was treated with Rilonacept. Three months later the patient was diagnosed with PCR-confirmed acute symptomatic SARS-CoV-2 infection. The patient continued to take rilonacept weekly and at a follow-up eight weeks after recovering, the patient reported no recurrence of pericarditis symptoms. Relevant diagnostic tests performed included: Echocardiogram that showed a small pericardial effusion and enhancement of the pericardium, and positive SARS-CoV-2 test three months later. At the time of the report, outcome of Acute Pericarditis was reported as resolved and outcome of event SARS-CoV-2 infection was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.