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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

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Case Details

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VAERS ID: 1661275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
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 - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Antibody test, Aspartate aminotransferase, Biopsy heart, Blood creatine phosphokinase MB, Blood lactic acid, C-reactive protein, Catheterisation cardiac, Ejection fraction, Electrocardiogram, Fibrin D dimer, Interleukin level, Interleukin-2 receptor assay, International normalised ratio, Magnetic resonance imaging, Myocarditis, Platelet count, Polymerase chain reaction, SARS-CoV-2 antibody test, Serum ferritin
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 73 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: without prior medical history
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:14477 IU/l; Comments: ALI was noted u/l; Test Name: IgG anti-nucleocapsid; Test Result: Negative ; Test Name: AST; Result Unstructured Data: Test Result:6086 IU/l; Comments: u/l ALI was noted; Test Name: endomyocardial biopsy; Result Unstructured Data: Test Result:showed cardiomyocytes with minute foci of cytoplas; Comments: performed on day 13 of hospital admission, showed cardiomyocytes with minute foci of cytoplasmic vacuolization and rare interstitial lymphocytic infiltrate, which is consistent with healing myocarditis, but did not meet conventional diagnostic criteria for acute myocarditis; Test Name: CK-MB; Result Unstructured Data: Test Result:42 ng/ml; Test Name: CK-MB; Result Unstructured Data: Test Result:42.4 ng/ml; Comments: elevated; Test Name: Lactic acid; Result Unstructured Data: Test Result:13 mmol/L; Comments: on admission normalized within 24 h of ECMO onset; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:Showed no obstructive coronary artery disease; Comments: showed no obstructive coronary artery disease; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:showed preservation of cardiac output and normal f; Comments: showed preservation of cardiac output and normal filling pressures, on day 13 of hospital admission; Test Name: CRP; Test Result: 5.6 mg/dl; Comments: elevated; Test Name: LVEF; Test Result: 15 %; Test Name: LVEF; Test Result: 50 %; Comments: documented by transthoracic echocardiography; Test Name: ECG; Result Unstructured Data: Test Result:Non-specific changes; Test Name: D-dimer; Result Unstructured Data: Test Result:greater than 20 ug/ml; Test Name: Interleukin-6; Result Unstructured Data: Test Result:17.2 pg/mL; Comments: [12 h after therapy]; Test Name: Interleukin-6; Result Unstructured Data: Test Result:17 pg/mL; Comments: mildly elevated; Test Name: interleukin-2 soluble receptor alpha; Result Unstructured Data: Test Result:1067 IU/ml; Comments: u/ml (NV <710); Test Name: INR; Result Unstructured Data: Test Result:4.5; Test Name: INR; Result Unstructured Data: Test Result:1.7; Comments: improved; Test Name: cardiac magnetic resonance; Result Unstructured Data: Test Result:showed LVEF of 35%, diffuse elevation of native T1; Comments: performed 45 days after the initial presentation, showed LVEF of 35%, diffuse elevation of native T1 values, small pericardial effusion with enhancement of the pericardium anterior and anterolaterally and small patchy areas of enhancement following delayed imaging after gadolinium in the mid-wall of the anterior wall, consistent with myopericarditis; Test Name: thrombocytes; Result Unstructured Data: Test Result:106 x10 9/l; Comments: Thrombocytopenia was noted persisted for several days; Test Name: PCR; Test Result: Negative ; Comments: PCR for SARS-CoV2 and other common respiratory viruses was negative; Test Name: SARS-CoV2 NC IgG; Test Result: Negative ; Test Name: SARS-CoV2 spike IgG; Result Unstructured Data: Test Result:64; Comments: a.u./ml; Test Name: SARS-CoV2 spike protein IgG antibody; Test Result: Positive ; Comments: (64 arbitrary units/ml); Test Name: Ferritin; Result Unstructured Data: Test Result:greater than 30000 ng/ml; Comments: elevated
CDC Split Type: USPFIZER INC202101116531

Write-up: fulminant myocarditis; This is a literature report associated with BNT162b2 mRNA COVID-19 vaccination in two patients. This author reported similar event for two patients. This is second of two reports. A 34-year-old female without prior medical history presented 9 days after her first vaccine dose. On day 4 after vaccine, she developed fevers, cough, chest pain, nausea, and vomiting. She presented to another institution with hypotension and sinus tachycardia, an echocardiogram showed severely reduced LVEF of 15%. Cardiac catheterization showed no obstructive coronary artery disease. She was transferred for initiation of VA-ECMO. On admission, she was in severe shock requiring multiple vasopressors. CRP, ferritin and CK-MB were elevated at 5.6 mg/dL, $g30,000 ng/mL, and 42.4 ng/mL, respectively. VA-ECMO and RRT were initiated. Treatment was initiated with methylprednisolone 1000 mg daily and continued for 3 days followed by a slow taper over, with IVIG 30 mg daily for 4 days, and anakinra 100 mg daily. Lactic acid 13 mmol/ L on admission normalized within 24 h of ECMO onset, INR improved from 4.5 to 1.7. Interleukin-6 level was mildly elevated at 17 pg/mL and interleukin-2 soluble receptor alpha was 1067 U/mL (NV less than 710). Thrombocytopenia was noted at 106x10 9 /L which persisted for several days. ALI was noted with ALT and AST at 14,477 and 6086 u/L which steadily improved thereafter. PCR for SARS-CoV2 and other common respiratory viruses was negative. SARS-CoV2 spike protein IgG antibody was positive (64 arbitrary units/ml), and IgG anti-nucleocapsid was negative, consistent with immunization due to vaccine without prior infection. Vasopressors were weaned off, LVEF was documented at 50% by transthoracic echocardiography, VA-ECMO was discontinued. She was treated with prednisone 1 mg/kg and anakinra with prednisone tapered first (by reducing 0.1 mg every week) and tapering anakinra planned after prednisone is discontinued. An endomyocardial biopsy performed on day 13 of hospital admission, after recovery of cardiac function and near resolution of the systemic hyperinflammation, showed cardiomyocytes with minute foci of cytoplasmic vacuolization and rare interstitial lymphocytic infiltrate, which is consistent with healing myocarditis, but did not meet conventional diagnostic criteria for acute myocarditis. A cardiac catheterization at the same time showed preservation of cardiac output and normal filling pressures. A cardiac magnetic resonance, performed 45 days after the initial presentation, showed LVEF of 35%, diffuse elevation of native T1 values, small pericardial effusion with enhancement of the pericardium anterior and anterolaterally and small patchy areas of enhancement following delayed imaging after gadolinium in the mid-wall of the anterior wall, consistent with myopericarditis. Genetic testing for 121 genes showed no variants associated with genetic disorders. Guideline-directed heart failure treatment was also initiated. She was discharged from the hospital after 73 days. 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 #2: Presentation included: Symptoms: Fever, cough, chest pain, nausea and vomiting. Vaccine type was BNT162b2 mRNA Covid-19. Timing was 9 days after 1st dose. Hemodynamics included Hypotension and tachycardia. ECG : Non-specific changes. Echocardiogram: LVEF 15%. Biomarkers included: CRP : 5.6 mg/dl; Interleukin: 17.2 pg/ml [12 h after therapy]; Ferritin : greater than 30,000 ng/ml; INR : 4.5; D-dimer : greater than 20 ug/ml; Lactic acid : 13 mmol/l; CK-MB : 42 ng/ml; SARS-CoV2 spike IgG : 64 a.u./ml; SARS-CoV2 NC IgG : negative. Immunosuppressive therapy included: Methylprednisolone : 1000 mg daily for 3 days, followed by a slow prednisone taper over several weeks; Immunoglobulins : 30 mg daily for 4 days; Anakinra : 100 mg daily. Outcome was Recovering, minimal symptoms, LVEF 35%, delayed enhancement after gadolinium at cardiac magnetic resonance; discharged from the hospital after 73 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The event myocarditis is considered possibly related to suspect BNT162b2 mRNA COVID-19 vaccination, based on temporal association and in absence of other apparent causes, and with unique features of systemic hyperinflammation associated with refractory shock. 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-202101116136 Same article/ drug/event and different patient


VAERS ID: 1673269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body fluid analysis, Pericardial effusion, Pericarditis, SARS-CoV-2 antibody test
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyndamax
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: biopsies of the fluid; Result Unstructured Data: Test Result: it might be pericarditis; Comments: it might be pericarditis; Test Date: 202108; Test Name: Antibody test; Result Unstructured Data: Test Result: Negative.
CDC Split Type: USPFIZER INC202101081807

Write-up: having so much fluid in his heart/had fluid around his heart; pericarditis; This is a spontaneous report from a contactable consumer (patient''s spouse). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; tafamidis (VYNDAMAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at an unspecified dose for an unspecified indication. Medical history and concomitant medications were not reported. The patient had the first shot of the Pfizer BioNTech COVID-19 vaccine "on 06Jan2021 or 07Jan2021 or 04Jan2021" and by 17Jan2021, he was rushed to the emergency room because he couldn''t breathe. He was having so much fluid in his heart and had to re-do the operation in Feb2021, and "they took biopsies of the fluid and they came back saying it might be pericarditis." She further described that he had fluid around his heart, they thought it was pericarditis and have been treating him all winter. He had a pericardial window and was on medication. The reporter stated that it started Jan2021 after the first shot, but "it might be too close to the first shot to actually be caused by it". The patient had a pericardial window now which would take the fluid out should it come back again, but would have to go on antibiotics. They did an antibody test last week (as of 20Aug2021) and the patient''s came back as negative; so he has an appointment for a third vaccine The outcome of the event(s) was not recovered. The reporter further provided that they are scheduled for a third dose of Moderna and Pfizer because the patient''s doctor said that if the Pfizer (vaccine) didn''t give him antibodies, they should try Moderna. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1673459 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
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? 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 INC202101127761

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer (patient) via Pfizer RXPathways. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient stated that over the past 4-5 weeks from the time of reporting, the patient has been having chest pain with breathing and movement. The patient thought of having some heart issues, so the patient went to PCP (primary care physician), then sent the patient to ER (emergency room), then referred to cardiologist. The cardiologist scheduled the patient for an Echo and Stress Test. Then on 24Aug2021, the pain was worse, so the patient went back to cardiologist. The patient was sent back to ER again and finally the ER diagnosed the patient with pericarditis. The patient had no past cardiac issues or heart related conditions. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.


VAERS ID: 1677583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
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? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101134355

Write-up: she knew/heard someone past away (die) due to inflammation of the heart; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. This consumer reported for two patients. This is the second of two reports. A female patient of an unspecified age received 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 immunization. The patient''s medical history and concomitant medications were not reported. The reporter would like to know if inflammation of the heart was a commonly reported side effect post-vaccination of the COMIRNATY vaccine and if there had been a lot of reports about it. The reporter stated that she knew/heard someone past away (die) due to inflammation of the heart (onset date not reported) as an AE post-vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) :PFIZER INC-202101132810 Same reporter/drug, different patient/AE; Reported Cause(s) of Death: she knew/heard someone past away (die) due to inflammation of the heart


VAERS ID: 1678297 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Pericarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown. No concomitant medication details was provided. No treatment medication details was provided. Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Date of first dose was not provided, thus appropriateness of product administration schedule is not assessable. Further information has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Date of first dose was not provided, thus appropriateness of product administration schedule is not assessable. Further information has been requested.


VAERS ID: 1681938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-12
Onset:2021-06-02
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Blood lactic acid, Blood lactic acid abnormal, C-reactive protein, C-reactive protein increased, Chest pain, Chills, Dyspnoea, Electrocardiogram, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Fibrin D dimer, Fibrin D dimer increased, International normalised ratio, International normalised ratio increased, Lymphadenopathy, Myocarditis, Oropharyngeal pain, Pancytopenia, Pericarditis, Prothrombin time, Prothrombin time prolonged, Pyrexia, Rash, Rash erythematous, SARS-CoV-2 test negative, Sinus tachycardia, Tachypnoea, Troponin, Troponin abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Agranulocytosis (narrow), Asthma/bronchospasm (broad), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Myelodysplastic syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Lactate; Result Unstructured Data: Test Result:3.8; Test Date: 20210604; Test Name: Lactate; Result Unstructured Data: Test Result:4.6; Test Date: 20210604; Test Name: CRp; Result Unstructured Data: Test Result:20; Test Date: 20210604; Test Name: EKG; Result Unstructured Data: Test Result:sinus tachycardia; Comments: ST elevation suggests acute pericarditis; Test Name: D-Dimer; Result Unstructured Data: Test Result:unknown results; Test Date: 20210604; Test Name: D-Dimer; Result Unstructured Data: Test Result:3618; Test Date: 20210604; Test Name: INR; Result Unstructured Data: Test Result:1.2; Test Date: 20210604; Test Name: PT; Result Unstructured Data: Test Result:13.2; Test Date: 20210604; Test Name: Sars COV2-PCR; Test Result: Negative ; Test Date: 20210604; Test Name: Troponin; Result Unstructured Data: Test Result:0.30
CDC Split Type: USPFIZER INC202101098983

Write-up: pancytopenia; pericarditis; myocarditis; left axillary adenopathy; fevers; Rash; chest pain; electrocardiogram ST segment elevation; chills; sore throat; shortness of breath; erythematous rash on trunk and limbs; arthralgia in the ankle; tachycardic / sinus tachycardia; mildly tachypneic; C-reactive protein increased; electrocardiogram abnormal; international normalised ratio increased; Troponin: 0.30; prothrombin time prolonged; Blood lactic acid/Lactate: 3.8; 2nd time-4.6; Fibrin d dimer/D-Dimer: 3618; This is a spontaneous report from a non-contactable consumer received from the FDA. The regulatory authority report number is not reported. An 18-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Arm Left on 12May2021 (lot number: EW0182) as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications provided as none. No history of allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0165), via intramuscular on 21Apr2021 as single dose for COVID-19 immunization. On 02Jun2021, the patient experienced chest pain, myocarditis, pancytopenia, pericarditis, pyrexia, rash, left axillary adenopathy, chills, sore throat, shortness of breath, erythematous rash on trunk and limbs, arthralgia in the ankle, tachycardic / sinus tachycardia, mildly tachypneic, C-reactive protein increased, electrocardiogram abnormal, electrocardiogram ST segment elevation, international normalised ratio increased, Troponin/ Troponin: 0.30, prothrombin time prolonged, Blood lactic acid (Lactate: 3.8; 2nd time-4.6), Fibrin D dimer (D-Dimer: 3618). Events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, chest pain reported as hospitalized from 04Jun2021, three days in hospital. Events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, tachycardic and mildly tachypneic resulted in emergency room visit. The patient with intensive care on 02Jun2021. The clinical course was reported as follows: Few hours after vaccine developed fevers for 2 days which resolved. Then 02Jun2021 developed fevers, rash, chest pain, admitted to hospital; 04Jun2021 with fevers, rash, pancytopenia, pericarditis, myocarditis. Patient was in usual state of health until 02Jun2021 and experienced fevers, chills, sore throat, shortness of breath, chest pain, erythematous rash on trunk and limbs, arthralgia in the ankle. Presented to ED on 04Jun -febrile, tachycardic and mildly tachypneic. Patient was still currently admitted in unit. left axillary adenopathy. Lab data included on 04Jun2021 (all lab results) Lactate: 3.8; Lactate: 4.6 (2nd time); CRP: 20; EKG: sinus tachycardia, ST elevation suggests acute pericarditis; INR:1.2; D-Dimer: 3618; PT: 13.2; Sars COV2-PCR: negative; Troponin: 0.30. Fibrin d dimer with unknown results on unspecified date. Outcome of the event fevers was recovered on unspecified date. Outcome of events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, chest pain was not recovered, while of the other events was unknown. This report was assessed by reporting consumer as serious. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1682056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101138389

Write-up: Died of cardiac arrest; Inflammation on his heart; This is a spontaneous report from a contactable consumer or other non-HCP (patient friend) via Medical Information Team. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient died recently and he was a bigger man. He experienced inflammation on his heart and died of cardiac arrest. It was unknown if an autopsy was done. The outcome of the event inflammation on his heart was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Died of cardiac arrest


VAERS ID: 1691985 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Carditis, Eye disorder, Hepatitis, Renal disorder
SMQs:, Hepatitis, non-infectious (narrow), Glaucoma (broad), Optic nerve disorders (broad), Corneal disorders (broad), Retinal disorders (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.MOD20213

Write-up: got blind; Hepatitis; heart inflammation; Eye problem; Kidney problem; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (got blind), HEPATITIS (Hepatitis) and CARDITIS (heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 BLINDNESS (got blind) (seriousness criterion medically significant), HEPATITIS (Hepatitis) (seriousness criterion medically significant), CARDITIS (heart inflammation) (seriousness criterion medically significant), EYE DISORDER (Eye problem) and RENAL DISORDER (Kidney problem). At the time of the report, BLINDNESS (got blind), HEPATITIS (Hepatitis), CARDITIS (heart inflammation), EYE DISORDER (Eye problem) and RENAL DISORDER (Kidney problem) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient reported "225 people got blind after vaccination. There are also other reports on hepatitis, eye problem, kidney problem, and heart inflammation. People are dying". Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.


VAERS ID: 1692221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2021-08-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101127713

Write-up: I refer there is Myocarditis thing; When he took a deep breath in, he had, it is like chest pain like it is crampy; This is a spontaneous report from a contactable consumer (parent). This consumer reported for his son. A 13-year-old male patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EW0168 and expiration date was 30Nov2021), via an unspecified route of administration on 25Aug2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EW0168), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The reporter stated that when his son took a deep breath in, he had, it was like chest pain like it was crampy. Reporter referred there was Myocarditis thing and patient had same thing in next morning like when he took a deep breath in there was some like chest pain in there. The outcome of events was unknown. Follow-up attempts were completed. No further information was expected.


VAERS ID: 1692237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase increased, Body mass index, Chest X-ray, Cytomegalovirus test negative, Echocardiogram, Ejection fraction, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Investigation, Laboratory test, Myocarditis, Parvovirus B19 test negative, Pericardial effusion, Polymerase chain reaction, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 test positive (10 months before); Vitiligo
Allergies:
Diagnostic Lab Data: Test Name: cpk; Result Unstructured Data: Test Result:317 IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:13 ng/ml; Test Name: Body mass index; Result Unstructured Data: Test Result:24.2; Comments: kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: cytomegalovirus (CMV) antibodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities, qualitatively; Comments: showed no structural abnormalities, qualitatively low normal left ventricular systolic function (LVSF), and no pericardial effusion; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:56; Test Name: EKG findings; Result Unstructured Data: Test Result:Abnormal T waves, ST-segment depression; Comments: Abnormal T waves, ST-segment depression; Test Name: electrocardiogram; Result Unstructured Data: Test Result:demonstrated normal sinus rhythm with ST-segment; Comments: demonstrated normal sinus rhythm with ST-segment depressions in V1 and V2; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: Epstein-Barr virus (EBV) titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:0.2 ug/ml; Comments: 0.2; Test Name: laboratories; Result Unstructured Data: Test Result:were unremarkable aside from elevated creatine; Comments: were unremarkable aside from elevated creatine phosphokinase-MB (CPK-MB) level of 13 ng/mL and troponin level of 3.34 ng/mL; Test Name: Parvovirus B19 antibodies; Test Result: Negative ; Test Name: pericardial effusion; Result Unstructured Data: Test Result:No; Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Positive ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: troponin level; Result Unstructured Data: Test Result:3.34 ng/ml; Comments: Initial; Test Name: troponin level; Result Unstructured Data: Test Result:4.85 ng/ml; Comments: peak; Test Name: troponin level; Result Unstructured Data: Test Result:3.15 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:7.2
CDC Split Type: USPFIZER INC202101133568

Write-up: perimyocarditis/presented to the emergency department (ED) with retrosternal pressure-like chest pain; This is a literature report. The full publication has been requested. This author reported similar events for eight patients. This is the first of eight reports. A 17-year-old (also reported as 17.6-year-old) male with a past medical history of vitiligo presented to the emergency department (ED) with retrosternal pressure-like chest pain. He denied shortness of breath, fever, vomiting, rhinorrhea, abdominal pain, or diarrhea. The patient tested positive for SARS-CoV-2 10 months before. He received the second dose of the BNT162b2 vaccine 4 days before presentation. Chest X-ray was negative, and electrocardiogram (ECG) demonstrated normal sinus rhythm with ST-segment depressions in V1 and V2. There were no ST-segment elevations or PR-segment depressions. Initial laboratories were unremarkable aside from elevated creatine phosphokinase-MB (CPK-MB) level of 13 ng/mL and troponin level of 3.34 ng/mL. The peak troponin was 4.85 ng/mL. The patient was transferred to our hospital. Transthoracic echocardiogram (TTE) showed no structural abnormalities, qualitatively low normal left ventricular systolic function (LVSF), and no pericardial effusion. Patient was managed with ibuprofen with no recurrence of pain. Patient had a negative respiratory pathogen panel (RPP), adenovirus plasma PCR, cytomegalovirus (CMV) antibodies, enterovirus plasma PCR, Epstein-Barr virus (EBV) titers, and Parvovirus B19 antibodies. SARS-CoV-2 nucleocapsid immunoglobulin G (IgG) was positive. Demographic and clinical characteristics: Body mass index (kg/m2) 24.2. Past medical history (PMH) Vitiligo. History of prior COVID-19 infection: Yes. BNT162b2 vaccine dose 2. Days between vaccine and symptom onset 4. Length of stay (hours) 48. Laboratories: White blood cell count (Ref: 5-10) 7.2; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 4.85; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 3.15; CKMB (Ref:0-3.5ng/mL) 13; CPK (Ref: 33-145 IU/L) 317; D-dimer (Ref: 0.27-0.41 ug/mL) 0.2 . COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 spike IgM Negative; SARS-CoV-2 nucleocapsid IgG Positive; EKG findings Abnormal T waves, ST-segment depression. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 56; Pericardial effusion present No; Cardiac MRI performed No;IVIG (intravenous immunoglobulin) No; Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs) Yes. DISCUSSION Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. No follow-up attempts are needed, information about batch number cannot be obtained.; Sender''s Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101137122 Same article/ drug/ event and Different patient.;US-PFIZER INC-202101137432 Same article/drug/event; different patient;US-PFIZER INC-202101137891 Same article/drug/event; different patient;US-PFIZER INC-202101138007 Same article/drug/event; different patient;US-PFIZER INC-202101137593 Same article/drug/event; different patient;US-PFIZER INC-202101136924 Same article/ drug/ event and Different patient.;US-PFIZER INC-202101138774 Same article/drug/event; different patient


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