Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Double stranded DNA antibody, Electromyogram, Illness, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Neuropathy; First shot on 18Jun2021, second shot on 11Aug2021; Panic; Her heart is racing. It feels like a blast of hormones that blast her; Burning; Autonomic Dysautonomia/autonomic issues/Autonomic Nervous system; sick; unbearable pain; skin discoloration; bulging vessels; lacks mobility; tachycardia; insomnia/she can't sleep; lost quite a bit of weight/probably 80 pounds; two bruises; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jun2021 (Lot number: EW0176, Expiration Date: 31Aug2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "k59.9", start date: 2011, stop date: Oct2016, notes: Illness/AE: k59.9; "Colectomy", start date: 2013 (unspecified if ongoing); "Illeostomy", start date: 2016 (unspecified if ongoing). There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "sick"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "unbearable pain"; SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "skin discoloration"; ANGIOPATHY (non-serious) with onset 2021, outcome "unknown", described as "bulging vessels"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "lacks mobility"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "tachycardia"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia/she can't sleep"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost quite a bit of weight/probably 80 pounds"; VACCINATION SITE BRUISING (non-serious) with onset 2021, outcome "unknown", described as "two bruises"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Autonomic Dysautonomia/autonomic issues/Autonomic Nervous system"; PANIC DISORDER (non-serious), outcome "unknown", described as "Panic"; PALPITATIONS (non-serious), outcome "unknown", described as "Her heart is racing. It feels like a blast of hormones that blast her"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "First shot on 18Jun2021, second shot on 11Aug2021". The events "unbearable pain", "skin discoloration", "bulging vessels", "lacks mobility", "tachycardia", "insomnia/she can't sleep" and "autonomic dysautonomia/autonomic issues/autonomic nervous system" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: anti-cyclic citrullinated peptide antibody: (Aug2021) unknown results, notes: Will follow; antinuclear antibody (normal high range 1:40): (Aug2021) less than 1:40; antinuclear antibody (normal high range 20): (Aug2021) less than 20; antinuclear antibody (0.0-0.9): (Aug2021) less than 0.2 ai; (Aug2021) less than 20; antinuclear antibody: (Aug2021) positive; abnormal; (Aug2021) less than 20; (Aug2021) less than 20; (Aug2021) less than 20; (Aug2021) less than 20; (Aug2021) 1:320; high; (Aug2021) 1:160; high; anti-thyroid antibody (normal high range 9.0): (Aug2021) less than 9.0; beta-2 glycoprotein antibody (0-25): (Aug2021) less than 9 gpi igg; beta-2 glycoprotein antibody (0-20): (Aug2021) less than 9 gpi igg; beta-2 glycoprotein antibody (0-32): (Aug2021) less than 9 gpi igg; c3 glomerulopathy (82-167): (Aug2021) 118 mg/dl; cardiolipin antibody: (Aug2021) less than 12 gpl; negative, notes: Indeterminate: 12-20, Low-Med Positive: greater than 28-88 High Positive: greater than 88; (Aug2021) less than 15 gpl; negative; (Aug2021) 17 mpl; high, notes: Negative: less than 13 Indeterminate: 13-20, Low-Med Positive: greater than 20-88 High Positive: greater than 88; complement factor c4 (14-44): (Aug2021) 21 mg/dl; double stranded dna antibody (normal high range 8.0): (Aug2021) less than 8.0; electromyogram: (18Aug2021) normal, notes: Performed by neurologist; magnetic resonance imaging head: (28Sep2021) negative; nerve conduction studies: (18Aug2021) normal, notes: Performed by neurologist; rheumatoid factor (normal high range 0.20): (Aug2021) less than 0.20; rheumatoid factor (normal high range 15): (Aug2021) less than 15; weight: (2021) lost. Therapeutic measures were taken as a result of autonomic nervous system imbalance.  Clinical course: Reporter stated that patient experiencing side effects and it's from the Pfizer covid vaccine and wants to know more info on whether there are doctors or programs that helps people who got sick after their vaccine shot. NDC number of Covid Vaccine was unknown, no other products and investigation assessment were reported. The reason for no lot number was not on vaccine card Expiry date for first and second vaccine. Covid Vaccine was unknown. She had a Covid vaccine. She had two of them. She got sick after first shot and after the second she has never recovered. No additional vaccines administered on same date of the Pfizer suspect and prior vaccinations within 4 weeks. She got first shot on 18Jun2021. Now she has autonomic issues and tachycardia. A lot of tachycardia is creating issues and she can't sleep. It is terrible. After the pharmacist shot it in caller's arm she said, "Oh I'm sorry." Caller had two bruises. Shots were given in caller's left arm. Caller is loosing movement in the finger on that side. She has skin discoloration and issues with her legs, knees, and feet. She makes noises because this has created so much stress. It has destroyed her family. She has doctors and nobody wants to deal with any of it. On 03Aug2021, tested for auto immune labs and results were positive ANA. No Specific relevant test for thromboembolic events and thrombocytopenia. ANA performed by Indirect Fluorescent antibody (IFA).  No follow-up attempts are possible. No further information is expected.