Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering.   Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are  assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.