Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood fibrinogen, Blood pressure measurement, Blood sodium
Clinical narrative: MIS-C; he had tested positive for severe acute respiratory syndrome  coronavirus 2 (SARS-CoV-2) by nasopharyngeal nucleic acid amplification test; he had tested positive for severe acute respiratory syndrome  coronavirus 2 (SARS-CoV-2) by nasopharyngeal nucleic acid amplification test; This is a literature report.  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 1,single (Batch/Lot number: unknown) and as dose 2,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fever" (unspecified if ongoing), notes: 3 days; "abdominal pain" (unspecified if ongoing), notes: 3 days; "nausea" (unspecified if ongoing), notes: 3 days; "vomiting" (unspecified if ongoing), notes: 3 days; "hospitalized" (unspecified if ongoing), notes: pediatric intensive care unit. The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Hypotension, reaction(s): "No reaction"; Normal saline boluses for hypotension, reaction(s): "No reaction", notes: 2. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 6 weeks after the suspect product(s) administration, outcome "unknown" and all described as "he had tested positive for severe acute respiratory syndrome  coronavirus 2 (SARS-CoV-2) by nasopharyngeal nucleic acid amplification test"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (hospitalization, medically significant), 13 weeks after the suspect product(s) administration, outcome "recovering", described as "MIS-C". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 36): 22 IU/l, notes: Admission; 57 IU/l, notes: 1 Day Before Discharge; 40 IU/l, notes: 2 Week Follow up; Aspartate aminotransferase (15-50): 46 IU/l, notes: Admission; 90 IU/l, notes: 1 Day Before Discharge; 40 IU/l, notes: 2 Week Follow up; Blood fibrinogen (170-410): 429 mg/dl, notes: Admission; 302 mg/dl, notes: 1 Day Before Discharge; Blood pressure measurement: hypotensive; his blood pressure, notes: remained Despite 2 normal saline boluses; improvement, notes: in his blood pressure after 24  hours; Blood sodium: 130, notes: Outside Hospital; 133, notes: Admission; 136, notes: 1 Day Before Discharge; 137, notes: 2 Week Follow up; Body temperature: 100.8 Fahrenheit, notes: febrile; remained febrile; Brain natriuretic peptide (normal high range 60.0): 160.7 pg/mL, notes: Admission; 280.9 pg/mL, notes: 1 Day Before Discharge; Capillary nail refill test: diminished; Computerised tomogram thorax: negative, notes: for a pulmonary embolus; C-reactive protein: improved; C-reactive protein (normal high range 1.0): 21.7 mg/dl, notes: Admission; 5.8 mg/dl, notes: 1 Day Before Discharge; 0.5 mg/dl, notes: less than 0.5 2 Week Follow up; C-reactive protein (0.0-10.0): 89.4 mg/l, notes: Outside Hospital; Culture: negative; Echocardiogram: normal.; Electrocardiogram: normal.; Fibrin D dimer: elevated; Fibrin D dimer (normal high range 0.50): 1.96, notes: ug(FEU)/mL,Admission; 3.28, notes: ug(FEU)/mL.1 Day Before Discharge; 0.44, notes: ug(FEU)/mL.2 Week Follow up; Haematocrit: 38.1 %, notes: Outside Hospital; 37.1 %, notes: Admission; 33.3 %, notes: 1 Day Before Discharge; 38.2 %, notes: 2 Week Follow up; Haemoglobin (12.5-16.4): 13.1 g/dl, notes: Outside Hospital; 12.5 g/dl, notes: Admission; 11.4 g/dl, notes: 1 Day Before Discharge; 12.6 g/dl, notes: 2 Week Follow up; Heart rate: tachycardic, notes: he remained; Interleukin level (normal high range 10): 211.2 pg/mL, notes: Admission; Lymphocyte count: 0.31, notes: 10^9/L.Outside Hospital; 0.5, notes: 10^9/L.Admission; 2.8, notes: 10^9/L.1 Day Before Discharge; 1.5, notes: 10^9/L.2 Week Follow up; Magnetic resonance imaging heart: demonstrated mild biventricular dilation with, notes: normal function, a trivial pericardial effusion and no myocarditis. His  coronary arteries were normal; Nucleic acid test: positive, notes: syndrome  coronavirus 2 (SARS-CoV-2); physical examination: he  was  ill; abdominal pain  and subsequently developed an, notes: erythematous  macular rash on his chest and palms, nonexudative conjunctivitis, and periorbital edema  and erythema; development of mucocutaneous signs, he, notes: was given the diagnosis of MIS-C; His fever and mucocutaneous signs resolved; mild fatigue, notes: Two weeks after his discharge; Platelet count (142-508): 188, notes: 10^9/L.Outside Hospital; 162, notes: 10^9/L.Admission; 367, notes: 10^9/L.1 Day Before Discharge; 380, notes: 10^9/L.2 Week Follow up; Procalcitonin (normal high range 0.5): 2.4 ng/ml, notes: Admission; 0.5 ng/ml, notes: less than 0.5.1 Day Before Discharge; Red blood cell sedimentation rate (normal high range 13): 15, notes: mm/h.Admission; 33, notes: mm/h.1 Day Before Discharge; 35, notes: mm/h.2 Week Follow up; SARS-CoV-2 antibody test (normal high range 1.40): 3.12, notes: Index S/C.Admission; Serum ferritin (7-142): 218 ng/ml, notes: Admission; 128 ng/ml, notes: 2 Week Follow up; Troponin (normal high range 0.029): 0.010 ng/ml, notes: <0.010.Admission; 0.010 ng/ml, notes: less than 0.010.1 Day Before Discharge; 0.010 ng/ml, notes: less than 0.010.2-Week Follow-up; Ultrasound abdomen: showed a normal appendix, notes: to evaluate the appendix , and further workup for possible MIS-C diagnosis; White blood cell count (4.5-13.5): 4.93, notes: 10^9/L.Outside Hospital; 3.4, notes: 10^9/L.Admission; 8.8, notes: 10^9/L.1 Day Before Discharge; 5.7, notes: 10^9/L.2 Week Follow up. Therapeutic measures were taken as a result of multisystem inflammatory syndrome in children.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on information in the case report possible casual association between the reported events and suspected drug 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.