Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, C-kit gene mutation, C-reactive protein, CD4/CD8 ratio, Complement analysis
Clinical narrative: SARS-CoV-2 vaccination complicated by small fiber neuropathy, mast cell activation syndrome, and pericarditis; SARS-CoV-2 vaccination complicated by small fiber neuropathy, mast cell activation syndrome, and pericarditis; SARS-CoV-2 vaccination complicated by small fiber neuropathy, mast cell activation syndrome, and pericarditis; This is a literature report for the following literature source(s).  A 66-year-old female patient received bnt162b2 (BNT162B2), in Dec2020 as dose 1, single (Lot number: EK5730) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), MAST CELL ACTIVATION SYNDROME (medically significant), SMALL FIBRE NEUROPATHY (medically significant), outcome "recovering" and all described as "SARS-CoV-2 vaccination complicated by small fiber neuropathy, mast cell activation syndrome, and pericarditis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (6-55): (unspecified date) 105 IU/l, notes: intermittently elevated; Antibody test: (unspecified date) 13.7, notes: elevated; Antibody test (normal high range 9.8): (unspecified date) 13.7 IU/ml; (unspecified date) Negative; Biopsy skin: (unspecified date) demonstrated normal Intra-Epidermal Nerve Fibre, notes: Density; Blood chromogranin A: (unspecified date) elevated; Blood immunoglobulin M: (unspecified date) Negative; Blood pressure measurement: (unspecified date) 176/127 mmHg, notes: elevated, 30 min after receiving the first dose of the BNT162b2 vaccine; CD4/CD8 ratio: (unspecified date) 12; (Feb2022) 3.7, notes: normalized; C-kit gene mutation: (unspecified date) Negative; Complement analysis: (unspecified date) was persistently high; Complement analysis (31-60): (unspecified date) greater than 60, notes: persistently high; C-reactive protein: (unspecified date) normal; Echocardiogram: (unspecified date) revealed a moderate pericardial effusion,, notes: pericarditis was diagnosed; Electromyogram: (unspecified date) were inconclusive; Fibrin D dimer: (unspecified date) normal; Flow cytometry: (unspecified date) lymphocyte panel revealed a CD4:CD8 ratio of 12; Gene mutation identification test: (unspecified date) Negative; Heart rate: (unspecified date) increased by 25-30 points when standing.; (unspecified date) tachycardia; Immunology test: (unspecified date) normal; Extensive hepatology evaluation: (unspecified date) Negative; (unspecified date) Negative; Light chain analysis: (unspecified date) small paraprotein migrating, notes: as IgA; (Apr2023) no longer present; Liver function test: (unspecified date) Negative; Nerve conduction studies: (unspecified date) were inconclusive; (unspecified date) Normal; Red blood cell sedimentation rate: (unspecified date) normal; Troponin: (unspecified date) normal; Tryptase: (unspecified date) elevated; Tryptase (normal high range 11): (unspecified date) 13.3-17.7 ug/L, notes: median value: 15; Urine analysis: (unspecified date) elevated. Therapeutic measures were taken as a result of pericarditis, mast cell activation syndrome, small fibre neuropathy.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Pericarditis, Mast cell activation syndrome, Small fiber neuropathy 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