Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Red blood cell sedimentation rate normal, Renin normal, Rheumatoid factor negative, SARS-CoV-2 antibody test negative
Clinical narrative: mast cell disorder; buzzing in my ear; autonomic dysfunction; chronic fatigue syndrome.; get easily winded with mild exaggeration and become incapacitated if I tried to do anything more involved; It's been almost a year and I can no longer do normal things; burning pain in my lower legs and feet/burning pain and vibrating pain in all four limbs; This has been an incredible nightmare; my condition worsened; Post exertion malaise; Rashes; New allergies; Tachycardia; Venous Pooling; Orthostatic Intolerance; Lightheadedness; Vascular throbbing/Heart palpitations; Diarrhea; Constipation; brain fog; This is a spontaneous report received from contactable reporter(s) (Physician).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown", described as "mast cell disorder"; TINNITUS (non-serious), outcome "not recovered", described as "buzzing in my ear"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "autonomic dysfunction"; CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown", described as "chronic fatigue syndrome."; DYSPNOEA (non-serious), outcome "unknown", described as "get easily winded with mild exaggeration and become incapacitated if I tried to do anything more involved"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "It's been almost a year and I can no longer do normal things"; BURNING SENSATION (non-serious), outcome "not recovered", described as "burning pain in my lower legs and feet/burning pain and vibrating pain in all four limbs"; NIGHTMARE (non-serious), outcome "unknown", described as "This has been an incredible nightmare"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "my condition worsened"; MALAISE (non-serious), outcome "unknown", described as "Post exertion malaise"; RASH (non-serious), outcome "unknown", described as "Rashes"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "New allergies"; TACHYCARDIA (non-serious), outcome "unknown"; PERIPHERAL VENOUS DISEASE (non-serious), outcome "unknown", described as "Venous Pooling"; ORTHOSTATIC INTOLERANCE (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness"; PALPITATIONS (non-serious), outcome "unknown", described as "Vascular throbbing/Heart palpitations"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; CONSTIPATION (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog". The events "mast cell disorder", "buzzing in my ear", "autonomic dysfunction", "chronic fatigue syndrome.", "get easily winded with mild exaggeration and become incapacitated if i tried to do anything more involved", "it's been almost a year and i can no longer do normal things", "burning pain in my lower legs and feet/burning pain and vibrating pain in all four limbs", "this has been an incredible nightmare" and "my condition worsened" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: test ruled that out, notes: might have developed long Covid infection, but a test ruled that out.  Follow up (06Apr2022): This is a follow-up spontaneous report received from the non-contactable Physician. This Physician reported for a 48-Year-old female patient. Updated Information included: Suffix, city, state and phone number added in reporter slide 1. Reporter added in slide 2. Best doctor information added. Events added.  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 current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event mast cell activation syndrome 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.