Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Raynaud's phenomenon, Red blood cell sedimentation rate, SARS-CoV-2 test negative, Vaccination complication
Clinical narrative: Had diarrhea on and off for two weeks; Felt like she had a tourniquet to her left arm/ Felt like she wasn't getting blood flow to her arm/feeling like she would pass out; Joint ache/little aches and pains to her joints; completely fatigued/Fatigue; Flu like symptoms/felt like she had the flu; Tachycardic, her heart rate was above 125; An autoimmune response affecting her autonomic nervous system/affecting her neurological system; Had unexplained neuropathy and she had full neuropathy in her toes and fingers; Felt like she has small fiber neuropathy; left arm and leg went numb/ numbness to her thigh and left bicep/ numb to both sides of her arms/Left arm and leg went numb/Neck and face got numb; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (lot: EK5730), via an unspecified route of administration in left arm on 24Dec2020 at single dose for covid-19 immunization. Medical history included Raynaud's syndrome (this is considered autoimmune, and she has had it maybe 15 years). There were no concomitant medications. Nurse calling as patient about Pfizer COVID-19 vaccine, and says her occupational health doctor has reported her experience to the CDC and FDA already. She says that she wasn't able to get a second dose injection. Weight was 129-130 lbs. Caller clarifies that her occupational health doctor had reported it to CDC and DPH. She says that she went to get the shot and didn't get a paper to say sign up for reaction stuff, she got the vaccine on Christmas Eve and then worked a bunch of days. She says they thought her symptoms would go away in a couple weeks, and when they didn't, her doctor reported her symptoms. She says that it started about 15 minutes after getting the vaccine, where they had her sit for 15 minutes after and a nurse checked her arm and said it was ok, and she told her that she feels ok and got up and left and got in the car with her husband who was driving. She says her left arm and leg went numb after she got in the car, so she told him don't leave since her left arm and leg were a bit numb so he pulled over into a parking lot. She says then her neck and face got numb, so she called her friend who is a nurse who said that it was not respiratory and not anaphylactic, maybe she is dehydrated since she worked last night so she ate and stayed close to the hospital. She says that if it was not Christmas Eve when they had so much to do, she would have went back in, but since she did not have shortness of breath or respiratory issues and had so much to do that day, she went about the day. She says she woke up the next day and her neck and face were completely numb, but she worked that night and told the resident there that said it might go away, and she was not having problems breathing. She says that a nurse said she had a reaction too, but the other nurse had a rash, and she didn't have a rash. Caller says on Monday she had the same numbness to her neck and face and ended up calling work health who said that the shot was so new, and everyone has different reactions, it should end up going away. She says that they did a COVID test because she had little aches and pains to her joints, but she also worked 12 hours Sunday. She says that they sent her for a COVID test which she went for on day 5 after getting the vaccine, which was Wednesday. She says she went in the morning and got the test at a testing tent then went home and was down and out with flu like symptoms, she couldn't get out of bed. She says that the test came back negative. She says that she had diarrhea now with her symptoms from the vaccine. She says she also had numbness to her thighs, after having it to her neck and face, then it moved to her thighs. She says for a couple days she could not get out of bed, she felt like she had the flu, but it was not the flu. She says her arms were numb, and on the 11th day after getting the vaccine she woke up and felt like she had a tourniquet to her left arm, that was on Sunday, it felt like she wasn't getting blood flow to her arm. She says she was numb to both sides of her arms, and her left arm felt like there was a tourniquet on it and felt like there was no circulation to her fingers and she couldn't feel her ring finger or middle finger on her left hand. She says she still had numbness to her thigh and left bicep, and she went to the emergency room at (Hospital name) where she works. She says she was not admitted to the hospital and was there about 6 hours. Caller says that all labs were normal at the ER that day, they did a MRI of her brain, cervical spine, and thoracic at (Hospital name). The Numbness treatment: Caller says that her primary care doctor tried to give her Gabapentin and told her to take 100 mg that night, and she could take it up to three times a day, and she took one dose that night that they prescribed it. She says she felt dizzy and decided not to take it again. Caller says she went to the emergency room again because she was completely fatigued, on day 19, she couldn't get out of bed and she talked to her doctor again and they said they don't know what happened to her body, so to see a neurologist in (Place name), which was impossible due to COVID they said they would see her in 4-5 months. She says she went to the ER at (Place name), and their neurologist said that her neuros were intact and couldn't explain her numbness, said that the vaccine was new, she was reacting to vaccine and they don't know what will happen with her symptoms. She says she was not admitted over night, she went home after 6 hours both times she went to the ER. Caller says she had diarrhea on and off for two weeks after getting the vaccine, she did no treatment, she had set up a telehealth appointment with a gastroenterologist, but she felt better so she canceled the appointment. She says her aches and pains to her joints, that only lasted a day or two, and also she worked 12 hours that day on her feet, so it could be from that, she now has no aches and pains in her joints. She says that the numbness hasn't gotten worse. She says on 28Jan she saw the neurologist in (Place name), and they felt like she had unexplained neuropathy and she had full neuropathy in her toes and fingers, then they did an EMG 08Feb. She says that she is still numb to her legs and arms, she still has feeling to the muscles, they did a pricking test and her arms and legs were numb but still had feeling, but her fingertips and toes lost feeling. She says her EMG was normal, but that only tests large muscle fiber. She says on 16Feb, she went to see her local rheumatologist Dr. (Name) out in (Place name). She says that they felt like she has small fiber neuropathy. She says that they did her orthostatic vitals, and she was so fatigued, with numbness to her arms, legs, face, and neck. She says during her ortho resting while standing she was tachycardia, her heart rate was above 125, and the doctor said that is not even you doing dishes, they are going with Hunts syndrome. She says that she thinks she is not gonna follow up with her, and is going to go to (Place name), the vaccine did something to her body, an autoimmune response affecting her autonomic nervous system, she was feeling like she would pass out laying down for 5 minutes and then sitting back up. She says she will see another neurologist at (Hospital name), and have someone who will think outside the box, and maybe eventually it will calm down. She says she still has the feeling like she will pass out when she stands up and has numbness to her arms and legs. She says a friend of hers recommended for her to call the number, that there are Pfizer doctors who might be able to explain something, she is not seeing the right doctor, she needs to see someone who does neuroimmunology, like at (Hospital name), it is affecting her neurological system, her local doctor she doesn't want to see her for vaccine reaction since they don't know. She says that she is hoping that someone will review this since she has no idea and it is not going away. She says she now has a (Hospital name) appointment on 10Mar with a neurologist. The outcome of the event Hypoaesthesia was not recovered, Diarrhea was recovering, Joint ache was recovered on unspecified date, other events was unknown.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between events Neuropathy peripheral, Small fibre neuropathy and Hypoaesthesia and BNT162B2 vaccine cannot be completely excluded. 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.