Received May 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Demyelinating syndrome; multiple sclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of DEMYELINATION (Demyelinating syndrome) and MULTIPLE SCLEROSIS (multiple sclerosis) in a 51-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 Tobacco user. Concurrent medical conditions included Coronary artery disease. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced DEMYELINATION (Demyelinating syndrome) (seriousness criteria hospitalization and medically significant) and MULTIPLE SCLEROSIS (multiple sclerosis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 01-Mar-2021 to 06-Mar-2021 due to DEMYELINATION and MULTIPLE SCLEROSIS. At the time of the report, DEMYELINATION (Demyelinating syndrome) and MULTIPLE SCLEROSIS (multiple sclerosis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Magnetic resonance imaging head: revealed non-enhancing white matter lesions, which were subcortical, periventricular, and pericallosal in distribution (MRI of brain axial FLAIR-FS). On 01-Mar-2021, Neurological examination: was nonfocal except for mild dysarthria and a slight right facial droop. In March 2021, Anti-aquaporin-4 antibody: AQP4-IgG not detected. In March 2021, Antibody test: MOG-IgG not detected. In March 2021, C-reactive protein: 0.4 mg/dl Reference range: Not Provided. In March 2021, CSF glucose: 63 mg/dl Reference range: Not Provided. In March 2021, CSF lymphocyte count: 74 % Reference range: Not Provided. In March 2021, CSF monocyte count: 26 % Reference range: Not Provided. In March 2021, CSF protein: 45 mg/dl CSF total protein. In March 2021, CSF red blood cell count: 1 per microlitre Reference range: Not Provided. In March 2021, CSF white blood cell count: 12 per microlitre lumbar puncture. In March 2021, Computerised tomogram abdomen: showed right axillary adenopathy, corresponding to the side of the COVID-19 vaccination. In March 2021, Cytomegalovirus test: (Negative) cytomegalovirus test (CMV). In March 2021, Enterovirus test: (Negative) Reference range: Not Provided. In March 2021, Flow cytometry: Flow cytometry of blood and CSF revealed no evidence of lymphoma. In March 2021, HIV test: (Negative) HIV screen. In March 2021, Herpes simplex test: (Negative) HSV. In March 2021, JC polyomavirus test: (Negative) Molecular tests for JC polyomavirus. In March 2021, Oligoclonal band assay (Unknown-2): Four oligoclonal bands were found in the CSF. In March 2021, Red blood cell sedimentation rate: 16 mm/hr Reference range: Not Provided. In March 2021, SARS-CoV-2 test: (Negative) Reference range: Not Provided. In March 2021, Syphilis test: (Negative) syphilis serology. In March 2021, Varicella virus test: (Negative) VZV test. In March 2021, White blood cell count: 13.5 10^9/L Reference range: Not Provided. On 23-Mar-2021, Magnetic resonance imaging head: some improvement in the white matter lesions. On 07-Jul-2021, Magnetic resonance imaging head: showed progression with multiple areas of T2 signal hyperintensity noted in the subcortical and periventricular white matter, with several new areas of involvement, while a few areas had decreased in size, all without associated enhancement (MRI of brain axial FLAIR-FS). On 30-Dec-2021, Neurological examination: he was noted to be off balance with a tandem gait and had a bilateral upper extremity intention tremor. No fasciculations in the forearms or thighs were noted. On 11-May-2022, Neurological examination: Tandem gait was normal, but right arm dysmetria persisted. In November 2022, Neurological examination: condition was considered stable. In January 2023, Magnetic resonance imaging head: last MRI of the brain showed no change in the demyelination pattern compared with imaging from 14 months prior. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case referred to Case 9 from Table 1 who received Moderna COVID-19 vaccine. Concomitant medications were not reported. Patient had no history of COVID-19. On 1-Mar-21, patient was admitted to the hospital for a two-day history of slurred speech. He denied headaches, fevers, dysphagia, or other sensory or motor deficits. Antibodies for CNS demyelinating disease, AQP4-IgG and MOG-IgG, were not detected. He still had mild dysarthria and subtle facial droop when discharged on 6-Mar-2021. No steroids were administered during hospitalization. The dysarthria and facial droop had resolved on follow-up on 6-Apr-2021. He was prescribed 1250 mg prednisone orally once daily for three days. At a follow-up visit on 30-Dec-2021, he reported leg weakness with stumbling and falls, fatigue, daily headaches, and jitteriness. He constantly heard "white noise." The neurologist prescribed interferon beta-1a. He continued to complain of fatigue, right arm dexterity issues, dizziness, and feeling off balance. At a neurology visit on 11-May-2022, tandem gait was normal, but right arm dysmetria persisted. He developed symptoms consistent with neurogenic bladder. Oxybutynin helped with the bladder symptoms. At a November 2021, neurology visit, his condition was considered stable. He continues with interferon therapy. 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)
Coronary artery disease
Medical History/Concurrent Conditions: Tobacco user
Test Date: 202103; Test Name: AQP4-IgG; Result Unstructured Data: AQP4-IgG not detected; Test Date: 202103; Test Name: MOG-IgG; Result Unstructured Data: MOG-IgG not detected; Test Date: 202103; Test Name: CT scan of the chest, abdomen, and pelvis; Result Unstructured Data: showed right axillary adenopathy, corresponding to the side of the COVID-19 vaccination; Test Date: 202103; Test Name: CRP; Test Result: 0.4 mg/dL; Test Date: 202103; Test Name: CSF glucose; Test Result: 63 mg/dL; Test Date: 202103; Test Name: Lymphocytes; Test Result: 74 %; Test Date: 202103; Test Name: monocytes; Test Result: 26 %; Test Date: 202103; Test Name: CSF total protein; Test Result: 45 mg/dL; Test Date: 202103; Test Name: CSF RBC; Result Unstructured Data: Test Result:1 /uL;Reference range: Not Provided; Test Date: 202103; Test Name: CSF WBC; Result Unstructured Data: Test Result:12 /uL;lumbar puncture; Test Date: 202103; Test Name: cytomegalovirus test (CMV); Test Result: Negative ; Test Date: 202103; Test Name: enterovirus test; Test Result: Negative ; Test Date: 202103; Test Name: Flow cytometry; Result Unstructured Data: Flow cytometry of blood and CSF revealed no evidence of lymphoma; Test Date: 202103; Test Name: HSV; Test Result: Negative ; Test Date: 202103; Test Name: HIV screen; Test Result: Negative ; Test Date: 202103; Test Name: Molecular tests for JC polyomavirus; Test Result: Negative ; Test Date: 20210301; Test Name: MRI of the brain; Result Unstructured Data: revealed non-enhancing white matter lesions, which were subcortical, periventricular, and pericallosal in distribution (MRI of brain axial FLAIR-FS); Test Date: 20210323; Test Name: MRI of the brain; Result Unstructured Data: some improvement in the white matter lesions; Test Date: 20210707; Test Name: MRI of the brain; Result Unstructured Data: showed progression with multiple areas of T2 signal hyperintensity noted in the subcortical and periventricular white matter, with several new areas of involvement, while a few areas had decreased in size, all without associated enhancement (MRI of brain axial FLAIR-FS); Test Date: 202301; Test Name: MRI of the brain; Result Unstructured Data: last MRI of the brain showed no change in the demyelination pattern compared with imaging from 14 months prior; Test Date: 20210301; Test Name: Neurologic examination; Result Unstructured Data: was nonfocal except for mild dysarthria and a slight right facial droop; Test Date: 20211230; Test Name: Neurologic examination; Result Unstructured Data: he was noted to be off balance with a tandem gait and had a bilateral upper extremity intention tremor. No fasciculations in the forearms or thighs were noted; Test Date: 20220511; Test Name: Neurologic examination; Result Unstructured Data: Tandem gait was normal, but right arm dysmetria persisted; Test Date: 202211; Test Name: Neurologic examination; Result Unstructured Data: condition was considered stable; Test Date: 202103; Test Name: CSF oligoclonal bands; Result Unstructured Data: Four oligoclonal bands were found in the CSF; Test Date: 202103; Test Name: ESR; Result Unstructured Data: Test Result:16 mm/h;Reference range: Not Provided; Test Date: 202103; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Test Date: 202103; Test Name: syphilis serology; Test Result: Negative ; Test Date: 202103; Test Name: VZV test; Test Result: Negative ; Test Date: 202103; Test Name: WBC; Result Unstructured Data: Test Result:13.5 10*9/L;Reference range: Not Provided