Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
fatal diagnosis of sporadic Creutzfeldt-Jakob disease; This is a literature report from License Party for the following literature source(s). Other Case identifier(s): AE-021754 (BioNTech SE). Abstract: Human prion disease is a rare, highly progressive neurodegenerative disease that is ultimately fatal. The majority of cases occur sporadically, although some may be genetic or acquired. Here, the authors highlight a case of a 64-year-old woman who presents with rapidly declining memory loss, behavior changes, headaches, and gait disturbance approximately one week following administration of the second dose of the novel Pfizer-BioNTech messenger ribonucleic acid (mRNA) COVID-19 vaccine. After extensive investigation, conclusive evidence identified the fatal diagnosis of sporadic Creutzfeldt-Jakob disease. Introduction: Human prion diseases were first described in the early 1920s and are delineated into three categories: sporadic, inherited, or acquired by way of infection. Of the sporadic type, there are Creutzfeldt-Jakob disease (CJD), fatal insomnia, and variably protease-sensitive prionopathy. Approximately 90% of cases of prion disease are sporadic CJD, which can be further divided into five subtypes based on clinical features, histological findings on autopsy, and molecular structure of the abnormal protein. The incidence of sCJD is very rare, approximately 1-2 cases per one million per population. In the case presented herein, the plausibility of the Pfizer-BioNTech COVID-19 vaccine triggering sCJD is explored. Case: A 64-year-old woman with a past medical history of bipolar depression and anxiety presents with rapidly progressive dementia, behavioral changes, headaches, and gait disturbance approximately one week after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine. Physical exam was essentially unremarkable except for confusion and significant distress regarding her condition. Initial labs, toxicology screening, and imaging were unremarkable except for a mildly increased white blood cell count. Psychiatry and neurology were consulted. Magnetic resonance (MR) imaging of the brain showed cortical diffusion restriction involving the bilateral frontal lobes, bilateral parietal lobes, and paramedian bilateral occipital lobes. Lumbar puncture: positive via the newest, highly sensitive real-time quaking-induced conversion (RT-QuIC) testing. T-tau protein measured at 38,979 (reference < 0-1,149). 14-3-3 protein was positive, neuron-specific enolase resulted at 16.3 (reference < 8.9). Exhibiting progressively worsening pyramidal and extrapyramidal symptoms, as well as akinetic mutism. Based on the Center for Disease Control and Prevention's diagnostic criteria, the findings place her case as probable sporadic CJD with a definitive diagnosis to be made by a proper autopsy with neuropathological studies.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Creutzfeldt-Jakob disease and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.; Reported Cause(s) of Death: fatal diagnosis of sporadic Creutzfeldt-Jakob disease
Akinetic mutism; Anxiety; Bipolar depression; Extrapyramidal symptoms (Exhibiting progressively worsening pyramidal and extrapyramidal symptoms)
Test Name: imaging; Result Unstructured Data: Test Result:Unremarkable; Test Name: 14-3-3 protein; Test Result: Positive ; Test Name: toxicology screening; Result Unstructured Data: Test Result:Unremarkable; Test Name: T-tau protein; Result Unstructured Data: Test Result:38,979; Test Name: Laboratory test; Result Unstructured Data: Test Result:Unremarkable; Test Name: Lumbar puncture; Test Result: Positive ; Test Name: Magnetic resonance (MR) imaging; Result Unstructured Data: Test Result:cortical diffusion restriction; Comments: cortical diffusion restriction involving the bilateral frontal lobes, bilateral parietal lobes, and paramedian bilateral occipital lobes; Test Name: neuron-specific enolase; Result Unstructured Data: Test Result:16.3; Test Name: Physical exam; Result Unstructured Data: Test Result:essentially unremarkable except for confusion; Comments: essentially unremarkable except for confusion and significant distress; Test Name: white blood cell count; Result Unstructured Data: Test Result:mildly increased