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From the 10/15/2021 release of VAERS data:

Found 4,148 cases where Age is Unknown and Vaccine targets COVID-19 (COVID19) and Symptom is Acute endocarditis or Atypical mycobacterium pericarditis or Autoimmune myocarditis or Bacterial pericarditis or Carditis or Endocarditis or Endocarditis bacterial or Endocarditis enterococcal or Endocarditis noninfective or Endocarditis staphylococcal or Endocarditis viral or Eosinophilic myocarditis or Fungal endocarditis or Giant cell myocarditis or Immune-mediated myocarditis or Lupus endocarditis or Lyme carditis or Meningococcal carditis or Myocarditis or Myocarditis bacterial or Myocarditis infectious or Myocarditis septic or Myopericarditis or Pericarditis or Pericarditis constrictive or Pericarditis infective or Pericarditis lupus or Pericarditis meningococcal or Pericarditis rheumatic or Pericarditis tuberculous or Pleuropericarditis or Purulent pericarditis or Streptococcal endocarditis or Subacute endocarditis or Viral myocarditis or Viral pericarditis



Case Details

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VAERS ID: 1412502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
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, Magnetic resonance imaging heart, Myocarditis, Neutrophil count, Platelet count, Polymerase chain reaction, Red blood cell sedimentation rate, SARS-CoV-2 test, Troponin T, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Alanine transaminase; Result Unstructured Data: Test Result:14; Comments: (units/L); Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:29; Comments: (units/L); Test Name: Albumin; Result Unstructured Data: Test Result:4.1 g/dl; Test Name: BMI; Result Unstructured Data: Test Result:19; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:normal; Test Name: C-reactive protein; Test Result: 6.7 mg/dl; Comments: (normal < 1.0), highly elevated; Test Name: echocardiogram; Result Unstructured Data: Test Result:normal; Test Name: ECG; Result Unstructured Data: Test Result:diffuse ST elevation; Test Name: ECG; Result Unstructured Data: Test Result:tachycardia; Comments: heart rate of 105 beats per minute.; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST segment; Comments: ST segment elevation (diffuse); Test Name: Holter monitor; Result Unstructured Data: Test Result:average heart rate; Test Name: heart rate; Result Unstructured Data: Test Result:105 beats per minute; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result:1.39; Comments: (thousand/cu mm); Test Name: Cardiac MRI; Result Unstructured Data: Test Result:confirmed myocarditis; Comments: LGE involving mid LV wall, myocardial edema of basal inferolateral LV wall; Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:5.93; Comments: (thousand/cu mm); Test Name: Platelet count; Result Unstructured Data: Test Result:208; Comments: (thousand/cu mm); Test Name: Respiratory pathogen panel PCR; Test Result: Negative ; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:13; Comments: mm/hr; Test Name: COVID-19 PCR; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:232 ng/ml; Comments: highly elevated, High-sensitivity troponin T: 232 (< 14); Test Name: Peripheral white blood cell count; Result Unstructured Data: Test Result:8.69; Comments: (thousand/cu mm)
CDC Split Type: USPFIZER INC2021665014

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.


VAERS ID: 1412503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Adenovirus test, Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Brain natriuretic peptide increased, C-reactive protein, C-reactive protein increased, Cytomegalovirus test, Drug screen, Drug screen negative, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, International normalised ratio, Lymphocyte count, Magnetic resonance imaging heart, Myocarditis, Neutrophil count, Platelet count, Prothrombin time, Red blood cell sedimentation rate, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Serum ferritin, Troponin I, White blood cell count
SMQs:, Cardiac failure (broad), Haemorrhage laboratory terms (broad), Drug abuse and dependence (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Partial thromboplastin time; Test Result: 31.4 s; Test Name: Adenovirus diagnostics; Test Result: Negative ; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:33 IU/l; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:41 IU/l; Test Name: Albumin; Result Unstructured Data: Test Result:4.1 g/dl; Test Name: Highest NT-pro BNP; Result Unstructured Data: Test Result:376 pg/mL; Test Name: NT pro-BNP; Result Unstructured Data: Test Result:376 pg/mL; Test Name: C-reactive protein; Test Result: 25.3 mg/dl; Test Name: C-reactive protein; Result Unstructured Data: Test Result:normal mg/dl; Test Name: Highest C-reactive protein; Test Result: 25.3 mg/dl; Test Name: Cytomegalovirus diagnostics; Test Result: Negative ; Test Name: Urine drug screen; Test Result: Negative ; Test Name: Enterovirus diagnostics; Test Result: Negative ; Test Name: Epstein-Barr virus diagnostics; Test Result: Negative ; Test Name: International Normalized Ratio INR; Result Unstructured Data: Test Result:1.06; Test Name: Absolute lymphocyte; Result Unstructured Data: Test Result:2.13; Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:7.46 x10 3/mm3; Test Name: Platelet count; Result Unstructured Data: Test Result:231 x10 3/mm3; Test Name: Prothrombin time; Test Result: 14.0 s; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:6; Test Name: COVID-19 spike antibody; Test Result: Positive ; Test Name: COVID-19 nucleocapsid antibody; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: Test Result:90 ug/L; Test Name: Highest troponin; Result Unstructured Data: Test Result:12.20 ng/ml; Test Name: Lowest troponin prior to discharge; Result Unstructured Data: Test Result:5.79 ng/ml; Test Name: Troponin I; Result Unstructured Data: Test Result:5.55 ng/ml; Test Name: Troponin I; Result Unstructured Data: Test Result:normal ng/ml; Test Name: Peripheral white blood cell count; Result Unstructured Data: Test Result:11.8 x10 3/mm3; Test Name: ECG; Result Unstructured Data: Test Result:showed abnormal T waves with diffuse ST elevation; Comments: showed abnormal T waves with diffuse ST elevation consistent with pericarditis.; Test Name: ECG; Result Unstructured Data: Test Result:showed normal function and coronaries, no effusion; Comments: showed normal function and coronaries, no effusion, trace mitral and aortic valve insufficiency, and decreased left ventricular basolateral and posterior regional strain; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Name: ECG; Result Unstructured Data: Test Result:unchanged; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:showed delayed enhancement at the left ventricular; Comments: showed delayed enhancement at the left ventricular subepicardial basal anterolateral segment and basal to mid ventricular inferolateral segments, consistent with myocardial necrosis. There was evidence of diffuse fibrosis on T1 weighted imaging and myocardial edema on T2 mapping.; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:elevated cardiac markers and inflammation on cardi; Comments: elevated cardiac markers and inflammation on cardiac MRI prompted the diagnosis of myopericarditis.; Test Name: urine drug screen; Test Result: Negative
CDC Split Type: USPFIZER INC2021665016

Write-up: acute myocarditis or myopericarditis; This is a literature report. This is the third 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 year 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 a foreign 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 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 3: A 17-year-old previously well male presented with chest pain two days after his second Pfizer- BioNTech COVID 19 vaccine. Chest pain was worse when lying flat and was associated with left arm pain and paresthesias. He had no recent or remote history of viral illness, and no known COVID 19 exposures. ECG showed abnormal T waves with diffuse ST elevation consistent with pericarditis. Notable laboratory studies included elevated troponin I (5.550 ng/mL, normal range, <0.045 ng/mL), NT Pro BNP (376pg/mL, normal range, <100 pg/mL) and CRP (25.3 mg/L, normal range, < 1.0 mg/dL). Echocardiogram showed normal function and coronaries, no effusion, trace mitral and aortic valve insufficiency, and decreased left ventricular basolateral and posterior regional strain. Cardiac MRI showed delayed enhancement at the left ventricular subepicardial basal anterolateral segment and basal to mid ventricular inferolateral segments, consistent with myocardial necrosis. There was evidence of diffuse fibrosis on T1 weighted imaging and myocardial edema on T2 mapping. SARS CoV 2 spike antibody was positive and nucleocapsid antibody was negative. Workup for other infections and a urine drug screen were negative. Troponin peaked at 12.200 ng/ml. His symptoms resolved with ibuprofen 600 mg orally every 6 hours and he was discharged at 48 hours. Based on the characteristics of his chest pain, ECG findings, and prompt response to anti-inflammatory medication, pericardial involvement was suspected. The presence of elevated cardiac markers and inflammation on cardiac MRI prompted the diagnosis of myopericarditis. At one week followup, he remained asymptomatic with normal troponin, CRP, and ECG; the echocardiogram was unchanged. Partial thromboplastin time: 31.4 seconds, Adenovirus diagnostics: Negative, Alanine transaminase: 33 IU/L, Aspartate transaminase: 41 iu/l, Albumin: 4.1 g/dl, Cytomegalovirus diagnostics: Negative, Urine drug screen: Negative, Enterovirus diagnostics: Negative, Epstein-Barr virus diagnostics: negative, International Normalized Ratio INR: 1.06, Absolute lymphocyte: 2.13, Absolute neutrophil count: 7.46x10 3/mm3, Platelet count: 231x10 3/mm3, Prothrombin time: 14.0 seconds, erythrocyte sedimentation rate: 6, Ferritin: 90ug/L, Lowest troponin prior to discharge: 5.79 ng/ml, Peripheral white blood cell count: 11.8x10 3/mm3. 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 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 foreign 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The event myocarditis is serious and unexpected with this suspect product, Pfizer-BioNTech COVID-19 mRNA vaccine. This case will be updated when new information becomes available.,Linked Report(s) : PFIZER INC-2021665013 Same reporter, drug, event but different patient


VAERS ID: 1412504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adenovirus test, Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Brain natriuretic peptide, C-reactive protein, Cytomegalovirus test negative, Echocardiogram, Electrocardiogram, Enterovirus test negative, Epstein-Barr virus test negative, International normalised ratio, Lymphocyte count, Magnetic resonance imaging heart, Myocarditis, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Platelet count, Polymerase chain reaction, Prothrombin time, Red blood cell sedimentation rate, SARS-CoV-2 antibody test negative, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative, Serum ferritin, Troponin T, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Adenovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Alanine transaminase; Test Result: 20 uL; Comments: units/L; Test Name: Aspartate transaminase; Test Result: 82 uL; Comments: units/L; Test Name: Albumin; Result Unstructured Data: Test Result:4.4 g/dl; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:Unknown results; Comments: normal <100; Test Name: C-reactive protein; Test Result: 12.7 mg/dl; Test Name: Cytomegalovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Normal; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST elevation; Test Name: Enterovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Epstein-Barr virus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: International Normalized Ratio INR; Result Unstructured Data: Test Result:Unknown results; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result:2.3; Comments: thousand/cumm; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:Fibrosis, myocardial edema, hyperemia, mild regurg; Comments: Fibrosis, myocardial edema, hyperemia, mild mitral regurgitation (RF ~18%); Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:9.5; Comments: thousand/cumm; Test Name: NT pro-BNP; Result Unstructured Data: Test Result:Unknown results pg/mL; Test Name: Platelet count; Result Unstructured Data: Test Result:236; Comments: thousand/cumm; Test Name: Respiratory pathogen panel PCR; Test Result: Negative ; Test Name: Prothrombin time; Result Unstructured Data: Test Result:Unknown results; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:40; Comments: mm/hr; Test Name: COVID-19 nucleocapsid antibody; Test Result: Negative ; Test Name: COVID-19 spike antibody; Test Result: Positive ; Test Name: COVID-19 PCR; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: Test Result:103 ug/dL; Test Name: Highest Troponin T; Result Unstructured Data: Test Result:1.09 ng/ml; Comments: on admission Troponin T: 1.09 (<0.01); Test Name: Lowest troponin prior to discharge; Result Unstructured Data: Test Result:0.4 ng/ml; Comments: Troponin T: 0.4 (<0.01); Test Name: Peripheral white blood cell count; Result Unstructured Data: Test Result:12.6; Comments: thousand/cu mm
CDC Split Type: USPFIZER INC2021665017

Write-up: Seven cases of acute myocarditis or myopericarditis in healthy male adolescents who presented with chest pain all within four days after the second dose of Pfizer-BioNTech COVID-19 vaccination.; This is a literature report from unknown source via contactable Physicians. This Physician reported similar events for seven patients. This is the fourth 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 year 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 local military patients and patients from a foreign 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 other 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 4: An 18-year-old previously well male was admitted with a chief complaint of chest pain three days after he received the second dose Pfizer-ioNTech COVID-19 vaccine. Soon after vaccination, he had developed malaise, arthralgia, myalgia, and subjective fever. He had no recent or remote history of viral illness, and no known COVID-19 exposures. Two days prior to admission he noted mid-sternal chest pain and presented to his primary care physician who noted ST elevation on ECG prompting transfer to an ED, where evaluation showed elevated troponin T (1.09 ng/mL, normal range, <0.01 ng/mL), ST-elevation on ECG and normal echocardiogram. Cardiac MRI demonstrated edema, hyperemia, and fibrosis, consistent with myocarditis. A nasopharyngeal SARS-CoV-2 PCR was negative and antibody testing showed positive spike and negative nucleocapsid antibodies for SARS-CoV-2. Adenovirus diagnostics: Negative serum PCR, Alanine transaminase (units/L): 20, Aspartate transaminase (units/L): 82, Albumin (g/dL): 4.4, Brain natriuretic peptide: Unknown results (normal <100), Highest C-reactive protein (mg/dL) (normal < 1.0): 12.7, Cytomegalovirus diagnostics: Negative serum PCR, Echocardiogram: Normal, Electrocardiogram: ST elevation, Enterovirus diagnostics: Negative serum PCR, Epstein-Barr virus diagnostics: Negative serum PCR, International Normalized Ratio INR: Unknown results, Absolute lymphocyte count (thousand/cu mm): 2.3, Cardiac MRI: Fibrosis, myocardial edema, hyperemia, mild mitral regurgitation (RF~18%), Absolute neutrophil count (thousand/cu mm): 9.5, NT pro-BNP: Unknown results, Platelet count (thousand/cu mm): 236, Respiratory pathogen panel PCR* (Manufacturer): Negative (BioFire), Erythrocyte sedimentation rate (mm/hr): 40, COVID-19 nucleocapsid antibody (Manufacturer): Negative (Roche), COVID-19 PCR: Negative, COVID-19 spike antibody (Manufacturer): Positive (Roche), Ferritin (ug/L): 103, Highest troponin (ng/mL) (normal range): Troponin T: 1.09 (<0.01), Lowest troponin prior to discharge (ng/mL) (normal range: Troponin T: 0.4 (<0.01), Peripheral white blood cell count (thousand/cu mm): 12.6. Troponin testing reduced over the course of the 3-day hospitalization and telemetry remained normal. He was treated with 70 grams IVIG and received 30 mg methylprednisolone intravenously every 12 hours for 2 doses followed by prednisone 30 mg orally twice daily with a gradual taper over 4 weeks. He also received ibuprofen 600 mg orally every 6 hours as needed for pain, and was discharged with a 30-day prescription for aspirin 81 mg orally once daily. At his first outpatient follow-up the following week, he felt well, troponin had normalized and both echocardiogram and ECG remained normal. Time between vaccine dose#2 and symptom onset (days): 4. Total hospital LOS (days): 4. ICU LOS (days): 4. 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 a foreign country and in 2.16 cases per 100,000 local 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 a foreign 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 local 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 acute myocarditis 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


VAERS ID: 1412505 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Adenovirus test, Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, C-reactive protein, Culture throat, Cytomegalovirus test, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Haematocrit, International normalised ratio, Lymphocyte count, Magnetic resonance imaging heart, Myocarditis, Neutrophil count, Platelet count, Prothrombin time, Red blood cell sedimentation rate, Serum ferritin, Severe acute respiratory syndrome, Sinus bradycardia, Troponin, White blood cell count
SMQs:, Disorders of sinus node function (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Partial Prothrombin time; Test Result: 30.4 s; Test Name: Adenovirus; Result Unstructured Data: Test Result:Negative serum PCR; Test Name: alanine transaminase; Result Unstructured Data: Test Result:22; Test Name: Aspartate; Result Unstructured Data: Test Result:150; Test Name: albumin; Result Unstructured Data: Test Result:4.0 g/dl; Test Name: c-reactive protein; Test Result: 18.1 mg/dl; Test Name: swab throat; Result Unstructured Data: Test Result:Negavtive streptococcal antigen test; Test Name: Cytomegalovirus; Result Unstructured Data: Test Result:Negative Serum PCR; Test Name: ECG; Result Unstructured Data: Test Result:ST elevation; Test Name: ECG; Result Unstructured Data: Test Result:T wave abnormailities; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal Function and structure; Test Name: Enterovirus; Result Unstructured Data: Test Result:Negative Serum PCR; Test Name: Epstein-Barr virus; Result Unstructured Data: Test Result:Negative Serum PCR; Test Name: packed cell volume; Result Unstructured Data: Test Result:normal; Test Name: INR; Result Unstructured Data: Test Result:1.13; Test Name: absolute lymphocyte count; Result Unstructured Data: Test Result:4.1; Test Name: cardiac MRI; Result Unstructured Data: Test Result:demonstrated diffuse, nearly complete transmural L; Comments: demonstrated diffuse, nearly complete transmural LV free wall gadolinium enhancement; Test Name: absolute neutrophil count; Result Unstructured Data: Test Result:9.8; Test Name: platelet count; Result Unstructured Data: Test Result:297; Test Name: Prothrombin time; Test Result: 12.1 s; Test Name: ESR; Result Unstructured Data: Test Result:38; Test Name: ferritin; Result Unstructured Data: Test Result:347 ug/L; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Comments: Showed positive spike and negative nucleocapsid antibodies; Test Name: sinus bradycardia; Result Unstructured Data: Test Result:Normal; Test Name: troponin; Result Unstructured Data: Test Result:3.21; Test Name: troponin; Result Unstructured Data: Test Result:0.96 ng/ml; Test Name: Peripheral White blood cell; Result Unstructured Data: Test Result:16.3
CDC Split Type: USPFIZER INC2021665018

Write-up: This is a literature report from the Pediatrics, 2021, entitled Symptomatic Acute Myocarditis in Seven Adolescents Following Pfizer BioNTech COVID- 19 Vaccination. Additionally reported in Pediatrics, 2021, entitled Myocarditis after SARS-CoV-2 Vaccination: True, True, and Related via contactable Physicians. This Physician reported similar events for seven patients. This is the fifth 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 year 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 United States (US) military patients and patients from Israel. The Israeli 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 European 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 pericarditis 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 5: A 17-year-old previously well male was admitted with a chief complaint of chest pain. His symptoms began 3 days after his second Pfizer-BioNTech COVID-19 vaccine with sore throat, headache, dry cough and body aches. He had no recent or remote history of viral illness, and no known COVID-19 exposures. He then developed subjective fever and was treated for suspected streptococcal pharyngitis with amoxicillin; however, a throat swab yielded a negative streptococcal antigen test. The next day he developed midsternal chest pain that was worse when lying flat and radiated to the left arm. Evaluation in the ED showed elevated troponin T (3.21 ng/mL, normal range, <0.01 ng/mL), ST-elevation on ECG and normal function and structure on echocardiogram. Initial cardiac MRI demonstrated diffuse, nearly complete transmural LV free wall gadolinium enhancement. A nasopharyngeal SARS-CoV-2 PCR was negative; antibody testing showed positive spike and negative nucleocapsid antibodies for SARS-CoV-2. He received 70 grams IVIG and was started on methylprednisolone 30 mg intravenously every 12 hours (2 doses), then transitioned to prednisone 30mg orally every 12 hours with a gradual taper over 4 weeks. He also received ibuprofen 600 mg orally every 6 hours for the first 3 days and then as needed. He was discharged home with a 30-day prescription for aspirin 81 mg by mouth once daily. Troponin level initially fell by 50% over the first 48 hours but on the third day of admission there was an acute rise that sustained for 12 hours before serial reduction. At discharge, the troponin T remained elevated (0.96 ng/mL, normal range, <0.01 ng/mL). Telemetry during the 5-day hospitalization showed occasional monomorphic PVCs and sinus bradycardia during sleep but was otherwise normal. Serial echocardiograms were normal. On follow-up 4 days after discharge, the echocardiogram was normal but ECG showed diffuse T wave abnormalities. Partial Prothrombin time: 30.4 seconds, Adenovirus: Negative serum PCR, alanine transaminase: 22, Aspartate: 150, albumin: 4.0g/dl, c-reactive protein: 18.1 mg/dl (normal <10), Cytomegalovirus: Negative Serum PCR, Enterovirus: Negative Serum PCR, Epstein-Barr virus: Negative Serum PCR, packed cell volume: normal, INR: 1.13, absolute lymphocyte count: 4.1, absolute neutrophil count: 9.8, platelet count: 297, Prothrombin time: 12.1 seconds, ESR: 38, ferritin: 347 ug/l, Peripheral White blood cell: 16.3. Author report 7 cases of clinical myocarditis or pericarditis 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 Lake Louise 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 Finland and in 2.16 cases per 100,000 US 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 than 16 years of age in Finland, 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 pericarditis 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 pericarditis 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 vaccine 17. Of these, 652, 758 adolescents received their second dose more than fourteen days ago 17. Currently, the Pfizer-BioNTech COVID-19 vaccine is the only COVID-19 vaccine authorized for children <18 years of age in the US. 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 pericarditis 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/pericarditis 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 US cases of myocarditis and pericarditis 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The event myocarditis is serious and unexpected with this suspect product, Pfizer-BioNTech COVID-19 mRNA vaccine. This case will be updated when new information becomes available.,Linked Report(s) : US-PFIZER INC-2021665013 Same reporter, drug, event but different patient


VAERS ID: 1412506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase, Antibody test negative, Antibody test positive, Aspartate aminotransferase, Blood albumin, Body mass index, Brain natriuretic peptide increased, C-reactive protein, C-reactive protein increased, Cytomegalovirus test negative, Echocardiogram, Electrocardiogram, Enterovirus test negative, Epstein-Barr virus antibody negative, International normalised ratio, Laboratory test, Lymphocyte count, Magnetic resonance imaging, Myocarditis, Neutrophil count, Platelet count, Polymerase chain reaction, Prothrombin time, Red blood cell sedimentation rate, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative, Serum ferritin, Troponin T, Troponin T increased, White blood cell count
SMQs:, Cardiac failure (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vasculitis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Partial thromboplastin time; Test Result: 27.9 s; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:22 IU/l; Comments: (units/L); Test Name: COVID-19 nucleocapsid antibody; Test Result: Negative ; Test Name: Antibody test; Test Result: Positive ; Comments: antibody testing showed positive spike and negative nucleocapsid antibodies for SARS-CoV-2; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:59; Comments: (units/L); Test Name: Albumin; Result Unstructured Data: Test Result:3.8 g/dl; Test Name: BMI; Result Unstructured Data: Test Result:22; Test Name: NT pro-BNP; Result Unstructured Data: Test Result:149 pg/mL; Test Name: C-reactive protein; Test Result: 1.5 mg/dl; Test Name: Highest C-reactive protein; Test Result: 1.8 mg/dl; Test Name: Cytomegalovirus Disagnostics; Test Result: Negative ; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Normal; Test Name: ECG; Result Unstructured Data: Test Result:ST-Elevated; Comments: ST-elevation on ECG but normal function; Test Name: Enterovirus diagnostics; Test Result: Negative ; Test Name: Epstein-Barr virus Diagnostics; Test Result: Negative ; Test Name: International Normalized Ratio INR; Result Unstructured Data: Test Result:1.06; Test Name: lab test; Result Unstructured Data: Test Result:Negative Lyme; Comments: Other diagnostics: Negative Lyme serology, negative Mycoplasma serum PCR, negative Parvovirus serum PCR; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result:1.4 /mm3; Test Name: MRI; Result Unstructured Data: Test Result:demonstrated diffuse edema; Comments: Cardiac MRI demonstrated diffuse edema; Test Name: Absolute neutrophil; Result Unstructured Data: Test Result:2.8 /mm3; Test Name: Platelet count; Result Unstructured Data: Test Result:189 /mm3; Test Name: Mycoplasma serum PCR; Test Result: Negative ; Test Name: Respiratory pathogen panel PCR; Test Result: Negative ; Test Name: Prothrombin time; Test Result: 11.4 s; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:3; Comments: (mm/hr); Test Name: COVID-19 spike antibody; Test Result: Positive ; Test Name: Nasopharyngeal SARS-CoV-2 PCR; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: Test Result:65 ug/L; Test Name: Highest troponin; Result Unstructured Data: Test Result:0.82 ng/ml; Test Name: Lowest troponin prior to Discharge; Result Unstructured Data: Test Result:0.01 ng/ml; Test Name: Elevated troponin T; Result Unstructured Data: Test Result:0.66 ng/ml; Comments: Evaluation in the ED showed an elevated troponin T (0.66 ng/mL, normal range, <0.01 ng/mL); Test Name: Peripheral white blood cell count; Result Unstructured Data: Test Result:5.0 /mm3
CDC Split Type: USPFIZER INC2021665019

Write-up: This is a literature report from the Pediatrics, 2021, entitled Symptomatic Acute Myocarditis in Seven Adolescents Following Pfizer BioNTech COVID-19 Vaccination with DOI: 10.1542/peds.2021-052478. Additionally reported in Pediatrics, 2021, entitled Myocarditis after SARS-CoV-2 Vaccination: True, True, and Related? with DOI: 10.1542/peds.2021-052644 via contactable Physicians. This Physician reported similar events for seven patients. This is the sixth 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 United States (US) military patients and patients from Israel. The Israeli 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 European 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 pericarditis 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 6: A 16-year-old previously well male was admitted with a chief complaint of chest pain. His initial symptoms began 3 days after the second Pfizer-BioNTech COVID-19 vaccine with malaise and subjective fever. He had no recent or remote history of viral illness, and no known COVID-19 exposures. The night prior to admission he developed acute midsternal chest pain that lasted for approximately 18 hours. Evaluation in the ED showed an elevated troponin T (0.66 ng/mL, normal range, <0.01 ng/mL), ST-elevation on ECG but normal function and structure on echocardiogram. Cardiac MRI demonstrated diffuse edema and subepicardial late gadolinium enhancement. A nasopharyngeal SARS-CoV-2 PCR was negative and antibody testing showed positive spike and negative nucleocapsid antibodies for SARS-CoV-2. He was treated with 70 grams IVIG and started on prednisone 30 mg orally twice daily with a gradual taper over 4 weeks. He did not receive any non-steroidal anti-inflammatory drugs (NSAID). Troponin T climbed after admission and remained elevated throughout the hospitalization. Chest pain resolved after administration of 6 mg of morphine in the initial ED evaluation. Telemetry was normal throughout hospitalization. He was discharged 3 days after admission. He had not yet returned for follow-up visit at the time of this submission. Exposure to COVID-19 in 14 days prior to illness onset was None. The patient underwent lab tests and procedures which included activated partial thromboplastin time prolonged: 27.9 seconds, alanine aminotransferase: 22 (units/L), antibody test negative: negative, antibody test positive: antibody testing showed positive spike and negative nucleocapsid antibodies for SARS-CoV-2, aspartate aminotransferase: 59 (units/L), blood albumin: 3.8 g/dl, body mass index: 22, brain natriuretic peptide increased: 149 pg/ml, c-reactive protein: 1.5 mg/dl, c-reactive protein increased: 1.8 mg/dl, cytomegalovirus test negative: negative, echocardiogram: normal, electrocardiogram: st-elevated, ST-elevation on ECG but normal function, enterovirus test negative: negative, epstein-barr virus antibody negative: negative, International Normalized Ratio INR: 1.06, Other diagnostics: Negative Lyme serology, negative Mycoplasma serum PCR, negative Parvovirus serum PCR, Absolute lymphocyte count: 1.4/mm3, Absolute neutrophil: 2.8 /mm3, Platelet count: 189, Mycoplasma serum PCR: Negative, Respiratory pathogen panel PCR: Negative, Prothrombin time: 11.4 seconds, Erythrocyte sedimentation rate: 3 (mm/hr), COVID-19 spike antibody: Positive, Ferritin: 65 ug/L, Highest troponin: 0.82 ng/ml, Lowest troponin prior to Discharge: 0.01 ng/ml, Peripheral white blood cell count: 5.0. 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 Lake Louise 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 Finland and in 2.16 cases per 100,000 US 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 Finland, 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 in the US. 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 US 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 chronological connection to the vaccine causality between reported event acute myocarditis and Pfizer-BioNTech COVID-19 mRNA vaccine cannot be completely 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-2021665013 Same reporter, drug, event but different patient


VAERS ID: 1412507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Adenovirus test, Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Body temperature, Brain natriuretic peptide, C-reactive protein, Cytomegalovirus test, Diagnostic procedure, Echocardiogram, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, International normalised ratio, Lymphocyte count, Magnetic resonance imaging, Myocarditis, Neutrophil count, Platelet count, Polymerase chain reaction, Prothrombin time, Red blood cell sedimentation rate, Serum ferritin, Troponin, White blood cell count
SMQs:, Haemorrhage laboratory terms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: partial thromboplastin time; Test Result: 35.6 s; Test Name: Adenovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR Negative serology; Test Name: alanine aminostranferase; Result Unstructured Data: Test Result:38; Comments: (units/L); Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:87; Comments: (units/L); Test Name: albumin; Result Unstructured Data: Test Result:3.5 g/dl; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Comments: 38.3 C began the day of vaccination; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:107.9 pg/mL; Test Name: c-reactive protein; Test Result: 7.7 mg/dl; Test Name: Cytomegalovirus diagnostics; Result Unstructured Data: Test Result:Negative; Comments: Negative serology; Test Name: Other diagnostics; Result Unstructured Data: Test Result:Negative; Comments: Negative Parvovirus IgM, positive Parvovirus IgG antibody, negative Mycoplasma PCR (throat swab); Test Name: Echocardiogram; Result Unstructured Data: Test Result:Mildly depressed; Comments: Mildly depressed RV and LV systolic function (LVEF 47%); Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST elevation; Comments: ST elevation, low voltage of extremity leads; Test Name: Enterovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Epstein-Barr virus diagnostics; Result Unstructured Data: Test Result:Negative; Comments: Negative serology; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.2; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result:1.05 cells/uL; Test Name: MRI; Result Unstructured Data: Test Result:LGE; Comments: LGE (subepicardial) involving mid and apical LV free wall, myocardial edema, hyperemia; Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:4.73 cells/uL; Test Name: platelet count; Result Unstructured Data: Test Result:208 cells/uL; Test Name: Respiratory pathogen panel PCR; Test Result: Negative ; Test Name: prothrombin time; Test Result: 14.8 s; Test Name: erythrocyte sedimentation rate; Test Result: 10 mmol; Test Name: ferritin; Result Unstructured Data: Test Result:84 ug/L; Test Name: troponin; Result Unstructured Data: Test Result:22.1 ng/ml; Test Name: Peripheral white blood; Result Unstructured Data: Test Result:8.11 cells/uL
CDC Split Type: USPFIZER INC2021665020

Write-up: seven cases of acute myocarditis or myopericarditis in healthy male adolescents who presented with chest pain all within four days after the second dose of Pfizer-BioNTech COVID-19 vaccination.; This is a literature report. This Physician reported similar events for seven patients. This is the seventh 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 patients and patients from another country. The 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 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 7: A 14-year-old previously well male presented to an urgent care clinic with pleuritic chest pain and shortness of breath two days after receiving his second Pfizer-BioNTech vaccine. A measured fever of 38.3 C began the day of vaccination. He had no recent or remote history of viral illness, and no known COVID-19 exposures. ECG showed ST segment elevation consistent with acute pericarditis. Additional evaluation included an echocardiogram which showed mildly depressed left and right ventricular systolic function and elevated troponin I (22.1 ng/mL, normal range, <0.045 ng/mL). His maximum temperature was 38.6o C on the day of admission. A nasopharyngeal SARS-CoV-2 PCR and serum nucleocapsid antibody were both negative. On hospital day 3, cardiac MRI showed areas with high T2 values indicating edema, T1 early postcontrast heterogeneity indicating hyperemia, and late gadolinium enhancement indicating myocardial fibrosis, all primarily in the subepicardial mid and apical left ventricle free wall. He was treated with NSAIDs (ketorolac 30 mg once, followed by naproxen 250 mg every 12 hours) and furosemide. Echocardiogram was improved one day after admission. He was discharged on hospital day 4 based on improvement of symptoms and ejection fraction; the troponin had declined to 8.02 ng/ml. His final diagnosis was myopericarditis. On follow-up 13 days later, he appeared well, but reported chest pain with exertion despite instructions to avoid strenuous exercise. An ECG showed non-specific T wave changes and echocardiogram was normal. Exposure to COVID-19 in 14 days prior to illness onset was None. The patient was hospitalized for 4 days. The patient underwent lab tests and procedures which included activated partial thromboplastin time prolonged: 35.6 seconds, alanine aminotransferase: 38 (units/L), aspartate aminotransferase: 87 (units/L), blood albumin: 3.5 g/dl, brain natriuretic peptide: 107.9 pg/ml, c-reactive protein: 7.7 mg/dl, echocardiogram: Mildly depressed RV and LV systolic function (LVEF 47%), electrocardiogram: ST elevation, low voltage of extremity leads, international normalised ratio: 1.2, lymphocyte count: 1.05 cells/ul, magnetic resonance imaging: LGE (subepicardial) involving mid and apical LV free wall, myocardial edema, hyperemia, neutrophil count: 4.73 cells/ul, platelet count: 208 cells/ul, prothrombin time: 14.8 seconds, red blood cell sedimentation rate: 10 mmol, ferritin: 84 ug/L, troponin: 22.1 ng/ml, Peripheral white blood: 8.11 cells/uL, Adenovirus diagnostics Negative, Cytomegalovirus diagnostics Negative, Other diagnostics: Negative, Parvovirus IgM, positive, Parvovirus IgG, antibody, negative, Mycoplasma PCR (throat swab), Enterovirus diagnostics: Negative serum PCR, Epstein-Barr virus diagnostics: Negative serology, Respiratory pathogen panel PCR: Negative. 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 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on chronological connection to the vaccine causality between reported event acute myocarditis and Pfizer-BioNTech COVID-19 mRNA vaccine cannot be completely 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-2021665013 Same reporter, drug, event but different patient


VAERS ID: 1413736 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210632922

Write-up: SUDDEN CARDIAC DEATH CAUSED BY MYOCARDITIS; This spontaneous report received via social media from a patient via a company representative concerned a 30 year old male. The patient''s weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: not reported) 1 total dose administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, after eight days of vaccination, the patient died of sudden cardiac death caused by myocarditis. The reporter figured all this in the news and thought it could be related. The cause of death was myocarditis. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210632922-covid-19 vaccine ad26.cov2.s-sudden cardiac death caused by myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MYOCARDITIS


VAERS ID: 1419806 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Carditis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Heart Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart Inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Heart Inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Heart Inflammation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information were reported. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.


VAERS ID: 1419848 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Chest pain; Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Heart disease, unspecified. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced CHEST PAIN (Chest pain). In June 2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with IBUPROFEN for Adverse event, at a dose of High dose, qid. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) outcome was unknown. No relevant concomitant medications were provided. Reportedly, the patient experienced chest pain and went to the hospital where he was diagnosed with pericarditis. Treatment medication also included steroids. Company Comment: This case concerns a male of unknown age hospitalized with a serious unexpected event of pericarditis, and nonserious chest pain. Event onset during the week following second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a male of unknown age hospitalized with a serious unexpected event of pericarditis, and nonserious chest pain. Event onset during the week following second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1419850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-03-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048A21A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Chills, Dizziness, Epistaxis, Gastrointestinal disorder, Guillain-Barre syndrome, Headache, Pain in extremity, Pericarditis, Seizure, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved. Concomitant medication and treatment information were not reported. It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.


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