Received May 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
forearm cellulitis/ right arm swelling consistent with cellulitis; Staphylococcus aureus septicemia; septic shock; Toxic shock syndrome; myopericarditis; pain at the vaccine injection site; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINATION SITE PAIN (pain at the vaccine injection site), STAPHYLOCOCCAL SEPSIS (Staphylococcus aureus septicemia), SEPTIC SHOCK (septic shock), TOXIC SHOCK SYNDROME (Toxic shock syndrome), CELLULITIS (forearm cellulitis/ right arm swelling consistent with cellulitis) and MYOPERICARDITIS (myopericarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: The patient's past medical history included SARS-CoV-2 infection (Mild) in November 2020. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced STAPHYLOCOCCAL SEPSIS (Staphylococcus aureus septicemia) (seriousness criteria hospitalization and medically significant). On 04-Mar-2021, the patient experienced CELLULITIS (forearm cellulitis/ right arm swelling consistent with cellulitis) (seriousness criterion hospitalization). In March 2021, the patient experienced VACCINATION SITE PAIN (pain at the vaccine injection site) (seriousness criterion hospitalization), SEPTIC SHOCK (septic shock) (seriousness criteria hospitalization and medically significant), TOXIC SHOCK SYNDROME (Toxic shock syndrome) (seriousness criteria hospitalization and medically significant) and MYOPERICARDITIS (myopericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Mar-2021 to 19-Mar-2021 due to CELLULITIS, MYOPERICARDITIS, SEPTIC SHOCK, STAPHYLOCOCCAL SEPSIS, TOXIC SHOCK SYNDROME and VACCINATION SITE PAIN. In 2021, VACCINATION SITE PAIN (pain at the vaccine injection site), STAPHYLOCOCCAL SEPSIS (Staphylococcus aureus septicemia), SEPTIC SHOCK (septic shock), TOXIC SHOCK SYNDROME (Toxic shock syndrome), CELLULITIS (forearm cellulitis/ right arm swelling consistent with cellulitis) and MYOPERICARDITIS (myopericarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 39.4 degree Celsius Fevers up to 39.4 degree Celsius. On 04-Mar-2021, Blood pressure measurement: 105/71 mmHg on presentation. On 04-Mar-2021, Body temperature: 37 degree Celsius on presentation. On 04-Mar-2021, Heart rate: 131 heart beats per minute on presentation. On 04-Mar-2021, Oxygen saturation: 97 % On presentation. On 04-Mar-2021, Physical examination: was ill-appearing and diaphoretic. He had a well-demarcated erythematous patch on the right forearm. In March 2021, Alanine aminotransferase (6-40 international unit per litre): 75 international unit per litre Reference range: provided. In March 2021, Aspartate aminotransferase (13-35 international unit per litre): 67 international unit per litre Reference range: provided. In March 2021, Band neutrophil percentage: 17 % bands. In March 2021, Blood culture: (Positive) Staphylococcus aureus (S. aureus). In March 2021, Cardiovascular examination: revealed a loud biphasic pericardial friction rub. In March 2021, Chest X-ray: showed a left lower lobe infiltrate and elevation of the right hemidiaphragm. In March 2021, Computerised tomogram limb: showed forearm swelling without an abscess. CT scan of the forearm with corresponding proximal and distal axial views demonstrating subcutaneous edema. In March 2021, Creatine kinase (30-326 international unit per litre): 800 international unit per litre elevated. In March 2021, Echocardiogram: showed an ejection fraction of 37% without regional wall motion abnormalities and demonstrated an ejection fraction of 60-65%, no cardiac vegetations, and a small pericardial effusion (Four days after the first echocardiogram). In March 2021, Ejection fraction: 60-65%, 37 % Reference range: Not provided, 49 % right ventricular ejection fraction and 53 % Left ventricular ejection fraction. In March 2021, Electrocardiogram: ST-segment elevation along with PR-segment depression in the anterior and lateral leads. finding consistent with pericarditis showing diffuse ST elevation in the lateral, anterolateral, and inferior leads. In March 2021, Hemoglobin (12.9-16.9 g/dL): 15.3 g/dL Reference range: provided. In March 2021, Lymphocyte percentage: 6 % Reference range: Not provided. In March 2021, Magnetic resonance imaging heart: showed a mild pericardial effusion, mild pericardial edema, and delayed enhancement suggestive of myopericarditis. T2 image in the four-chamber view reveals subepicardial edema in the entire lateral wall and the adjacent pericardium. Corresponding T1 phase-sensitive inversion recovery (PSIR) post-contrast image reveals subepicardial late gadolinium hyperenhancement and the adjacent pericardium. There was a circumferential pericardial effusion. Findings were compatible with acute myocarditis and pericarditis. In March 2021, Monocyte percentage: 7 % Reference range: Not provided. In March 2021, Neutrophil percentage: 70 % Reference range: Not provided. In March 2021, Platelet count (130-375 10^9/L): 100 10^9/L Reference range: provided. In March 2021, Respiratory pathogen panel: (Negative) viral respiratory pathogen panel. In March 2021, SARS-CoV-2 test: (Negative) Reference range: Not provided. In March 2021, Troponin I (0.000-0.028 ng/mL): 2.734 ng/mL elevated. In March 2021, White blood cell count (3.2-11.0 10^9/L): 7.0 10^9/L Reference range: provided. On 10-Jun-2021, Echocardiogram: A follow-up transthoracic echocardiogram on 6/10 showed a low-normal left ventricular ejection fraction of 53% and no pericardial effusion. On 10-Jun-2021, Ejection fraction: 53 % low-normal left ventricular ejection fraction. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TOXIC SHOCK SYNDROME (Toxic shock syndrome) and MYOPERICARDITIS (myopericarditis) to be related. No further causality assessments were provided for VACCINATION SITE PAIN (pain at the vaccine injection site), STAPHYLOCOCCAL SEPSIS (Staphylococcus aureus septicemia), SEPTIC SHOCK (septic shock) and CELLULITIS (forearm cellulitis/ right arm swelling consistent with cellulitis). This case referred to Case 1 from Table 1 who received Moderna COVID-19 vaccine. Concomitant medications were not reported. Five days after the second dose, patient developed myalgias and fevers up to 39.4°C. Eight days after the second dose, he presented to the ER with worsening myalgias, fevers, weakness, and difficulty walking. He had pain at the vaccine injection site. He had no sore throat, cough, shortness of breath, headaches, or diarrhea. He received ceftriaxone and azithromycin. He developed septic shock and was transferred to the Intensive Care Unit (ICU). Given the concern for toxic shock syndrome, antibiotics were changed to cefazolin and clindamycin. The day after admission, he developed severe chest pain. Colchicine was added for pericarditis. He developed worsening right arm swelling consistent with cellulitis. His reduced ejection fraction cardiomyopathy was thought to be both toxic shock syndrome and COVID-19 vaccine-related. After a 16-day hospital stay, he was discharged to complete a six-week course of intravenous cefazolin and a three-month course of colchicine for pericarditis. On 1-Jul-2021, he told his cardiologist that he had completely recovered. 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-2026-795550, US-MODERNATX, INC.-MOD-2026-795551, US-MODERNATX, INC.-MOD-2026-795557, US-MODERNATX, INC.-MOD-2026-795558, US-MODERNATX, INC.-MOD-2026-795559, US-MODERNATX, INC.-MOD-2026-795560 (E2B Linked Report).; Reporter's Comments: Causality for Staphylococcal sepsis, Septic shock, Toxic shock syndrome and Cellulitis, was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795557:Patient Case Number 9 (51-year-old male) US-MODERNATX, INC.-MOD-2026-795550:Patient Case Number 2 (22-year-old female) US-MODERNATX, INC.-MOD-2026-795558:Patient Case Number 11 (18-year-old female) US-MODERNATX, INC.-MOD-2026-795560:Patient Case Number 17 (78-year-old female) US-MODERNATX, INC.-MOD-2026-795559:Patient Case Number 16 (21-year-old female) US-MODERNATX, INC.-MOD-2026-795551:Patient Case Number 4 (21-year-old female)
Medical History/Concurrent Conditions: SARS-CoV-2 infection (Mild)
Test Date: 202103; Test Name: alanine aminotransferase (ALT); Result Unstructured Data: Test Result:75 [iU]/L;Reference range: provided; Test Date: 202103; Test Name: aspartate aminotransferase (AST); Result Unstructured Data: Test Result:67 [iU]/L;Reference range: provided; Test Date: 202103; Test Name: bands; Test Result: 17 %; Test Date: 202103; Test Name: Blood cultures; Test Result: Positive ; Test Date: 20210304; Test Name: blood pressure (BP); Result Unstructured Data: 105/71 mmHg on presentation; Test Date: 20210301; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Cel;Fevers up to 39.4 degree Celsius; Test Date: 20210304; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Cel;on presentation; Test Date: 202103; Test Name: Cardiac examination; Result Unstructured Data: revealed a loud biphasic pericardial friction rub; Test Date: 202103; Test Name: Chest radiograph; Result Unstructured Data: showed a left lower lobe infiltrate and elevation of the right hemidiaphragm; Test Date: 202103; Test Name: CT scan of the forearm; Result Unstructured Data: showed forearm swelling without an abscess. CT scan of the forearm with corresponding proximal and distal axial views demonstrating subcutaneous edema; Test Date: 202103; Test Name: creatine kinase; Result Unstructured Data: Test Result:800 [iU]/L;elevated; Test Date: 202103; Test Name: echocardiogram; Result Unstructured Data: showed an ejection fraction of 37% without regional wall motion abnormalities; Test Date: 202103; Test Name: transesophageal echocardiogram; Result Unstructured Data: demonstrated an ejection fraction of 60-65%, no cardiac vegetations, and a small pericardial effusion (Four days after the first echocardiogram); Test Date: 20210610; Test Name: transthoracic echocardiogram; Result Unstructured Data: A follow-up transthoracic echocardiogram on 6/10 showed a low-normal left ventricular ejection fraction of 53% and no pericardial effusion; Test Date: 202103; Test Name: ejection fraction; Result Unstructured Data: 60-65%; Test Date: 202103; Test Name: Ejection fraction; Test Result: 37 %; Test Date: 202103; Test Name: Ejection fraction; Test Result: 49 %; Test Date: 202103; Test Name: Left ventricular ejection fraction; Test Result: 53 %; Test Date: 20210610; Test Name: Left ventricular ejection fraction; Test Result: 53 %; Test Date: 202103; Test Name: ECG; Result Unstructured Data: ST-segment elevation along with PR-segment depression in the anterior and lateral leads. finding consistent with pericarditis showing diffuse ST elevation in the lateral, anterolateral, and inferior leads; Test Date: 202103; Test Name: hemoglobin (Hb); Result Unstructured Data: Test Result:15.3 g/dL;Reference range: provided; Test Date: 20210304; Test Name: heart rate (HR); Result Unstructured Data: Test Result:131 {beats}/min;on presentation; Test Date: 202103; Test Name: lymphocytes; Test Result: 6 %; Test Date: 202103; Test Name: Cardiac MRI; Result Unstructured Data: showed a mild pericardial effusion, mild pericardial edema, and delayed enhancement suggestive of myopericarditis. T2 image in the four-chamber view reveals subepicardial edema in the entire lateral wall and the adjacent pericardium. Corresponding T1 phase-sensitive inversion recovery (PSIR) post-contrast image reveals subepicardial late gadolinium hyperenhancement and the adjacent pericardium. There was a circumferential pericardial effusion. Findings were compatible with acute myocarditis and pericarditis; Test Date: 202103; Test Name: monocytes; Test Result: 7 %; Test Date: 202103; Test Name: neutrophils; Test Result: 70 %; Test Date: 20210304; Test Name: oxygen saturation (SpO2); Test Result: 97 %; Test Date: 20210304; Test Name: Physical examination; Result Unstructured Data: was ill-appearing and diaphoretic. He had a well-demarcated erythematous patch on the right forearm; Test Date: 202103; Test Name: platelets (PLT); Result Unstructured Data: Test Result:100 10*9/L;Reference range: provided; Test Date: 202103; Test Name: viral respiratory pathogen panel; Test Result: Negative ; Test Date: 202103; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 202103; Test Name: Troponin I; Result Unstructured Data: Test Result:2.734 ng/mL;elevated; Test Date: 202103; Test Name: WBC count; Result Unstructured Data: Test Result:7.0 10*9/L;Reference range: provided