Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Mast cell activation syndrome, Paraesthesia, Pericarditis
Clinical narrative: left chest pain; severe sympathetic adverse reaction; BP and HR elevated; BP and HR elevated, 180/110; short of breath; total body paresthesia; head pressure; disassociation; shaking/tremors/internal electrical vibration; chills; pericarditis; mast cell activation syndrome; small fiber neuropathy; postural orthostatic tachycardia syndrome; physical activity is extremely compromised; my quality of life is profoundly diminished; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 09:30 as dose 2, single (Lot number: FF2589) at the age of 60 years for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "IBS" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0187, Vaccine Administration Time: 09:30 AM), administration date: 20Aug2021, when the patient was 60-year-old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "BP and HR elevated"; BLOOD PRESSURE INCREASED (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "BP and HR elevated, 180/110"; CHILLS (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered"; DISSOCIATION (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "disassociation"; HEAD DISCOMFORT (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "head pressure"; CHEST PAIN (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "left chest pain"; MAST CELL ACTIVATION SYNDROME (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered"; QUALITY OF LIFE DECREASED (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "my quality of life is profoundly diminished"; PERICARDITIS (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered"; PHYSICAL DISABILITY (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "physical activity is extremely compromised"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered"; SYMPATHETIC NERVE INJURY (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "severe sympathetic adverse reaction"; TREMOR (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "shaking/tremors/internal electrical vibration"; DYSPNOEA (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "short of breath"; SMALL FIBRE NEUROPATHY (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "small fiber neuropathy"; PARAESTHESIA (hospitalization, disability) with onset 30Sep2021 at 09:00, outcome "not recovered", described as "total body paresthesia". The patient was hospitalized for chest pain, sympathetic nerve injury, heart rate increased, blood pressure increased, dyspnoea, paraesthesia, head discomfort, dissociation, tremor, chills, pericarditis, mast cell activation syndrome, small fibre neuropathy, postural orthostatic tachycardia syndrome, physical disability, quality of life decreased (hospitalization duration: 2 day(s)). The events "left chest pain", "severe sympathetic adverse reaction", "bp and hr elevated", "bp and hr elevated, 180/110", "short of breath", "total body paresthesia", "head pressure", "disassociation", "shaking/tremors/internal electrical vibration", "chills", "pericarditis", "small fiber neuropathy", "postural orthostatic tachycardia syndrome", "physical activity is extremely compromised" and "my quality of life is profoundly diminished" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 180/110, notes: BP and HR elevated, 180/110; Heart rate: (unspecified date) elevated, notes: BP and HR elevated, 180/110; Nasopharyngeal swab: (15Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of chest pain, sympathetic nerve injury, heart rate increased, blood pressure increased, dyspnoea, paraesthesia, head discomfort, dissociation, tremor, chills, pericarditis, mast cell activation syndrome, small fibre neuropathy, postural orthostatic tachycardia syndrome, physical disability, quality of life decreased.   Clinical information: Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. Adverse event: Developed left chest pain within 24 hours followed by severe sympathetic adverse reaction. (Number Withheld) call with transport to Emergency Room. BP and HR elevated, 180/110. Chest pain, short of breath, total body paresthesia, head pressure, disassociation, shaking, chills, tremors, internal electrical vibration. This worsened and I developed about 30+ more symptoms. Hospitalized, diagnosed with pericarditis, mast cell activation syndrome, small fiber neuropathy, postural orthostatic tachycardia syndrome. I am almost 1 year out my physical activity is extremely compromised and my quality of life is profoundly diminished. If covid prior vaccination: Yes. If covid tested post vaccination: Yes.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events chest pain, sympathetic nerve injury, heart rate increased, blood pressure increased, dyspnoea, paraesthesia, head discomfort, dissociation, tremor, chills, pericarditis, mast cell activation syndrome, small fibre neuropathy, postural orthostatic tachycardia syndrome, physical disability, quality of life decreased..  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.