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From the 10/8/2021 release of VAERS data:

Found 3,741 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: 1449462 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / OT

Administered by: Unknown       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? 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: Myocarditis; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were reported. No treatment medication details was reported. Company comment Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.


VAERS ID: 1449483 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH GW0217 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Chills, Cough, Myocardial infarction, Myocarditis, Pain, Pyrexia, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021738285

Write-up: Heart attack; Myocarditis (heart inflammation); Chest pain; Having breathing problems; dry cough; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year old male patient received bnt162b2 (Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:00 (Batch/Lot Number: GW0217) as single dose for covid-19 immunisation at Pharmacy or Drug Store. He had received bnt162b2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 14:00 (Batch/Lot Number: EW0191) for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 12 hours of 2nd shot on 17Jun2021, the patient experienced fever, chills, body aches. On 18Jun2021, started having breathing problems, chest pain, dry cough. On 19Jun2021 patient ended up in Hospital suffered heart attack and was suffering myocarditis (heart inflammation). Patient was hospitalized for 3 days. The events were reported as serious with seriousness criteria life threatening, caused/prolonged hospitalization. Adverse event (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events. Myocarditis treatment was taken. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1449547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Pain, Pericarditis, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021817295

Write-up: Her doctor now says she has pericarditis due to the shot.; she had felt real bad; all over pain; vomiting; This is a spontaneous report from two contactable consumers. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jun2021 as dose number unknown, single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 prior vaccination and post vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 10Jun2021, the patient felt real bad after the injection with vomiting and all over pain. The doctor said she has pericarditis due to the shot. The patient visited emergency room/physician office due to the events. Therapeutic measures (unspecified) were taken as a result of the events. The outcome for the events were not recovered. Information on Lot/Batch information has been requested.


VAERS ID: 1456672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein increased, Ejection fraction, Electrocardiogram, Magnetic resonance imaging, Myocarditis, Troponin
SMQs:, 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:1; Test Name: Lowest left ventricular ejection fraction; Test Result: 60 %; Comments: inferior wall hypokinesis; Test Name: ECG; Result Unstructured Data: Test Result:Inferolateral ST elevation; Test Name: MRI findings; Result Unstructured Data: Test Result:Edema, delayed enhancement, pericardial effusion; Test Name: Baseline troponin; Result Unstructured Data: Test Result:11; Test Name: Peak troponin; Result Unstructured Data: Test Result:100
CDC Split Type: USPFIZER INC2021769145

Write-up: acute myocarditis/cough, fever on day +1, chest pain on day +3; This is a literature report from the Circulation. This literature study from two contactable physicians reported similar events for five patients. This is the second of five reports. A 26-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications was not reported. 3days after 2nd dose, patient experience cough, fever on day +1, chest pain on day +3. The patient demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The patient underwent lab tests and procedures on an unknown date which included: Baseline troponin:11, Peak troponin:100, C-reactive protein increased (CRP):1, Electrocardiogram (ECG): Inferolateral ST elevation, Lowest left ventricular ejection fraction: 60% (inferior, wall hypokinesis), MRI findings: Edema, delayed enhancement, pericardial effusion. Anti-inflammatory Treatment included Colchicine. Clinical course:2 days in intensive care, no inotropes or mechanical circulatory support. Discharged stable. The outcome of event was unknown. Full publication: The BNT162b2 mRNA (Pfizer-BioNTech) and the mRNA-1273 (Moderna) COVID-19 vaccines have gained widespread use across the globe to prevent further severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection spread. Early studies and surveillance data suggest these vaccines are associated with no significant adverse events other than very rare anaphylaxis.1,2 Surveillance for other reactions continues. Myocarditis and inflammatory myocardial cellular infiltrate have been reported after vaccination, especially after the smallpox vaccine.3 Nevertheless, myocarditis occurring after the BNT162b2 mRNA and mRNA-1273 vaccines has not been reported in trials.1,2 Here, we describe 8 patients hospitalized with chest pain who were diagnosed with myocarditis by laboratory and cardiac magnetic resonance imaging (MRI) within 2-4 days of receiving either the BNT162b2 or mRNA-1273 vaccine. Patients provided written informed consent, and the collection of clinical cases followed local Institutional Review Boards. The data that support the findings of this study are available from the corresponding author upon reasonable request. Two of the patients (3 and 4) had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56. All but one patient developed symptoms after their second dose. Systemic symptoms began within 24 hours after vaccine administration in 5 out of 8 patients, with chest pain presenting between 48 and 96 hours later. Chest pain was most commonly described as constant, non-positional, and non-pleuritic (only patient 7 reported pericardial pain), consistent with acute myocarditis mainly without pericardial involvement. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia. All patients were tested for and were negative for SARS-CoV-2. Left ventricular ejection fraction (LVEF) was reduced (<50%) in 2 of 8 (25%) patients with a median LVEF of 51.5% (first to third quartile: 48 to 59%). Five patients demonstrated regional wall motion abnormalities with inferior and infero-lateral walls involved, and the remaining 3 cases had generalized hypokinesis. Some patients were tachycardic at presentation, but no patients required inotropes or mechanical circulatory support. All but three patients (1, 2, and 5) underwent coronary imaging by computed tomography or catheter-based angiography to rule out coronary artery disease. Cardiac MRI revealed patchy delayed gadolinium enhancement consistent with myocarditis in all patients, and most patients also demonstrated findings consistent with myocardial edema. Cardiac biopsy, performed in one of the patients before initiation of steroid, did not demonstrate myocardial infiltrate. All patients had resolution of their chest pain, were discharged from the hospital in stable condition, and were alive with preserved LVEF at last contact. The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable. Trials that tested the BNT162b2 and mRNA-1273 vaccines showed that systemic reactogenicity more often occurred after dose 2 and generally within 48 hours after vaccination.1, 2 On average,our patients presented with symptoms of acute myocarditis 3 days after the second injection, and in 5 out of 8 patients fever appeared a day before, supporting the hypothesis that myocarditis could be an mRNA-vaccine related adverse reaction. The only patient who experienced myocarditis after the first vaccination had a previous infection to SARS-COV-2. No eosinophilia was noted in our patients, unlike myocarditis associated with Smallpox vaccination.3,4 Potential mechanisms for myocarditis post-mRNA-based vaccination include a non-specific innate inflammatory response or a molecular mimicry mechanism between viral spike protein and an unknown cardiac protein.5With regard to therapy, 3 patients received nonsteroidal anti-inflammatory drugs, 2 colchicine, 2prednisone, and 3 received no medications. We would consider the use of corticosteroids in fulminant myocarditis due to the likely immune-mediated post-vaccination mechanism.4 However, corticosteroids could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the LVEF. Pending publication of long-term outcome data after SARS-CoV-2 vaccine-related myocarditis, we suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with re-evaluation prior to sports participation.4 As a case report collection, the current research letter emphasizes the real incidence of acute myocarditis after mRNA COVID-19 vaccine, which appears to be extremely rare. In fact, the Centers for Disease Control Vaccine Adverse Event Reporting System # received reports of chest pain in 5166 and myocarditis in 399 recipients of the BNT162b2 or mRNA1273 vaccine, whereas more than 129 million individuals have been fully vaccinated with these two vaccines. In conclusion, providers should be vigilant for myocarditis after COVID-19 mRNA vaccination; further research is required to understand the long-term cardiovascular risks. The event myocarditis occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021768972 Same reporter/drug/event and different patients.


VAERS ID: 1456675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Biopsy heart, C-reactive protein, Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Troponin
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 infection (previous infection to SARS-COV-2 without need for hospitalization.)
Allergies:
Diagnostic Lab Data: Test Name: coronary imaging by computed tomography or catheter-based angiography; Result Unstructured Data: Test Result:unknown results; Comments: coronary imaging by computed tomography or catheter-based angiography, to rule out coronary artery disease; Test Name: Cardiac biopsy; Result Unstructured Data: Test Result:found no active myocarditis; Comments: Performed before initiation of steroid, did not demonstrate myocardial infiltrate.; Test Name: CRP; Result Unstructured Data: Test Result:9.5; Comments: Values are expressed as the multiple of the upper limit of normal for each laboratory''s reference range.; Test Name: Lowest left ventricular ejection fraction; Result Unstructured Data: Test Result:47 percent, generalized hypokinesis; Comments: Lowest left ventricular ejection fraction; Test Name: ECG; Result Unstructured Data: Test Result:Diffuse ST-segment elevation with depression in aV; Comments: Diffuse ST-segment elevation with depression in aVR, V1; Test Name: cardiac MRI findings; Result Unstructured Data: Test Result:Edema, delayed enhancement, pericardial effusion; Comments: Cardiac MRI revealed patchy delayed gadolinium enhancement consistent with myocarditis in all patients; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Name: troponin; Result Unstructured Data: Test Result:102; Comments: Baseline troponin; Values are expressed as the multiple of the upper limit of normal for each laboratory''s reference range.; Test Name: troponin; Result Unstructured Data: Test Result:520; Comments: Peak troponin; the day after admission; Values are expressed as the multiple of the upper limit of normal for each laboratory''s reference range.; Test Name: troponin; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC2021769148

Write-up: hospitalized with chest pain who were diagnosed with myocarditis; This is a literature report from the Circulation, DOI: 10.1161/CIRCULATIONAHA.121.055913 entitled Myocarditis after BNT162b2 and mRNA-1273 Vaccination. This author reported same events for 5 patients. This is the 5th of 5 reports, refer to patient 3 in table 1. Myocarditis occurring after the BNT162b2 mRNA and mRNA-1273 vaccines has not been reported in trials. Here, we describe 8 patients hospitalized with chest pain who were diagnosed with myocarditis by laboratory and cardiac magnetic resonance imaging (MRI) within 2-4 days of receiving either the BNT162b2 or mRNA-1273 vaccine (Table 1). Patients provided written informed consent, and the collection of clinical cases followed local Institutional Review Boards. The data that support the findings of this study are available from the corresponding author upon reasonable request. The patient in this case refer to patient 3 in table 1, who is a 40-year-old male in US. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient''s medical history included had a previous infection to SARS-COV-2/previously been infected by SARS-CoV-2 without need for hospitalization. Concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis, which required hospitalization. The outcome of the event was unknown. Additional patient demographics identified in table 1 was as follows: Day of presentation was 2 days after 1st dose; Presenting symptom(s) was Chest pain; The baseline troponin was 102, and the peak troponin was 520, the C-reactive protein (CRP) was 9.5 (the values of baseline troponin, peak troponin and CRP are expressed as the multiple of the upper limit of normal for each laboratory''s reference range); ECG showed Diffuse ST-Segment elevation with depression in aVR, V1; Lowest left ventricular ejection fraction was 47 percent, generalized hypokinesis; The cardiac magnetic resonance imaging (MRI) findings was "Edema, delayed enhancement, pericardial effusion"; anti-inflammatory treatment included Prednisone, Colchicine for this patient; Clinical course was "Hemodynamically stable, Endomyocardial biopsy found no active myocarditis.". Additional information on article was as follows: Chest pain was most commonly described as constant, non-positional, and non-pleuritic (only patient 7 reported pericardial pain), consistent with acute myocarditis mainly without pericardial involvement. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia. All patients were tested for and were negative for SARS-CoV-2. Left ventricular ejection fraction (LVEF) was reduced (less than 50 percent) in 2 of 8 (25 percent) patients with a median LVEF of 51.5 percent (first to third quartile: 48 to 59 percent). All but three patients (1, 2, and 5) underwent coronary imaging by computed tomography or catheter-based angiography to rule out coronary artery disease. Cardiac MRI revealed patchy delayed gadolinium enhancement consistent with myocarditis in all patients, and most patients also demonstrated findings consistent with myocardial edema. Cardiac biopsy, performed in one of the patients before initiation of steroid, did not demonstrate myocardial infiltrate. With regard to therapy, 3 patients received nonsteroidal anti-inflammatory drugs, 2 colchicine, 2prednisone, and 3 received no medications. We would consider the use of corticosteroids in fulminant myocarditis due to the likely immune-mediated post-vaccination mechanism. However, corticosteroids could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the LVEF. All patients had resolution of their chest pain, were discharged from the hospital in stable condition, and were alive with preserved left ventricular ejection fraction (LVEF) at last contact. Pending publication of long-term outcome data after SARS-CoV-2 vaccine-related myocarditis, we suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with re-evaluation prior to sports participation. The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable. Trials that tested the BNT162b2 and mRNA-1273 vaccines showed that systemic reactogenicity more often occurred after dose 2 and generally within 48 hours after vaccination. On average, our patients presented with symptoms of acute myocarditis 3 days after the second injection, and in 5 out of 8 patients fever appeared a day before, supporting the hypothesis that myocarditis could be an mRNA-vaccine related adverse reaction. The only patient who experienced myocarditis after the first vaccination had a previous infection to SARS-COV-2. No eosinophilia was noted in our patients, unlike myocarditis associated with Smallpox vaccination. Potential mechanisms for myocarditis post-mRNA-based vaccination include a non-specific innate inflammatory response or a molecular mimicry mechanism between viral spike protein and an unknown cardiac protein. As a case report collection, the current research letter emphasizes the real incidence of acute myocarditis after mRNA COVID-19 vaccine, which appears to be extremely rare. In fact, the Centers for Disease Control Vaccine Adverse Event Reporting System received reports of chest pain in 5166 and myocarditis in 399 recipients of the BNT162b2 or mRNA1273 vaccine, whereas more than 129 million individuals have been fully vaccinated with these two vaccines. In conclusion, providers should be vigilant for myocarditis after COVID-19 mRNA vaccination; further research is required to understand the long-term cardiovascular risks. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021768972 Same reporter/drug/event and different patients.


VAERS ID: 1459428 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypertensive crisis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Hypertension (narrow), 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? 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: This spontaneous case was reported by a nurse and describes the occurrence of PERICARDITIS (Seen a lot of pericarditis cases in both young and old people) and HYPERTENSIVE CRISIS (Seeing more cases of a hypertensive crisis) 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 PERICARDITIS (Seen a lot of pericarditis cases in both young and old people) (seriousness criterion medically significant) and HYPERTENSIVE CRISIS (Seeing more cases of a hypertensive crisis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Seen a lot of pericarditis cases in both young and old people) and HYPERTENSIVE CRISIS (Seeing more cases of a hypertensive crisis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1463337 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-07
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Gait inability, Illness, Loss of personal independence in daily activities, Pain, Pericarditis, Pyrexia, Sleep disorder, Speech disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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? 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: USPFIZER INC2021821167

Write-up: Pericarditis; extreme chest pain; had to sleep sitting up; couldn''t breath; couldn''t walk or talk; couldn''t walk or talk; fever; couldn''t function for weeks; it was painful; She has been sick; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on 07Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 Immunization. On 11Mar2021, 4 days after second vaccination, the patient had extreme chest pain after walking on a flat walk that she normally does and she reports walking trail is nothing new to her. Patient also reports patient is 61-years-old, and she''s going to have aches and pains and she has to get over it, and went home. It kind of passed. And then patient was diagnosed with Pericarditis. Patient states that she couldn''t breath, couldn''t walk or talk, and had a fever. She states she couldn''t function for weeks, it was painful and she had to sleep sitting up. On an unspecified date in Mar2021, patient has been very very sick. It was reported patient used to work in clinical trials and she knows we need the information and it is important. Reporter does not wish to complete a safety report because she believes her husband might have completed one already and Reporter would like to know if are we receiving reports of women experiencing this or is it only adolescent boys. The outcome of event for Pericarditis was Not recovered, and rest of the events was taken as Unknown. Information about lot/batch number cannot be obtained. Additional information has been requested. Follow-up attempts are completed; information about lot/batch number cannot be obtained


VAERS ID: 1466127 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Military       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin
SMQs:, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:Unknown results; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:Unknown results; Test Name: Troponin level; Result Unstructured Data: Test Result:Elevated
CDC Split Type: USPFIZER INC2021812011

Write-up: Myocarditis; Same event reported for seven patients, this is the first of 7 reports. Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger RNA (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. 2.8 million doses of mRNA COVID-19 vaccine administered in this period. While the observed number of myocarditis cases was small, the number was higher than expected after a second vaccine dose. Conclusions and relevance: Myocarditis occurred in previously healthy patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunization on an unspecified date. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021812721 same reporter/drug/event, different patient;US-PFIZER INC-2021812722 same reporter/drug/event, different patient;US-PFIZER INC-2021812723 same reporter/drug/event, different patient;US-PFIZER INC-2021812724 same reporter/drug/event, different patient;US-PFIZER INC-2021812725 same reporter/drug/event, different patient;US-PFIZER INC-2021812726 same reporter/drug/event, different patient


VAERS ID: 1466128 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Military       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin
SMQs:, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:Unknown results; Test Name: electrocardiogram findings; Result Unstructured Data: Test Result:Unknown Results; Test Name: Troponin level; Result Unstructured Data: Test Result:Elevated
CDC Split Type: USPFIZER INC2021812721

Write-up: Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Objective: To describe myocarditis presenting after COVID-19 vaccination within the Health System. This retrospective case series studied patients within the Health System who experienced myocarditis after COVID-19 vaccination between Jan and Apr2021. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger RNA (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Results a total of 23 male patients (median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All members were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. They administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. While the observed number of myocarditis cases was small, the number was higher than expected among male members after a second vaccine dose. Conclusions and relevance: In this case series, myocarditis occurred in previously healthy patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunization on an unspecified date. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism


VAERS ID: 1466129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin abnormal
SMQs:, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: Troponin level; Result Unstructured Data: Test Result:Elevated
CDC Split Type: USPFIZER INC2021812723

Write-up: Myocarditis; Same event for seven patients reported, this is the fourth of 7 reports. Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger RNA (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Results a total of 23 male patients median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. More than 2.8 million doses of mRNA COVID-19 vaccine administered in this period. While the observed number of myocarditis cases was small, the number was higher than expected after a second vaccine dose. Conclusions and relevance: In this case series, myocarditis occurred in previously healthy patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history included COVID-19 infection. The patient''s concomitant medications were not reported. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021812011 same reporter/drug/event, different patient


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