Sex: M
Vaccine: COVID19
Symptoms: Investigation, Light chain analysis, Magnetic resonance imaging, Magnetic resonance imaging head, Neurological examination
Clinical narrative: recrudescence of underlying asymptomatic polyneuropathy; influenza like illness; This is a literature report.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus type 2" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "migraine" (unspecified if ongoing); "eosinophilic granulomatosis with polyangiitis" (unspecified if ongoing), notes: diagnosed 10 years ago; "polyneuropathy" (unspecified if ongoing), notes: He had been diagnosed with EGPA associated , with polyneuropathy 10 years ago; "asthma" (unspecified if ongoing); "rhinosinusitis" (unspecified if ongoing); "rash" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mycophenolate mofetil, notes: for 2 years; Glucocorticoids, notes: for 3 years; Linagliptin; Metformin; Losartan; Hydrochlorothiazide; Rosuvastatin; Pregabalin for migraine prophylaxis. The following information was reported: POLYNEUROPATHY (medically significant), 5 days after the suspect product(s) administration, outcome "unknown", described as "recrudescence of underlying asymptomatic polyneuropathy"; INFLUENZA LIKE ILLNESS (non-serious), 5 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (5-34): 27 uL; Amino acid level (0.00-0.40): 0.24 umol/l, notes: Results on presentation; Antineutrophil cytoplasmic antibody: Negative; negative; Antinuclear antibody: less than 1:10; less than 1:10; Antinuclear antibody negative: negative; Antiribosomal P antibody: negative; Aspartate aminotransferase (5-34): 27 uL; Beta-2 glycoprotein antibody (0-20): 0, notes: SGU, Results on presentation; Beta-2 glycoprotein antibody: 1, notes: Results on presentation; Biopsy peripheral nerve: had findings suggestive of vasculitis; Blood albumin (3.3-5.0): 4.2 g/dl; Blood alkaline phosphatase (53-128): 9 uL; Blood bilirubin (0.2-1.2): 0.5 mg/dl; Blood calcium (8.4-10.2): 9.6 mg/dl; Blood chloride (98-110): 100 mmol/L; Blood cholinesterase: Negative; negative; Blood creatine phosphokinase (30-200): 70 uL, notes: Results on presentation; Blood creatinine (0.72-1.25): 1.12 mg/dl; Blood glucose (70-100): 144 mg/dl; Blood immunoglobulin G: negative; negative; negative; Blood potassium (3.5-5.0): 3.2 mmol/L; Blood sodium (135-145): 141 mmol/L; Blood urea (9-21): 15 mg/dl; Body temperature: 101, notes: degree F; Carbon dioxide (21-29): 28 mmol/L; C-reactive protein (normal high range 0.49): 0.5 mg/dl; 020 mg/dl; Cryoglobulins: negative; CSF cell count (0-5): 2, notes: mm cube; CSF glucose (40-90): 90 mg/dl; CSF protein (15-40): 31 mg/dl; DNA antibody: Negative, notes: Results on presentation; negative, notes: Result on follow-up; Electromyogram: was suggestive of mild chronic denervation in the, notes: left upper and lower extremities but no acute findings; Electrophoresis protein: Normal pattern, notes: Results on presentation; Normal pattern, notes: Result on follow-up; Eosinophil count (0.00-0.50): 0.94 kiU/L; Globulin (2.3-3.5): 3.3 g/dl; Glycosylated haemoglobin (4.0-6.0): 7 %; 6.8 %, notes: 6 months ago; Haematocrit (39.0-51.0): 47.4 %; Haemoglobin (13.0-17.0): 14.7 g/dl; Hepatitis B antibody: Negative; Hepatitis B antigen: negative; Hepatitis C antibody: Non-reactive; HIV antibody: non-reactive; HIV antigen: non-reactive; Immunology test: normal; Influenza virus test: negative; C3 (82-193): 165 mg/dl; 114 mg/dl; C4 (15-57): 46 mg/dl; 38 mg/dl; NCV: was suggestive of mild chronic denervation in the, notes: the left upper and lower extremities but no acute findings; negative; negative; SSA (0-40): 1, notes: AU/ml Results on presentation; Less than1.0, notes: AU/ml Result on follow-up; 1, notes: AU/ml. Results on presentation; less than 1.0, notes: AU/ml. Result on follow-up; negative; Light chain analysis (3.30-9.40): 9.82 mg/l, notes: Result on follow-up; Light chain analysis (0.26-1.65): 1.96; Light chain analysis (5.71-26.30): 5.02 mg/l, notes: Result on follow-up; Light chain analysis: unknown; Magnetic resonance imaging: unremarkable; unremarkable; unremarkable; Magnetic resonance imaging head: unremarkable; Neurological examination: revealed asymmetric findings; Ophthalmological examination: unremarkable; Platelet count (130-400): 312 x10 9/l; Polymerase chain reaction: negative; Porphyrins urine: Within normal limits; Protein total normal (6.0-8.3): 7.5 g/dl; Red blood cell count (4.20-5.60): 6.71 MiU/L; Red blood cell sedimentation rate (0-25): 1, notes: mm/hr. Results prior to presentation; 14, notes: mm/hr. Results on presentation; 2, notes: mm/hr. Result on follow-up; Rheumatoid factor (normal high range 30.0): less than 13, notes: Results on presentation; less than 14, notes: Result on follow-up; Serology test: negative; Vitamin B12 (213-816): 268 pg/mL, notes: Results on presentation; White blood cell count (3.98-9.57): 10.24 x10 9/l, notes: mild leucocytosis; 9.74 x10 9/l. Therapeutic measures were taken as a result of polyneuropathy, influenza like illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.