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This is VAERS ID 1497531

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History of Changes from the VAERS Wayback Machine

First Appeared on 7/23/2021

VAERS ID: 1497531
VAERS Form:2
Age:
Sex:Male
Location:Hawaii
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:0000-00-00
Entered:2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown      Purchased by: ??
Symptoms: Blood creatine phosphokinase MB, Body temperature, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram, Full blood count, Headache, Heart rate, Myocarditis, PO2, Pyrexia, Respiratory rate, Red blood cell sedimentation rate, Ejection fraction, Troponin T, Procalcitonin, N-terminal prohormone brain natriuretic peptide, Vaccination site pain, Inflammatory marker test, Respiratory viral panel, Myocardial necrosis marker, Blood pressure measurement, Magnetic resonance imaging heart, SARS-CoV-2 test, SARS-CoV-2 antibody test

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Name: CKMB; Result Unstructured Data: Test Result:54.6 IU/l; Comments: At presentation; elevated; Test Name: CKMB; Result Unstructured Data: Test Result:54.6 IU/l; Comments: Peak; Test Name: Blood pressure; Result Unstructured Data: Test Result:119/72 mmHg; Test Name: Temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Name: Chest X-rays; Result Unstructured Data: Test Result:unremarkable; Test Name: CRP; Result Unstructured Data: Test Result:18.5 mg/l; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:LVEF 63%, increased patchy echogenicity; Comments: LVEF 63%, increased patchy echogenicity of the myocardium, normal left ventricular systolic function.; Test Name: LVEF; Test Result: 63 %; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:ST segment elevation in lateral leads,; Comments: ST segment elevation in lateral leads, left axis deviation. normal left ventricular function throughout the hospitalisation.; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:improved, but continued mild ST segment elevation; Test Name: Complete blood count; Result Unstructured Data: Test Result:notable for neutrophilia without leukocytosis; Test Name: Heart rate; Result Unstructured Data: Test Result:116; Comments: beats per minute; Test Name: Inflammatory markers; Result Unstructured Data: Test Result:mildly elevated; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:unknown results; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:elevated; Test Name: NT-proBNP; Result Unstructured Data: Test Result:108 pg/mL; Comments: At presentation; Test Name: NT-proBNP; Result Unstructured Data: Test Result:498 pg/mL; Comments: Peak; Test Name: SpO2 in room air; Test Result: 96 %; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.15 ng/ml; Test Name: ESR; Result Unstructured Data: Test Result:7; Comments: mm/hr; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Test Name: Respiratory viral panel PCR; Test Result: Negative ; Test Name: SARS-CoV-2 IgG; Result Unstructured Data: Test Result:Negative (0.24); Comments: Normal range: less than 1.40 index; Test Name: SARS-CoV-2 RT-PCR; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:304 ng/L; Comments: At presentation; Test Name: Troponin T; Result Unstructured Data: Test Result:832 ng/L; Comments: Peak
CDC 'Split Type': USPFIZER INC2021881859

Write-up: myocarditis; fever; headache; tender vaccination site; This is a Literature report. This reporter reported similar event for two patients, this is the first of 2 reports. Authors describe, for the first time, adolescents presenting with chest pain and imaging evidence of myocarditis in close temporal association with the BNT162b2 vaccination. Two adolescent males, aged 15-16 years of age, presented in the Emergency Department with chest pain within 3 days of BNT162b2 vaccine administration, one of them after the first, the other after the second dose of the vaccine. One patient noted mild and typical vaccine-related symptoms including tactile fever, headache, and tender vaccination site within a day of vaccine administration, while the other patient had no such symptoms. Within a couple of days after vaccination, both patients developed acute onset, mid-sternal, non-radiating chest pain associated with chest tightness. One patient had a history of mild intermittent asthma, otherwise, they had no known medical conditions and no prior surgeries. Their initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure. They had a normal cardiac exam without a murmur or friction rub. Inflammatory markers were mildly elevated. Complete blood count was notable for neutrophilia without leukocytosis. Cardiac enzymes were elevated in both cases at presentation. Infectious workup including immunoglobulin G and real-time reverse transcription polymerase chain reaction for SARS-CoV-2 and respiratory viral panel polymerase chain reaction containing the most common aetiologic agents of viral myocarditis were negative in both patients. Chest X-rays were unremarkable. Electrocardiograms showed ST elevation and T wave inversion in lateral leads. Both patients had normal left ventricular systolic function on echocardiogram. Small areas of increased echogenicity could be detected throughout the myocardium in one of the patients, especially in the interventricular septum and lateral wall of the left ventricle. Cardiac MRI with early gadolinium enhancement using electrocardiogram- gated turbo spin echo T1-weighted sequences showed mild global early enhancement of the myocardium, with pronounced enhancement in the subendocardial layer of the left ventricle, findings consistent with inflammation of the myocardium without evidence of myocardial necrosis, fibrosis, or oedema. Cardiac catheterisation was not performed as there was low suspicion for acute coronary syndrome and the cardiac MRI was consistent with myocarditis. One patient received intravenous immunoglobulin, while the other patient improved without any treatment. Echocardiograms continued to show normal left ventricular function throughout the hospitalisation. Troponin T peaked at 832 and 1210 ng/L, but creatine kinase myocardial band did not increase beyond initial levels. Chest pain resolved a day after admission and both patients were discharged from the hospital within 4 days of admission. Electrocardiograms showed improved, but continued mild ST segment elevation at discharge. Authors present two adolescents with evidence of myocarditis shortly after BNT162b2 vaccination. The presentation of these adolescents were consistent with myocarditis based on clinical, imaging, and laboratory findings, and no other alternative aetiology was found. Authors excluded acute or recent COVID-19 infection and did not find evidence of other viral aetiologies. The temporal association with the preceding COVID-19 vaccine raised the suspicion of a vaccinerelated self-limited myocarditis. This case series suggests that chest pain within a week of COVID- 19 vaccination with an mRNA vaccine should raise the suspicion of focal myocarditis. A 15-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included mild intermittent asthma. The patient''s concomitant medications were not reported. The patient experienced myocarditis on an unspecified date 3 days after the vaccination, fever, headache, and tender vaccination site on an unspecified date within a day of vaccine administration. The patient was hospitalized for event myocarditis. The patient underwent lab tests and procedures which included CKMB (normal range: less than 4.1): 54.6 iu/l at presentation, elevated; 54.6 iu/l peak. Blood pressure: 119/72 mmhg. Temperature: 37.2 centigrade. Chest x-ray: unremarkable. CRP (normal range: less than 5.0): 18.5 mg/l. Echocardiogram findings: LVEF 63%, increased patchy echogenicity of the myocardium, normal left ventricular systolic function. LVEF: 63 %. Electrocardiogram findings: ST segment elevation in lateral leads, left axis deviation, normal left ventricular function throughout the hospitalisation. Electrocardiogram findings: improved, but continued mild ST segment elevation. Complete blood count: notable for neutrophilia without leukocytosis. Heart rate: 116 beats per minute. Inflammatory markers: mildly elevated. Cardiac MRI: unknown results. Cardiac enzymes: elevated. NT-proBNP (normal range: 0-125): 108 pg/mL at presentation, 498 pg/mL peak. SpO2 in room air: 96%. Procalcitonin (normal range: less than 0.10): 0.15 ng/ml. ESR (normal range: 0-15): 7 mm/hr. Respiratory rate: 18. Respiratory viral panel PCR: Negative. SARS-CoV-2 IgG (Normal range: less than 1.40 index): Negative (0.24). SARS-CoV-2 RT-PCR: Negative. Troponin T (normal range: less than 20): 304 ng/L at presentation, 832 ng/L peak. The patient received treatment of intravenous immunoglobulin for event myocarditis. The outcome of event myocarditis was resolved, outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on known drug safety profile and plausible temporal relationship, a possible causal association between the event "myocarditis" and the suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-2021881937 same article, product, different patient, similar event

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