Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer, Fibrin D dimer increased, International normalised ratio, International normalised ratio increased
Clinical narrative: pancytopenia; pericarditis; myocarditis; left axillary adenopathy; fevers; Rash; chest pain; electrocardiogram ST segment elevation; chills; sore throat; shortness of breath; erythematous rash on trunk and limbs; arthralgia in the ankle; tachycardic / sinus tachycardia; mildly tachypneic; C-reactive protein increased; electrocardiogram abnormal; international normalised ratio increased; Troponin: 0.30; prothrombin time prolonged; Blood lactic acid/Lactate: 3.8; 2nd time-4.6; Fibrin d dimer/D-Dimer: 3618; This is a spontaneous report from a non-contactable consumer received from the FDA. The regulatory authority report number is not reported. An 18-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Arm Left on 12May2021 (lot number: EW0182) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications provided as none. No history of allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0165), via intramuscular on 21Apr2021 as single dose for COVID-19 immunization. On 02Jun2021, the patient experienced chest pain, myocarditis, pancytopenia, pericarditis, pyrexia, rash, left axillary adenopathy, chills, sore throat, shortness of breath, erythematous rash on trunk and limbs, arthralgia in the ankle, tachycardic / sinus tachycardia, mildly tachypneic, C-reactive protein increased, electrocardiogram abnormal, electrocardiogram ST segment elevation, international normalised ratio increased, Troponin/ Troponin: 0.30, prothrombin time prolonged, Blood lactic acid (Lactate: 3.8; 2nd time-4.6), Fibrin D dimer (D-Dimer: 3618). Events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, chest pain reported as hospitalized from 04Jun2021, three days in hospital. Events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, tachycardic and mildly tachypneic resulted in emergency room visit. The patient with intensive care on 02Jun2021. The clinical course was reported as follows: Few hours after vaccine developed fevers for 2 days which resolved. Then 02Jun2021 developed fevers, rash, chest pain, admitted to hospital; 04Jun2021 with fevers, rash, pancytopenia, pericarditis, myocarditis. Patient was in usual state of health until 02Jun2021 and experienced fevers, chills, sore throat, shortness of breath, chest pain, erythematous rash on trunk and limbs, arthralgia in the ankle. Presented to ED on 04Jun -febrile, tachycardic and mildly tachypneic. Patient was still currently admitted in unit. left axillary adenopathy. Lab data included on 04Jun2021 (all lab results) Lactate: 3.8; Lactate: 4.6 (2nd time); CRP: 20; EKG: sinus tachycardia, ST elevation suggests acute pericarditis; INR:1.2; D-Dimer: 3618; PT: 13.2; Sars COV2-PCR: negative; Troponin: 0.30. Fibrin d dimer with unknown results on unspecified date. Outcome of the event fevers was recovered on unspecified date. Outcome of events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, chest pain was not recovered, while of the other events was unknown. This report was assessed by reporting consumer as serious.   No follow-up attempts are needed. No further information is expected.