Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Loss of personal independence in daily activities, Magnetic resonance imaging, Magnetic resonance imaging spinal, Medical device pain
Clinical narrative: was causing a lot of worsening of her orthopedic issues and was just worsening pain in her right hamstring, hip problem and tailbone issue and was out of control as far as pain and limitations; Weight loss; it was like maybe breast implant illness; runny nose to the point of disturbance with daily activities; runny nose to the point of disturbance with daily activities; eyes red and injected or irritated; itchy rashes on her skin; pain in her right breast; migraines with auras; proximal limb fasciculations; weakness; migratory dysesthesias; truncal ataxia; vision difficulties; tinnitus; hearing problems; confusion; complete memory lapses; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Orthopedic issues began prior to vaccine" (ongoing), notes: Orthopedic issues began prior to vaccine; "Breast implants" (unspecified if ongoing); "Restless legs" (unspecified if ongoing); "Low blood pressure" (unspecified if ongoing), notes: has low blood pressure and low pulse historically; "Low pulse" (unspecified if ongoing), notes: has low blood pressure and low pulse historically. Concomitant medication(s) included: PRAMIPEXOLE taken for restless legs syndrome. Vaccination history included: BNT162b2 (Dose 1, Batch/lot number: EJ1685, Dosage text: 1st dose, unknown dosage, unknown anatomical location, Indication as reported by the primary source: is an ER doctor), administration date: 18Dec2020, when the patient was 43-year-old, for COVID-19 Immunization, reaction(s): "Had a really prominent reaction like heart related cardiac stuff", "Had one system after another like an autoimmune disease", "Weight loss", "Having intermittent like sustained tachycardia and brief episodes", "Her heartrate would be sustained around 120-140 and typically her heartrate is around 70 maybe and is pretty low", "Severe palpitations", "Sweating", "Would check her blood pressure at home and it was 170/110 and normally it is around 105/65", "It was sinus tachycardia and the EKG was done in Jan2021", "Was causing a lot of worsening of her orthopedic issues and was just worsening pain in her right hamstring, hip problem and tailbone issue and was out of control as far as pain and limitations"; BNT162b2 (Dose 2, Batch/lot number: ER4176), administration date: 10Jan2021, when the patient was 43-year-old, for COVID-19 Immunization, reaction(s): "Had a really prominent reaction like heart related cardiac stuff", "Weight loss", "Was causing a lot of worsening of her orthopedic issues and was just worsening pain in her right hamstring, hip problem and tailbone issue and was out of control as far as pain and limitations", "Had one system after another like an autoimmune disease", "Having intermittent like sustained tachycardia and brief episodes", "Severe palpitations", "Sweating", "It was sinus tachycardia and the EKG was done in Jan2021". The following information was reported: AMNESIA (non-serious) with onset Dec2021, outcome "unknown", described as "complete memory lapses"; CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "unknown", described as "confusion"; HYPOACUSIS (non-serious) with onset Dec2021, outcome "unknown", described as "hearing problems"; MIGRAINE WITH AURA (non-serious) with onset Dec2021, outcome "unknown", described as "migraines with auras"; DYSAESTHESIA (non-serious) with onset Dec2021, outcome "unknown", described as "migratory dysesthesias"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset Dec2021, outcome "unknown", described as "proximal limb fasciculations"; TINNITUS (non-serious) with onset Dec2021, outcome "unknown"; ATAXIA (non-serious) with onset Dec2021, outcome "unknown", described as "truncal ataxia"; VISUAL IMPAIRMENT (non-serious) with onset Dec2021, outcome "unknown", described as "vision difficulties"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "weakness"; PAIN (hospitalization, medically significant), outcome "unknown", described as "was causing a lot of worsening of her orthopedic issues and was just worsening pain in her right hamstring, hip problem and tailbone issue and was out of control as far as pain and limitations"; WEIGHT DECREASED (medically significant), outcome "not recovered", described as "Weight loss"; MEDICAL DEVICE PAIN (non-serious), outcome "unknown", described as "it was like maybe breast implant illness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "runny nose to the point of disturbance with daily activities"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "eyes red and injected or irritated"; RASH PRURITIC (non-serious), outcome "unknown", described as "itchy rashes on her skin"; BREAST PAIN (non-serious), outcome "unknown", described as "pain in her right breast". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 170/110; (unspecified date) 105/65; (unspecified date) 140/90; Blood test: (unspecified date) Negative, notes: far back is negative or at least non-diagnostic; Electrocardiogram: (Jan2021) Sinus Tachycardia, notes: Result: sinus tachycardia; Unit: Not provided; Heart rate: (unspecified date) around 70 may be and is pretty low, notes: around 70 may be and is pretty low; (Dec2020) around 120-140; Magnetic resonance imaging: (Mar2022) Nothing they could identify, notes: Result: nothing they could identify; Unit: Not provided; Magnetic resonance imaging spinal: (Mar2022) she does not have MS or anything they can identify, notes: she does not have MS or anything they can identify; Weight: (unspecified date) Lost 20 pounds; (unspecified date) 110 to 115 pounds. Therapeutic measures were taken as a result of pain.  Clinical information:  Patient got her 1st shot on 18Dec2020 and within a couple of days had a really prominent reaction like heart related cardiac stuff since that time; was previously healthy other than some orthopedic issues that occurred prior to the vaccine; has had one symptom after another like an autoimmune disease and for the past year and 9 months this is to the point it has literally ruined her life; finally went to see a rheumatologist yesterday who was doing expansive workups and for at least the past 1.5 years of her life she was unrecognizable after getting the COVID vaccine and felt finally she can call to land this on Pfizer's radar. Cardiac events began definitely within a few days after getting the 1st dose and she started having intermittent like sustained tachycardia and brief episodes and then by the time 25Dec2020 came around, her heartrate sustained around 120-140 and typically her heartrate was around 70 maybe and was pretty low. Lost 20 pounds and at the time was about 125 pounds and dropped 20 pounds within a month or two; would wake up in the middle of the night with severe palpitations and sweating episodes that lasted several months like that and then ended up migrating and had huge hypertensive episodes and would be just sitting there doing nothing and would feel like her body was going to explode and would check her blood pressure at home and it was 170/110 and normally it was around 105/65. Patient states the cardiac issues, weight loss, sweating episodes, palpitations, hypertensive episodes were less frequent and less intense but she got these symptoms on occasion. For seriousness criteria, for cardiac symptoms and weight loss, states they were medically significant and not disabling but she was still able to work and function through things even if she had big episodes; they did an EKG while she was having one and it was sinus tachycardia and the EKG was done in Jan2021. She would do an occasional EKG while at work and just put on a pulse ox on feeling it ramping up and it was consistently every time between 120-140 sinus tachycardia. Did not pass out or felt like she was having stroke symptoms and so she never did anything about these symptoms. Weight Loss was ongoing and kind of improved and generally was in the range of around 125 pounds and pretty consistent and her weight was between 110-115 pounds and was still having some difficulty putting on weight this far out. Autoimmune disease does not have anything then and it was literally so migratory and literally changing from one thing to the next and for three months had full on neurological symptoms and that would quell and then in the summer had rheumatological symptoms, has some GI symptoms and one thing would completely be migratory and she does not have a diagnosis but it was just something going on in her body attacking itself and began just a few days after the COVID vaccine; this was ongoing. The cardiac stuff had hypertension spikes and was left with residual borderline hypertension right around 140/90 consistently. Then was causing a lot of worsening of her orthopedic issues and was just worsening pain in her right hamstring, hip problem and tailbone issue and was out of control as far as pain and limitations; had multiple surgeries to tried to fix these problems and the surgeries were after the vaccine and her pain response was really exaggerated and had an incredibly difficult time recovering from any of her surgeries.  She was usually very robust and this was intensely out of character and from a neuro standpoint from Dec2021 through Jun2022 had new onset migraines with auras, proximal limb fasciculations, had weakness, migratory dysesthesia, truncal ataxia, vision difficulties, tinnitus, hearing problems, confusion, complete memory lapses.Saw a neurologist and had a neurological workup including full MRIs of the brain and spinal cord with and without contrast she thinks around Mar2022 and they said basically she does not have MS or anything they can identify. Did have, previous to the vaccine, breast implants and started getting pain in one of them after the vaccine and it was like maybe breast implant illness and she got those out in Feb2022; after getting those out the neurologic symptoms did very slowly get better and were not completely gone but better and she does not know what bearing that had on anything or if this autoimmune attack on the breast implants did end up causing illness. As soon as the neuro symptoms were fairly quiet this summer she started having really intense rheumatological problems and allergic type responses, joints swollen, fingers and wrists so painful she could not hold a cup of coffee, feet randomly swelling up and did gain a couple pounds that she shed immediately and was started on Prednisone she thinks it was just joint fluid that caused her to gain a couple pounds; has no lots, expiry dates or NDC numbers to provide for the Prednisone; had pains in the right side again and it was completely out of control crazy spikes of pain that literally had her almost immobile on the bathroom floor and sweating and vomiting. From the allergic standpoint, had runny nose to the point of disturbance with daily activities, eyes red and injected or irritated, itchy rashes on her skin and thinks this was starting around 10Aug2022 and had old Prednisone that she picked up while in [withheld] and went ahead and self medicated as no one can help her figure out and they were throwing their hands up and she felt completely rejected by the medical community and all they know was to get a traditionally to get a MRI and she has something wrong; had to leave her job, start a new career and can't manage her own life; has no lots, expiry dates or NDC numbers to provide for the Prednisone. Was started on 40mg Prednisone for about a week and then kept trying to taper off and every time they would go below 20mg, she would have a return of some symptoms or another and is still on 20mg right now; while she on Prednisone, she felt pretty good and was almost normal; saw her rheumatologist yesterday for the first time and she does have to get off of Prednisone and in the near future can do further rheumatological testing and stopped taking that over the course of a couple weeks. Got the 2nd dose of the Pfizer COVID vaccine and had a bad reaction to the 1st one and was due to have the 2nd and is an emergency room doctor so then when she was feeling like she was ok over the summer in 2021 got the booster Pfizer COVID vaccine and again that was when it was just was blowing everything up from that when the pain in her right breast and the neurological symptoms started. 2nd Pfizer COVID vaccine dose administered 10Jan2021 with lot she thought it was handwritten on her card and is EK or ER4176; booster Pfizer COVID vaccine administered on 10Dec2021 and in December was when she started getting the neurological symptoms and that has lot FJ8762; no expiry dates or NDC numbers written on her patient card. Her cognitive function was just not what it was and doing tasks later was not a good idea; frustrated because she called the CDC a couple of times and no one called her back and she kept hoping she was going to get better to a point. Every day for the last she does not know how many years like 15 years, has taken a medication called Pramipexole for restless legs and took it every night; does not think she was on other medications she can think of at that time; the restless leg orthopedic thing and nerve damage are related to her orthopedic issues and it was all kinds of localized problems; does not take medications, was historically very active, had low blood pressure and low pulse historically, stable weight and was super high functioning as she was an emergency room physician. Had MRIs, some blood work to assess the rheumatologic stuff, inflammatory markers and everything thus far back was negative or at least non-diagnostic for what was happening to her and she just met with a rheumatologist for the first time. Since this was a significant deal, she would like the report reference number and placed it in a place she can remember to look for it; asked if DSU may or may not contact her and she felt this was such a significant issue that somebody higher up needs to recognize this; thought she just had some unfortunate rare side effect where it has completely turned her body against itself.  Causality: The reported events are directly related to the Pfizer COVID vaccine and she never had any significant health issues that were anything longstanding or concerning of any kind and can literally say she got the shot and in days had this and literally felt better so thought she would go ahead and get the booster and was hit with the neurological symptoms.  Follow up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.