Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Computerised tomogram thorax abnormal, Dyspnoea, Hypotension, Immunoglobulin therapy
Clinical narrative: sepsis; myocarditis; pneumonia; This is a spontaneous report from a contactable HCP (nurse). A 16 years old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular in arm right on 01May2021 10:00 AM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient is not pregnancy at time of vaccination. The patient's medical history was not reported. The patient had no known allergies (NKA). The patient's concomitant medication was reported as no prescribed medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Symptomatic COVID-19 (Non-PCR rapid NAA) from nasal swab on 19Dec2020 was negative. The patient admitted on 19May2021 with sepsis secondary to myocarditis and pneumonia, status post (s/p) intravenous immunoglobulin (IVIG), after presenting with fever, myalgia, sore throat, hypotension, elevated troponin, elevated C-reactive protein (CRP), and leukocytosis with left shift. Sore throat has been present for about a week (onset estimated on 12May2021) and fevers began on 17May2021 with a T max of 103. On 18May2021, she began developing shortness of breath and upon evaluation by the primary care physician (PCP) on 19May2021, she was admitted. During initial workup on 19May2021 upon admission, hospitalist was high concerned as she developed hypotension of 91/48 on 20May2021 at 08:35 am. Computerized tomography (CT) of chest on 20May2021 showed patchy consolidation of the posterior lower lobes bilaterally. Upon transfer to another place, further serologies were collected which showed leukocytosis with left shift, highly elevated C-reactive protein (CRP), elevated troponin, elevated Interleukin-6 (IL-6), elevated ferritin, negative covid antibodies (abs) test, negative respiratory viral panel  (RVP), and negative COVID PCR. Coronavirus NAA from nasal swab on 18May2021 was negative. Respiratory Viral Panel from nasal swab on 19May2021 was negative. COVID-19 (Standard NAA) from nasal swab on 19May2021 was negative. SARS CoV2 Antibodies from blood test on 20May2021 was negative. SARS COV2 IgM Antibodies from blood test on 20May2021 was positive. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. Intravenous immunoglobulin (IVIG) 2grams/kg started on 20May2021 at 22:57. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events sepsis, myocarditis, pneumonia were related to suspect drug based on the temporal relation between the vaccination and onset of events. 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.