Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lymphocyte count, Magnetic resonance imaging heart, Multisystem inflammatory syndrome in children, Myocarditis
Clinical narrative: Multisystem Inflammatory-like Syndrome; encephalopathy; myocarditis; isolated CLOCC; This is a literature report.  A 12 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2,single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing), notes: child lives in an endemic area for Lyme disease; "erythema migrans" (unspecified if ongoing), notes: completed amoxicillin treatment for a clinical diagnosis of Lyme disease. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose), for COVID-19 immunisation. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (hospitalization, medically significant, life threatening), outcome "recovered", described as "Multisystem Inflammatory-like Syndrome"; ENCEPHALOPATHY (hospitalization, medically significant, life threatening), outcome "recovered", described as "encephalopathy"; MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "recovered", described as "myocarditis"; CENTRAL NERVOUS SYSTEM LESION (hospitalization, medically significant, life threatening), outcome "recovered", described as "isolated CLOCC". The patient underwent the following laboratory tests and procedures: adenovirus test: negative, notes: Blood, NP swab; alanine aminotransferase (3-30): 35 IU/l; antibody test: negative; aspartate aminotransferase (2-40): 24 IU/l; blood glucose: 85 mg/dl; blood immunoglobulin g: negative; negative; negative; blood immunoglobulin m: negative; negative; blood sodium: 125 mmol, notes: hyponatremia; body temperature: 38.3 Centigrade; brain natriuretic peptide (normal high range 100): 190 pg/mL, notes: peaked; central nervous system function test: negative; c-reactive protein: 5.8 mg/dl, notes: elevated; culture: negative; drug specific antibody: negative; negative; echocardiogram: normal systolic and diastolic ventricular function, notes: normal coronary dimensions, no significant valvar dysfunction, and no pericardial effusion; ehrlichia test: negative; electrocardiogram: widespread repolarization abnormalities,, notes: with nonspecific ST-T wave changes; enterovirus test: negative; epstein-barr virus test: negative; gram stain: negative; herpes simplex test: negative; immune complex assay: negative, notes: index values at time of admission and 9 days after admission. (0.24 acute and 0.70 convalescent); inflammatory marker test: a marker of t-cell activation, notes: that is increased in viral, bacterial, and tick-borne infections; investigation: negative; 0.43, notes: mcg/mL FEU; negative; 21, notes: cmH2O; investigation (137-838): 690 IU/ml, notes: units/mL; lymphocyte count (1490-3110): 1080 cells/uL, notes: lymphopenia; magnetic resonance imaging heart: no evidence of active myocarditis, notes: or late gadolinium enhancement; cytotoxic lesion of the corpus callosum.; neurological examination: focal with a positive babinski response on  left; neutrophil count (4520-9170): 9840 cells/uL, notes: neutrophilia; platelet count: 313 kiU/mL; polymerase chain reaction: negative; protein total: 14.9 mg/dl; prothrombin time (12.1-14.6): 15.7 seconds; red blood cell count: 0; red blood cell sedimentation rate: 5, notes: mm/hr; respiratory syncytial virus test: negative; troponin t: 0.22 ng/ml, notes: elevated; varicella virus test: negative; west nile virus test: negative; white blood cell count: 2 with percent neutrophils, notes: 35 percent lymphocytes, 58 percent macrophages. Additional information:A MIS-C-like illness in a 12-year-old boy naïve to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who developed encephalopathy and myocarditis following COVID-19 mRNA vaccination and was found to have an isolated CLOCC. The child lives in an endemic area for Lyme disease. Nineteen days prior to presentation (five days after his first COVID-19 vaccine), he developed a lesion consistent with erythema migrans (EM), and completed amoxicillin treatment for a clinical diagnosis of Lyme disease. He received the second dose of the Pfizer-BioNTech COVID-19 vaccine two days prior to hospital presentation. That night, he developed severe headache, and over the next 48 h had persistent headache, emesis, visual hallucinations, worsening encephalopathy and was noted to have an elevated troponin indicating cardiac involvement. A timeline of the development of MIS-C-like symptoms after Lyme disease and COVID-19 vaccination is shown in Figure 1. He was admitted to the pediatric intensive care unit for close neurologic and cardiac monitoring and underwent brain magnetic resonance imaging (MRI). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the events Multisystem inflammatory syndrome in children, Encephalopathy, Myocarditis, Central nervous system lesion  with the suspect drug BNT162B2 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