Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD); positive SARS-CoV-2 antigen test/ COVID-19 illness; This literature-non-study case was reported in a literature article and describes the occurrence of CREUTZFELDT-JAKOB DISEASE (Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD)) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (positive SARS-CoV-2 antigen test/ COVID-19 illness). In September 2022, the patient experienced CREUTZFELDT-JAKOB DISEASE (Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD)) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on sometime in September 2022 due to CREUTZFELDT-JAKOB DISEASE. The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) in 2022 at an unspecified dose and frequency; Methylprednisolone (intravenous use) in 2022 at an unspecified dose and frequency and Levetiracetam in 2022 at an unspecified dose and frequency. The patient died in 2023. The reported cause of death was post-covid neurodegeneration/ sporadic creutzfeldt-jakob disease (scjd). It is unknown if an autopsy was performed. At the time of death, COVID-19 (positive SARS-CoV-2 antigen test/ COVID-19 illness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, CSF test: Initial cerebrospinal fluid (CSF) analysis was normal. In 2022, Electroencephalogram: initial EEG revealed diffuse intermixed theta and delta activity throughout the trace with diffuse slowing, suggestive of severe encephalopathy likely due to an infectious, post-ictal, vascular, or metabolic etiology and A repeat EEG demonstrated diffuse slowing with intermixed periodic lateralized epileptiform discharges (PLEDs), which are nonspecific and not considered characteristic of CJD. In 2022, Viral test: (Negative) negative results for many possible viral encephalitis etiologies. In August 2022, SARS-CoV-2 test: (Positive) SARS-Cov-2 antigen test. In September 2022, Magnetic resonance imaging head: More extensive cortical-based abnormalities involving the bilateral frontal, parietal, and posterior temporal lobes which was done 7 days after initial MRI Scan. In September 2022, Physical examination: gait abnormalities and abnormal finger to nose testing bilaterally. In September 2022, Venogram: a magnetic resonance venography (MRV) scan showed normal patent dural venous vessels. On 22-Sep-2022, Magnetic resonance imaging head: subtle abnormal signal intensity throughout most of the parietal cortex bilaterally with nonspecific periventricular white matter T2 hyperintensities that favored sequelae of chronic small vessel disease but no masses, hemorrhage, or acute/subacute ischemia (first visit). On 11-Oct-2022, Magnetic resonance imaging head: A third brain MRI scan showed cortical-based high/intermediate T2/fluid attenuated inversion recovery (FLAIR) signal intensity with restricted diffusion involving the bilateral frontal, parietal, and temporal lobes, as well as the insula. Additionally, intermediate T2/FLAIR signal intensity involving both amygdalae and hippocampi and high T2/FLAIR bilateral hyperintensity involving lentiform nuclei, caudate nuclei, and thalami were noted. The entire cortex of both cerebral hemispheres showed intermediate to high T2/FLAIR signal intensity in the frontal, parietal, and temporal lobes, with similar changes now evident in the caudate, putamina, and thalami as noted on the axial FLAIR. Signal hyperintensity of the cortical gyri (cortical ribbon sign), typical of Creutzfeldt-Jakob disease, is now more evident on DWI. In October 2022, CSF test: CSF biomarker analysis obtained from the Pathology Surveillance Center in late Oct-2022 for prion disease, obtained from the Pathology Surveillance Center in late October, indicated that the patient had a > 98% likelihood of prion disease based on a positive real-time quaking-induced conversion (RT-QuIC), along with elevated T-tau protein (result valule-17293 pg/mL, Normal range- 0- 1149 pg/mL) and 14-3-3 gamma protein concentrations (60801 AU/mL, Normal range-<30 1,999 AU/mL). For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. A previously healthy patient had a positive SARS-CoV-2 antigen test in Aug-2022 after experiencing moderate flu-like symptoms, including chest tightness, dry cough, fever, malaise, and generalized weakness. Two weeks afterwards, he began to experience difficulty completing basic tasks, suffering from brain fog in addition to fatigue, frequent nightmares, and episodes of vertigo. Over the next 2 weeks, his symptoms worsened, resulting in recurrent episodes of vertigo, visual disturbances, tremors, cerebellar ataxia, and difficulty concentrating. Consequently, he presented to the emergency room (ER) in Sep-2022. Initial evaluation in the ER revealed an alert, oriented, and communicative with a chief complaint of worsening neuropsychiatric symptoms. Past medical history was unremarkable, besides a recent COVID-19 illness 4 weeks prior. He had previously received two doses of the Moderna COVID-19 vaccine without complications. The wife, who accompanied the patient, also claimed to notice some mood and behavior alterations over the past few weeks. It was determined to hospitalized patient to perform additional diagnostic evaluations. Lumbar puncture was performed to rule out infectious etiologies. Initial cerebrospinal fluid (CSF) analysis was normal, and while waiting for additional CSF results, empiric therapy for infectious and/or autoimmune encephalitis with intravenous immunoglobulin and IV methylprednisolone was started. A sample of his CSF was sent to the (withheld) Pathology Surveillance Center for the possibility of CJD. Over the subsequent weeks, the patient deteriorated rapidly, developing occasional episodes of myoclonic jerks, seizures, weakness, speech apraxia, and dysarthria. A repeat brain MRI several days after admission. In response to the onset of seizures, an electroencephalography (EEG) was conducted. By mid-to-late October, he was suffering from severe confusion and disorientation, generalized myoclonus, akinetic mutism, and global neurocognitive decline. The prior MRI, however, demonstrated cortical ribboning, a finding more typical of CJD. Given the patient's clinical and laboratory findings, the patient met all of the required criteria for a probable diagnosis of sporadic CJD (sCJD) according to the Centers for Disease Control and Prevention's (CDC) diagnostic guidelines. He was ultimately transferred to hospice and died in early 2023, approximately 5 months after symptom onset. Author concluded that this case highlights the unusually rapid progression of CJD symptoms following COVID-19 infection. While the link between SARS-CoV-2 and CJD remains unclear, clinicians should remain vigilant. New or rapidly worsening cognitive decline after COVID-19 may signal the onset of a rapidly progressive neurodegenerative disorder like CJD, warranting prompt evaluation and monitoring. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2025: Live follow-up received with FTA contains significant information: Reporter information, literature citation, patient details, laboratory test, suspect product information, treatment medications, events added, cause of death and narrative updated. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2025: Live follow-up received with FTA contains significant information: Reporter information, literature citation, patient details, laboratory test, suspect product information, treatment medications, events added, cause of death and narrative updated.; Reporter's Comments: Company comment: Concurrent COVID 19 infection is a confounder. It is possible that virus induced immune dysregulation have accelerated underlying neurodegenerative process, which manifested following vaccination and COVID 19 infection. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD)
Test Date: 2022; Test Name: cerebrospinal fluid (CSF) analysis; Result Unstructured Data: Initial cerebrospinal fluid (CSF) analysis was normal; Test Date: 202210; Test Name: CSF biomarker analysis for prion disease; Result Unstructured Data: CSF biomarker analysis obtained from the Pathology Surveillance Center in late Oct-2022 for prion disease, obtained from the Pathology Surveillance Center in late October, indicated that the patient had a > 98% likelihood of prion disease based on a positive real-time quaking-induced conversion (RT-QuIC), along with elevated T-tau protein (result valule-17293 pg/mL, Normal range- 0- 1149 pg/mL) and 14-3-3 gamma protein concentrations (60801 AU/mL, Normal range-<30 1,999 AU/mL); Test Date: 2022; Test Name: Electroencephalography; Result Unstructured Data: initial EEG revealed diffuse intermixed theta and delta activity throughout the trace with diffuse slowing, suggestive of severe encephalopathy likely due to an infectious, post-ictal, vascular, or metabolic etiology; Test Date: 2022; Test Name: Electroencephalography; Result Unstructured Data: A repeat EEG demonstrated diffuse slowing with intermixed periodic lateralized epileptiform discharges (PLEDs), which are nonspecific and not considered characteristic of CJD; Test Date: 202209; Test Name: MRI of brain; Result Unstructured Data: More extensive cortical-based abnormalities involving the bilateral frontal, parietal, and posterior temporal lobes which was done 7 days after initial MRI Scan; Test Date: 20220922; Test Name: MRI of brain; Result Unstructured Data: subtle abnormal signal intensity throughout most of the parietal cortex bilaterally with nonspecific periventricular white matter T2 hyperintensities that favored sequelae of chronic small vessel disease but no masses, hemorrhage, or acute/subacute ischemia (first visit); Test Date: 20221011; Test Name: MRI of brain; Result Unstructured Data: A third brain MRI scan showed cortical-based high/intermediate T2/fluid attenuated inversion recovery (FLAIR) signal intensity with restricted diffusion involving the bilateral frontal, parietal, and temporal lobes, as well as the insula. Additionally, intermediate T2/FLAIR signal intensity involving both amygdalae and hippocampi and high T2/FLAIR bilateral hyperintensity involving lentiform nuclei, caudate nuclei, and thalami were noted. The entire cortex of both cerebral hemispheres showed intermediate to high T2/FLAIR signal intensity in the frontal, parietal, and temporal lobes, with similar changes now evident in the caudate, putamina, and thalami as noted on the axial FLAIR. Signal hyperintensity of the cortical gyri (cortical ribbon sign), typical of Creutzfeldt-Jakob disease, is now more evident on DWI; Test Date: 202209; Test Name: Physical examination; Result Unstructured Data: gait abnormalities and abnormal finger to nose testing bilaterally; Test Date: 202208; Test Name: SARS-Cov-2 antigen test; Test Result: Positive ; Test Date: 202209; Test Name: magnetic resonance venography (MRV); Result Unstructured Data: a magnetic resonance venography (MRV) scan showed normal patent dural venous vessels; Test Date: 2022; Test Name: viral encephalitis test; Test Result: Negative