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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: 1692249 (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: American trypanosomiasis, Blood creatine phosphokinase increased, Blood immunoglobulin M, Body mass index, Chest X-ray, Cytomegalovirus test, Echocardiogram, Ejection fraction, Electrocardiogram, Enterovirus test, Epstein-Barr virus antibody positive, Fibrin D dimer, HIV test, HIV test negative, Investigation, Magnetic resonance imaging heart, Mycoplasma test, Myocarditis, Pericardial effusion, Polymerase chain reaction, Respiratory viral panel, SARS-CoV-2 antibody test, Toxocariasis, Troponin I, 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), Ocular infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Trypanosoma cruzi IgG; Test Result: Negative ; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:61.5 ng/ml; Test Name: Leptospira immunoglobulin M; Test Result: Negative ; Test Name: BMI; Result Unstructured Data: Test Result:25.1; Comments: kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: CMV IgG; Test Result: Negative ; Test Name: CMV IgM; Result Unstructured Data: Test Result:borderline-positive; Test Name: TTE; Result Unstructured Data: Test Result:showed no structural abnormalities and qualitative; Comments: showed no structural abnormalities and qualitatively normal LVSF.; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:55; Test Name: Left ventricular ejection fraction on MRI; Result Unstructured Data: Test Result:60; 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:diffuse ST elevation; Comments: ECG showed diffuse ST elevation and PR-segment depression (demonstrating sinus rhythm with normal axis and intervals. Diffuse PR depressions and horizontal ST-segment elevations are illustrated); Test Name: enterovirus PCR; Test Result: Negative ; Test Name: EBV antibody panel; Result Unstructured Data: Test Result:consistent with past infection; Comments: consistent with past infection; Test Name: d-dimer; Result Unstructured Data: Test Result:0.2 ug/ml; Test Name: human immunodeficiency virus (HIV) antigen/antibody; Test Result: Negative ; Test Name: human immunodeficiency virus (HIV) antigen/antibody; Test Result: Negative ; Test Name: Lyme antibody titers; Test Result: Negative ; Test Name: cardiac MRI; Result Unstructured Data: Test Result:consistent with acute Myocarditis; Comments: Cardiac MRI findings were consistent with acute myocarditis, showing late gadolinium enhancement pattern and myocardial edema, normal biventricular size and function, and pericardial thickening.; Test Name: Mycoplasma IgM; Test Result: Positive ; Test Name: pericardial effusion; Result Unstructured Data: Test Result:No; Test Name: adenovirus PCR; Test Result: Negative ; Test Name: nasopharyngeal PCR; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: Toxocara canis IgG; Test Result: Negative ; Test Name: troponin-I; Result Unstructured Data: Test Result:4.82 ng/ml; Comments: elevated; Test Name: troponin-I; Result Unstructured Data: Test Result:5.56 ng/ml; Comments: peak; Test Name: troponin-I; Result Unstructured Data: Test Result:0.72 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:4.3
CDC Split Type: USPFIZER INC202101136924

Write-up: perimyocarditis/presented to the ED with left-sided chest pain and intermittent palpitations for approximately 1 day; This is a literature report. The full publication has been requested. This author reported similar events for eight patients. This is the second of eight reports. A 16-year-old (also reported as 16.7-year-old) male with no past medical history presented to the ED with left-sided chest pain and intermittent palpitations for approximately 1 day. He denied fever, shortness of breath, or recent illness. There was no history of SARS-CoV-2 infection. Patient had received the second dose of BNT162b2 vaccine 3 days prior to presentation. His troponin-I was elevated at 4.82 ng/mL, and ECG showed diffuse ST elevation and PR-segment depression (demonstrating sinus rhythm with normal axis and intervals. Diffuse PR depressions and horizontal ST-segment elevations are illustrated). The patient was managed with ibuprofen with resolution of pain. TTE showed no structural abnormalities and qualitatively normal LVSF. Cardiac MRI findings were consistent with acute myocarditis, showing late gadolinium enhancement pattern and myocardial edema, normal biventricular size and function, and pericardial thickening. Further workup showed negative SARS-CoV-2 nucleocapsid IgG, negative human immunodeficiency virus (HIV) antigen/antibody, adenovirus PCR, enterovirus PCR, Lyme antibody titers, Leptospira immunoglobulin M (IgM), Trypanosoma cruziIgG, and Toxocara canis IgG. EBV antibody panel was consistent with past infection. CMV IgM was borderline-positive, but IgG was negative. RPP was negative. Mycoplasma IgM was positive; however, nasopharyngeal PCR was negative. The decision was made to treat with doxycycline for Mycoplasma infection, although the IgM was suspected to be a false-positive. The patient was discharged home on doxycycline, ibuprofen, and lansoprazole. Demographic and clinical characteristics: Body mass index (kg/m2) 25.1. Past medical history (PMH) No. History of prior COVID-19 infection No. BNT162b2 vaccine dose # 2. Days between vaccine and symptom onset 3. Length of stay (hours) 71. Laboratories: White blood cell count (Ref: 5-10) 4.3; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.56; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.72; CKMB (Ref:0-3.5ng/mL) 61.5; d-dimer (Ref: 0.27-0.41 mmg/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 PR depression, diffuse ST-segment elevation. Imagine Chest radiograph (cardiopulmonary findings) Negative. Left ventricular ejection fraction on ECHO 55. Pericardial effusion present No. Cardiac MRI performed Yes. Left ventricular ejection fraction on MRI 60. Myocardial edema on MRI Yes. Late gadolinium enhancement on MRI Yes. Treatment/intervention: 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-202101133568 Same article/ drug/ event and Different patient.


VAERS ID: 1692250 (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: American trypanosomiasis, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Body mass index, Cardiac telemetry, Chest X-ray, Cytomegalovirus test, Echocardiogram, Ejection fraction, Electrocardiogram, Enterovirus test, Epstein-Barr virus antibody, Fibrin D dimer, HIV antibody, HIV antigen, Leptospira test, Lyme disease, Magnetic resonance imaging, Magnetic resonance imaging heart, Mycoplasma test, Myocarditis, Parvovirus B19 test, Pericardial effusion, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin, Troponin I, Troponin increased, Viral test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Myopericarditis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Trypanosoma cruzi antibodies; Test Result: Negative ; Test Name: cpk; Result Unstructured Data: Test Result:523 IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:Unknown results ng/ml; Test Name: BMI; Result Unstructured Data: Test Result:39.7; Comments: kg/m2; Test Name: telemetry; Result Unstructured Data: Test Result:had a single 4 beat episode of monomorphic ventric; Comments: had a single 4 beat episode of monomorphic ventricular tachycardia; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: CMV anti bodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:no significant valvular dysfunction; Comments: no significant valvular dysfunction, qualitatively normal biventricular systolic function, and no significant pericardial effusion; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed normal biventricular function; Comments: showed normal biventricular function; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:58; Test Name: Left ventricular ejection fraction on MRI; Result Unstructured Data: Test Result:61; Test Name: ECG; Result Unstructured Data: Test Result:demonstrated normal sinus rhythm with no other abn; Comments: demonstrated normal sinus rhythm with no other abnormalities.; Test Name: ECG; Result Unstructured Data: Test Result:demonstrated sinus rhythm; Comments: demonstrated sinus rhythm with occasional premature ventricular contractions (PVCs), diffuse ST-segment elevations, and no PR depression; Test Name: enterovirus PCR; Test Result: Negative ; Test Name: EBV titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:Unknown results ug/ml; Test Name: human immunodeficiency virus (HIV) antigen/antibody; Test Result: Negative ; Test Name: HIV antigen/ antibody.; Test Result: Negative ; Test Name: Leptospira immunoglobulin M; Test Result: Negative ; Test Name: Lyme antibodies; Test Result: Negative ; Test Name: Myocardial edema on MRI; Result Unstructured Data: Test Result:Yes; Test Name: cardiac MRI; Result Unstructured Data: Test Result:Yes; Comments: late gadolinium enhancement pattern and edema consistent with acute myocarditis; Test Name: cardiac MRI; Result Unstructured Data: Test Result:showed a late gadolinium enhancement pattern and e; Comments: showed a late gadolinium enhancement pattern and edema consistent with acute myocarditis; Test Name: Mycoplasma IgM; Test Result: Negative ; Test Name: Parvovirus B19 PCR; Test Result: Negative ; Test Name: pericardial effusion; Result Unstructured Data: Test Result:No; 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; Result Unstructured Data: Test Result:0.45 ng/ml; Comments: first presentation; Test Name: Troponin; Result Unstructured Data: Test Result:34.5 ng/ml; Comments: second presentation; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:0.72 ng/ml; Test Name: peak troponin; Result Unstructured Data: Test Result:34.50 ng/ml; Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: White blood cell count; Result Unstructured Data: Test Result:10.4
CDC Split Type: USPFIZER INC202101137122

Write-up: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.; This is a literature report The full publication has been requested. This author reported similar events for eight patients. This is the third of eight reports. A 17-year-old male with a history of mild perimyocarditis in 2014, presented to the ED with 1 day of retrosternal pressure. In the ED, his troponin was 0.45 ng/mL, and the ECG demonstrated normal sinus rhythm with no other abnormalities. TTE showed normal biventricular function. Patient had received his first BNT162b2 vaccine 14 days earlier. He was discharged with a 2-week course of ibuprofen with complete resolution of symptoms. He had no history of SARS-CoV-2 infection. Patient re-presented to the ED with retrosternal chest pressure 19 days after his first presentation. He received the second BNT162b2 dose 4 days before. Troponin-I level at his second presentation was 34.5 ng/mL. ECG demonstrated sinus rhythm with occasional premature ventricular contractions (PVCs), diffuse ST-segment elevations, and no PR depression. He was treated with 1 dose of intravenous immunoglobulin (IVIG). On telemetry, he had a single 4 beat episode of monomorphic ventricular tachycardia. TTE showed no significant valvular dysfunction, qualitatively normal biventricular systolic function, and no significant pericardial effusion. Cardiac MRI showed a late gadolinium enhancement pattern and edema consistent with acute myocarditis. The patient was found to be SARS-CoV-2 nucleocapsid IgG-positive and SARS-CoV-2 PCR-negative. Extensive infectious workup was negative, including adenovirus plasma PCR, CMV anti bodies, enterovirus plasma PCR, EBV titers, Leptospira antibodies, Lyme antibodies, Mycoplasma IgM, Parvovirus B19 PCR, Trypanosoma cruzi antibodies, and HIV antigen/antibody. Body mass index (kg/m2) 39.7, History of prior COVID-19 infection: No, Length of stay (hours) 95, Laboratories included: White blood cell count (Ref: 5-10) 10.4, Peak troponin-I (Ref: 0.00-0.08 ng/mL) 34.50, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.72, CKMB (Ref:0-3.5ng/mL) N/A, CPK (Ref: 33-145 IU/L) 523, d-dimer (Ref: 0.27-0.41 mmg/mL) N/A. COVID-19 testing: SARS-CoV-2 PCR Negative, SARS-CoV-2 spike IgM Negative, SARS-CoV-2 nucleocapsid IgG Positive. EKG: EKG findings Abnormal PR depression, diffuse ST-segment elevation. Imaging: Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 58, Pericardial effusion present No, Cardiac MRI performed Yes, Left ventricular ejection fraction on MRI 61, Myocardial edema on MRI (yes/no) Yes, Late gadolinium enhancement on MRI (yes/no) Yes, Treatment/intervention included: IVIG (intravenous immunoglobulin) and Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs). 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. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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-202101133568 Same article/ drug/ event and Different patient.


VAERS ID: 1692252 (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 - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adenovirus test, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood immunoglobulin M, Body mass index, Chest X-ray, Cytomegalovirus test, Echocardiogram, Ejection fraction, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Fibrin D dimer, Haemodynamic test, Magnetic resonance imaging heart, Myocarditis, Parvovirus B19 test, Respiratory viral panel, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sinus rhythm, Troponin, Troponin I, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dilatation; Marfan''s syndrome; SARS-CoV-2 infection (with mild symptoms)
Allergies:
Diagnostic Lab Data: Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: cpk; Result Unstructured Data: Test Result:312 IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:Unknown ng/ml; Test Name: Leptospira immunoglobulin M; Test Result: Negative ; Test Name: BMI; Result Unstructured Data: Test Result:16.8; Comments: 16.8 kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: Chest radiograph (cardiopulmonary findings); Result Unstructured Data: Test Result:normal; Test Name: CMV antibodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:patent foramen ovale; Comments: showed patent foramen ovale, mild mitral valve prolapse with mild-to-moderate mitral regurgitation, mild aortic root dilation (unchanged), and qualitatively low normal LVSF; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:57; Test Name: Left ventricular ejection fraction on MRI; Result Unstructured Data: Test Result:61; Test Name: electrocardiogram; Result Unstructured Data: Test Result:normal Sinus rhythm; Comments: normal sinus rhythm with no other changes; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: EBV titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:less than 0.19 ug/ml; Test Name: Hemodynamic test; Result Unstructured Data: Test Result:remained hemodynamically stable; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:significant for focal edema at the basal inferolat; Comments: significant for focal edema at the basal inferolateral segments, normal biventricular size and global systolic function, and stable aortic root dilation. The patient had 12- and 8- beat runs of irregular polymorphic ventricular tachycardia (Figure 1B). Myocardial edema, left ventricular ejection fraction 61, late gadolinium enhancement; Test Name: Parvovirus B19 PCR; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: sinus rhythm; Result Unstructured Data: Test Result:normal; Test Name: Troponin; Result Unstructured Data: Test Result:7.2 ng/ml; Test Name: Troponin; Result Unstructured Data: Test Result:11.8 ng/ml; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:0.28 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:11.80 ng/ml; Test Name: White blood cell count; Result Unstructured Data: Test Result:6.6
CDC Split Type: USPFIZER INC202101137432

Write-up: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine; This is a literature report. This author reported similar events for eight patients. This is the fourth of eight reports. The authors describe clinical characteristics of 8 adolescents who presented over the course of 36 days to (Hospital) with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine. A 15-year-old male with Marfan syndrome and aortic root dilation presented to the ED with sudden onset of retrosternal chest pain, fatigue, and abdominal pain for 1 day. He denied fever, shortness of breath, or recent illness. The patient had a history of SARS-CoV-2 infection in January 2021 with mild symptoms. He had received the first dose of the BNT162b2 vaccine 3 days prior to admission. In the ED, his troponin was 7.2 ng/ mL and ECG demonstrated normal sinus rhythm with no other changes. Chest X-ray was normal. The peak troponin level was 11.8 ng/mL. Pain resolved while he was still in ED. The patient was asymptomatic at the time of admission. TTE showed patent foramen ovale, mild mitral valve prolapses with mild-to-moderate mitral regurgitation, mild aortic root dilation (unchanged), and qualitatively low normal LVSF. Cardiac MRI (magnetic resonance imaging) was significant for focal edema at the basal inferolateral segments, normal biventricular size and global systolic function, and stable aortic root dilation. The patient had 12- and 8-beat runs of irregular polymorphic ventricular tachycardia. The runs occurred within 1 minute of each other, and the patient was asymptomatic at the time. He remained hemodynamically stable. Infectious workup was negative, including adenovirus plasma PCR, CMV antibodies, enterovirus plasma PCR, EBV titers, Leptospira IgM, Parvovirus B19 PCR, and RPP (Respiratory viral panel). Body mass index (kg/m2) 16.8, Past medical history (PMH) Marfan syndrome, History of prior COVID-19 infection: Yes, Days between vaccine and symptom onset 2, Length of stay (hours) 71, Laboratories: White blood cell count (Ref: 5-10) 6.6, Peak troponin-I (Ref: 0.00-0.08 ng/mL) 11.80, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.28, CKMB (creatine kinase myocardial band, Ref:0-3.5ng/mL) N/A, CPK (creatine phosphokinase Ref: 33-145 IU/L) 312, d-dimer (Ref: 0.27-0.41 mmg/mL) less than 0.19, COVID-19 testing: SARS-CoV-2 PCR Negative, SARS-CoV-2 spike IgM Negative, SARS-CoV-2 nucleocapsid IgG Negative, EKG (electrocardiogram): EKG findings Normal sinus Rhythm, Imaging: Chest radiograph (cardiopulmonary findings) Negative, Left ventricular ejection fraction on ECHO (echocardiogram) 57, Pericardial effusion present No, Cardiac MRI performed Yes, Left ventricular ejection fraction on MRI 61, Myocardial edema on MRI (yes/no) Yes, Late gadolinium enhancement on MRI (yes/no) Yes, treatment: no intravenous immunoglobulin; nonsteroidal anti-inflammatory drugs. 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. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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) : PFIZER INC-202101133568 Same article/drug/event; different patient


VAERS ID: 1692253 (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: Adenovirus test, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body mass index, Chest X-ray, Cytomegalovirus test, Echocardiogram, Ejection fraction, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Fibrin D dimer, Myocarditis, Parvovirus B19 test, Respiratory viral panel, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin I, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vitiligo (patients mother)
Allergies:
Diagnostic Lab Data: Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: cpk; Result Unstructured Data: Test Result:unknown IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:Unknown ng/ml; Test Name: BMI; Result Unstructured Data: Test Result:30.8; Comments: 30.8 kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Result Unstructured Data: Test Result:Negative (Normal); Test Name: CMV antibodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities and qualitative; Comments: showed no structural abnormalities and qualitatively normal LVSF; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:60; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Diffuse ST-segment elevation; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: EBV titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:0.52 ug/ml; Test Name: Parvovirus B19 antibodies; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 spike IgM; Test Result: Positive ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:0.81 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:2.42 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:1.92 ng/ml; Test Name: White blood cell count; Result Unstructured Data: Test Result:10
CDC Split Type: USPFIZER INC202101137593

Write-up: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.; This is a literature report. This author reported similar events for eight patients. This is the fifth of eight reports. The authors describe clinical characteristics of 8 adolescents who presented over the course of 36 days to (Hospital) with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine. A 16-year-old male with no past medical history presented to the ED with intermittent retrosternal chest pressure over 2 days. He denied fever, shortness of breath, or recent illness. He had received his second dose of the BNT162b2 vaccine 1 day before symptom onset. Post-vaccination symptoms included mild body aches and headache. Family history was positive for vitiligo in the patient''s mother. Troponin-I was elevated at 1.92 ng/mL, and the peak level obtained was 2.42 ng/mL. ECG demonstrated ST-segment elevation. Chest X-ray was negative. TTE showed no structural abnormalities and qualitatively normal LVSF. He had no recurrence of chest pain while admitted. Patient recovered with no medical intervention. Infectious workup was negative, including RPP, adenovirus plasma PCR, CMV antibodies, enterovirus plasma PCR, EBV titers, and Parvovirus B19 antibodies. Additional workup showed SARS-CoV-2 nucleocapsid IgG-negative. Body mass index (kg/m2) 30.8, Past medical history (PMH) No PMH, History of prior COVID-19 infection No, Days between vaccine and symptom onset 1, Length of stay (hours) 34, Laboratories: White blood cell count (Ref: 5-10) 10, Peak troponin-I (Ref: 0.00-0.08 ng/mL) 2.42, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.81, CKMB (creatine kinase myocardial band, Ref:0-3.5ng/mL) N/A, CPK (creatine phosphokinase, Ref: 33-145 IU/L) N/A, d-dimer (Ref: 0.27-0.41 mmg/mL) 0.52, COVID-19 testing: SARS-CoV-2 PCR Negative, SARS-CoV-2 spike IgM Positive, SARS-CoV-2 nucleocapsid IgG Negative, EKG electrocardiogram; findings Diffuse ST-segment elevation, Imaging: Chest radiograph (cardiopulmonary findings) Negative, Left ventricular ejection fraction on ECHO echocardiogram; 60, Pericardial effusion present No, Cardiac MRI (magnetic resonance imaging) not performed, Left ventricular ejection fraction on MRI, Myocardial edema on MRI (yes/no), Late gadolinium enhancement on MRI (yes/no), Treatment: No IVIG (intravenous immunoglobulin), No Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs). 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. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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-202101133568 Same article/drug/event; different patient


VAERS ID: 1692256 (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: Adenovirus test, Blood creatine phosphokinase MB, Blood culture, Body mass index, Body temperature, Chest X-ray, Echocardiogram, Ejection fraction, Electrocardiogram, Enterovirus test, Fibrin D dimer, Gastrointestinal examination, Myocarditis, Physical examination, Respiratory viral panel, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin I, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Insulin resistance; Obesity
Allergies:
Diagnostic Lab Data: Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:19.9 ng/ml; Test Name: blood culture; Test Result: Negative ; Test Name: BMI; Result Unstructured Data: Test Result:29.5; Comments: 29.5 kg/m2; Test Name: temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: fever; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities and qualitative; Comments: showed no structural abnormalities and qualitatively normal LVSF.; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:62; Test Name: electrocardiogram; Result Unstructured Data: Test Result:normal Sinus rhythm; Comments: demonstrated normal sinus rhythm, with no significant ST-segment changes; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:0.53 ug/ml; Test Name: gastrointestinal panel; Test Result: Negative ; Test Name: physical examination; Result Unstructured Data: Test Result:diffuse reproducible chest wall tenderness; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: troponin; Result Unstructured Data: Test Result:5.10 ng/ml; Comments: elevated; Test Name: troponin; Result Unstructured Data: Test Result:1.30 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:5.9
CDC Split Type: USPFIZER INC202101137891

Write-up: perimyocarditis/3 days of sharp, intermittent, retrosternal pain, with associated fever (38 degree C), headache, loose bowel movement, and cough; This is a literature report. This author reported similar events for eight patients. This is the sixth of eight reports. A 15-year-old (also reported as 15.8-year-old) male with obesity, insulin resistance, and dyslipidemia presented to outside hospital ED with 3 days of sharp, intermittent, retrosternal pain, with associated fever (38 degree C), headache, loose bowel movement, and cough. Patient denied any trauma or recent viral illnesses. No prior history of SARS-CoV-2 infection. He had received the second dose of the BNT162b2 vaccine 2 days prior to symptom onset. On physical examination, there was diffuse reproducible chest wall tenderness. Laboratories unremarkable aside from elevated peak troponin-I of 5.1 ng/mL and Creatine Kinase Myocardial Band of 19.9 ng/mL. ECG demonstrated normal sinus rhythm, with no significant ST-segment changes. Chest X-ray was normal. TTE showed no structural abnormalities and qualitatively normal LVSF. He recovered with no medical intervention. Infectious workup was negative but limited to RPP, adenovirus plasma PCR, enterovirus plasma PCR, SARS-CoV-2 nucleocapsid IgG, blood culture, and gastrointestinal panel. Demographic and clinical characteristics: Body mass index (kg/m2) 29.5. Past medical history (PMH) Insulin resistance dyslipidemia. History of prior COVID-19 infection No. BNT162b2 vaccine dose #2. Days between vaccine and symptom onset 2. Length of stay (hours) 37. Laboratories: White blood cell count (Ref: 5-10) 5.9; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.10; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 1.30; CKMB (Ref:0-3.5ng/mL) 19.9; D-dimer (Ref: 0.27-0.41 mmg/mL) 0.53. COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 nucleocapsid IgG Negative EKG findings Normal sinus rhythm. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 62; Pericardial effusion present No; Cardiac MRI performed No. 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) : PFIZER INC-202101133568 Same article/drug/event; different patient


VAERS ID: 1692257 (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 MB, Blood immunoglobulin G, Blood immunoglobulin M, Body mass index, Chest X-ray, Echocardiogram, Ejection fraction, Electrocardiogram, Electrocardiogram ambulatory, Fibrin D dimer, Mycoplasma test, Myocarditis, Respiratory viral panel, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin I, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:44.5 ng/ml; Test Name: IgG; Result Unstructured Data: Test Result:positive for mycoplasma; Test Name: IgM; Result Unstructured Data: Test Result:Positive for Mycoplasma; Test Name: BMI; Result Unstructured Data: Test Result:17.3; Comments: 17.3 kg/m2; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities, qualitatively; Comments: showed no structural abnormalities, qualitatively normal LVSF, and no significant pericardial effusion.; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:60; Test Name: EKG; Result Unstructured Data: Test Result:Intraventricular conduction delay, transient; Comments: Intraventricular conduction delay, transient ST-segment depression; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Intraventricular conduction delay; Comments: Intraventricular conduction delay, transient ST-segment depression; Test Name: 24-hour Holter; Result Unstructured Data: Test Result:showed 13 multiform PVCs, including 1 couplet; Test Name: d-dimer; Result Unstructured Data: Test Result:0.11 ug/ml; Test Name: nasopharyngeal PCR for Mycoplasma; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: troponin-I; Result Unstructured Data: Test Result:22.05 ng/ml; Comments: peak; Test Name: troponin-I; Result Unstructured Data: Test Result:11.56 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.9
CDC Split Type: USPFIZER INC202101138007

Write-up: perimyocarditis/self-resolving chest pain/intermittent, non-radiating, retrosternal pain; This is a literature report. This author reported similar events for eight patients. This is the seventh of eight reports. A 15-year-old (also reported as 15.2-year-old) male with no past medical history presented with a 2-day history of intermittent, non-radiating, retrosternal pain. He denied recent fever, shortness of breath, or recent illness. No history of SARS-CoV-2 infection. Three days prior to presentation, the patient received his second BNT162b2 vaccine. Upon further interviewing, he reported 2 episodes of self-resolving chest pain 3 days after the first dose of the BNT162b2 vaccine of unclear significance given he did not seek medical care. Chest X-ray was normal. Initial laboratories were unremarkable aside from elevated CPK-MB level of 44.5 ng/mL with a peak troponin level of 22.05 ng/mL. ECG showed intraventricular conduction delay with transient ST-segment depression. TTE showed no structural abnormalities, qualitatively normal LVSF, and no significant pericardial effusion. A 24-hour Holter showed 13 multiform PVCs, including 1 couplet. Patient was managed with ibuprofen with resolution of pain on day 3 of admission. RPP was negative, and Mycoplasma IgG and IgM were positive; however, nasopharyngeal PCR for Mycoplasma was negative. The decision was made to treat with azithromycin for Mycoplasma infection. Patient reported chest pain after first vaccine although he did not seek medical care. Demographic and clinical characteristics: Body mass index (kg/m2) 17.3. No Past medical history (PMH). History of prior COVID-19 infection No. BNT162b2 vaccine dose #2. Days between vaccine and symptom onset 3. Length of stay (hours) 65. Laboratories: White blood cell count (Ref: 5-10) 8.9; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 22.05; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 11.56; CKMB (Ref:0-3.5ng/mL) 44.5; d-dimer (Ref: 0.27-0.41 mmg/mL) 0.11. COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 nucleocapsid IgG Negative EKG findings Intraventricular conduction delay, transient ST-segment depression. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 60; Pericardial effusion present No. Treatment/intervention: 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) : PFIZER INC-202101133568 Same article/drug/event; different patient


VAERS ID: 1692258 (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 MB, Chest X-ray, Echocardiogram, Ejection fraction, Electrocardiogram, Fibrin D dimer, Myocarditis, Respiratory viral panel, SARS-CoV-2 antibody test, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:33.9 ng/ml; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities; Comments: showed no structural abnormalities, qualitatively low normal left ventricular systolic function (LVSF); Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:61; Test Name: ECG; Result Unstructured Data: Test Result:demonstrated mild diffuse ST-segment elevation; Test Name: EKG findings; Result Unstructured Data: Test Result:Mild diffuse ST-segment elevation; Test Name: d-dimer; Result Unstructured Data: Test Result:unknown ug/ml; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:2.86 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:5.09 ng/ml; Comments: elevated
CDC Split Type: USPFIZER INC202101138774

Write-up: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.; This is a literature report. This is the eighth of eight reports. The authors describe clinical characteristics of 8 adolescents who presented over the course of 36 days to (Hospital) with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine. A 17-year-old male with no past medical history presented to the ED with 3 days of sharp, retrosternal pain. He denied fever, shortness of breath, or recent illness. There was no history of SARSCoV-2 infection. Patient had received the second dose of the BNT162b2 vaccine 1 day prior to symptom onset. His troponin-I was elevated with a peak of 5.09 ng/mL. ECG demonstrated mild diffuse ST-segment elevation. TTE showed no structural abnormalities and qualitatively normal LVSF. The patient was managed with ibuprofen with resolution of pain. Infectious workup was negative but limited to RPP and SARS-CoV-2 nucleocapsid IgG. Past medical history (PMH) No PMH, History of prior COVID-19 infection No, Days between vaccine and symptom onset 1, Length of stay (hours) 34, Laboratories: Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.09, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 2.86, CKMB (creatine kinase myocardial band, Ref:0-3.5ng/mL) 33.9, COVID-19 testing: SARS-CoV-2 PCR Negative, EKG electrocardiogram; findings Mild diffuse ST-segment elevation, Imaging: Chest radiograph (cardiopulmonary findings) Negative, Left ventricular ejection fraction on ECHO echocardiogram; 61, Pericardial effusion present No, Cardiac MRI (magnetic resonance imaging) performed No, Left ventricular ejection fraction on MRI, Myocardial edema on MRI (yes/no), Late gadolinium enhancement on MRI (yes/no), Treatment/intervention: IVIG (intravenous immunoglobulin) No, Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs) Yes. 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. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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-202101133568 Same article/ drug/ event and Different patient.;US-PFIZER INC-202101133568 Same article/drug/event; different patient


VAERS ID: 1692282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-26
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 - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Myocarditis, Nervousness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101147202

Write-up: myocarditis; nervous; experienced numbness in their shoulder, neck and jaw; This is a spontaneous report from a contactable consumer (Patient''s wife) reporting for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant), nervous, experienced numbness in their shoulder, neck and jaw on an unknown date in 2021. Caller stated that she and her husband got their first dose in 26May2021. Both of them are kind of nervous and has experienced numbness in their shoulder, neck and jaw. It took 5 hours to go away. Her husband had developed a heart issue. They were told by their Doctor that it was not normal and it advised not to take the vaccine yet. It has been 99 days since they got their first dose. Caller stated that she lost two friends from COVID and her husband has myocarditis which he didn''t have before getting the vaccine. Caller stated that she was just afraid to get the second shot with all of this misinformation circulating out there. The outcome for all events was unknown. Information on Lot/Batch number has been requested.


VAERS ID: 1706488 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Bronchitis, Carditis, Dehydration, Diarrhoea, Hypotension, Myocardial infarction, Oxygen saturation, Oxygen saturation decreased, Scan with contrast, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Overweight
Preexisting Conditions: Comments: The patient was in excellent health with no pre-existing health issues, nor medication, prior to the vaccine.
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: Blood pressure; Result Unstructured Data: 88/50 or 88/60; Test Name: Oxygen saturation; Result Unstructured Data: 98-99 percentage; Test Name: Oxygen saturation; Result Unstructured Data: 60 %; Test Name: Scan with contrast; Result Unstructured Data: vaccine caused heart attack, oxygen drop to 60 from 98-99 percent
CDC Split Type: USJNJFOC20210921562

Write-up: HEART INFLAMMATION; HEART ATTACK TRIGGERED BRONCHITIS; OXYGEN PLUMMETED TO 60 PERCENT; HEART ATTACK; DEHYDRATION; VOMITING; DIARRHEA; BP WENT TO 88/50 OR 88/60; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s concurrent condition included: overweight (10-15 pounds overweight). The patient was in excellent health with no pre-existing health issues, nor medication, prior to the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. Just after the vaccine was taken, the patient went to urgent care and emergency room (ER) several times for dehydration, caused by vomiting and diarrhea. The first urgent care visit was 02-AUG-2021. On 03-AUG-2021, the patient was in another emergency room. On 06-AUG-2021, the patient went back to urgent care and again on 08-AUG-2021, where patient''s blood pressure (BP) went to 88/50 or 88/60. On 09-AUG-2021, the patient had a heart attack, which doctors attributed to the JNJ vaccine. The patient was hospitalized on an unspecified date. The patient was left with heart inflammation, which would pass in late NOV-2021 or early DEC-2021 according to Cardiologist. The heart attack triggered bronchitis and the patient was at the tail end of that. The oxygen plummeted to 60 percent in the emergency room of hospital out of nowhere. The patient was peacefully getting intravenous fluids there and suddenly could not breathe at all. About 2 minutes passed with 60 percent oxygen, where the patient was about to die. Very fortunately, after the patient opened the green curtain in front, the emergency room doctor was standing there right in front and saved patient''s life, with many nurses running to patient. The only reason the patient was alive was that the patient went to the ER with no wait and the ER doctor was standing next to patient behind the green curtain. If the ER doctor was down the hall, the patient would have died as patient was told or if patient would have gone to another hospital, which had a very long wait, the patient would have died in the waiting room most likely. The patient was ended up getting stabilized and admitted then taken by ambulance to another hospital at midnight. The patient spent 5 days in the Cardiac Unit there. The CT scan of heart with contrast revealed that vaccine caused the heart attack and oxygen to drop to 60 percent from normal 98-99 percent level. The patient also ended up medical care clinic 2 days after hospital discharge also for several breathing issues and bronchitis. The patient had not recovered from heart inflammation, and the outcome of heart attack, dehydration, heart attack triggered bronchitis, vomiting, diarrhea, BP went to 88/50 or 88/60 and oxygen plummeted to 60 percent was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210923692.; Sender''s Comments: V0-20210921562-Covid-19 vaccine ad26.cov2.s- Heart attack, heart inflammation,heart attack triggered bronchitis,oxygen plummeted to 60 percent, BP went to 88/50 or 88/60 .This event(s) is considered unassessable. The event(s) has an 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: 1711185 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Chest discomfort, Chest pain, Discomfort, Feeling abnormal, Hypotension, Pericarditis, Vaccination site haemorrhage
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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: blood pressure; Result Unstructured Data: low
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: hard to explain sensation in the middle of my chest; chest tighten and pressure mostly concentrated around the middle and left side of my chest but mostly the left side; blood pressure is low; feeling strange; noticed dry liquid on my shoulder as well as some blood; feel occasional sharp jabs in my left shoulder and back shoulder blade; pressure down the leg in artery and in neck artery; pericarditis; 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. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (hard to explain sensation in the middle of my chest), CHEST DISCOMFORT (chest tighten and pressure mostly concentrated around the middle and left side of my chest but mostly the left side), HYPOTENSION (blood pressure is low), FEELING ABNORMAL (feeling strange), VACCINATION SITE HAEMORRHAGE (noticed dry liquid on my shoulder as well as some blood), ARTHRALGIA (feel occasional sharp jabs in my left shoulder and back shoulder blade), DISCOMFORT (pressure down the leg in artery and in neck artery) and PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 1000) for Adverse reaction, at a dose of 1000 milligram three times a day. At the time of the report, CHEST PAIN (hard to explain sensation in the middle of my chest), CHEST DISCOMFORT (chest tighten and pressure mostly concentrated around the middle and left side of my chest but mostly the left side), HYPOTENSION (blood pressure is low), FEELING ABNORMAL (feeling strange), VACCINATION SITE HAEMORRHAGE (noticed dry liquid on my shoulder as well as some blood), ARTHRALGIA (feel occasional sharp jabs in my left shoulder and back shoulder blade), DISCOMFORT (pressure down the leg in artery and in neck artery) and PERICARDITIS (pericarditis) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. The patient experienced a feeling of chest tightening and chest pressure a few hour after vaccination. Since than the patient exhibited most symptoms of pericarditis, based on patient''s research and conclusion. The patient also felt occasional sharp jabs in left shoulder and shoulder blade. The chest tightness tends to be worse when patient lays down. The patient cannot under any circumstances go to any clinic or hospital as these are epicentres of infection. Company Comment: This case concerns a patient with no relevant medical history reported, who experienced the expected event of pericarditis. The patient started experiencing tightening and pressure in chest on the same day after dose of Spikevax. The patient stated that symptoms of pericarditis were experienced based on patient''s research and conclusion, however, the diagnosis was not confirmed by the HCP as the patient did not go to hospital or clinic. The rechallenge was unknown not applicable. The reporter assessed the event as related to the product. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a patient with no relevant medical history reported, who experienced the expected event of pericarditis. The patient started experiencing tightening and pressure in chest on the same day after dose of Spikevax. The patient stated that symptoms of pericarditis were experienced based on patient''s research and conclusion, however, the diagnosis was not confirmed by the HCP as the patient did not go to hospital or clinic. The rechallenge was unknown not applicable. The reporter assessed the event as related to the product. The benefit-risk relationship of Spikevax in not affected by this report.


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