Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Biopsy muscle, Blood test, Cerebrovascular accident
Clinical narrative: trouble walking;Her sister could barely walk; her sister had to use a wheelchair; Her sister slurred her words, and had problems remembering things now; her sister was slurring her words (and she could barely understand her sister); myasthenia gravis; Her sister slurred her words, and had problems remembering things now; her sister was slurring her words (and she could barely understand her sister); Her sister's memory was getting worse; she was so weak standing in line for her second COVID-19 Vaccine dose; she was so weak standing in line for her second COVID-19 Vaccine dose; Her sister was hunched over; her sister couldn't breathe; Her sister couldn't get out of bed, and had been falling; Guillain-Barre syndrome; Her sister said the need to urinate came on so quickly; She thought her sister looked like she had a stroke; her sister almost went off the road while driving; This is a spontaneous report from a contactable Nurse via Pfizer sponsored program. A 47-year-old female patient (reporter's sister) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0161, Expiration Date: Unknown), via an unspecified route, administered in Left Arm on 01May2021 at 16:00 (47-year-old at vaccination) as a Dose 2, single  for COVID-19 immunization. The patient's medical history included bipolar disorder from 2002 for at least 15 years if not longer and ongoing. Her sister had bouts of depression before finally being diagnosed with bipolar disorder. Her sister takes a cocktail of medications that work for her and keep her very steady. Her sister saw a doctor every 3 months for her bipolar disorder. The patient's concomitant medications were not reported. Vaccination Facility Type was reported as Pharmacy / Drug Store and not other Facility. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737, Expiration Date: Unknown) via an unspecified route, administered in Left Arm on 10Apr2021 at 16:00 (46-year-old at vaccination) as a Dose 1, single  for COVID-19 immunization. Reporter stated that on Apr2021, her sister had "jelly legs," and couldn't walk very well, her sister took her dog for a walk and fell on her face, and knees. When she saw her sister to celebrate her sister's birthday, her sister had 2 black-eyes from the fall. Her sister didn't think she broke anything. The reporter stated that her sister received both doses of the Pfizer Covid-19 vaccine with her second dose being 01May2021. The reporter stated her sister had since experience trouble walking and they are awaiting results of a possible Guillain-Barre diagnosis. Reporter stated she was having a hard time getting someone to see her sister. Reporter asked "what other people doing in this situation. Should reporter take her back to the ER, could be a medical emergency". Reported that her sister has a neurology appointment 13Aug2021 and she had called them multiple times to be seen sooner, but they won't. Reporter stated that one doctor sent her for a muscle biopsy said she had myasthenia gravis, but another doctor said it could be Guillain-Barre syndrome from the Covid shot. Reporter stated, "she had to go on vacation with her daughter and her husband in the meantime and she was scared to leave the patient alone with just her mom". The reporter asked "what should they do in this situation. Was there a team of doctors Pfizer could put us in touch with or someone Pfizer could call" Nurse had inquired about additional information regarding Guillain-Barre syndrome in people who have received the Pfizer Covid-19 vaccine. Reporter stated that "her mom didn't go to church yesterday because her sister couldn't breathe". Reporter tearfully stated, "she don't know if she'll come back from this". After her sister had the second Covid-19 Vaccine dose, her sister got worse, and her sister had to use a wheelchair. The reporter took her sister to the Emergency Room, and her sister spent 9 days at the hospital. The doctors did a muscle biopsy on her sister and sent her sister to a different hospital. Her sister's doctor asked if her sister had the Covid-19 Vaccine. The doctor suggested her sister could have Guillain-Barre syndrome, but the doctor was not 100 percent sure. The reporter wanted to know if Pfizer could provide her sister any help, and if what her sister experienced was a normal response to the Covid-19 Vaccine, and if there was something her sister could do. Her sister slurred her words, and had problems remembering things now. Reported her sister said she wished she never got the second COVID-19 Vaccine shot. Her sister told her she was so weak standing in line for her second COVID-19 Vaccine dose and had to hold onto a shelf in the Pharmacy. While her sister was waiting at the Pharmacy, her sister was leaning on their mother, and thought to herself that she could barely stand up. Her sister had drove to the Pharmacy with her mother that day. Her mother said she should have never let her sister drive that day because on the way home her sister almost went off the road while driving. Reported her sister had a brain MRI scheduled on 21Jun2021. After her sister's brain MRI, her sister had gotten so much worse. After her sister had the brain MRI on 21Jun2021, she got her sister ice cream. Her sister ended up with ice cream all over her face and shirt. Her sister could barely walk. She thought her sister looked like she had a stroke. She told her sister to pack a bag because she was going to take her sister to the Emergency Room on 22Jun2021. Reported her sister had 2 separate appointments with 2 different neurologists, one appointment for 28Jun2021, and the other appointment for 02Jul2021. Her sister wasn't able to make either neurologist appointment because her sister was admitted to the hospital on 22Jun2021. Clarified she noticed in mid-May2021 (after her sister had the second Covid-19 Vaccine dose) that her sister was slurring her words (and she could barely understand her sister). Her sister's memory was getting worse. Her sister was hunched over, and barely able to make it into her house when she came to visit her. Her sister was having a hard time getting around. Her sister couldn't get out of bed, and had been falling, so her sister was sleeping on the couch because the couch was lower to the floor. She said her sister was wetting herself. Her sister said the need to urinate came on so quickly, her sister was not getting out of bed in time to make it to the bathroom. Her sister was not using a Poise pad for the incontinence. The reporter clarified her sister went to her primary care doctor initially and sent her sister to a back doctor. Since she felt her sister's condition was emergent, she put her sister in a wheelchair to go get her for the back doctor's appointment. She and her mother had to walk on either side of her sister otherwise, because her sister was barely walking. The back doctor was no help at all to her sister. The back doctor said normally his patient's can walk when they show up at his office. The back doctor told her sister since she couldn't walk, he couldn't do anything for her, and suggested her sister go back to physician, and her sister be tested for Lyme's Disease. Her sister was insistent physician do Lyme's Disease testing, which physician did, and her sister's Lyme's Disease tests were all negative. Physician then then referred her sister to a neurologist. Her sister was given Prednisone IV steroids while in the hospital. Her sister was now taking PO (clarified as oral) Prednisone 20mg twice a day at home. She did not have the Prednisone IV or Prednisone 20mg NDC, Lot, and Expiry Date. Reported her sister was started on oral Prednisone while in the hospital, but Physician (Neurologist) then put her sister on Prednisone IV in order to keep her sister in the hospital because her sister's insurance company was trying to kick her out of the hospital. Clarified her sister left the hospital AMA (against medical advice) on 01Jul2021 because her neurologist was on vacation, and Physician's partner didn't do anything for her after she was in the hospital for almost a week. Her sister was supposed to have a muscle biopsy on 28Jun2021, and then the muscle biopsy was rescheduled for either 01Jul2021 or 02Jul2021. When her sister was told by the surgeon, physician that he was not going to do the muscle biopsy on 01Jul2021 or 02Jul2021, her sister decided to sign herself out of the hospital because she had been there for 9 days without having any testing. Physician suggested her sister have the muscle biopsy at another hospital. Her sister had the muscle biopsy as an outpatient procedure on 08Jul2021 at another hospital, but does not have the muscle biopsy results yet, which may take up to 2 weeks. Reported her sister saw a Physician's Assistant who kept her sister on the same regimen of medications. The reporter confirmed that the patient was hospitalized for 9 days. Her sister had good days, and bad days, and was not falling as much. Her sister was doing ok with a walker, but could barely walk on her own, and couldn't stand to put on or take off her pants. No further information provided. The outcome of events trouble walking, her sister could barely walk, use a wheelchair, slurred her words, urinate came on so quickly, problems remembering, memory was getting worse was not recovered and the outcome of other events was unknown. The causal relationship between BNT162B2 and event got worse, and her sister had to use a wheelchair, urinate came on so quickly, slurring her words and memory was getting worse was assessed as related by the reporter. Method of assessment was Global introspection.; Sender's Comments: As there is limited information in the case provided, the causal association between the events near death experience, myasthenia gravis, gait disturbance, wheelchair user, dysarthria, guillain-Barre syndrome, urinary incontinence, cerebrovascular accident, memory impairment, condition worsened and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.