Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Magnetic resonance imaging, Malaise, Oxygen saturation abnormal, Postural orthostatic tachycardia syndrome
Clinical narrative: bradycardia and tachycardia episodes; bradycardia and tachycardia episodes; sudden onset chest pain; small vessel stroke in her brain stem; diagnosed with dysautonomia; diagnosed with POTS; Shortness of breath; fine hand tremors; burning hand syndrome; GI burning and belching / burning abdomen; GI burning and belching; blood pressure issues; chest discomfort; exercise intolerance; little waves of hot flashes; O2 sat variations; not well; light headedness and profound weakness; light headedness and profound weakness; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (lot number: EM9809 or EM9509) second dose on 18Feb2021 (vaccination age 67-year-old) on left arm at single dose for COVID-19 immunization. Medical history included ongoing Trigeminal neuralgia from Dec2020 (diagnosed 5 month ago after shingles vaccine), continuously being worked up by her primary for autoimmune disorders, she had a stroke in her brainstem. Concomitant medications included carbamazepine (TEGRETOL) for Trigeminal neuralgia (Has been taking for 5 months since being diagnosed with trigeminal neuralgia. She mentions its the only thing that calms the nerve down). Historical vaccine included BNT162B2 (lot number: EN5318) first dose on 25Jan2021 (vaccination age 67-year-old) on forearm left deltoid for Covid-19 immunization and shingles vaccine Shingrix on 17Dec2020 (vaccination age 67-year-old) for immunization and developed a neuropathy (3-4 days later) and trigeminal neuralgia 4 days post-shingles vaccine. 10 days post second dose of Covid vaccine (28Feb2021), she developed sudden onset of chest pain and lightheadedness and profound weakness. She was driving to her son's house and got to the nearest hospital and she was worked up for a blood clot and a heart attack. Everything came up negative but she had bradycardia. So, she was put on a 20 day monitor and she had signs of tachycardia, bradycardic episodes with activity and exercise intolerance. She is still continuing with the chest pain and she ended up in the emergency room two more times, hospitalized once, and she had a angiogram. The cardiologist gave her a diagnosis of POTS and the internal medicine gave her a diagnosis of dysautonomia. She is continuously being worked up by her primary for autoimmune disorders. Finally, her primary doctor threw up her hands and said "I don't know" because she continued to have other symptoms like light headedness, and shortness of breath. Of course, it is all linked to random surges of fine hand tremors and her heart would start racing where she may just be standing at the sink. Cardiology didn't want to do anything with her because she was in normal sinus rhythm. The caller explains she was told they saw a lot of tachycardia and bradycardia but she was in normal sinus rhythm, she didn't belong with a cardiologist. Five months ago, she got the shingles vaccine and developed trigeminal neuralgia 4 days post-shingles vaccine. At that point they did an MRI of the brain, thinking maybe she had MS because that is one of the side effects of MS, but she didn't. She had a normal MRI. She has been to neurology and has had a lot of testing done. She knows the long hauler's with COVID are coming up with dysautonomia. However, she has had multiple Covid tests and is very, very safe. She does not believe that she had Covid, but she does believe this may be a reaction to both the shingles vaccine with the trigeminal neuralgia and the Covid vaccine. Before these vaccines, she was on absolutely no medications and was completely healthy. These 2 vaccines, whether it's in her genetic system or whatever, but she continues to have GI burning, belching and burning hands. They did another MRI and found she had a small vessel stroke in her brain stem. There are so many things that are happening to her right now. She is also seeing rheumatology. She just is not well. Though the CDC doesn't know about her newer symptoms, she reported to the CDC what she had at the time. They haven't gotten back to her on either of them. Five months ago was the shingles vaccine and she would have thought they would have reached back out to her because it is truly too coincidental that she takes a shingles vaccine and 3-4 days later develop a neuropathy, and the shingles vaccine is supposed to prevent neuropathy. She is so active. She walked coast to coast, and now literally just even walking up a flight of stairs, her heart rate goes up to 115 to 120. She can be at rest and her heart rate can be in the 40's. She is also having blood pressure issues as well. Her blood pressure can be 89/46 and then be 152/90, so she is just kind of an "autonomic nervous system mess". Her primary care referred her to a neurologist and a rheumatologist whom she will be seeing Wednesday. She doesn't know what other specialties she may ended up seeing. The MRI was supposed to help find reasons for all these symptoms, but in fact, all it did was add another condition to her already perplexing condition. She submitted one report via CDC for the shingles vaccine on 17Dec2020, which three days later, she had trigeminal neuralgia. Her symptoms are ongoing and it's not disappearing like she had hoped. It keeps progressing and she keeps getting new symptoms. Sudden onset chest pain: Was 10 days after the vaccine, while driving to her son's house. She also developed light headedness and profound weakness. She went to the hospital (ER) and was sent home. 3 days later, she was still having significant chest pain so she went back into the ER. She was on a monitor that was showing all of these tachycardic and bradycardic episodes. She wasn't getting contacted but she was still having pain. The third time she went into the ER, she was admitted to the hospital. They transported her to cardiac care and they did an angiogram, which is when she was given the diagnosis of dysautonomia and POTS. The neurologist says that she does not have POTS because she is not presenting with consistent orthostatic hypotension and tachycardia when he does the TILT test. However, she has a lot of autonomic symptoms, so the doctor decided to do an MRI. Her previous doctor was doing all of this autoimmune testing that was coming back negative. She was tested for an adrenal tumor and had urine tests which got ruled out because she is surging, it is obvious she is having adrenal surges. The caller doesn't believe her doctor was convinced he would see anything on the MRI, so when he called her and told her she had a small vessel stroke in the pons/ medulla area, he thought maybe it could attribute to the symptoms. However, these new GI symptoms she is having does not fit. Therefore, they are continuing to do more studies like gastric emptying, a skin biopsy, CAT scan and an angiogram. She is meeting with a rheumatologist on Wednesday. She also adds she will probably do an MRI of the abdomen because she is having such a burning abdomen. She is waking up in the middle of the night with her abdomen just on fire. It seems like she is continuing to just add new symptoms. The chest pain goes away and she only gets it when she gets tachycardia or when she is taking a walk- it's not having it continuously. She had burning hand syndrome, it was burning hands in a bath, which that that lasted an hour when she was getting out of the bath and she hasn't had that since. Everything is kind of a weird conglomerate of dysfunction, like the blood pressure variations, O2 sat variations. She just wants answers. She is adjusting and adapting. But, she does wants to bring this to Pfizer's attention because maybe genetically there is something in her that even though the COVID vaccine is not a live virus, the idea is to mimic the live virus to give you immunity, and long hauler's are experiencing some of these symptoms that she is having, Not that Pfizer is going to do anything differently- she is still encouraging vaccines and she is not telling many people because she doesn't want people to use this as an excuse to not get the Covid vaccine. Caller confirms the dates of all of these events were reported to the CDC. Her doctor would have all of the dates including the dates of the angiogram, ER visits, the findings, and then the testing dates. Dates are unknown by the caller. She confirms she was in the emergency room 3 times, she was admitted and transferred to Cardiac care on the third time. She believes she was admitted for 3 days. She believes she was admitted in the evening, they did the angiogram the next day and she was discharged the following day. The MRI that was sent in 01 Dec 2020 was negative for anything. The MRI that was done last Thursday, 07 May or 09May2021 showed an infarct. So, she did have an  MRI that was clear in December and then the recent MRI showed the stroke. They are doing a CAT scan angiogram 28May2021. She explains she has no lifestyle history for developing a stroke. She wasn't even on baby aspirin or any statins. Now, they are now wanting to put her on statins. Before this, she had no history. She confirms her ER visits and one hospitalization were after the COVID vaccine and was all based on chest pain. The caller confirms the only thing that happened to her after the shingles vaccine was that she was in excruciating pain and then the doctor got an MRI going and determined she had trigeminal neuralgia. She was never hospitalized or went to the ER for the shingles vaccine. The chest pain she still gets on and off. Last night, she had it. She can get chest pain when she is walking. The chest pain is not continuous and consistent, it's more based on activity. Last night, her whole intestines were burning and she noticed "oh I'm feeling some chest discomfort". She is not worried about the chest pain anymore because she knows it is either a bradycardia that her chest is unhappy with or tachycardia that her heart is unhappy with and it's giving her discomfort. Her heart rate can literally go from 50 (which is bradycardic) to 120 in less than 5 -10 seconds. Her heart just goes racing like she is having a marathon, that's how fast it goes. It will last this way for a minute and  her heart rate will eventually meander it's way down so that's why she thinks she is getting chest pain. She works with elders and wanted to keep the world and community safe. She wanted to get back into the world and see her mother who is in a nursing home. Caller mentions she was taking 200mg twice a day of the Tegretol (before the COVID vaccine). She had to up her dosage because she had another outbreak so now her dose is 300mg, twice a day. She clarifies a tooth infection flared up her trigeminal neuralgia. All of the auto immune results were negative, except the MRI, which she thinks is the only thing that was positive. She is doing an autonomic test in September. At this point, her doctor has given a diagnosis of dysautonomia and she is presenting as such. Her neurologist is needing verification and so he is not giving her a diagnosis even though she has all of the symptoms of dysautonomia. Vaccination Facility Type: administered it to their elder care home. The event chest pain required a visit to Emergency Room and Physician Office (has weekly telephone visits because she keeps getting different symptoms. They are scratching their heads trying to figure out what other testing is needed. She is now developing little waves of hot flashes and is not having a fun time. She was living a very healthy lifestyle and was always energetic previous to this). The patient was hospitalized for 3 days. Family Medical History Relevant to AEs was No, other than her mother has hereditary angioedema. She hasn't been tested so does not even know if that is significant. She knows she has been reading about long hauler's having dysautonomia and a whole array of neurological symptoms. It is kind of intriguing as well as kind of suspicious. Everything is being managed well by her primary doctor who is very concerned and is doing everything she can to try and find and answer. The caller is very curious if there is a lot of funding, would she be put into a link and a pool to be involved in some studies or something? Is it something genetic?  There is certainly enough money out to do this work. Caller is questioning if she would get a booster given that she is questioning if she should get a booster because she doesn't know. She doesn't know if she is going to get the second shingles vaccine. She does not know what it could result in for her given these 2 complications with these 2 vaccines. Causality: Because she had the shingles vaccine and developed trigeminal neuralgia, which is a neuropathic, and then getting the Covid vaccine and having all of these symptoms, it is just too coincidental. She is going to talk to her doctor about MS since she is presenting with gut things which is more "MS-ish". MS is hard to diagnose so she doesn't know, they are still testing. At this point, because all the boxes checked besides the last MRI, she is leaning towards the COVID vaccine being the cause of her symptoms. The causality for event sudden onset chest pain was related. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events bradycardia, tachycardia, chest pain and brain stem stroke cannot be excluded. The available information upon initial assessment is limited, especially as a definitive diagnosis was not available. The patient was reported to have pre-existing trigeminal neuralgia and previous brainstem stroke and is being worked up for autoimmune disorders; the role of these conditions in the development of the symptoms also cannot be ruled out. This case will be reassessed once additional information becomes 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.