Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
COVID-19 vaccine-induced myopericarditis; epigastric burning pain that radiated to the throat; numbness in the face and neck; This literature-non-study case was reported in a literature article and describes the occurrence of MYOPERICARDITIS (COVID-19 vaccine-induced myopericarditis) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Family history included Hypertrophic cardiomyopathy since an unknown date. Concurrent medical conditions included Generalized anxiety disorder (medical history was significant for generalized anxiety disorder). Concomitant products included Fluoxetine hydrochloride (Fluoxetine), Lorazepam and Ethinylestradiol;Norethindrone for an unknown indication. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced HYPOAESTHESIA (numbness in the face and neck). On 30-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOPERICARDITIS (COVID-19 vaccine-induced myopericarditis) (seriousness criteria hospitalization and medically significant). In February 2022, the patient experienced ABDOMINAL PAIN UPPER (epigastric burning pain that radiated to the throat). The patient was hospitalized from 01-Oct-2021 to 02-Oct-2021 due to MYOPERICARDITIS. In 2021, HYPOAESTHESIA (numbness in the face and neck) had resolved. In 2022, MYOPERICARDITIS (COVID-19 vaccine-induced myopericarditis) and ABDOMINAL PAIN UPPER (epigastric burning pain that radiated to the throat) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2015, Echocardiogram: normal. On 01-Oct-2021, Blood pressure measurement: 138/90 mmHg on admission. On 01-Oct-2021, Body temperature: 38.3-38.9 degree Celsius and 37.1 degree Celsius on admission. On 01-Oct-2021, Heart rate: 120 heart beats per minute on admission. In October 2021, Angiogram: negative for pulmonary embolism. In October 2021, C-reactive protein: 7.57 mg/dl Reference range: Not provided. In October 2021, Echocardiogram: showed a normal ejection fraction of 60-65%. In October 2021, Ejection fraction: 60-65%. In October 2021, Electrocardiogram: revealed anterior precordial T-wave inversions. In October 2021, Fibrin D dimer: 1.37 microgram per millilitre Reference range: not provided. In October 2021, Haemoglobin: 12.1 g/dL Reference range: Not available. In October 2021, Magnetic resonance imaging heart: revealed normal systolic function and mild lateral pericardial enhancement consistent with pericarditis but without evidence to support myocarditis. In October 2021, Platelet count: 285 10^9/L Reference range: not provided. In October 2021, SARS-CoV-2 test: (Negative) Reference range: not provided. In October 2021, Troponin I (Unknown-0.034 ng/mL): 0.208 ng/mL elevated. In October 2021, White blood cell count: 4.5 10^9/L Reference range: not provided. In March 2022, Cardiovascular examination: normal. In 2022, Electrocardiogram ambulatory: A 14-day Holter monitor documented episodes of sinus tachycardia and no ventricular or supraventricular ectopy. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOPERICARDITIS (COVID-19 vaccine-induced myopericarditis) to be related. No further causality assessments were provided for HYPOAESTHESIA (numbness in the face and neck) and ABDOMINAL PAIN UPPER (epigastric burning pain that radiated to the throat). This case referred to Case 4 Table 1 who received Moderna COVID-19 vaccine. Patient had no history of COVID-19. On 28-sep-2021, she received both the influenza vaccine and the second dose of the COVID-19 vaccine, she developed numbness in the face and neck shortly after the injection that self-resolved. Three days after vaccination, she was admitted to the hospital for palpitations, chest discomfort, dyspnea on exertion, headache, body aches, nausea, fever (38.3-38.9 degree ), and chills. She was diagnosed with COVID-19 vaccine-induced myopericarditis and discharged the following day on metoprolol and indomethacin. Five months after hospitalization, she continued to experience intermittent left costal margin and epigastric burning pain that radiated to the throat and worsened when she lay on the left side. A 14-day Holter monitor documented episodes of sinus tachycardia and no ventricular or supraventricular ectopy. At the nine-month mark, the cardiac symptoms had resolved. 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 adverse events following immunization (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: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795547:Patient Case Number 1 (22-year-old male)
Generalized anxiety disorder (medical history was significant for generalized anxiety disorder); Hypertrophic cardiomyopathy
Fluoxetine; Lorazepam; Ethinylestradiol;Norethindrone
Test Date: 202110; Test Name: CT angiography of the chest; Result Unstructured Data: negative for pulmonary embolism; Test Date: 20211001; Test Name: BP; Result Unstructured Data: 138/90 mmHg on admission; Test Date: 20211001; Test Name: Body temperature; Result Unstructured Data: 38.3-38.9 degree Celsius; Test Date: 20211001; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Cel;on admission; Test Date: 202203; Test Name: cardiac examination; Result Unstructured Data: normal; Test Date: 202110; Test Name: CRP; Test Result: 7.57 mg/dL; Test Date: 2015; Test Name: echocardiogram; Result Unstructured Data: normal; Test Date: 202110; Test Name: echocardiogram; Result Unstructured Data: showed a normal ejection fraction of 60-65%; Test Date: 202110; Test Name: ejection fraction; Result Unstructured Data: 60-65%; Test Date: 202110; Test Name: ECG; Result Unstructured Data: revealed anterior precordial T-wave inversions; Test Date: 2022; Test Name: Holter monitor; Result Unstructured Data: A 14-day Holter monitor documented episodes of sinus tachycardia and no ventricular or supraventricular ectopy; Test Date: 202110; Test Name: D-dimer; Result Unstructured Data: Test Result:1.37 ug/mL;Reference range: not provided; Test Date: 202110; Test Name: Hb; Result Unstructured Data: Test Result:12.1 g/dL;Reference range: Not available; Test Date: 20211001; Test Name: heart rate; Result Unstructured Data: Test Result:120 {beats}/min;on admission; Test Date: 202110; Test Name: cardiac MRI; Result Unstructured Data: revealed normal systolic function and mild lateral pericardial enhancement consistent with pericarditis but without evidence to support myocarditis; Test Date: 202110; Test Name: PLT; Result Unstructured Data: Test Result:285 10*9/L;Reference range: not provided; Test Date: 202110; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 202110; Test Name: Troponin I; Result Unstructured Data: Test Result:0.208 ng/mL;elevated; Test Date: 202110; Test Name: WBC; Result Unstructured Data: Test Result:4.5 10*9/L;Reference range: not provided