Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ST segment abnormal, Myocarditis, Pain, SARS-CoV-2 antibody test
Clinical narrative: chest pain; body aches; dizziness; SOB; near syncopal event; an EKG showed non-specific ST abnormalities with labs showing elevated troponin,; mildly elevated CRP; Upon readmission, her troponin was elevated (2.06 on 5/10); myocarditis; This is a spontaneous report from a contactable nurse. A 16-year-old female patient (pregnant: No) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 16-year-old, via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine, unknown if any other medications the patient received within 2 weeks of vaccination. Known Allergies: NSAIDs. On 19Apr2021, the patient experienced myocarditis, chest pain, body aches, dizziness, SOB, near syncopal event, an EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, with outcome of recovering. Upon readmission, her troponin was elevated (2.06 on 5/10) on 19Apr2021 with outcome of recovering. Seriousness criteria-Caused/prolonged hospitalization. The patient was hospitalized for myocarditis from 19Apr2021 to 23Apr2021. The patient was hospitalized for other events for 6 days. The adverse event result in Doctor or other healthcare professional office/clinic visit. Emergency room/department or urgent care. Clinical course as follows: patient is a 16 yo girl, s/p admission (19Apr-23Apr2021) with myocarditis, s/p IVIG (19April) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (15April). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. An EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Upon readmission, her troponin was elevated (2.06 on 10May). It was unknown prior to vaccination the patient diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. covid test type post vaccination: Blood test. covid test name post vaccination: SARS COV2 ANTIBODIES QUALITATIVE on 19Apr2021, covid test result: Positive. covid test type post vaccination: Nasal Swab, covid test name post vaccination: Respiratory Virus Panel by PCR on 19Apr2021, covid test result: Negative.  Information on the Lot/batch number has been requested.; Sender's Comments: The reported myocarditis with chest pain, body aches, dizziness, SOB, near syncopal event and the abnormal lab data were possibly related to the bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), considering temporal relationship and the inflammation features.  The case will be reassessed should additional information become 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.