Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood pressure measurement, Blood test, Cardiac disorder, Electrocardiogram
Clinical narrative: 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; hypertensive episodes; neurological symptoms; GI symptoms; orthopedic issues; rheumatological symptoms; severe palpitations; sweating; it was sinus tachycardia and the EKG was done in Jan2021; 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; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685) 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; "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; "breast implants" (unspecified if ongoing), notes: previous to the vaccine, breast implants and started getting pain. There were no concomitant medications. Past drug history included: Pramipexole for restless legs, notes: restless legs. The following information was reported: TACHYCARDIA (non-serious) with onset Dec2020, outcome "unknown", described as "having intermittent like sustained tachycardia and brief episodes"; HEART RATE ABNORMAL (non-serious) with onset Dec2020, outcome "unknown", described as "her heartrate would be sustained around 120-140 and typically her heartrate is around 70 maybe and is pretty low"; SINUS TACHYCARDIA (non-serious) with onset Jan2021, outcome "unknown", described as "it was sinus tachycardia and the EKG was done in Jan2021"; CARDIAC DISORDER (medically significant), outcome "recovering", described as "had a really prominent reaction like heart related cardiac stuff"; WEIGHT DECREASED (medically significant), outcome "recovering", described as "Weight loss"; PAIN (medically significant), outcome "not recovered", 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"; AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "had one system after another like an autoimmune disease"; PALPITATIONS (non-serious), outcome "unknown", described as "severe palpitations"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; HYPERTENSION (non-serious), outcome "unknown", described as "hypertensive episodes"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological symptoms"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI symptoms"; MUSCULOSKELETAL DISORDER (non-serious), outcome "not recovered", described as "orthopedic issues"; RHEUMATIC DISORDER (non-serious), outcome "unknown", described as "rheumatological 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, notes: her blood pressure at home and it was 170/110 and normally it is around 105/65; (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 decreased: (unspecified date) Lost 20 pounds, notes: 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. 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 was to the point it has literally ruined her life; finally went to go 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 feels finally she can call to land this on Pfizer's radar.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 December 25th came around, her heartrate would be sustained around 120-140 and typically her heartrate is 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 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 was still having some difficulty putting on weight this far out. Autoimmune disease: Does not have anything now 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 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 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 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 will stop taking that over the course of a couple weeks.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. 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; 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 body against itself.; Sender's Comments: Based on the available information in the case, the causal association between the event Autoimmune disorder, Pain aggravated, Weight loss, Heart disorder 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.