Received May 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
S. aureus left shoulder septic arthritis; S. aureus Osteomyelitis; This literature-non-study case was reported in a literature article and describes the occurrence of SEPTIC ARTHRITIS STAPHYLOCOCCAL (S. aureus left shoulder septic arthritis) and STAPHYLOCOCCAL OSTEOMYELITIS (S. aureus Osteomyelitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced SEPTIC ARTHRITIS STAPHYLOCOCCAL (S. aureus left shoulder septic arthritis) (seriousness criteria hospitalization and medically significant) and STAPHYLOCOCCAL OSTEOMYELITIS (S. aureus Osteomyelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Feb-2022 to 25-Feb-2022 due to SEPTIC ARTHRITIS STAPHYLOCOCCAL and STAPHYLOCOCCAL OSTEOMYELITIS. The patient was treated with Surgery (humeral head resection and antibiotic spacer placement) for Septic arthritis staphylococcal and Surgery (humeral head resection and antibiotic spacer placement) for Staphylococcal osteomyelitis. At the time of the report, SEPTIC ARTHRITIS STAPHYLOCOCCAL (S. aureus left shoulder septic arthritis) and STAPHYLOCOCCAL OSTEOMYELITIS (S. aureus Osteomyelitis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Body temperature: 38.3 degree Celsius Fevers upto 38.3 degree Celsius. On 20-Dec-2021, Influenza virus test: (Negative) Influenza test. On 20-Dec-2021, Physical examination: left shoulder had reduced range of motion and was tender to palpation. On 20-Dec-2021, Respiratory syncytial virus test: (Negative) Respiratory syncytial virus test. On 20-Dec-2021, SARS-CoV-2 test: (Negative) SARS-CoV-2 test. On 20-Dec-2021, X-ray limb: showed advanced degenerative changes. On 07-Jan-2022, Magnetic resonance imaging: MRI of left shoulder (sagittal T2 fat saturation (FS), subacromial-subdeltoid bursitis, sagittal T1, coronal proton density (PD) FS, and axial PD FS) showed findings consistent with septic arthritis and osteomyelitis, a large joint effusion, heterogeneous appearance of the proximal humerus, subacromial and subdeltoid bursitis, and severe glenohumeral arthritis. On 10-Feb-2022, Antimicrobial susceptibility test: Operative cultures, including those from the shoulder joint, grew methicillin-susceptible S. aureus. On 10-Feb-2022, Biopsy bone: open biopsy of the humerus showed acute and chronic inflammation consistent with osteomyelitis. In February 2022, C-reactive protein: 10.2 milligram per decilitre Reference range not provided. In February 2022, Haemoglobin: 13.8 g/dL Reference range not provided. In February 2022, Platelet count: 204 10^9/L Reference range not provided. In February 2022, White blood cell count: 7.2 10^9/L Reference range not provided. In 2022, C-reactive protein: Normalized (<0.2 mg/dL). On 12-Jul-2022, Antimicrobial susceptibility test: Operative cultures yielded S. aureus.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case refers to Patient 17 from Table 1 who received Moderna COVID-19 vaccine. Concomitant medications were not reported. Patient had no history of COVID-19. One week after the last administered dose, the patient started to develop fevers and left shoulder pain that limited movement. At an urgent care visit on 20-Dec-2021, the left shoulder had reduced range of motion and was tender to palpation. Lab tests were done and was sent home. On 04-Jan-2022, patient received a steroid injection for presumed osteoarthritis of the glenohumeral joint and rotator cuff tear. On 17-Feb-2022, she was hospitalized to start intravenous antibiotic therapy. The patient chose intravenous antibiotic therapy alone instead of including humeral head resection with antibiotic spacer placement after shared decision-making with orthopedic surgery. The patient received intravenous cefazolin for seven weeks. CRP normalized though shoulder pain persisted. The patient eventually had a humeral head resection and antibiotic spacer placement on 12-Jul-2022. Operative cultures yielded S. aureus (Staphylococcus aureus). The patient was retreated with six weeks of intravenous ceftriaxone. The patient was doing well as on the last visit with orthopedics on 27-Feb-2023. There were no plans for further surgery. This is 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 are 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: Septic arthritis and osteomyelitis are confounded by a subsequent intra-articular corticosteroid injection and radiographic findings suggestive of a pre-existing degenerative shoulder lesion, which may predispose to joint infection. 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)
Test Date: 20220210; Test Name: Operative cultures test; Result Unstructured Data: Operative cultures, including those from the shoulder joint, grew methicillin-susceptible S. aureus; Test Date: 20220712; Test Name: Operative cultures test; Result Unstructured Data: Operative cultures yielded S. aureus.; Test Date: 20220210; Test Name: open biopsy of the humerus; Result Unstructured Data: open biopsy of the humerus showed acute and chronic inflammation consistent with osteomyelitis; Test Date: 20211217; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Cel;Fevers upto 38.3 degree Celsius; Test Date: 2022; Test Name: CRP; Result Unstructured Data: Normalized (<0.2 mg/dL); Test Date: 202202; Test Name: CRP; Test Result: 10.2 mg/dL; Test Date: 202202; Test Name: Hb; Result Unstructured Data: Test Result:13.8 g/dL;Reference range not provided; Test Date: 20211220; Test Name: Influenza test; Test Result: Negative ; Test Date: 20220107; Test Name: MRI of the shoulder; Result Unstructured Data: MRI of left shoulder (sagittal T2 fat saturation (FS), subacromial-subdeltoid bursitis, sagittal T1, coronal proton density (PD) FS, and axial PD FS) showed findings consistent with septic arthritis and osteomyelitis, a large joint effusion, heterogeneous appearance of the proximal humerus, subacromial and subdeltoid bursitis, and severe glenohumeral arthritis; Test Date: 20211220; Test Name: Physical examination; Result Unstructured Data: left shoulder had reduced range of motion and was tender to palpation; Test Date: 202202; Test Name: PLT; Result Unstructured Data: Test Result:204 10*9/L;Reference range not provided; Test Date: 20211220; Test Name: Respiratory syncytial virus test; Test Result: Negative ; Test Date: 20211220; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 202202; Test Name: WBC; Result Unstructured Data: Test Result:7.2 10*9/L;Reference range not provided; Test Date: 20211220; Test Name: Shoulder radiograph; Result Unstructured Data: showed advanced degenerative changes