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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 2||- / -|
Administered by: Unknown Purchased by: ??
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Body mass index, C-reactive protein, Catheterisation cardiac, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Heart rate, Lymphocyte count, Myocarditis, Neutrophil count, Platelet count, White blood cell count, Red blood cell sedimentation rate, Polymerase chain reaction, Troponin T, Magnetic resonance imaging heart, SARS-CoV-2 test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2
Write-up: myopericarditis; This is a literature report from a source via contactable Physicians. This Physician reported similar events for seven patients. This is the second of seven reports. Introduction: On 11Dec2020, the FDA issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 mRNA vaccine for prevention of COVID-19 for individuals 16 years of age and older.1. On 10May2021, the FDA revised the EUA for this vaccine to include children 12 years and older. The Pfizer vaccine remains the only vaccine with an EUA for 12-to 17-year-old children. This vaccine demonstrated 94-95% efficacy in preventing COVID-19 infection in 16- 55-year-old participants, and 100% efficacy in the 12-15 years old age group. Systemic reactogenicity occurred more commonly in younger patients and after the second dose of vaccine. Post-immunization myocarditis is a known rare adverse event following other vaccinations, particularly following smallpox vaccination. Recently the news media has highlighted reports of myocarditis after COVID-19 mRNA vaccination involving military patients and patients from another country. The foreign cohort identified a male predominance with an incidence of 1/20,000 (men aged 18 to 30 years old). However, a conclusive causal link to vaccination has not been confirmed at this time. Additionally, two recently published foreign case reports describe myocarditis after COVID-19 mRNA vaccination in a 56-year-old man with previous COVID-19 and a 39-year-old man with no history of COVID-19. This report summarizes case histories of 7 healthy male adolescents 14 to 19 years of age who developed acute myocarditis or myopericarditis within 4 days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine, none of whom met criteria for MIS-C. All 7 patients were vaccinated in April and May of 2021 and have been reported to VAERS. Patient 2: A 19-year-old previously well male presented to a general ED with acute, persistent chest pain three days after his second Pfizer-BioNTech COVID-19 vaccine. He felt unwell for three days after vaccination with myalgias, fatigue, weakness, and subjective low-grade fe-vers. He had no recent or remote history of viral illness, and no known COVID-19 expo-sures. ECG showed diffuse ST elevation consistent with acute myocardial injury or pericar-ditis. Urgent cardiac catheterization showed normal coronary arteries and normal left ven-tricular function. Initial high sensitivity troponin T (232 ng/L, normal range, <14 ng/L) and CRP (6.7 mg/dL, normal range,<1.0 mg/dL) were highly elevated. Cardiac MRI confirmed myocarditis on the basis of the finding of patchy, mid-wall late gadolinium enhancement along the basal inferolateral wall segment. A nasopharyngeal swab for SARS-CoV-2 was negative. He remained hemodynamically stable and was discharged home two days later with the diagnosis of myopericarditis. He was treated with one 30 mg dose of intravenous ketorolac, 0.6 mg colchicine daily, and 650 mg aspirin three times daily. One week later, he was seen in follow-up. He complained of mild fatigue, but had no chest pain or shortness of breath, and his ECG showed tachycardia with a heart rate of 105 beats per minute. ST segment resolution was noted. As a result of his sinus tachycardia, a 48-hour Holter monitor was done which showed an average heart rate of 83 beats per minute with a 1% premature ventricular contraction (PVC) burden. No other arrhythmias were noted. An echocardiogram was normal. The colchicine (0.6 mg) and aspirin (325 mg) daily were continued. Exposure to COVID-19 in 14 days prior to illness onset was None. The patient underwent lab tests and procedures which included alanine aminotransferase: 14 (units/L), aspartate aminotransferase: 29 (units/L), blood albumin: 4.1 g/dl, body mass index: 19, catheterisation cardiac: normal, c-reactive protein: 6.7 mg/dl (normal < 1.0), highly elevated, echocardiogram: normal, electrocardiogram: diffuse st elevation, electrocardiogram: tachycardia, heart rate of 105 beats per minute, electrocardiogram: ST segment elevation (diffuse), electrocardiogram ambulatory: average heart rate, lymphocyte count: 1.39 (thousand/cu mm), magnetic resonance imaging heart: confirmed myocarditis, LGE involving mid LV wall, myocardial edema of basal inferolateral LV wall, neutrophil count: 5.93 (thousand/cu mm), Platelet count: 208 (thousand/cu mm), Respiratory pathogen panel PCR: Negative, Erythrocyte sedimentation rate: 13 mm/hr, Peripheral white blood cell count: 8.69 (thousand/cu mm). Discussion: Author report 7 cases of clinical myocarditis or myopericarditis that developed in 14 to 19-year-old males within 4 days of receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine with no evidence of acute SARS-CoV-2 infection and who did not fulfill criteria for MIS-C. Extensive diagnostic evaluation for other myocarditis etiologies was negative, including respiratory pathogens from nasopharyngeal swabs, serum PCR tests, and infectious serologies. Additionally, all cardiac MRIs were diagnostic for myocarditis based on the modified criteria rather than MIS-C characteristics described by (withheld) et al (diffuse myocardial edema without evidence of late gadolinium enhancement). There was some suggestion of abnormal left ventricular myocardial echocardiographic strain corresponding to regions of myocardial necrosis on cardiac MRI. All patients in this series had myocarditis or myopericarditis, which is the term for diagnosis of both myocardial and pericardial inflammation. These terms are often used interchangeably, which can make surveillance of these diseases challenging. Myocarditis and pericarditis are rare diseases. The true baseline incidence of myocarditis is unknown and varies by season, geography, and age: it has been reported to occur in 1.95/100,000 person- years in children <15 years of age in another country and in 2.16 cases per 100,000 military service members in a 30-day period. It is more common in males, and among children demonstrates a bimodal incidence pattern, with peaks at <2 years of age and in adolescence. An evaluation for potential viral causes is recommended, although a cause is usually not found. There have been prior reports of myocarditis following smallpox vaccination10. In patients with myocarditis, restriction from competitive sports is recommended for at least 3 months until cleared by a cardiologist in order to avoid sudden cardiac events while the heart muscle recovers. Less is known about the true incidence of pericarditis. Pericarditis can occur in the setting of a variety of infectious and non-infectious illnesses. In a study of patients more than16 years of age in another country, the incidence rate of hospitalizations for acute pericarditis was 3.32/100,000 person-years, with males at higher risk than females and in 2007, the incidence of acute pericarditis in one study was 27.2 cases per 100,000 per year. Treatment for myocarditis and pericarditis may vary considerably depending on the patient characteristics, clinical condition, underlying cause, and physician preference. Consistent with a known male preponderance of myocarditis and pericarditis, all seven of our cases were male. The Pfizer-BioNTech clinical trials demonstrated an increased systemic reactogenicity and immunogenicity in younger study participants following mRNA vaccine. For example, 41.5% of adolescents developed chills after dose #2, compared to 35.1% of subjects 18-55 years of age. In terms of immunogenicity, an analysis of SARS-CoV-2 50% neutralizing titers 1 month after dose#2 demonstrated higher geometric mean titer (GMT) in children 12-15 years of age (GMT=1,239.5), compared to subjects 16-25 years of age (GMT=705.1). Adverse events often occurred more frequently after dose #2 and within 2 days following vaccination and included injection site pain, fatigue, myalgia, chills, arthralgia, fever, injection site swelling or redness, nausea, malaise, and lymphadenopathy. It is possible that myocarditis or myopericarditis may be an additional rare adverse event related to systemic reactogenicity, but currently no causal association has been established between this vaccine and myopericarditis. In our case series, 6 patients received non-steroidal anti-inflammatory drug (NSAID) treatment. Four patients received IVIG and oral prednisone; one of these four patients also initially received high-dose methylprednisolone. The recognition of a possible temporal relationship of COVID-19 vaccine and myocarditis is critical, because the correct diagnosis may spare healthy adolescents and young adults presenting with chest pain and ECG ST elevation from undergoing unnecessary invasive medical procedures such as cardiac catheterization. It is unclear if treatment with intravenous immunoglobulin and/or corticosteroids, in the absence of MIS-C criteria, is warranted with all cases of myocarditis that develop temporally after COVID-19 vaccination. Notably, 3 patients recovered with NSAID therapy alone. Myocarditis and myopericarditis after COVID-19 vaccination appear rare. As of 23May2021, the Centers for Disease Control and Prevention (CDC) reports that 1,560,652 people <18 years of age have completed a two-dose series of COVID-19 vaccine17. Of these, 652, 758 adolescents received their second dose more than fourteen days ago17. Currently, the Pfizer-BioNTech COVID-19 vaccine is the only COVID-19 vaccine authorized for children <18 years of age. We urge physicians and healthcare providers to consider myocarditis in the evaluation of adolescents and young adults who develop chest pain after COVID-19 vaccination. All cases of myocarditis in patients with recent COVID-19 vaccination should be reported promptly to VAERS. Our case series has inherent limitations. We compiled cases through personal communications between colleagues rather than using a systematic surveillance system to identify cases. It was not possible to exclude all alternative etiologies including idiopathic and other infectious etiologies, and there was not a systematic diagnostic evaluation for other viral etiologies. Cardiac biopsy was not performed on any patients, because they were all clinically stable during hospitalization. However, no patient had evidence of a preceding or concurrent symptomatic viral illness to implicate as an etiology of myocarditis, and the lack of eosinophilia dissuades a hypersensitivity reaction. The pathophysiology of myocarditis in these patients is indeterminate and we do not know if it is the same or different than classic myopericarditis or myopericarditis following other vaccines, associated with acute COVID-19, or MIS-C. Given the nature of a case series, we cannot determine the incidence rate of myocarditis/myopericarditis following COVID-19 mRNA vaccination. Finally, a negative nucleocapsid antibody does not conclusively rule out the possibility of natural infection. This report summarizes a series of cases of myocarditis and myopericarditis following the Pfizer BioNTech COVID-19 mRNA vaccine in adolescent males. All cases in this report occurred after the second vaccine dose. Fortunately, none of our patients was critically ill and each was discharged home. At present, there is no definite causal relationship between these cases and vaccine administration. Information on the lot/batch number has been requested.; 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 myopericarditis due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and viral serologies 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) : PFIZER INC-2021665013 Same reporter, drug, event but different patient.
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