Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
acute myocarditis; pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (acute myocarditis) and PERICARDITIS (pericarditis) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: The patient's past medical history included Myopericarditis (an episode of myopericarditis) in 2018. Concurrent medical conditions included Gender dysphoria (only medication was injectable testosterone therapy). On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced MYOCARDITIS (acute myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 18-May-2021 to 20-May-2021 due to MYOCARDITIS and PERICARDITIS. In 2021, MYOCARDITIS (acute myocarditis) and PERICARDITIS (pericarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Angiocardiogram: demonstrated normal coronary arteries except for a possible distal left anterior descending coronary artery spontaneous dissection based on a decrease in caliber. In May 2021, Borrelia test: (Negative) Lyme disease screen. In May 2021, C-reactive protein (Unknown-0.8 mg/dl): 5.4 mg/dl Reference range: Available. In May 2021, Chest X-ray: was clear. In May 2021, Echocardiogram: showed a normal ejection fraction (55%) with no wall motion abnormalities. In May 2021, Ejection fraction: 55 % normal. In May 2021, Electrocardiogram: showed ST elevation in the anterolateral leads and ST depression in the inferior limb leads. demonstrating findings consistent with myocarditis, ST elevation in the anterolateral, lateral limb leads, and ST depression in the inferior limb leads. In May 2021, Fibrin D dimer (Unknown-0.50 milligram per litre): 0.24 milligram per litre Reference range: available. In May 2021, Haemoglobin: 15.2 g/dL Reference range: Not Available. In May 2021, Magnetic resonance imaging heart: demonstrated findings consistent with acute myocarditis and no evidence of acute or old coronary artery dissection. There was diffuse patchy myocardial and epicardial enhancement of the entire lateral and inferolateral walls and basal inferior wall. Global systolic function was mildly reduced. Cardiac MRI T1 phase-sensitive inversion recovery (PSIR) images Post-contrast image in the four-chamber view reveals patchy diffuse subepicardial and mid-myocardial late gadolinium hyperenhancement in the entire lateral wall. Corresponding short-axis view reveals subepicardial to mid-myocardial hyperenhancement in the lateral wall and adjacent pericardium with minimal pericardial effusion. Findings were compatible with acute myocarditis and pericarditis. In May 2021, Platelet count: 234 10^9/L Reference range: Not Available. In May 2021, Troponin I: 9.828 ng/mL Reference range: Not Available. In May 2021, White blood cell count: 12.2 10^9/L Reference range: Not Available. On 18-May-2021, Blood pressure measurement: 136/67 mmHg on presentation. On 18-May-2021, Body temperature: 36.9 degree Celsius on presentation. On 18-May-2021, Cardiovascular examination: normal. On 18-May-2021, Heart rate: 139 heart beats per minute on presentation. On 18-May-2021, Oxygen saturation: 100 % on presentation. On 18-May-2021, Pulmonary physical examination: normal. In 2021, Magnetic resonance imaging heart: A repeat cardiac MRI seven months later showed resolution of findings of myocarditis without evidence of fibrosis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case referred to Case 2 from Table 1 who received Moderna COVID-19 vaccine. Concomitant medications were not reported. Patient had no history of COVID-19. Three days after the second vaccine dose, the patient presented to the emergency room with sharp, crushing upper chest pain that worsened with deep inspiration. There was no associated shortness of breath. Pertinent laboratory results included negative Lyme disease screen. The patient was started on intravenous heparin, aspirin, and ticagrelor prior to transfer to author's hospital. On hospital day 3, the patient was discharged to complete a three-month course of colchicine and a six week course of aspirin and ticagrelor. The patient recovered within two weeks. A repeat cardiac MRI seven months later showed resolution of findings of myocarditis without evidence of fibrosis. The patient continued to do well from a cardiac standpoint two years out. This was a descriptive case series prospectively identified and collected by the authors during formal or informal consultation from January to December 2021. The aims of this descriptive case series were twofold. First, to present detailed clinical case presentations of serious AEFI with COVID-19 vaccines seen at one rural healthcare system during the first year after the introduction of COVID-19 vaccines. Second, to review the medical literature regarding similarly reported cases. Author concluded that they encountered a variety of AEFI with COVID-19 vaccines, including myocarditis, demyelinating disease, encephalitis, Bell's palsy, burning mouth syndrome, MIS, ITP, pneumonitis, colitis, staphylococcal infection, and erythromelalgia. This detailed case series were presented to help clinicians consider a diagnosis of AEFI when no other explanation had been found after a thorough diagnostic evaluation. These described adverse events following COVID-19 vaccination do not imply causality. They hope this descriptive case series leads to further case-control studies from healthcare organizations to explore the possible risks, incidence, and causal relationships of such adverse events following COVID-19 vaccination. This case was linked to US-MODERNATX, INC.-MOD-2026-795547 (E2B Linked Report).; Reporter's Comments: Myocarditis and pericarditis are confounded by a history of prior myopericarditis, which is a recognized risk factor for recurrence and may predispose to inflammatory myocardial events independent of vaccination. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795547:Patient Case Number 1: 22-year-old male
Gender dysphoria (only medication was injectable testosterone therapy)
Medical History/Concurrent Conditions: Myopericarditis (an episode of myopericarditis)
Test Date: 202105; Test Name: Coronary angiography; Result Unstructured Data: demonstrated normal coronary arteries except for a possible distal left anterior descending coronary artery spontaneous dissection based on a decrease in caliber; Test Date: 20210518; Test Name: Blood pressure; Result Unstructured Data: 136/67 mmHg on presentation; Test Date: 20210518; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Cel;on presentation; Test Date: 202105; Test Name: Lyme disease screen; Test Result: Negative ; Test Date: 20210518; Test Name: Cardiac examination; Result Unstructured Data: normal; Test Date: 202105; Test Name: chest radiograph; Result Unstructured Data: was clear; Test Date: 202105; Test Name: CRP; Test Result: 5.4 mg/dL; Test Date: 202105; Test Name: echocardiogram; Result Unstructured Data: showed a normal ejection fraction (55%) with no wall motion abnormalities; Test Date: 202105; Test Name: ejection fraction; Test Result: 55 %; Test Date: 202105; Test Name: ECG; Result Unstructured Data: showed ST elevation in the anterolateral leads and ST depression in the inferior limb leads. demonstrating findings consistent with myocarditis, ST elevation in the anterolateral, lateral limb leads, and ST depression in the inferior limb leads; Test Date: 202105; Test Name: D-dimer; Result Unstructured Data: Test Result:0.24 mg/L;Reference range: available; Test Date: 202105; Test Name: Hb; Result Unstructured Data: Test Result:15.2 g/dL;Reference range: Not Available; Test Date: 20210518; Test Name: Heart rate; Result Unstructured Data: Test Result:139 {beats}/min;on presentation; Test Date: 202105; Test Name: cardiac MRI; Result Unstructured Data: demonstrated findings consistent with acute myocarditis and no evidence of acute or old coronary artery dissection. There was diffuse patchy myocardial and epicardial enhancement of the entire lateral and inferolateral walls and basal inferior wall. Global systolic function was mildly reduced. Cardiac MRI T1 phase-sensitive inversion recovery (PSIR) images Post-contrast image in the four-chamber view reveals patchy diffuse subepicardial and mid-myocardial late gadolinium hyperenhancement in the entire lateral wall. Corresponding short-axis view reveals subepicardial to mid-myocardial hyperenhancement in the lateral wall and adjacent pericardium with minimal pericardial effusion. Findings were compatible with acute myocarditis and pericarditis; Test Date: 2021; Test Name: cardiac MRI; Result Unstructured Data: A repeat cardiac MRI seven months later showed resolution of findings of myocarditis without evidence of fibrosis; Test Date: 20210518; Test Name: oxygen saturation (SpO2); Test Result: 100 %; Test Date: 202105; Test Name: platelets (PLT); Result Unstructured Data: Test Result:234 10*9/L;Reference range: Not Available; Test Date: 20210518; Test Name: lung examination; Result Unstructured Data: normal; Test Date: 202105; Test Name: troponin I; Result Unstructured Data: Test Result:9.828 ng/mL;Reference range: Not Available; Test Date: 202105; Test Name: WBC; Result Unstructured Data: Test Result:12.2 10*9/L;Reference range: Not Available