Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Gastrooesophageal reflux disease, Gingival blister, Head discomfort, Heart rate increased
Clinical narrative: passed out; feels like death; she just wants to die; dementia; scleroderma; Small fiber neuropathy that came up in her skin biopsies; Mast cell activation syndrome; shortness of breath; chronic cough; ears ringing; ears stopped up; rapid heart beat; palpitations; severe jaw pain; gum blisters in her mouth; jaw, face, and scalp burning; Eyelid heaviness; severe fatigue; insomnia; twitches; body tremors; Teeth clenching; severe anxiety; a feeling of electricity running through her veins like a radio transmitter running through her body; really bad acid reflux; severe GI issues; acute severe gastritis; weight loss; severe hair loss; severe brain fog; dizzy all of the time; dry skin; can't think clearly, feels lost, and emotionless; joint pain; vision issues; numbness and tingling in the face, hands, right foot, and right calf.; rashes that keep popping up on her torso, shoulders and neck.; can't think clearly, feels lost, and emotionless; Severe head pressure; flu like symptoms; numbness and tingling in the face, hands, right foot, and right calf; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mast cell activation syndrome" (unspecified if ongoing), notes: had Mast cell activation syndrome& allergic to all kinds of food, has drug allergies now.; "allergic to all kinds of food" (unspecified if ongoing); "has drug allergies now" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, left arm), administration date: 08Mar2021, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 06Jun2022, outcome "unknown", described as "passed out"; NEAR DEATH EXPERIENCE (medically significant), outcome "not recovered", described as "feels like death"; SUICIDAL IDEATION (medically significant), outcome "not recovered", described as "she just wants to die"; DEMENTIA (medically significant), outcome "not recovered"; SCLERODERMA (medically significant), outcome "not recovered"; NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "Small fiber neuropathy that came up in her skin biopsies"; MAST CELL ACTIVATION SYNDROME (medically significant), outcome "not recovered"; DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath"; COUGH (non-serious), outcome "not recovered", described as "chronic cough"; TINNITUS (non-serious), outcome "not recovered", described as "ears ringing"; EAR DISORDER (non-serious), outcome "recovering", described as "ears stopped up"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "rapid heart beat"; PALPITATIONS (non-serious), outcome "not recovered"; PAIN IN JAW (non-serious), outcome "recovering", described as "severe jaw pain"; GINGIVAL BLISTER (non-serious), outcome "recovering", described as "gum blisters in her mouth"; BURNING SENSATION (non-serious), outcome "not recovered", described as "jaw, face, and scalp burning"; EYELID IRRITATION (non-serious), outcome "not recovered", described as "Eyelid heaviness"; FATIGUE (non-serious), outcome "not recovered", described as "severe fatigue"; INSOMNIA (non-serious), outcome "not recovered"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "twitches"; TREMOR (non-serious), outcome "not recovered", described as "body tremors"; BRUXISM (non-serious), outcome "not recovered", described as "Teeth clenching"; ANXIETY (non-serious), outcome "not recovered", described as "severe anxiety"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "a feeling of electricity running through her veins like a radio transmitter running through her body"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "not recovered", described as "really bad acid reflux"; GASTROINTESTINAL DISORDER (non-serious), outcome "not recovered", described as "severe GI issues"; GASTRITIS (non-serious), outcome "not recovered", described as "acute severe gastritis"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "weight loss"; ALOPECIA (non-serious), outcome "not recovered", described as "severe hair loss"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "severe brain fog"; DIZZINESS (non-serious), outcome "not recovered", described as "dizzy all of the time"; DRY SKIN (non-serious), outcome "not recovered"; EMOTIONAL POVERTY (non-serious), THINKING ABNORMAL (non-serious), outcome "not recovered" and all described as "can't think clearly, feels lost, and emotionless"; ARTHRALGIA (non-serious), outcome "recovering", described as "joint pain"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "vision issues"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness and tingling in the face, hands, right foot, and right calf."; RASH (non-serious), outcome "not recovered", described as "rashes that keep popping up on her torso, shoulders and neck."; HEAD DISCOMFORT (non-serious), outcome "recovering", described as "Severe head pressure"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "flu like symptoms"; PARAESTHESIA (non-serious), outcome "not recovered", described as "numbness and tingling in the face, hands, right foot, and right calf". The events "passed out", "feels like death", "she just wants to die", "dementia", "scleroderma", "small fiber neuropathy that came up in her skin biopsies", "mast cell activation syndrome", "shortness of breath", "chronic cough", "ears ringing", "ears stopped up", "rapid heart beat", "palpitations", "severe jaw pain", "gum blisters in her mouth", "jaw, face, and scalp burning", "eyelid heaviness", "severe fatigue", "insomnia", "twitches", "body tremors", "teeth clenching", "severe anxiety", "a feeling of electricity running through her veins like a radio transmitter running through her body", "really bad acid reflux", "severe gi issues", "acute severe gastritis", "weight loss", "severe hair loss", "severe brain fog", "dizzy all of the time", "dry skin", "can't think clearly, feels lost, and emotionless", "joint pain", "vision issues", "numbness and tingling in the face, hands, right foot, and right calf.", "rashes that keep popping up on her torso, shoulders and neck.", "severe head pressure", "flu like symptoms" and "numbness and tingling in the face, hands, right foot, and right calf" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (2016) negative, notes: She was not ANA positive in 2016, she was negative; Blood immunoglobulin G: (15Dec2021) 8, notes: She said that her Centromere IGG,F range is an 8. It is very high. Standard range is like a 1. 15Dec2021 at clinic. She has had several tests done since then and they have not dropped; Blood test: (unspecified date) Unknown Results; Electrocardiogram: (unspecified date) Unknown Results; Insulin-like growth factor: (15Dec2021) 8, notes: She said that her Centromere IGG,F range is an 8. It is very high. Standard range is like a 1. 15Dec2021 at clinic. She has had several tests done since then and they have not dropped; Magnetic resonance imaging: (unspecified date) Unknown Results, notes: had 3 MRI's for that alone; Scleroderma: (2016) strongly positive, notes: She had blood work done in 2016 and did not have scleroderma. It is strongly positive for Scleroderma in her blood work now; Tilt table test: (unspecified date) positive, notes: Her Tilt table test came back positive. Therapeutic measures were taken as a result of arthralgia.  Clinical information: Caller reported that she had shortness of breath, internal vibrations, chronic cough ears ringing, ears stopped up, rapid heart beat and palpitations, severe jaw pain and gum blisters in her mouth, Small fiber neuropathy that came up in her skin biopsies. She passed out during a tilt table test at the hospital, it had to do with her blood pressure and heart, She had Mast cell activation syndrome and was allergic to all kinds of food and had drug allergies now. She had jaw, face, and scalp burning. Eyelid heaviness, severe fatigue, insomnia and stays up all night long with internal vibrations, twitches and body tremors that keep her up at night. Teeth clenching and severe anxiety 24/7. She had to get a mouth guard made for the teeth clenching. She reported a feeling of electricity running through her veins like a radio transmitter running through her body. She reported severe GI issues, acute severe gastritis, and weight loss. She now had food sensitivities, like she was allergic to everything and was sensitive to medications now. Severe head pressure and eye pressure for 4-5 months and had 3 MRI's for that alone. She reported severe hair loss, severe brain fog, dizzy all of the time, feels like she had dementia, dry skin, joint pain, and vision issues. She had Covid-19 vaccine triggered scleroderma. She did not not have scleroderma before she was vaccinated. She had blood work done in 2016 and did not have scleroderma. It was strongly positive for Scleroderma in her blood work now. She had numbness and tingling in the face, hands, right foot, and right calf. It has affected her central nervous system. She had rashes that keep popping up on her torso, shoulders and neck. There were days where she wakes up and felt like death and she was just wants to die. She had to quit her job last Dec and had no income. She said that she can no longer function. She can't think clearly, feels lost, and emotionless. She had really bad acid reflux. It had been one symptom after another. This has been non stop for 17 months. Caller said that she received her last dose of the Pfizer Covid-19 vaccine on 29Mar2021. She had seen 75 plus doctors in the last 17 months. She had all of the doctors and the dates. She had been seeing her neurologist more that her primary care physician. She has been to clinic twice and no one knows what to do as this is all so new. Her neurologist put her on Naltrexone low dose. She noticed her symptoms and the events starting in Apr2021 right after she received the vaccine. She has had over 70 doctors visit. She was going back to her lung specialist on Wednesday. Her shortness of breath was on and off. She did not breath the same as she used to, it was a struggle. She was very dizzy all of the time now even when she gets up. Her Tilt table test came back positive. Feeling of electricity running through her veins like a radio transmitter running through her body comes and goes, but was persisting. Dry Skin: Feels like she has aged 20 years: Joint pain: has improved with the Naltrexone.Scleroderma: is still showing in her blood work. Rashes: Come and go, but are persisting. There were days where she wakes up and feels like death. She just wants to die: She said that it depends on the day, but was persisting. This was like a debilitating chronic illness. Pfizer needs to step up and do something about this.She said that her Centromere IGG,F range was an 8. It was very high. Standard range was like a 1. 15Dec2021 at clinic. She has had several tests done since then and they have not dropped. Caller does not have her Vaccination card with at the time of the call. She was very sick with flu like symptoms after the second dose of the Covid-19 vaccine. Test results: She said that she has a had a ton of blood work done try, ECG's and all kinds of tests done. She was not ANA positive in 2016, she was negative. The patient did not require a visit to emergency Room but Physician Office: Yes, did not go to emergency even though she felt like she was dying and could not breathe. She did not have any prior Vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of passed out", "feels like death" die", "dementia", "scleroderma", "small fiber neuropathy ", "mast cell activation syndrome". 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