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From the 1/14/2022 release of VAERS data:

Found 8,620 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

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Case Details

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VAERS ID: 1872289 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Inflammatory marker test, Laboratory test, Pericarditis, Red blood cell sedimentation rate, SARS-CoV-2 test, Troponin T, Ventricular internal diameter, Viral test
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: CRP; Test Result: 23.1 mg/dl; Test Name: echocardiography; Result Unstructured Data: Test Result:moderate circumferential pericardial effusion; Test Name: Transthoracic Echocardiogram; Result Unstructured Data: Test Result:Normal RV size; Comments: Normal RV size and function; Small to moderate circumferential pericardial effusion; Test Name: LVEF; Test Result: 65 %; Comments: Transthoracic Echocardiogram; Test Name: ECG; Result Unstructured Data: Test Result:new-onset atrial fibrillation; Test Name: Inflammatory markers; Result Unstructured Data: Test Result:Elevated; Test Name: exam; Result Unstructured Data: Test Result:found to have a friction rub; Test Name: ESR; Result Unstructured Data: Test Result:81; Comments: Units: mm/hour; Test Name: SARS CoV-2; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:undetectable; Test Name: LVIDd; Result Unstructured Data: Test Result:3.6; Comments: Units: cm; Test Name: viral serologies; Test Result: Negative
CDC Split Type: USPFIZER INC202101525200

Write-up: pericarditis; A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and Expiration date: Not reported), via unspecified route of administration on an unspecified date as Dose 2, Single for Covid-19 immunization. The patient''s medical history included hypertension. The patient''s concomitant medication was not reported. On an unknown date, the patient developed low grade fevers, night sweats, chest discomfort and palpitations after four weeks after her second dose of the vaccine. The patient noticed that her symptoms improved when leaning forward. On examination, it was found to have a friction rub. ECG revealed new-onset atrial fibrillation and echocardiography demonstrated a small to moderate circumferential pericardial effusion, echocardiogram: normal RV size and function, small to moderate circumferential pericardial effusion transthoracic echocardiogram, electrocardiogram: new onset atrial fibrillation, transthoracic Echocardiogram: LVEF: 65%; LVIDd: 3.6 cm; Normal RV size and function; Small to moderate circumferential pericardial effusion inflammatory markers were significantly elevated, CRP (C-reactive protein): 23.1 mg/dL (reference range: less than 0.80 mg/dL); ESR (Estimated red blood cell sedimentation rate): 81 mm/hour (reference range: less than 15 mm/hour), Cardiac Biomarkers: Troponin T: undetectable, ventricular internal diameter: 3.6 cm, and viral serologies such as SARS-CoV-2 negative. Cardiac MRI and coronary evaluation was not performed. Based on these clinical features, the patient was diagnosed with pericarditis. The patient was started with on colchicine with improvement in her symptoms. Both patients tested negative for SARS-CoV-2. Long-term follow-up of patients with cardiovascular events following the receipt of mRNA based COVID-19 vaccines is needed. At the time of publication, all patients presented in this case series demonstrated clinical improvement. we report the first case series of patients with myocarditis, stress cardiomyopathy, and pericarditis after receiving the mRNA-based COVID-19 vaccines. While we cannot definitively prove association of the vaccines with these adverse events, we believe reporting these complications may enable further monitoring and investigation. However, it was crucial to emphasize that these findings are rare while SARS-CoV-2 infection was associated with a much higher incidence of cardiovascular complications. The outcome of the event Pericarditis was reported as recovering. ; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Pericarditis. 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-202101513854 Same article/drug and different patient/event.


VAERS ID: 1875897 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Multisystem inflammatory syndrome, Myocarditis
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), 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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101505338

Write-up: multisystem-inflammatory syndrome; myocarditis; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of BNT162B2. The patient experienced myocarditis (medically significant) on an unspecified date with outcome of unknown , multisystem-inflammatory syndrome (medically significant) on an unspecified date with outcome of unknown. The patient was hospitalized for myocarditis and multisystem-inflammatory syndrome for 10 days. Therapeutic measures were taken as a result of myocarditis and multisystem-inflammatory syndrome including norepinephrine infusion, high-flow oxygen therapy, steroids, intravenous immunoglobulin and antibiotics. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1875907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Blood pressure measurement, C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, HIV test, Heart rate, Inflammatory marker test, Influenza virus test, Investigation, Laboratory test, Magnetic resonance imaging heart, Myocarditis, Physical examination, Red blood cell sedimentation rate, Respiratory syncytial virus test, SARS-CoV-2 test, Troponin T, Ventricular internal diameter
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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:no evidence of coronary artery disease (CAD); Comments: No coronary artery disease or anomalies; Test Name: blood pressure; Result Unstructured Data: Test Result:145/95 mmHg; Test Name: CRP; Test Result: 1.8 mg/dl; Test Name: Transthoracic Echocardiogram; Result Unstructured Data: Test Result:mildly reduced left ventricular (LV) ejection frac; Comments: mildly reduced left ventricular (LV) ejection fraction (EF) of 47% with no regional wall motion abnormalities.; Test Name: LVEF; Test Result: 47 %; Comments: Transthoracic Echocardiogram; Test Name: LVEF; Test Result: 56 %; Comments: Cardiac MRI; Test Name: RVEF; Test Result: 54 %; Test Name: electrocardiogram (ECG); Result Unstructured Data: Test Result:notable for diffuse ST elevations; Test Name: heart rate; Result Unstructured Data: Test Result:71; Comments: Units: beats per minute (bpm); Test Name: HIV; Test Result: Negative ; Test Name: inflammatory markers; Result Unstructured Data: Test Result:elevated; Test Name: influenza; Test Result: Negative ; Test Name: LVEDVi; Result Unstructured Data: Test Result:84; Comments: Units: mL/m2; Test Name: RVEDVi; Result Unstructured Data: Test Result:86; Comments: Units: mL/m2; Test Name: laboratory studies; Result Unstructured Data: Test Result:evidence of myocardial injury; Test Name: T1 values; Result Unstructured Data: Test Result:1070-1160; Comments: Units: ms; Test Name: T2 values; Result Unstructured Data: Test Result:57-59; Comments: Units: ms elevated; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:LVEF: 56%; LVEDVi: 84 mL/m 2; RVEF: 54%; RVEDVi: 8; Comments: LVEF: 56%; LVEDVi: 84 mL/m 2; RVEF: 54%; RVEDVi: 86 mL/m2; Subepicardial LGE involving the basal to mid lateral wall, with corresponding elevated native T1 and T2 values; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:mild hypokinesis of the basal to mid lateral wall,; Comments: mild hypokinesis of the basal to mid lateral wall, with corresponding elevated native T1 values (1070-1160 ms; reference range: 950-1050 ms), elevated T2 values (57-59 ms; reference range: 40-50 ms), and subepicardial delayed enhancement in the lateral wall.; Test Name: Physical exam; Result Unstructured Data: Test Result:unremarkable; Test Name: ESR; Result Unstructured Data: Test Result:26; Comments: Units: mm/hour; Test Name: RSV; Test Result: Negative ; Test Name: SARS CoV-2; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:1.37 ng/ml; Test Name: LVIDd; Result Unstructured Data: Test Result:4.7; Comments: Units: cm
CDC Split Type: USPFIZER INC202101513854

Write-up: acute myocarditis; This is a literature report. This author reported four reports for different patients with different events. This is first of four reports. A 19-year-old male student with no significant past medical history presented to our hospital with acute substernal chest pressure and shortness of breath four days after receiving the second dose of the Pfizer-BioNTech vaccine. On presentation, he was afebrile, with a heart rate of 71 beats per minute (bpm), and blood pressure of 145/95 mmHg. Physical exam was unremarkable. His electrocardiogram (ECG) was notable for diffuse ST elevations, and laboratory studies demonstrated evidence of myocardial injury and elevated inflammatory markers (This patient was 19-year-old Male. Cardiac Biomarkers: Troponin T: 1.37 ng/mL (reference range: less than 0.03 ng/mL). Inflammatory Markers: CRP: 1.8 mg/dL (reference range: Less than 0.80 mg/dL); ESR: 26 mm/hour (reference range: less than 20 mm/hour). Transthoracic Echocardiogram: LVEF: 47%; LVIDd: 4.7 cm; Normal RV size and function; No valvular disease. Cardiac MRI: LVEF: 56%; LVEDVi: 84 mL/m 2; RVEF: 54%; RVEDVi: 86 mL/m2; Subepicardial LGE involving the basal to mid lateral wall, with corresponding elevated native T1 and T2 values. Coronary angiography: No coronary artery disease or anomalies). There was no evidence of coronary artery disease (CAD) on coronary angiography, and echocardiography showed a mildly reduced left ventricular (LV) ejection fraction (EF) of 47% with no regional wall motion abnormalities. Cardiac magnetic resonance imaging (CMR) identified mild hypokinesis of the basal to mid lateral wall, with corresponding elevated native T1 values (1070-1160 ms; reference range: 950-1050 ms), elevated T2 values (57-59 ms; reference range: 40-50 ms), and subepicardial delayed enhancement in the lateral wall. Based on the clinical presentation and updated Lake Louise Criteria for myocardial inflammation by CMR, the patient was diagnosed with acute myocarditis. Subsequent viral studies were negative for human immunodeficiency virus (HIV), influenza, respiratory syncytial virus (RSV), and SARS-CoV-2. The patient''s chest pain resolved, and he was discharged on lisinopril and metoprolol succinate. We report the first case series of patients with myocarditis, stress cardiomyopathy, and pericarditis after receiving the mRNA-based COVID-19 vaccines. While we cannot definitively prove association of the vaccines with these adverse events, we believe reporting these complications may enable further monitoring and investigation. However, it is crucial to emphasize that these findings are rare while SARS-CoV-2 infection is associated with a much higher incidence of cardiovascular complications. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101525198 Same article/drug and different patient/event.;US-PFIZER INC-202101525200 Same article/drug and different patient/event.;US-PFIZER INC-202101525199 Same article/drug and different patient/event.


VAERS ID: 1875916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, HIV test, Inflammatory marker test, Pericarditis, Red blood cell sedimentation rate, SARS-CoV-2 test, Troponin T, Ventricular internal diameter
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Idiopathic thrombocytopenic purpura
Allergies:
Diagnostic Lab Data: Test Name: CRP; Test Result: 72.6 mg/dl; Test Name: Transthoracic Echocardiogram; Result Unstructured Data: Test Result:Normal RV size; Comments: Normal RV size and function; Small pericardial effusion; Test Name: electrocardiogram (ECG); Result Unstructured Data: Test Result:sinus tachycardia and small pericardial effusion; Test Name: HIV; Test Result: Negative ; Test Name: inflammatory markers; Result Unstructured Data: Test Result:elevated; Comments: without evidence of myocardial injury; Test Name: ESR; Result Unstructured Data: Test Result:9; Comments: Units: mm/hour; Test Name: SARS CoV-2; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:undetectable; Test Name: LVIDd; Result Unstructured Data: Test Result:4.5; Comments: Units: cm
CDC Split Type: USPFIZER INC202101525199

Write-up: pericarditis; This is a literature report. This author reported four reports for different patients with different events. This is third of four reports. The patient was a 21-year-old woman with a history of idiopathic thrombocytopenic purpura, who presented three weeks after her first dose of the Pfizer-BioNTech vaccine with chest pain that worsened during inspiration and while supine. She was found to have sinus tachycardia, a small pericardial effusion on echocardiogram, and elevated inflammatory markers without evidence of myocardial injury. Based on the clinical presentation, the patient was diagnosed with pericarditis. Her symptoms improved significantly with initiation of colchicine. Long-term follow-up of patients with cardiovascular events following the receipt of mRNAbased COVID-19 vaccines is needed. At the time of publication, all patients presented in this case series demonstrated clinical improvement. Author report the first case series of patients with myocarditis, stress cardiomyopathy, and pericarditis after receiving the mRNA-based COVID-19 vaccines. While we cannot definitively prove association of the vaccines with these adverse events, we believe reporting these complications may enable further monitoring and investigation. However, it is crucial to emphasize that these findings are rare while SARS-CoV-2 infection is associated with a much higher incidence of cardiovascular complications. This patient was 21-year-old Female. Viral serologies: SARS-CoV-2, HIV negative. Cardiac Biomarkers: Troponin T: undetectable. Inflammatory Markers: CRP: 72.6 mg/dL (reference range: less than 3 mg/dL); ESR: 9 mm/hour (reference range: less than 19 mm/hour). Transthoracic Echocardiogram: LVEF: 60%; LVIDd: 4.5 cm; Normal RV size and function; Small pericardial effusion. Cardiac MRI: Not performed. Coronary Evaluation: Not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the limited information provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. Case will be reassessed upon receipt of follow-up information. 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-202101513854 Same article/drug and different patient/event.


VAERS ID: 1875924 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Nevada  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Myocarditis, Supraventricular tachycardia
SMQs:, Supraventricular tachyarrhythmias (narrow), 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: Superventricular Tachycardia; Result Unstructured Data: Test Result:239; Comments: Superventricular Tachycardia of 239
CDC Split Type: USPFIZER INC202101541363

Write-up: Myocarditis; Superventricular Tachycardia of 239; This is a spontaneous report from a contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (COMIRNARY; Formulation, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced myocarditis and superventricular tachycardia of 239 on an unspecified date. The patient underwent lab tests and procedures which included heart rate: 239 on Superventricular Tachycardia of 239. The outcome of an event is unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1879574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101512117

Write-up: myocarditis; This is a spontaneous report from a non-contactable consumer (lawyer). A 13-year-old 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 NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient was hospitalized on unknown date with myocarditis after receiving the Pfizer BioNTech Covid-19 vaccine. He was now out of sports for at least 6 months. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1884621 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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.MOD20213

Write-up: Psyncopy 2; Myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (Psyncopy 2) and MYOCARDITIS (Myocarditis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Psyncopy 2) (seriousness criterion medically significant) and MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Psyncopy 2) and MYOCARDITIS (Myocarditis) 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. No concomitant product use was provided by the reporter. No treatment medication was provided. The patient experienced myocarditis and psyncopy 2 days after vaccine. Company comment: This case concerns a patient with unknown age and gender with no relevant medical history, who experienced the unexpected serious event of Syncope and the expected serious event of Myocarditis. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a patient with unknown age and gender with no relevant medical history, who experienced the unexpected serious event of Syncope and the expected serious event of Myocarditis. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1896417 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2021-05-07
Onset:2021-05-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antinuclear antibody, Blood immunoglobulin A, Blood immunoglobulin G, Body temperature, C-reactive protein, Cardiac function test, Disease recurrence, Echocardiogram, Ejection fraction, Electrocardiogram, Haemodynamic test, Investigation, Magnetic resonance imaging heart, Myocarditis, Polymerase chain reaction, Red blood cell sedimentation rate, Rheumatoid factor, Rheumatological examination, SARS-CoV-2 antibody test, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization (6 days of hospitalization); Myocarditis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: antinuclear antibody test; Test Result: Negative ; Test Date: 2021; Test Name: IgA; Test Result: Negative ; Test Date: 2021; Test Name: IgG; Test Result: Negative ; Test Date: 20210507; Test Name: Body temperature; Result Unstructured Data: Test Result:101.3 Fahrenheit; Test Date: 2021; Test Name: cardiac testing; Result Unstructured Data: Test Result:normal; Comments: at 2 week follow up; Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:29 mg/l; Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:normal; Comments: at 2 week follow up; Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:normal; Comments: an outpatient cardiology visit 3 days; Test Name: ejection fraction; Test Result: 53 %; Test Name: Electrocardiogram (EKG); Result Unstructured Data: Test Result:normal biventricular systolic and diastolic; Comments: normal biventricular systolic and diastolic function and no evidence of regional wall motion abnormalities or an effusion; Test Date: 2021; Test Name: Electrocardiogram (EKG); Result Unstructured Data: Test Result:normal; Comments: an outpatient cardiology visit 3 days; Test Date: 2021; Test Name: Electrocardiogram (EKG); Result Unstructured Data: Test Result:revealed diffuse ST-segment elevations; Test Date: 2021; Test Name: Electrocardiogram (EKG); Result Unstructured Data: Test Result:showed diffuse ST- segment changes; Test Date: 2021; Test Name: Electrocardiogram (EKG); Result Unstructured Data: Test Result:normal; Comments: at 2 week follow up; Test Date: 2021; Test Name: hemodynamically; Result Unstructured Data: Test Result:stable; Test Date: 2021; Test Name: Telemetry; Result Unstructured Data: Test Result:revealed occasional isolated premature; Comments: revealed occasional isolated premature ventricular contractions; Test Name: Cardiac magnetic resonance imaging (cMRI); Result Unstructured Data: Test Result:showed low normal left ventricular ejection; Comments: showed low normal left ventricular ejection fraction 53% trivial pericardial effusion and subepicardial late gadolinium in the same distribution as seen in the previous episode but with interval increased enhancement Figure 2; Test Date: 2021; Test Name: Cardiac magnetic resonance imaging (cMRI); Result Unstructured Data: Test Result:showed 2 small areas of delayed gadolinium; Comments: showed 2 small areas of delayed gadolinium enhancement of the left ventricular myocardium.; Test Date: 2021; Test Name: Respiratory pathogen panel PCR testing; Result Unstructured Data: Test Result:including SARSCoV2 was negative; Test Date: 2021; Test Name: Respiratory viral pathogen panel polymerase chain reaction (PCR) testing; Result Unstructured Data: Test Result:including severe acute respiratory syndrome; Comments: including severe acute respiratory syndrome coronavirus 2 SARSCoV2 as well as SARSCoV2 nucleocapsid IgG and IgA was negative; Test Date: 2021; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:5; Comments: 5 mm/h; Test Date: 2021; Test Name: rheumatoid factor; Test Result: Negative ; Test Date: 2021; Test Name: Rheumatologic testing; Result Unstructured Data: Test Result:antinuclear antibody test and rheumatoid factor; Comments: antinuclear antibody test and rheumatoid factor was negative; Test Date: 2021; Test Name: SARCoV2 nucleocapsid IgA; Test Result: Negative ; Test Date: 2021; Test Name: SARCoV2 nucleocapsid IgG; Test Result: Negative ; Test Date: 2021; Test Name: SARSCoV2; Test Result: Negative ; Test Date: 2021; Test Name: SARSCoV2 IgM antibody for the spike protein; Test Result: Positive ; Comments: positive consistent with recent immunization; Test Date: 2021; Test Name: Serum troponin; Result Unstructured Data: Test Result:normal; Comments: at 2 week follow up; Test Name: Serum troponin; Result Unstructured Data: Test Result:9.17 ng/ml; Test Date: 2021; Test Name: Serum troponin; Result Unstructured Data: Test Result:51.37 ng/ml; Comments: peaked at 51.37; Test Date: 2021; Test Name: Serum troponin; Result Unstructured Data: Test Result:23 ng/ml; Test Date: 2021; Test Name: Serum troponin level; Result Unstructured Data: Test Result:506 ng/ml
CDC Split Type: USPFIZER INC202101589217

Write-up: recurrence of acute myocarditis; recurrence of acute myocarditis; This is a literature report. Author describe a case of an adolescent male patient who had recurrence of acute myocarditis temporally associated with receipt of a second dose of the PfizerBioNTech mRNA COVID19 vaccine. Case Presentation: A 17-year-old male adolescent with no significant medical history came to medical attention in Jan2021 with chest pain consistent with myocarditis. Serum troponin level peaked at 506 ngmL normal < 0.04 ng/mL. Cardiac magnetic resonance imaging (cMRI) showed 2 small areas of delayed gadolinium enhancement of the left ventricular myocardium. Electrocardiogram (EKG) showed diffuse ST segment changes. Respiratory viral pathogen panel polymerase chain reaction (PCR) testing including severe acute respiratory syndrome coronavirus 2 SARSCoV2 as well as SARSCoV2 nucleocapsid IgG and IgA was negative. He received supportive care and was discharged after 6 days of hospitalization with normal cardiac testing including serum troponin, EKG and echocardiogram at 2week follow-up. On 15Apr2021 he received his first dose of the PfizerBioNTech COVID19 mRNA vaccine without any side effects noted. One day after receiving the second dose of the PfizerBioNTech COVID19 mRNA vaccine on 07May2021 he developed fever T max 101.3 degree F and body aches that responded to acetaminophen. The following day he developed sudden onset of severe burning left sided chest pain that radiated to the left shoulder and the upper left arm. He reported that the chest pain worsened with exertion and movement and was similar to that experienced during his previous episode of myocarditis. He denied any other symptoms. The patient presented to our emergency department hemodynamically stable however EKG revealed diffuse ST-segment elevations. Initial laboratory test results showed a serum troponin of 23 ng/mL , C-reactive protein of 29 mg/L normal 05 mgL and erythrocyte sedimentation rate of 5 mmh normal < 15 mmh. Respiratory pathogen panel PCR testing including SARSCoV2 was negative. SARCoV2 nucleocapsid IgG and IgA were negative and SARSCoV2 IgM antibody for the spike protein was positive consistent with recent immunization. Rheumatologic testing including antinuclear antibody test and rheumatoid factor was negative. He was admitted to the pediatric intensive care unit for telemetry and observation Initial echocardiogram revealed normal biventricular systolic and diastolic function and no evidence of regional wall motion abnormalities or an effusion. Telemetry revealed occasional isolated premature ventricular contractions. Troponin peaked at 51.37 ngmL cMRI showed low normal left ventricular ejection fraction 53% trivial pericardial effusion and subepicardial late gadolinium in the same distribution as seen in the previous episode but with interval increased enhancement. His chest pain improved with nonsteroidal anti-inflammatory drug treatment and supportive care and he was discharged after 6 days of hospitalization. At the time of discharge his troponin was 0.17 ngmL and EKG findings were normal At an outpatient cardiology visit 3 days after discharge the patients cardiac evaluation including EKG and echocardiogram was normal. Our patient had his first episode of idiopathic acute myocarditis 4 months before recurrence This recurrent episode of myocarditis may have been triggered by the vaccine administration through an autoinflammatory or autoimmune phenomenon Cardiac MRI during both illnesses demonstrated enhancement after gadolinium administration in the same distribution during both episodes. This case highlights the possibility that the COVID19 mRNA vaccine may trigger recurrent acute myocarditis in children and adolescents who have had a previous episode of acute myocarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information provided, the contributory role of the suspect product BNT162B2 to reported events myocarditis/disease recurrence cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1899682 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (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: USJNJFOC20211149169

Write-up: MYOCARDITIS; PERICARDITIS; This spontaneous report received from a consumer concerned multiple patients (123 of 3,030) of unspecified age, sex, race and ethnic origin. The height and weight of the patients were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Reporter states that "of the 3,030 events of myocarditis and pericarditis, 123 were attributed to Janssen COVID vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211149169-COVID-19 VACCINE AD26.COV2.S-myocarditis, pericarditis. 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).


VAERS ID: 1904657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-29
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? 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: USJNJFOC20211157170

Write-up: MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20211157170-COVID-19 VACCINE AD26.COV2.S-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).


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