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This is VAERS ID 1497534

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First Appeared on 7/23/2021

VAERS ID: 1497534
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 - / 2 - / -

Administered by: Unknown      Purchased by: ??
Symptoms: Blood creatine phosphokinase MB, Body temperature, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram, Full blood count, Heart rate, Myocarditis, PO2, Respiratory rate, Red blood cell sedimentation rate, Ejection fraction, Troponin T, Cardiac function test, Procalcitonin, N-terminal prohormone brain natriuretic peptide, Vital signs measurement, 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:
Allergies:
Diagnostic Lab Data: Test Name: CKMB; Result Unstructured Data: Test Result:39.3 IU/l; Comments: At presentation; Test Name: CKMB; Result Unstructured Data: Test Result:39.3 IU/l; Comments: Peak; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/91 mmHg; Comments: at presentation; Test Name: Temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: at presentation; Test Name: cardiac exam; Result Unstructured Data: Test Result:normal, without a murmur or friction rub; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unremarkable; Test Name: CRP; Result Unstructured Data: Test Result:24.3 mg/l; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:LVEF 60%; Comments: Both patients had normal left ventricular systolic function.; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:improved, but continued mild ST segment elevation; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:continued to show normal left ventricular function; Test Name: LVEF; Test Result: 60 %; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:ST segment elevation in inferolateral; Comments: ST segment elevation in inferolateral leads, T wave inversion Electrocardiogram shows ST segment elevation, especially in the lateral leads; Test Name: Complete blood count; Result Unstructured Data: Test Result:notable for neutrophilia without leukocytosis; Test Name: Heart rate; Result Unstructured Data: Test Result:108; Comments: units: beats per minute; at presentation; Test Name: Inflammatory markers; Result Unstructured Data: Test Result:mildly elevated; Test Name: Cardiac MRI findings; Result Unstructured Data: Test Result:Early gadolinium enhancement; Comments: Early gadolinium enhancement(4 minutes) of the myocardium; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:elevated; Test Name: NT-proBNP; Result Unstructured Data: Test Result:325 pg/mL; Comments: At presentation; Test Name: NT-proBNP; Result Unstructured Data: Test Result:364 pg/mL; Comments: Peak; Test Name: SpO2 in room air; Test Result: 100 %; Test Name: Procalcitonin; Result Unstructured Data: Test Result:less than 0.06 ng/ml; Test Name: ESR; Result Unstructured Data: Test Result:31; Comments: units: mm/hr; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Test Name: Respiratory viral panel PCR; Test Result: Negative ; Test Name: SARS-CoV-2 IgG; Test Result: Negative ; Comments: Result: 0.03. 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:431 ng/L; Comments: At presentation; Test Name: Troponin T; Result Unstructured Data: Test Result:1210 ng/L; Comments: Peak; Test Name: Vital signs; Result Unstructured Data: Test Result:notable for sinus tachycardia; Comments: initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure Heart rate, beats per minute 108, Blood pressure, mmHg 131/91, Temperature, degree Celsius 37.2, Respiratory rate 20, SpO2 in room air, % 100.
CDC 'Split Type': USPFIZER INC2021881937

Write-up: myocarditis; This is a Literature report from Cardiology in the Young, 2021, DOI: 10.1017/S1047951121002547, entitled "Self-limited myocarditis presenting with chest pain and ST segment elevation in adolescents after vaccination with the BNT162b2 mRNA vaccine". This reporter reported 2 reports; this is the 2 of 2 reports. We 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 (patient of this case) 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 (patient of this case) 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 (not patient of this case) 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 (Table 1). Complete blood count was notable for neutrophilia without leukocytosis. Cardiac enzymes were elevated in both cases at presentation (Table 1). 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 (Fig 1). Both patients had normal left ventricular systolic function on echocardiogram (Table 1). 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 (Fig 1). 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 (Fig 1), 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 (patient in this case) 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 (Table 1). 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. Discussion: We 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. We 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. Our case series suggests that chest pain within a week of COVID- 19 vaccination with an mRNA vaccine should raise the suspicion of focal myocarditis. Table 1. Demographics, clinical findings, and diagnostic test results of the patients with myocarditis following BNT162b2 vaccine administration: Patient B: Demographics: Age, years: 16; Sex Male; Ethnicity/race:[redacted]; History of cardiac conditions: None; BNT162b2 vaccine: Number of doses given: 2; Days after last vaccine administration to onset of chest pain: 2; Vital signs at presentation: Heart rate, beats per minute: 108; Blood pressure, mmHg: 131/91; Temperature, degree celsius: 37.2; Respiratory rate: 20; SpO2 in room air, %: 100; Cardiac markers (normal range): Troponin T, ng/L (<20 ng/L): At presentation: 431, Peak: 1210; CKMB, U/L (<4.1 U/L): At presentation: 39.3, Peak: 39.3; NT-proBNP, pg/mL (0-125 pg/mL): At presentation: 325, Peak: 364; Other laboratory results (normal range): ESR, mm/hr (0-15 mm/hr): 31; Procalcitonin (<0.10 ng/mL): <0.06; CRP, mg/L (<5.0 mg/L): 24.3; SARS-CoV-2 RT-PCR: Negative; SARS-CoV-2 IgG (<1.40 index): Negative (0.03); Respiratory viral panel PCR: Negative; Electrocardiogram findings: ST segment elevation in inferolateral leads, T wave inversion; Echocardiogram findings: LVEF 60%; Cardiac MRI findings: Early gadolinium enhancement (4 minutes) of the myocardium. Figure 1. Electrocardiogram, echocardiogram, and cardiac MRI findings associated with myocarditis after BNT162b2 vaccination. (a) Electrocardiogram shows ST segment elevation, especially in the lateral leads. (b) The echocardiogram shows patchy echogenic foci in the left ventricle with intact left ventricular systolic function. Arrow indicates echogenic areas in the interventricular septum. (c) Cardiac MRI with gadolinium enhancement using electrocardiogram-gated turbo spin echo T1-weighted sequences demonstrates early enhancement of the myocardium of the left ventricle, especially in the subendocardial layer, but no necrosis or significant oedema, consistent with myocarditis. Arrow indicates bright, enhanced areas of the left ventricular myocardium. Insert shows pre-gadolinium image with no myocardial enhancement. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocarditis due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.,Linked Report(s) : US-PFIZER INC-2021881859 same article, product, different patient, event


Record is removed as of 11/12/2021

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