Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, C-reactive protein, Double stranded DNA antibody, Electrocardiogram
Clinical narrative: Small-fiber neuropathy; postural orthostatic tachycardia syndrome; high-pitched right ear tinnitus; This is a literature report.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", described as "Small-fiber neuropathy"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), outcome "recovering"; TINNITUS (medically significant), outcome "recovering", described as "high-pitched right ear tinnitus". The patient underwent the following laboratory tests and procedures: Amino acid level: Normal or negative; Antibody test (normal high range 7): 21.8, notes: Pre-PLEx titer (units/mL); 6.8, notes: Post-PLEx titer (units/mL); Antibody test (normal high range 15): 41.9, notes: Pre-PLEx titer (units/mL); 5, notes: Post-PLEx titer (units/mL); Antibody test (normal high range 8): 39.1, notes: Pre-PLEx titer (units/mL); 3.5, notes: Post-PLEx titer (units/mL); Antibody test (normal high range 9.8): 41.5, notes: Pre-PLEx titer (units/mL); 15.7, notes: Post-PLEx titer (units/mL); Antibody test (normal high range 25): 61.3, notes: Pre-PLEx titer (units/mL); 30.8, notes: Post-PLEx titer (units/mL); Antibody test (normal high range 9): 18.7, notes: Pre-PLEx titer (units/mL); 3.7, notes: Post-PLEx titer (units/mL); 25.5, notes: Pre-PLEx titer (units/mL); 3.3, notes: Post-PLEx titer (units/mL); Antinuclear antibody: Normal or negative; Biopsy skin: Revealed decreased epidermal nerve fiber density, notes: of 2.2/mm2 (normal 13.8) at the distal leg and 7.5/mm2 at the thigh (normal 21.1); Blood homocysteine: Normal or negative; Blood test: Normal or negative; Blood thyroid stimulating hormone: Normal or negative; C-reactive protein: Normal or negative; Double stranded DNA antibody: Normal or negative; Electrocardiogram: revealed significant postural tachycardia; Electromyogram: Normal, notes: In upper and lower extremities; Electrophoresis: Normal or negative; Full blood count: Normal or negative; Glycosylated haemoglobin increased: 5.7 %, notes: Mildly elevated; Heart rate: varying from 50 beats per minute (bpm) supine, notes: to 180 bpm standing with episodes of supraventricular tachycardia; Comprehensive metabolic profile: Normal or negative; Normal or negative; Magnetic resonance imaging: unremarkable; Magnetic resonance imaging head: unremarkable; Nerve conduction studies: Normal, notes: In upper and lower extremities; Neurological examination: normal except diminished sensation, notes: to temperature in the feet; Red blood cell sedimentation rate: Normal or negative; Vitamin B12: Normal or negative; Vitamin B6: Normal or negative. Therapeutic measures were taken as a result of neuropathy peripheral, postural orthostatic tachycardia syndrome, tinnitus. Clinical course: After two doses, he had paresthesias as well as burning and stabbing pain in the arms, face, and eyes, accompanie by high-pitched right ear tinnitus. He subsequently developed orthostatic intolerance and was unable to stand and walk without syncope. These symptoms progressed for 5 months and cardiac monitoring revealed significant postural tachycardia with heart rate varying from 50 beats per minute (bpm) supine to 180 bpm standing with episodes of supraventricular tachycardia. Neurological examination was normal except diminished sensation to temperature in the feet. The patient was treated with nadolol 40 mg/day, with improvement in tachycardia. Gabapentin 600 mg three times daily for 1 month, amitriptyline 50 mg/day for 2 months, and trazodone 50 mg twice daily for 2 months resulted in no improvement in pain. He was then treated with intravenous immunoglobulin 2 g/kg one time, but he developed hemolytic anemia with the second treatment. He was started on subcutaneous immunoglobulin 200 mg/kg per week for three doses, with improvement of his neuropathic pain but significant worsening of tinnitus. A course of prednisone at 0.5 mg/kg per day for 1 month had no effect. He underwent five plasma exchanges (PLEx) over 10 days without side effects. His neuropathic pain began to improve after the second exchange and resolved after five exchanges. In addition, after the fourth exchange his heart rate and blood pressure remainder stable upon standing, permitting him to ambulate normally. His tinnitus persisted but improved. Subsequent antibody testing showed reduction of all titers; Sender's Comments: Based on the information provided, a causal relationship between BNT162B2  and the reported events  "Small-fiber neuropathy, tinnitus, postural orthostatic tachycardia 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 RAs, Ethics Committees, and Investigators, as appropriate.