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Life Threatening? No
Write-up: back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This is a spontaneous report from a contactable other health professional (parent). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Apr2021 15:30 at the age of 16 years old (Lot Number: E000167) as 2nd dose, single for covid-19 immunisation. The patient had no medical history, no known allergies. Concomitant medications received within 2 weeks of vaccination included vitamins nos (MULTIVITAMIN [VITAMINS NOS]), acetaminophen. The patient previously received the first dose of bnt162b2 (lot number: EN6208) intramuscular in Arm left on 07Apr2021 13:00 at the age of 16 years old for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Arm pain the first few days after receiving vaccine (2021). Then last night (02May2021), at 03:00 he came to his parent''s room and said his back was hurting. His parent gave him one Advil. He tried to go back to sleep but came back an hour later saying it felt like his heart was being squeezed. The doctor on call recommended they go to the ER. At the ER, they performed 2 EKGs, bloodwork, chest X-ray and an echocardiogram on 02May2021. His diagnosis upon discharge: acute chest pain and acute pericarditis on 02May2021. His bloodwork showed an elevated white blood count on 02May2021. They were to follow up with the pediatric cardiologist later this week. This events happened three days after his receiving his 2nd Covid vaccine shot. The adverse events result in Emergency room department or urgent care. Treatment received for the adverse events included Two EKGs, bloodwork, chest X-ray and echocardiogram. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn''t been tested for COVID-19. The outcome of the events was recovering.; Sender''s Comments: The causal relationship between BNT162B2 and the events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
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