Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood pressure measurement, Blood test, Electrocardiogram, Gastrointestinal disorder
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; Had one system after another like an autoimmune disease; Having intermittent like sustained tachycardia and brief episodes; Severe palpitations; residual borderline hypertension right around 140/90 consistently.; Sweating; for three months had full on neurological symptoms; in the summer had rheumatological symptoms; has some GI symptoms; It was sinus tachycardia and the EKG was done in Jan2021; 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 10Jan2021 as dose 2, single (Lot number: ER4176) at the age of 43 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), notes: Did have, previous to the vaccine, breast implants; "Restless legs" (unspecified if ongoing); "Low pulse" (unspecified if ongoing), notes: has low blood pressure and low pulse historically; "Low blood pressure" (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", "neurological symptoms", "GI symptoms", "orthopedic issues", "hypertensive episodes". The following information was reported: SINUS TACHYCARDIA (medically significant) with onset Jan2021, outcome "unknown", described as "It was sinus tachycardia and the EKG was done in Jan2021"; 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 "recovering", described as "Weight loss"; AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "Had one system after another like an autoimmune disease"; TACHYCARDIA (medically significant), outcome "unknown", described as "Having intermittent like sustained tachycardia and brief episodes"; PALPITATIONS (medically significant), outcome "unknown", described as "Severe palpitations"; HYPERTENSION (medically significant), outcome "unknown", described as "residual borderline hypertension right around 140/90 consistently."; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; NEUROLOGICAL SYMPTOM (non-serious), outcome "recovered", described as "for three months had full on neurological symptoms"; RHEUMATIC DISORDER (non-serious), outcome "unknown", described as "in the summer had rheumatological symptoms"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "has some GI symptoms". The event "had one system after another like an autoimmune disease" required physician office visit. 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: (Dec2020) around 120-140; Magnetic resonance imaging head: (Mar2022) Nothing they could identify, notes: Result: nothing they could identify; Unit: Not provided; Weight: (unspecified date) Lost 20 pounds; (unspecified date) range of around 125 pounds; (unspecified date) her weight now is between 110-115 pounds. Therapeutic measures were taken as a result of pain.  Clinical course: Calling about the Pfizer COVID vaccine and got her 1st shot 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 system 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 go see a rheumatologist yesterday who is doing expansive workups and for at least the past 1.5 years of her life she is unrecognizable after getting the COVID vaccine and  feels finally she can call to land this on Pfizer's radar. HCP information: Has no further HCP information to provide. Patient details: Caller states she was age 42 or 43 at the time the reported events began and clarified she was age 43 at the onset of the events. 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 would be sustained around 120-140 and typically her heartrate is around 70 maybe and is 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  is around 105/65. States the cardiac issues, weight loss, sweating episodes, palpitations, hypertensive episodes are less frequent and less intense but she will get these symptoms on occasion. For seriousness criteria, for cardiac symptoms and weight loss, states they are 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: Ongoing and kind of improved and generally was in the range of around 125 pounds and pretty consistent and her weight now is between 110-115 pounds and is still having some difficulty putting on weight this far out. Autoimmune disease: Does not have anything now and it is 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 is 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 try 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 is usually very robust and this is 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 dysesthesias, 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 are not completely gone but better and she does not know what bearing this 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 feels completely rejected by the medical community and all they know is 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 feels pretty good and is 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 will stop 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 thinks is 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. 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 was feeling better so thought she would go ahead and get the booster and was hit with the neurological symptoms. Her cognitive function is just not what it was and doing tasks later is 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 takes 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 is related to her orthopedic issues and it is all kinds of localized problems; does not take medications is historically very active, has low blood pressure and low pulse historically, stable weight and is super high functioning as she is an emergency room physician. Had MRIs, some blood work to assess the rheumatologic stuff, inflammatory markers and everything thus far back is negative or at least non-diagnostic for what is happening to her and she just met with a rheumatologist yesterday for the first time. Since this is a significant deal, she would like the report reference number and will place it in a place she can remember to look for it; body against itself. asked if DSU may or may not contact her and she feels this is such a significant issue that somebody higher up needs to recognize this; thinks she just had some unfortunate rare side effect where it has completely turned her Is there a product complaint to report? Yes Description of product complaint: Description of complaint: Non suspect product 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; has no lots, expiry dates or NDC numbers to provide for the Prednisone.; Sender's Comments: Based on the available information in the case, the causal association between the event Autoimmune disorder, Pain aggravated, Weight loss, Tachycardia, Palpitations, Sinus tachycardia, Borderline hypertension and the suspect drug BNT162B2 cannot be 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.