Sex: F
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Encephalomyelitis, Fall, Hyperaesthesia, Investigation
Clinical narrative: she had myeloencephalitis, so she had the inflammation in her spinal cord and in her brain; mother would scream when you touched her; mother also developed c difficile; West Nile Virus and had encephalitis from it; leptin lymphocytic meningitis; memory was worse at that point and remained worse; soft-tissue infection on her foot; and she was worried that they could be looking at osteomyelitis at some point; she had fecal incontinence; UTI; lethargic; had a loss of appetite; was unstable on her feet; fell; Alzheimer's disease; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  An 86-year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "dementia", start date: 2015 (unspecified if ongoing); "cognitive age related impairment", start date: 2017 (unspecified if ongoing), notes: cognitive age related impairment; "subdural hematoma" (unspecified if ongoing), notes: 2 years prior; "horrible twisted feet/ bunions and are torched to the side" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; PANTOPRAZOLE; PRAVASTATIN; DULOXETINE; DONEPEZIL; CELECOXIB. The patient's daughter went part-time for work around 2015 because that is when she started to realize that her mother couldn't do her pill box or do stuff like that anymore. She started to accompany her mother to all of her doctor's appointments. At that point is when she noticed it but she thinks it started even prior to that. They did testing and at first it showed just cognitive age related impairment on that initial testing in 2017 and then they did testing again in Mar2021 or so and that showed definite change. They also did a functional MRI that showed loss of volume in regions that are pretty commonly associated with Alzheimer's. Her mother is on Aricept to try and help with that, she is on the max dose of 10 BID. The reporter's mother (the patient) fell on 22Sep2021 and had a CT scan to rule out a bleed, her mother also had a subdural hematoma previously but that was 2 years prior. They did the CT scan on 24Sep2021, on 25Sep2021 she was lethargic, had a loss of appetite and was unstable on her feet, on 27Sep2021 she had fecal incontinence so she went to the hospital and then they transferred her to another one. They sat in the emergency room and they didn't what it was, they said it was a UTI even though her urine was clear. They started her on antibiotics on 28Sep2021 and then on 29Sep2021 her mother would scream when you touched her and went to the hospital again and they finally got her admitted on 30Sep2021 to withheld. They had 32 other cases of this at that time and immediately had suspected it and tested her for it whereas the other 2 hospitals didn't. They did the LP which came back as leptin lymphocytic meningitis, she was diagnosed with that on 01Oct2021 but those symptoms developed on 22Sep2021. Her mother also developed C difficile on 06Oct2021 and then went to a step down unit on 12Oct2021 and ultimately was fully discharged on 16Oct2021 but her memory was worse at that point and remained wore. Her mother was back at her baseline by the end of Nov2021. In 22Sep2021 her mother had the West Nile Virus and had encephalitis from it, she was hospitalized for that and the West Nile Virus was even in her spinal cord, she had myeloencephalitis, so she had the inflammation in her spinal cord and in her brain so she was hospitalized for 2 weeks and that was in Oct2021 into early Nov2021. That messed up her mother and made her much more cognitively impaired but she rebounded from all that and now this happened, but that all probably didn't help her with in her recent past having had the encephalitis. It was around Oct2021, towards the end of Sep2021 when the first symptoms showed for that.  Foot Infection (soft-tissue infection on her foot): Her parents used to have help that would come to their house after her mother had West Nile but they no longer have that help so the reporter has to rely on report from her father. She calls multiple times a day and he didn't say anything about her mother's foot. Her mother in general has horrible twisted feet, they have bunions and are torched to the side, they look horrible. She has areas that protrude and any shoes that she wears no matter how soft and stretchy they are cause rubbing. She believes it is her mother's left foot and on the small toe over that toe joint. It began a concern when the reporter first heard about it which she thinks was around the week of 17Jan2022 and then her mom saw the doctor on 20Jan2022. The reporter's dad didn't tell her about her mother's foot until either 17Jan2022 or 18Jan2022 and then the reporter took her to the doctor on 20Jan2022. The doctor started the clindamycin because she concerned about it being over the joint and she was worried that they could be looking at osteomyelitis at some point. It looks much better according to her dad, she had to check today and that it what he was telling her but what does he know. He knows the before to after though and he says it looks better. The patient started taking several medications such as antibiotics and steroids, along with the usual medications (levothyroxine, pantoprazole, duloxetine, donepezil, pravastatin, celecoxib, etc.) she takes for her Alzheimer's disease, dementia, and West-Nile virus encephalopathy. The patient was hospitalized for West Nile viral infection (start date: 30Sep2021, hospitalization duration: 16 days); for meningitis aseptic, clostridium difficile colitis (start date: 30Sep2021, discharge date: 16Oct2021, hospitalization duration: 16 days); the patient was hospitalized for hyperaesthesia (start date: 30Sep2021). The events " West Nile virus and had encephalitis from it", "she had fecal incontinence" were evaluated at the emergency room visit. The events "and she was worried that they could be looking at osteomyelitis at some point" and "soft-tissue infection on her foot" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (24Sep2021) result unknown; investigation: (2017) cognitive age related impairment; (Mar2021) showed definite change; lumbar puncture: (01Oct2021) leptin lymphocytic meningitis; magnetic resonance imaging: (Mar2021) loss of volume in regions, notes: commonly associated with Alzheimer's; sars-cov-2 test: (unspecified date) got diagnosed. Therapeutic measures were taken as a result of dementia Alzheimer's type, West Nile viral infection, osteomyelitis, anal incontinence, soft tissue infection. Aricept for Alzheimer's since 2021, clindamycin for foot infection. The outcome for the event "West Nile Virus and had encephalitis from it" was recovered on Nov2021, while for the other events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, the Company considered there was not a reasonable possibility that the serious events were related to the suspect vaccine (BNT162B2). The events were more likely consistent with underlying or intercurrent medical conditions.