Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | 046B21A | — |
The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed; Vertebrobasilar insufficiency; multilevel cervical spondylosis; bilateral foraminal narrowing C5/C6; right hand sometime shaking; frontal lobe atrophy; Corticobasal degeneration/dementia; disturbances of walking abilities; cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline; The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses; This spontaneous case was reported by an other health care professional and describes the occurrence of CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia) and CEREBRAL ATROPHY (frontal lobe atrophy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A, 014C21A and 60H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Donepezil hydrochloride (Donepezil) for Alzheimer's disease. The patient's past medical history included Numbness of head (head skin numbness) in 2019. Family history included Dementia (The patient's grandmother and great-grandmother on mother side both had dementia in their 75-80, which unfortunately made less critical to this diagnosis of Alzheimer's, which eventually turned out to be wrong) since an unknown date. Concurrent medical conditions included Sleep disorder NOS and Memory impairment (Some deterioration in patient's memory and mild impairment) since 2019. Concomitant products included Valeriana officinalis root (Valerian root) for Sleep disorder NOS, Melatonin for an unknown indication. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient started Donepezil hydrochloride (Donepezil) (unknown route) 5 milligram once a day. In September 2022, Donepezil hydrochloride (Donepezil) (unknown route) dosage was changed to 10 milligram once a day. In July 2021, the patient experienced AMNESIA (The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses). In May 2022, the patient experienced CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia) (seriousness criterion medically significant). In 2022, the patient experienced COGNITIVE DISORDER (cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline) and GAIT DISTURBANCE (disturbances of walking abilities). In 2023, the patient experienced CEREBRAL ATROPHY (frontal lobe atrophy) (seriousness criterion medically significant). In July 2023, the patient experienced TREMOR (right hand sometime shaking). On an unknown date, the patient experienced BEHAVIOUR DISORDER (The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed), VERTEBROBASILAR INSUFFICIENCY (Vertebrobasilar insufficiency), SPINAL OSTEOARTHRITIS (multilevel cervical spondylosis) and VERTEBRAL FORAMINAL STENOSIS (bilateral foraminal narrowing C5/C6). The patient was treated with Rehabilitation therapy (rehabilitation) for Cognitive disorder. In September 2023, BEHAVIOUR DISORDER (The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed) had resolved. At the time of the report, CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia), CEREBRAL ATROPHY (frontal lobe atrophy), AMNESIA (The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses), VERTEBROBASILAR INSUFFICIENCY (Vertebrobasilar insufficiency), SPINAL OSTEOARTHRITIS (multilevel cervical spondylosis) and VERTEBRAL FORAMINAL STENOSIS (bilateral foraminal narrowing C5/C6) outcome was unknown and COGNITIVE DISORDER (cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline), GAIT DISTURBANCE (disturbances of walking abilities) and TREMOR (right hand sometime shaking) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2020, Magnetic resonance imaging head: unremarkable, no brain issues were found. On 24-Feb-2020, Magnetic resonance imaging neck: MRI was performed for the neck area, which did not reveal any issues. On 11-Oct-2020, Magnetic resonance imaging neck: Unremarkable except for multilevel cervical spondylosis. There was mild resultant bilateral foraminal narrowing at C5/C6.. On 10-Nov-2020, Magnetic resonance imaging neck: Unremarkable, no issue was revealed. On 11-Jan-2022, Laboratory test: Short memory measurements based on sequence of pictures of animals. First try: 56% and 1245ms, second try: 48% and 1373ms. On 02-Feb-2022, Magnetic resonance imaging head: Unremarkable, no issues revealed. In February 2022, Magnetic resonance imaging head: Showed minimal white matter changes, related to age. In May 2022, Magnetic resonance imaging neck: MRI images unremarkable. In 2023, Lumbar puncture: Tests performed in [withheld], excluded Alzheimer's, because lumbar puncture had shown normal levels of proteins in patient's spinal fluid. In 2023, Positron emission tomogram: Further study, using PET scan, resulted in a diagnosis of Corticobasal degeneration. In September 2023, Magnetic resonance imaging: The 3 Tesla MRI scan (augmented by NeuroQuant analysis) also showed very noticeable atrophy of the frontal brain areas. Significant deterioration and atrophy.. In September 2024, Magnetic resonance imaging: A new 3Tesla MRI was arranged, and it was performed in Sep-2024, at the same location where the Sep 2023 3Tesla MRI was done. They were remarkably similar; those images did not show any significant change between Sep 2023 and Sep 2024. Moreover, the 3T MRI reports gave NeuroQuant7 determined numerical values related to brain degradation, such as, for instance, the volume of gray matter: MRI 3 Tesla, Sep 2023, gray matter: 401 cm^3; MRI 3 Tesla, Sep 2024, gray matter: 393 cm^3. These numbers were determined by NeuroQuant software version 4.1.1 for both 2023 and 2024 data. The Sep-2023 scan was analyzed by NeuroQuant version 3.1.1, giving 387 cm^3. The same as Sep-2023 MRI data, analyzed by NeuroQuant version 4.1.1, gave 401 cm^3. This difference (14 cm^3, or 3.5%) was assumed as an estimation for the error bars for all data points.. In November 2024, Whole-genome sequencing: The NIH genome results also came with a conclusion negative NIAID research whole genome sequencing result. Specifically, both 23andme and NIH genetics results showed that patient's APOE genotype (T/T for rs429358 and C/T for rs7412) corresponds to "lower risk" of Alzheimer's. Both genetics results also showed that patient did not have mutations in BChE gene. The BChE-K version (rs1803274) was explicitly linked to faster cognitive decline on Donepezil (5,6). The atypical BChE variant (rs1799807 AA), may also indicate reduced BChE ability to break down acetylcholine-like compounds, potentially amplifying Donepezil's effects. For both of these genes patient's alleles were wild-type, i.e. do not show mutations that would explain adverse reaction do Donepezil. This finding did not support our earlier hypothesis that Donepezil may explain patient's fast decline in 2022-2023. On an unknown date, Arteriogram carotid: MRA showed no blockage but revealed Vertebral basilar system was diminutive in size. The patient may had inherited Vertebral basilar system of diminutive size from grandmother. On an unknown date, Blood pressure measurement: Typical blood pressure was always low, around 110/70. On an unknown date, CSF culture: no amyloid plaques observed.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia), CEREBRAL ATROPHY (frontal lobe atrophy), COGNITIVE DISORDER (cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline), AMNESIA (The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses), GAIT DISTURBANCE (disturbances of walking abilities), TREMOR (right hand sometime shaking), BEHAVIOUR DISORDER (The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed) and VERTEBROBASILAR INSUFFICIENCY (Vertebrobasilar insufficiency) to be related. No further causality assessments were provided for SPINAL OSTEOARTHRITIS (multilevel cervical spondylosis) and VERTEBRAL FORAMINAL STENOSIS (bilateral foraminal narrowing C5/C6). The patient had experienced a rare and profound neurological condition following mRNA COVID-19 vaccination. Within weeks of receiving two vaccine doses, she developed an inability to form new long-term memories, while her existing memories remained intact. The sudden onset, in the absence of structural brain damage on initial imaging, closely paralleled the clinical profile of patient [withheld], albeit with a non-surgical etiology. In 2022, the patient was misdiagnosed with Alzheimer's disease and treated Donepezil for over a year, during which she exhibited accelerated cognitive and physical decline, as well as frontal lobe atrophy confirmed by 3T MRI in 2023. Treatment was discontinued that year, and by 2024, partial cognitive recovery and stabilization in gray matter volume were documented. The initial hypotheses were that the patient was homozygous TT at rs1799807 in the BCHE gene-a rare variant associated with reduced butyrylcholinesterase activity and possible Donepezil toxicity. However, full genome analysis did not confirm this. BCHE genotypes, especially for patients with atypical clinical response, prompt the need of further studies toward genetical pharmacogenetic screening practices in dementia therapy. The patient had two neurological injuries, and the patient sustained arose from distinct mechanisms, the first, a functional shutdown of memory encoding potentially triggered by vaccine-induced immune or molecular mechanism interference: the second, a pharmacogenetic injury likely caused by a neuroimmune reaction. Using a coincidence-based statistical framework, the likelihood that the initial memory shutdown was caused by the vaccine was estimated at over 99.998%. The patient's condition reflected a selective disruption of memory encoding processes, involving pathways such as PKM-KIBRA signaling, CREB-mediated transcription, and dendritic translation. Around 2019, when a patient was 55 years old, she started to complain about head skin numbness. Some deterioration in patient's memory was observed in 2019 and 2020, but it was very mild impairment. For example, she would forget some names, which would be typical of any normal person. The main reason to see the doctors in [withheld name] Multispecialty Group in 2019 was the numbness of her scalp 5, which patient had complained about. In 2019 and 2020, she did a lot of reading and driving (including to physical therapy and acupuncture appointments, which tried to help with the numbness). The patient had not been sick with Covid all that time. At the end of 2020, she was almost in completely perfect shape. In October 2020, she went horseback riding. The patient did horse riding as a child. Another example was in December 2020, the patient took photos and videos on her phone without any problems. But in the summer of 2021, memory loss accelerated greatly and even began to become dangerous. In 26-Jun-2021, she was unable to turn on TV programs (social media alike) on a computer. In October to December 2021, memory problems grew like a snowball. On 11-Oct-2021, she forgot that she had already received the parcel and was still waiting for it. From July to September 2021, the patient had some memory lapses. On 07-Oct-2021, the patient lost her tights in the morning, and was looking for them on the second floor, while they were in the drawer downstairs. In the evening the patient took out baked fish but forgot to turn off the oven. On 29-Oct-2021, the patient was forgetting and waiting for who had already come home. On 18-Nov-2021, the patient in the middle of the night saw that the branches were swaying and covering the streetlamp. At this moment, the patient recalled that the electrician had come yesterday and changed the electric meter, and the patient had not even remembered about it the evening before. On 21-Nov-2021, the patient was going to [withheld state] to see friends, since the friends had a newborn son. On 29-Dec-2021, the patient forgot that they all had come together. On 02-Jan-2022, the patient lost on the airport. From January to February 2022, the patient went to a neurologist to study her conditions. On 03-May-2022, the patient [withheld name] neurology doctor gave an assessment of Alzheimer's disease, unspecified and prescribed Donepezil 5mg/day based on cognitive evaluation. From these observations, it appeared possible that the patient's memory mechanism damage might be caused by or memory mechanism was switched off by mRNA vaccination in April and May of 2021. But it also could have been a coincidence. Come up with a more definite conclusion about mRNA as the cause only in late 2023, after the initial wrong diagnosis of Alzheimer's was excluded, and after coincidence analysis with health impacts of another person was performed. In early 2022, the patient went to see [withheld name] neurologists and after another MRI scan (which again was unremarkable), the patient was diagnosed with Alzheimer's disease, unspecified. The patient was diagnosed with Alzheimer's Disease in May-2022 based on cognitive evaluations, while MRI images were unremarkable, and treatment with Donepezil started (5mg/day since May-2022, doubled to 10mg/day from Sep-2022). The patient's condition was deteriorating very fast in the second half of 2022, impacting cognitive abilities. Moreover, disturbances of walking abilities started to appear, which were now very severe. It was decided to stop Donepezil treatment in Sep 2023, based on vascular insufficiency hypothesis. It was reported that the patient's brain atrophy may have been caused by Donepezil, and not by natural progression of her disease. The doctors typically believed that Donepezil cannot cause long-term brain degradation. The MRI was used to measurements to determine if Donepezil was an issue. The standard MRI performed in February 2022 was unremarkable, no brain issues were found. From May-2022 till Sep-2023 the patient was taking Donepezil. For MRI-based measurements of gray matter volume also showed, as a shaded area, the time when patient was treated by Donepezil (5mg/day between May-2022 and Sep-2022, and 10mg/day between after Sep-2022 and Sep-2023). One can see that significant degradation coincided with the application of Donepezil. Moreover, after Donepezil treatment stopped, the degradation of gray matter volume stopped as well, and stabilization was observed. This, and especially stabilization, supported the hypothesis that patient's fast brain degeneration between May-2022 and Sep-2023 was caused by Donepezil itself, however this may also be a coincidence, due to progression of neuroinflammation response. She was a very active buyer, but starting in Summer 2022 reduced to a third of normal, and by Dec-2022 the activity was stopped completely, the patient had lost computer abilities. Starting around January to February 2023, the patient was not reading any more. In late 2022, early 2023, the patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed, so that every evening became a nightmare. Starting from around Apr-2023, when the patient stand up and started to walk, the first several steps were very small, about 5cm in length. Gait significantly deteriorated by that time. Starting from around July-2023, the patient's right hand sometime shaking, when she was sitting calmly, and watching TV. By around early 2023, the patient was not engaging in conversation. When the patient stopped taking Donepezil in Sep-2023, some improvements were observed in conversation, cognitive functions and walking, and since then it was observed slowing down of degradation of cognitive function, and even some modest improvements, involuntary shaking of hands was gone. The patient was now much more engaged in conversations. The patient's temper and character returned to normal, she was not selfish and egoistic anymore, there was no agitation, she was nice and kind, and even in the evenings at bedtime and could have normal conversation and could make jokes. The patient's computer skills were coming back. The patient's behavior prior to the 2022/2023 new year party versus her behavior prior to the 2023/2024 new year's party (when she was no longer taking the medicine) was much better and more manageable. The patient's behavior improved after stopping donepezil medication. The patient's typical blood pressure was always low, around 110/70, and she was always drinking coffee, but around 2015 stopped drinking coffee. It was reported that it caused a reduction of the average blood pressure that may have contributed to developing the symptoms. This led to the hypothesis of Vertebrobasilar insufficiency due to hypotension in her case. It was suggested that it was not Alzheimer's, and not vascular dementia, and suggested that it was Vertebrobasilar insufficiency, which had all symptoms. Very early onset for patient may be caused by stopping drinking coffee around 2015, and by transitioning to a much less active lifestyle when she stopped working in 2019. Based on the Vertebrobasilar insufficiency diagnosis hypothesis, it was suggested that there will be no amyloid plaques observed (which was later confirmed by spinal fluid test) and decided to stop donepezil treatment in Sep 2023. Also, from Jun-2023 the patient resumed drinking coffee for breakfast and lunch. From June to the end of Aug-2023 the patient was going swimming pool several times per week. All this seemed to help with speech, reasoning, crosswords skills, etc. The patient for years was taking double doses of Valerian root calming herbal pills for sleep. It was found that Benzodiazepines cause memory loss, and they have similar actions as Valerian root. This may have contributed to the development of patient's memory issues. In August to Sep-2023 it was reduced and then stopped taking valerian root for patient, replacing it with melatonin. In Jul-2024 the patient went through a clinical trial (which was real stimulation, not placebo). This stimulation helped to improve patient's conditions and possibly restored some skills. The NIH genome result also came with a negative conclusion. In Jul-2024, the patient was receiving transcranial current stimulation, and the walking abilities were improved. The patient was a good painter from childhood. The patient's painting skills were restored from 05-Aug-2024 to 09-Aug-2024. Since patient's vaccination happened during the specified window, it was concluded that with probability 93% (which was 100%-7%) her dementia may have been caused by vaccination. Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live follow up received which contains no new information.; Reporter's Comments: Company Comment: The medical history of memory impairment, family history of dementia, and co suspect product Donepezil remains as contributor factors for the event corticobasal degeneration. The event Spinal osteoarthritis and Vertebral foraminal stenosis were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of the product is not affected by this report.
Dementia (The patient's grandmother and great-grandmother on mother side both had dementia in their 75-80, which unfortunately made less critical to this diagnosis of Alzheimer's, which eventually turned out to be wrong.); Memory impairment (Some deterioration in patient's memory and mild impairment); Sleep disorder NOS
Medical History/Concurrent Conditions: Numbness of head (head skin numbness)
Valerian root; Melatonin; Donepezil
Test Name: MRA test; Result Unstructured Data: MRA showed no blockage but revealed Vertebral basilar system was diminutive in size. The patient may had inherited Vertebral basilar system of diminutive size from grandmother.; Test Name: Blood pressure; Result Unstructured Data: Typical blood pressure was always low, around 110/70; Test Name: Spinal fluid test; Result Unstructured Data: no amyloid plaques observed.; Test Date: 20220111; Test Name: Memory measurements; Result Unstructured Data: Short memory measurements based on sequence of pictures of animals. First try: 56% and 1245ms, second try: 48% and 1373ms.; Test Date: 2023; Test Name: Lumbar puncture; Result Unstructured Data: Tests performed in (withheld), excluded Alzheimer's, because lumbar puncture had shown normal levels of proteins in patient's spinal fluid.; Test Date: 202309; Test Name: The 3 Tesla MRI scan; Result Unstructured Data: The 3 Tesla MRI scan (augmented by NeuroQuant analysis) also showed very noticeable atrophy of the frontal brain areas. Significant deterioration and atrophy.; Test Date: 202409; Test Name: The 3 Tesla MRI scan; Result Unstructured Data: A new 3Tesla MRI was arranged, and it was performed in Sep-2024, at the same location where the Sep 2023 3Tesla MRI was done. They were remarkably similar; those images did not show any significant change between Sep 2023 and Sep 2024. Moreover, the 3T MRI reports gave NeuroQuant7 determined numerical values related to brain degradation, such as, for instance, the volume of gray matter: MRI 3 Tesla, Sep 2023, gray matter: 401 cm^3; MRI 3 Tesla, Sep 2024, gray matter: 393 cm^3. These numbers were determined by NeuroQuant software version 4.1.1 for both 2023 and 2024 data. The Sep-2023 scan was analyzed by NeuroQuant version 3.1.1, giving 387 cm^3. The same as Sep-2023 MRI data, analyzed by NeuroQuant version 4.1.1, gave 401 cm^3. This difference (14 cm^3, or 3.5%) was assumed as an estimation for the error bars for all data points.; Test Date: 20200224; Test Name: Brain MRI; Result Unstructured Data: unremarkable, no brain issues were found; Test Date: 20220202; Test Name: Brain MRI; Result Unstructured Data: Unremarkable, no issues revealed; Test Date: 202202; Test Name: Brain MRI; Result Unstructured Data: Showed minimal white matter changes, related to age; Test Date: 20201011; Test Name: C-spine MRI; Result Unstructured Data: Unremarkable except for multilevel cervical spondylosis. There was mild resultant bilateral foraminal narrowing at C5/C6.; Test Date: 20200224; Test Name: MRI; Result Unstructured Data: MRI was performed for the neck area, which did not reveal any issues; Test Date: 202205; Test Name: MRI; Result Unstructured Data: MRI images unremarkable; Test Date: 20201110; Test Name: MRI cervical spine; Result Unstructured Data: Unremarkable, no issue was revealed; Test Date: 2023; Test Name: PET scan; Result Unstructured Data: Further study, using PET scan, resulted in a diagnosis of Corticobasal degeneration.; Test Date: 202411; Test Name: Genome; Result Unstructured Data: The NIH genome results also came with a conclusion negative NIAID research whole genome sequencing result. Specifically, both 23andme and NIH genetics results showed that patient's APOE genotype (T/T for rs429358 and C/T for rs7412) corresponds to "lower risk" of Alzheimer's. Both genetics results also showed that patient did not have mutations in BChE gene. The BChE-K version (rs1803274) was explicitly linked to faster cognitive decline on Donepezil (5,6). The atypical BChE variant (rs1799807 AA), may also indicate reduced BChE ability to break down acetylcholine-like compounds, potentially amplifying Donepezil's effects. For both of these genes patient's alleles were wild-type, i.e. do not show mutations that would explain adverse reaction do Donepezil. This finding did not support our earlier hypothesis that Donepezil may explain patient's fast decline in 2022-2023.