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From the 11/12/2021 release of VAERS data:

Found 5,176 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

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1647208 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Troponin I
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:
Allergies:
Diagnostic Lab Data: Test Name: Ejection fraction; Test Result: 46 %; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm with; Comments: Sinus rhythm with non-specific T wave abnormalities; Test Name: CMR; Result Unstructured Data: Test Result:revealed patchy midmyocardial increased T2 signal; Comments: revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis (4-chamber view demonstrating areas of increased T2 signal and LGE in the subepicardial apical and apical lateral segments; Test Name: nasopharyngeal SARS-CoV-2 PCR testing; Test Result: Negative ; Test Name: Peak cardiac troponin I; Result Unstructured Data: Test Result:5.21 ng/ml
CDC Split Type: USPFIZER INC202101048389

Write-up: myocarditis following SARS-CoV-2 vaccination; Cardiovascular imaging, 2021, pp 1-2, DOI 10.1016/j.jcmg.2021.06.003 entitled A Series of Patients With Myocarditis Following SARS-CoV-2 Vaccination With mRNA-1279 and BNT162b2. This author reported similar events for five patients. This is the fourth of five reports. An adult male patient (age reported as 16-20) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single; and 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 and concomitant medications were not reported. The patient developed Cardiac Magnetic Resonance Imaging (CMR)-proven myocarditis shortly after vaccination. The patient with no infectious prodrome developed severe chest pain and elevated troponin I within 2 days-4 days of second vaccination. The patient did not develop any other complications and was discharged home. Lag between vaccination and presentation was 4 days. There was no fever. The symptoms at presentation included pleuritic and positional chest pain; headache. The patient underwent lab tests and procedures which included ejection fraction: 46 % (normal $g 55%), electrocardiogram: Sinus rhythm with non-specific T wave abnormalities, Cardiac Magnetic Resonance Imaging (CMR): revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis (4-chamber view demonstrating areas of increased T2 signal and LGE in the subepicardial apical and apical lateral segments), nasopharyngeal SARS-CoV-2 PCR testing: negative and troponin I: 5.21 ng/ml. The outcome of the event was unknown. Large clinical trials of both BNT162b2 and mRNA1273 in more than 70,000 individuals showed good safety profiles for both of the mRNA-based vaccines and no reports of myocarditis. However, myocarditis has been described after other vaccinations, such as seasonal influenza and smallpox and regulatory agencies are evaluating the risk of COVID-19 vaccine-associated myocarditis based on reports. Findings in patients with suspected COVID-19 vaccine-associated myocarditis have not been well described in published reports, and the author''s report tries to document some of these changes. Although the clinical presentation, Findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, the authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis. 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 currently available,The casual association between the reported event and suspected vaccine BNT162B2 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100999284 same article/drug/event, different patients


VAERS ID: 1647211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Troponin I
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ejection fraction; Test Result: 50 %; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Ectopic atrial rhythm; Comments: Ectopic atrial rhythm with diffuse ST elevation and PR depression; Test Name: CMR; Result Unstructured Data: Test Result:revealed patchy midmyocardial increased T2 signal; Comments: revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis (Figure 1).; Test Name: nasopharyngeal SARS-CoV-2 PCR testing; Test Result: Negative ; Test Name: Peak cardiac troponin I; Result Unstructured Data: Test Result:19.7 ng/ml
CDC Split Type: USPFIZER INC202101048410

Write-up: myocarditis following SARS-CoV-2 vaccination; This is a literature report. Cardiovascular imaging, 2021, pp 1-2, DOI 10.1016/j.jcmg.2021.06.003, entitled A Series of Patients With Myocarditis Following SARS-CoV-2 Vaccination With mRNA-1279 and BNT162b2. This author reported similar events for five patients. This is the fifth of five reports. An adult (16-20 years old) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, 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 were not reported. The patient developed Cardiac Magnetic Resonance Imaging (CMR)-proven myocarditis shortly after vaccination. The patient developed Cardiac Magnetic Resonance Imaging (CMR)-proven myocarditis shortly after vaccination on an unspecified date. The patient with no infectious prodrome developed severe chest pain and elevated troponin I within 2 days-4 days of second vaccination. The patient did not develop any other complications and was discharged home. on an unspecified date. The patient with no infectious prodrome developed severe chest pain and elevated troponin I within 2 days-4 days of second vaccination. The patient did not develop any other complications and was discharged home. The patient did not develop any other complications and was discharged home. Lag between vaccination and presentation was 3 days. There was no fever. The symptoms at presentation included non-positional chest pressure; myalgias. The event assessed as serious (hospitalization, and medically significant). The patient underwent lab tests and procedures which included ejection fraction: 50 % on an unspecified date, electrocardiogram: ectopic atrial rhythm on an unspecified date Ectopic atrial rhythm with diffuse ST elevation and PR depression, magnetic resonance imaging heart: revealed patchy midmyocardial increased t2 signal on an unspecified date revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis (Figure 1) , sars-cov-2 test: negative on an unspecified date, troponin i: 19.7 ng/ml on an unspecified date. Large clinical trials of both BNT162b2 and mRNA1273 in more than 70,000 individuals showed good safety profiles for both of the mRNA-based vaccines and no reports of myocarditis. However, myocarditis has been described after other vaccinations, such as seasonal influenza (3) and smallpox (4) and regulatory agencies are evaluating the risk of COVID-19 vaccine-associated myocarditis based on reports. CMR findings in patients with suspected COVID-19 vaccine-associated myocarditis have not been well described in published reports, and the report tries to document some of these changes. Although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in 6 patients, authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patients. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis. 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 currently available,The casual association between the reported event and suspected vaccine BNT162B2 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100999284 Same article/drug/event; Different patient


VAERS ID: 1647265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Endocarditis, 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: USPFIZER INC202101050812

Write-up: Had an issue with the lining of my heart; myocarditis; pericarditis; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. On an unspecified date, the patient experienced had an issue with the lining of my heart, myocarditis, pericarditis. Patient asked if she was eligible to take the booster or third shot. Went to pharmacist and had to fill out a form Number 14 says a history of myocarditis, inflammation of the heart, and pericarditis She got myocarditis and pericarditis three weeks ago after her first two COVID-19 shots. Her shots were fine. Is was said that she should not get the booster if she has pericarditis. Clarified her myocarditis and pericarditis have nothing to do with her COVID-19 vaccines. It happened at the Withheld. She was on a lot of blood thinners. Patient was on Colchicine and 3000mg of Aspirin (Intent: treatment). Therapeutic measures were taken as a result of had an issue with the lining of my heart, myocarditis, pericarditis. Events were considered as serious (medically significant). Patient received treatment with Colchicine and 3000mg of Aspirin. The clinical outcome of events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101057410

Write-up: he ended up in the hospital with Paracydis/The side effect listed should be: Pericarditis; This is a spontaneous report from a Pfizer-sponsored program reported by a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, after the 2nd dose the patient ended up in the hospital with pericarditis which was supposedly a common side effect of the vaccine. The patient wanted to know what Pfizer recommends and if this should be reported. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1654981 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: USJNJFOC20210849032

Write-up: MYOCARDITIS; PERICARDITIS; This spontaneous report received from a consumer via a company representative concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. No past medical history or concurrent conditions were reported. All patients (some 3%) received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown)1 total, dose and 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. On an unspecified date, the patients experienced myocarditis and pericarditis. The myocarditis were in men with a median age of 36 years old. The median age for the pericarditis cases was 59 years. The action taken with covid-19 vaccine 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: 20210849032-COVID-19 VACCINE AD26.COV2.S - myocarditis and pericarditis. These events are considered unassessable. The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1655045 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101060911

Write-up: she knows of a young gentleman who took the shot of the vaccine and developed carditis; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter state that" she knows of a young gentleman who took the shot of the vaccine and developed carditis" on an unspecified date with outcome of unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1657905 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-06
Onset:2021-06-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood lactic acid, Blood lactic acid increased, Chills, Electrocardiogram, Electrocardiogram abnormal, Lactic acidosis, Myocarditis, Pyrexia, Rash maculo-papular, Septic shock, Tachycardia, Tachypnoea, Troponin, Troponin increased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: blood lactic acid; Result Unstructured Data: Test Result:increased; Test Date: 20210606; Test Name: EKG; Result Unstructured Data: Test Result:pericarditis Positive; Comments: pericarditis Positive; Test Date: 20210606; Test Name: lactic acidosis; Result Unstructured Data: Test Result:5.5; Comments: peaking at 5.5; Test Date: 20210606; Test Name: troponin; Result Unstructured Data: Test Result:increased; Comments: peaking at 2.9 approximately
CDC Split Type: USPFIZER INC202101099151

Write-up: septic shock with myopericarditis; septic shock with myopericarditis; rigors; fever; diffuse maculopapular rash; tachycardic; tachypneic; blood lactic acid increased; electrocardiogram abnormal; lactic acidosis; troponin increased; This is a spontaneous report from a non-contactable consumer or other non hcp. A 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via intramuscular route of administration, administered on 06Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation. It was reported that medications at time of Vaccination was none. No known allergies. The patient experienced septic shock with myopericarditis, rigors, fever, diffuse maculopapular rash, tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis, troponin increased on 06Jun2021. Symptoms started out with rigors and a fever. This progressed to a diffuse maculopapular rash that resolved within 24 hours. It was reported that event were Serious, Life Threatening Hospitalized and patient visited emergency room. It was reported that Permanent Disability and Congenital Anomaly / Birth Defect was no. Following day, he was tachycardic and tachypneic when he presented to the emergency department. Ultimately he was found to be in septic shock with myopericarditis. He required pressors. He was currently still in the hospital. It was reported that Prolonged Hospitalization Existence was no and days in hospital was unknown. The patient underwent lab tests and procedures which included blood lactic acid: increased, electrocardiogram: pericarditis positive on 06Jun2021 (pericarditis Positive), lactic acidosis: 5.5 on 06Jun2021(peaking at 5.5), troponin: increased on 06Jun2021 (peaking at 2.9 approximately. The outcome of event septic shock with myopericarditis , tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis and troponin increased was not recovered and for rest event outcome was recovered on 07Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1657913 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
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? Yes
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 INC202101103604

Write-up: Myocarditis; This is a spontaneous report from a contactable consumer (reported for her husband). The case was for the husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis. The clinical course was as follows: the reporter husband who is stuck getting this stupid thing that could probably kill him because he was a man and men who are 40 down to 17 are getting myocarditis and you people didn''t seem to care about that. This case assessed as serious (life threatening and medically significant). The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1661090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, 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: Test Date: 202101; Test Name: Heart rate; Result Unstructured Data: heart rate around 130
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Myocarditis inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis inflammation) in a female patient of an unknown age 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 MYOCARDITIS (Myocarditis inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis inflammation) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Heart rate: 130 (High) heart rate around 130. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported. "Patient mentions another girl at the hospital (patient 2, reported in a crosslinked case) experienced accelerated the heat rate around 130, in January, and now has to see a cardiologist all the time for a myocarditis inflammation caused by the vaccine." Company Comment: Very limited information regarding this event has been provided at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time.


VAERS ID: 1661274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Antibody test, Aspartate aminotransferase, Blood creatine phosphokinase MB, Blood fibrinogen, Blood lactic acid, Blood pressure measurement, C-reactive protein, Cardiac arrest, Catheterisation cardiac, Echocardiogram, Electrocardiogram, Fibrin D dimer, Haemoglobin, Heart rate, Interleukin level, International normalised ratio, Investigation, Myocarditis, Platelet count, Polymerase chain reaction, SARS-CoV-2 antibody test, Serum ferritin, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (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? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Speech impairment NOS; Trisomy 21 (complicated by speech impairment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: alanine transferase; Result Unstructured Data: Test Result:7995 IU/l; Comments: u/l; Test Name: anti-nucleocapsid IgG; Test Result: Negative ; Test Name: aspartate transferase; Result Unstructured Data: Test Result:9003 IU/l; Comments: u/l; Test Name: creatine kinase myocardial band level; Result Unstructured Data: Test Result:252 ng/ml; Comments: normal value less than 5; Test Name: fibrinogen; Test Result: 100 mg/dl; Comments: dropped to 100 mg/dL; Test Name: Lactic acid; Result Unstructured Data: Test Result:6 mmol/L; Test Name: Lactic acid; Result Unstructured Data: Test Result:28 mmol/L; Comments: increased (NV - Less than 2); Test Name: blood pressure; Result Unstructured Data: Test Result:77/54 mmHg; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:showed no coronary obstructions; Test Name: CRP; Test Result: 13.1 mg/dl; Comments: highly elevated on admission; Test Name: Transthoracic echocardiogram; Test Result: 20 %; Comments: showed severe left ventricular systolic dysfunction (LVEF 20%) and a small circumferential pericardial effusion without tamponade; Test Name: electrocardiogram; Result Unstructured Data: Test Result:diffuse ST segment elevation; Comments: found to have diffuse ST segment elevation; Test Name: D-dimer; Result Unstructured Data: Test Result:4.21 ug/ml; Test Name: D-dimer; Result Unstructured Data: Test Result:greater than 20 ug/ml; Comments: increased critically high greater than 5.0; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.7; Comments: decreased; Test Name: heart rate; Result Unstructured Data: Test Result:133; Comments: per min; Test Name: Interleukin-6; Result Unstructured Data: Test Result:333 pg/mL; Comments: (NV less than 13); Test Name: INR; Result Unstructured Data: Test Result:2.0; Test Name: INR; Result Unstructured Data: Test Result:10.0; Comments: increased; Test Name: other respiratory virus; Test Result: Negative ; Comments: other common respiratory viruses more frequently associated with myocarditis was negative; Test Name: thrombocytes; Result Unstructured Data: Test Result:223 x10 9/l; Test Name: thrombocytes; Result Unstructured Data: Test Result:21 x10 9/l; Comments: developed progressively; Test Name: Polymerase chain reaction; Test Result: Negative ; Comments: for SARS-CoV2; Test Name: SARS-CoV2 NC igG; Test Result: Negative ; Test Name: SARS-CoV2 spike igG; Result Unstructured Data: Test Result:62.8; Comments: a.u./ml; Test Name: SARS-CoV2 spike protein IgG antibody; Test Result: Positive ; Comments: (62.8 arbitrary units/ml [NV less than 15.0]); Test Name: Ferritin; Result Unstructured Data: Test Result:23000 ng/ml; Comments: highly elevated on admission
CDC Split Type: USPFIZER INC202101116136

Write-up: fulminant myocarditis; recurrent cardiac arrest; refractory shock; This is a literature report from the International Journal of Cardiology, 2021, DOI:10.1016/j.ijcard.2021.08.018 entitled Fulminant myocarditis and systemic hyperinflammation temporally associated with BNT162b2 mRNA COVID-19 vaccination in two patients. This author reported similar events for two patients. This is first of two reports. A 27-year-old male with trisomy 21 complicated by speech impairment without history of cardiovascular disease presented in cardiogenic shock 2 days after his second vaccine dose. He had received the first dose without adverse effects. Approximately 36 h after the second dose, he developed nausea and vomiting. He presented to another hospital in shock (blood pressure 77/54 mmHg and heart rate 133/min) and found to have diffuse ST segment elevation in electrocardiogram (Fig. 1). Cardiac catheterization showed no coronary obstructions. Initially, creatine kinase myocardial band level (CK-MB) was 252 ng/mL (normal value [NV] < 5). Transthoracic echocardiogram showed severe left ventricular systolic dysfunction (LVEF 20%) and a small circumferential pericardial effusion without tamponade. A diagnosis of presumed fulminant pericarditis was made and methylprednisolone 1000 mg and human immunoglobulin (IVIG) 60 g were given. The course was complicated by hemodynamically unstable ventricular tachycardia refractory to electrical cardioversion followed by pulseless electrical activity. He was resuscitated with veno-arterial extracorporeal mechanical oxygenation (VA-ECMO). After return of circulation, he was supported by multiple vasopressors, mechanical ventilation, and renal replacement therapy (RRT). Despite these interventions, multiorgan failure and refractory shock persisted. Lactic acid increased from 6 to 28 mmol/L (NV less than 2), D-dimer increased from 4.21 to greater than 20 ug/mL (critically high $g5.0), INR increased from 2.0 to 10.0, and fibrinogen dropped to 100 mg/dL. C-reactive protein (CRP) and ferritin were highly elevated on admission at 13.1 mg/dL (NV less than 0.5) and 23,000 ng/mL, respectively, leading to a decision to administer anakinra (Kineret). Interleukin-6 level eventually came back highly elevated at 333 pg/mL (NV less than 13). thrombocytopenia developed progressively from 223x10 9 /L to 21x10 9 /L, while hemoglobin decreased from 11.5 to 8.7 g/dL. The patient demonstrated acute liver injury (ALI) with alanine transferase (ALT) and aspartate transferase (AST) at 7995 and 9003 u/L. Polymerase chain reaction (PCR) for SARS-CoV2 and other common respiratory viruses more frequently associated with myocarditis was negative. SARS-CoV2 spike protein IgG antibody was positive (62.8 arbitrary units/ml [NV less than 15), and anti-nucleocapsid IgG was negative, consistent with immunization status. Approximately 21 h after admission, patient died due to recurrent cardiac arrest and refractory shock. Family declined request for autopsy. In summary, both cases presented features of fulminant myocarditis with a temporal association with the BNT162b2 mRNA Covid-19 vaccination, in absence of other apparent causes and with unique features of systemic hyperinflammation associated with refractory shock. These cases identify the need for awareness of a potential, albeit extremely rare, link of BNT162b2 mRNA Covid-19 vaccination associated with fulminant myocarditis as part of a severe systemic hyperinflammatory syndrome, requiring mechanical cardiac support and, most importantly, immunosuppressive therapy. The degree of the inflammatory biomarkers and multiorgan dysfunction seen in the two cases described, as in some patients with Covid-19, is indeed out of proportion to with hemodynamic failure and shock and it is not rapidly resolved by cardiac mechanical support, reflecting a significant degree of vasoplegia. The optimal immunosuppressive treatment for systemic hyperinflammation associated with fulminant myocarditis is unknown. They chose a combination of high dose methylprednisolone, IVIG and anakinra (Table 1) as a strategy used across a variety of immunologic and rheumatologic diseases characterized with inappropriate macrophage activation. Table 1 Key biomarkers at admission and immunomodulating therapy: Patient #1: Presentation included Symptoms: Nausea and vomiting. Vaccine type was BNT162b2 mRNA Covid-19. Timing was 2 days after second dose. Hemodynamics included Hypotension and tachycardia. ECG: ST segment elevation. Echocardiogram: LVEF 20%. Biomarkers included: CRP: 13.1 mg/dl; Interleukin-6 : 333 pg/ml; Ferritin : 23,000 ng/ml; INR : 2.0; D-dimer : 4.21 ug/ml; Lactic acid : 6 mmol/l; CK-MB : 252 ng/ml; SARS-CoV2 spike IgG : 62.8 a.u./ml; SARS-CoV2 NC IgG : negative. Immunosuppressive Therapy included: Methylprednisolone : 1000 mg; Immunoglobulins : 60 mg; Anakinra : 100 mg (2 doses). Outcome was Deceased 21 h after admission. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of events myocarditis, cardiac arrest, and shock. This case will be reassessed upon receipt of additional information.,Linked Report(s) :PFIZER INC-202101116531 Same article/ drug/event and different patient; Reported Cause(s) of Death: recurrent cardiac arrest; refractory shock; fulminant myocarditis


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