Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
COVID-19; pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (pericarditis) in a 49-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Concurrent medical conditions included Obesity and Diabetes. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant) and COVID-19 (COVID-19). The patient was treated with Colchicine at an unspecified dose and frequency and Rilonacept at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) had resolved and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: Small effusion. On an unknown date, Ejection fraction: Preserved. On an unknown date, Electrocardiogram: normal value. On an unknown date, Magnetic resonance imaging heart: Circumferential pericardial late gadolinium enhancement (LGE). On an unknown date, White blood cell count (4.00-11.00 thousand per microlitre): 11.1 thousand per microlitre. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. This case referred to case no 6 from table 1 of the article. Concomitant medications were not reported. In this study patients presented with recurrent or incessant, difficult-to-treat pericarditis following SARS-CoV2 vaccination between October 2021 and January 2025. All patients had a clear temporal relationship between vaccination and the onset of symptoms of pericarditis, and all were negative for acute SARS-CoV2 infection. Patient had chest pain as clinical presentation. It was her first episode which was recurrent and the had 4 times recurrences. SARS-CoV2 test and C-reactive protein (CRP) was not done. Patient was treated with corticosteroids for 3 months. Patient had 4 times emergency department (ED) visits. Times from latest recurrence was 12 months. Corticosteroids were required in all eight patients due to persistent or worsening symptoms. Corticosteroids were tapered off gradually, two suffered side effects and four patients experienced a recurrence during tapering. Two experienced minor flares when the interval between the rilonacept dose was increased to every 3 and 4 weeks, with a resolution of symptoms when resuming weekly injections. All six (100 %) continue to be on weekly treatment at this time. Author concluded that pericarditis following SARS-CoV-2 vaccination can evolve into a recurrent, difficult-to-manage inflammatory condition. Effective treatment may require IL-1 blockade to disrupt the autoinflammatory cycle. Prompt recognition and early escalation of therapy are essential to reduce morbidity and prevent complications. This case was linked to US-MODERNATX, INC.-MOD-2025-787777 (E2B Linked Report).; Reporter's Comments: Concurrent medical conditions of Obesity and Diabetes are risk factors to develop pericarditis. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787777:49 Years Female
Diabetes; Obesity
Test Name: First available Transthoracic Echo; Result Unstructured Data: Small effusion; Test Name: LVEF; Result Unstructured Data: Preserved; Test Name: ECG; Result Unstructured Data: normal value; Test Name: First available CMR; Result Unstructured Data: Circumferential pericardial late gadolinium enhancement (LGE); Test Name: WBC