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From the 10/15/2021 release of VAERS data:

Found 4,148 cases where Age is Unknown and Vaccine targets COVID-19 (COVID19) and Symptom is Acute endocarditis or Atypical mycobacterium pericarditis or Autoimmune myocarditis or Bacterial pericarditis or Carditis or Endocarditis or Endocarditis bacterial or Endocarditis enterococcal or Endocarditis noninfective or Endocarditis staphylococcal or Endocarditis viral or Eosinophilic myocarditis or Fungal endocarditis or Giant cell myocarditis or Immune-mediated myocarditis or Lupus endocarditis or Lyme carditis or Meningococcal carditis or Myocarditis or Myocarditis bacterial or Myocarditis infectious or Myocarditis septic or Myopericarditis or Pericarditis or Pericarditis constrictive or Pericarditis infective or Pericarditis lupus or Pericarditis meningococcal or Pericarditis rheumatic or Pericarditis tuberculous or Pleuropericarditis or Purulent pericarditis or Streptococcal endocarditis or Subacute endocarditis or Viral myocarditis or Viral pericarditis



Case Details

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VAERS ID: 1490048 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Myocarditis, Pericarditis, Pneumonitis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Myocarditis/ swelling around my heart on my heart; Pericarditis; Swelling around left lung; My ribs and collar bones feel bruised; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) and 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. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised). At the time of the report, MYOCARDITIS (Myocarditis/ swelling around my heart on my heart), PERICARDITIS (Pericarditis), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised) outcome was unknown. Not Provided The concomitant medications were not reported. The treatment information was not provided. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.


VAERS ID: 1493258 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC2021888656

Write-up: Pericarditis; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1493374 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210742124

Write-up: PERICARDITIS; MYOCARDITIS; This spontaneous report received from a consumer via social media concerned 20 patient. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported, frequency 1, total, for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced pericarditis, and myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pericarditis and myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210742124-covid-19 vaccine ad26.cov2.s-pericarditis and myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1497427 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue, Myocarditis, Somnolence, X-ray
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (had COVID in March)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: bloodwork; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: ekg; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: x-ray; Result Unstructured Data: Test Result:unknown results
CDC Split Type: USPFIZER INC2021859377

Write-up: it causes like inflammation around the heart or the heart lining; Shortness of breath; Chest heaviness; Fatigue; He cannot even wake up for their work; This is a spontaneous report from a contactable consumer (Parent). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date (had COVID in March). The patient''s concomitant medications were not reported. In 2021, patient was having problems and he is still having issues, patient have already been to the doctor, they took blood work, they took X-ray, they took an EKG and she was saying that it causes like inflammation around the heart or the heart lining and they took and EKG they did not take a heart echo cardiogram but it''s like he is been going through this and it''s going to be 2 weeks. He is having a shot now 2 weeks and how long does this last or what should he do because actually the clinic didn''t say the nothing. It took four days to get the report back from the EKG which should only took a day because the blood work in chest X-ray come back like quick. Patient had shortness of breath, he has chest heaviness, he has fatigue and he cannot even wake up for their work and they got it at same day. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1497531 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Hawaii  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase MB, Blood pressure measurement, Body temperature, C-reactive protein, Chest X-ray, Echocardiogram, Ejection fraction, Electrocardiogram, Full blood count, Headache, Heart rate, Inflammatory marker test, Magnetic resonance imaging heart, Myocardial necrosis marker, Myocarditis, N-terminal prohormone brain natriuretic peptide, PO2, Procalcitonin, Pyrexia, Red blood cell sedimentation rate, Respiratory rate, Respiratory viral panel, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin T, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Name: CKMB; Result Unstructured Data: Test Result:54.6 IU/l; Comments: At presentation; elevated; Test Name: CKMB; Result Unstructured Data: Test Result:54.6 IU/l; Comments: Peak; Test Name: Blood pressure; Result Unstructured Data: Test Result:119/72 mmHg; Test Name: Temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Name: Chest X-rays; Result Unstructured Data: Test Result:unremarkable; Test Name: CRP; Result Unstructured Data: Test Result:18.5 mg/l; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:LVEF 63%, increased patchy echogenicity; Comments: LVEF 63%, increased patchy echogenicity of the myocardium, normal left ventricular systolic function.; Test Name: LVEF; Test Result: 63 %; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:ST segment elevation in lateral leads,; Comments: ST segment elevation in lateral leads, left axis deviation. normal left ventricular function throughout the hospitalisation.; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:improved, but continued mild ST segment elevation; Test Name: Complete blood count; Result Unstructured Data: Test Result:notable for neutrophilia without leukocytosis; Test Name: Heart rate; Result Unstructured Data: Test Result:116; Comments: beats per minute; Test Name: Inflammatory markers; Result Unstructured Data: Test Result:mildly elevated; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:unknown results; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:elevated; Test Name: NT-proBNP; Result Unstructured Data: Test Result:108 pg/mL; Comments: At presentation; Test Name: NT-proBNP; Result Unstructured Data: Test Result:498 pg/mL; Comments: Peak; Test Name: SpO2 in room air; Test Result: 96 %; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.15 ng/ml; Test Name: ESR; Result Unstructured Data: Test Result:7; Comments: mm/hr; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Test Name: Respiratory viral panel PCR; Test Result: Negative ; Test Name: SARS-CoV-2 IgG; Result Unstructured Data: Test Result:Negative (0.24); Comments: Normal range: less than 1.40 index; Test Name: SARS-CoV-2 RT-PCR; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:304 ng/L; Comments: At presentation; Test Name: Troponin T; Result Unstructured Data: Test Result:832 ng/L; Comments: Peak
CDC Split Type: USPFIZER INC2021881859

Write-up: myocarditis; fever; headache; tender vaccination site; This is a Literature report. This reporter reported similar event for two patients, this is the first of 2 reports. Authors describe, for the first time, adolescents presenting with chest pain and imaging evidence of myocarditis in close temporal association with the BNT162b2 vaccination. Two adolescent males, aged 15-16 years of age, presented in the Emergency Department with chest pain within 3 days of BNT162b2 vaccine administration, one of them after the first, the other after the second dose of the vaccine. One patient noted mild and typical vaccine-related symptoms including tactile fever, headache, and tender vaccination site within a day of vaccine administration, while the other patient had no such symptoms. Within a couple of days after vaccination, both patients developed acute onset, mid-sternal, non-radiating chest pain associated with chest tightness. One patient had a history of mild intermittent asthma, otherwise, they had no known medical conditions and no prior surgeries. Their initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure. They had a normal cardiac exam without a murmur or friction rub. Inflammatory markers were mildly elevated. Complete blood count was notable for neutrophilia without leukocytosis. Cardiac enzymes were elevated in both cases at presentation. Infectious workup including immunoglobulin G and real-time reverse transcription polymerase chain reaction for SARS-CoV-2 and respiratory viral panel polymerase chain reaction containing the most common aetiologic agents of viral myocarditis were negative in both patients. Chest X-rays were unremarkable. Electrocardiograms showed ST elevation and T wave inversion in lateral leads. Both patients had normal left ventricular systolic function on echocardiogram. Small areas of increased echogenicity could be detected throughout the myocardium in one of the patients, especially in the interventricular septum and lateral wall of the left ventricle. Cardiac MRI with early gadolinium enhancement using electrocardiogram- gated turbo spin echo T1-weighted sequences showed mild global early enhancement of the myocardium, with pronounced enhancement in the subendocardial layer of the left ventricle, findings consistent with inflammation of the myocardium without evidence of myocardial necrosis, fibrosis, or oedema. Cardiac catheterisation was not performed as there was low suspicion for acute coronary syndrome and the cardiac MRI was consistent with myocarditis. One patient received intravenous immunoglobulin, while the other patient improved without any treatment. Echocardiograms continued to show normal left ventricular function throughout the hospitalisation. Troponin T peaked at 832 and 1210 ng/L, but creatine kinase myocardial band did not increase beyond initial levels. Chest pain resolved a day after admission and both patients were discharged from the hospital within 4 days of admission. Electrocardiograms showed improved, but continued mild ST segment elevation at discharge. Authors present two adolescents with evidence of myocarditis shortly after BNT162b2 vaccination. The presentation of these adolescents were consistent with myocarditis based on clinical, imaging, and laboratory findings, and no other alternative aetiology was found. Authors excluded acute or recent COVID-19 infection and did not find evidence of other viral aetiologies. The temporal association with the preceding COVID-19 vaccine raised the suspicion of a vaccinerelated self-limited myocarditis. This case series suggests that chest pain within a week of COVID- 19 vaccination with an mRNA vaccine should raise the suspicion of focal myocarditis. A 15-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included mild intermittent asthma. The patient''s concomitant medications were not reported. The patient experienced myocarditis on an unspecified date 3 days after the vaccination, fever, headache, and tender vaccination site on an unspecified date within a day of vaccine administration. The patient was hospitalized for event myocarditis. The patient underwent lab tests and procedures which included CKMB (normal range: less than 4.1): 54.6 iu/l at presentation, elevated; 54.6 iu/l peak. Blood pressure: 119/72 mmhg. Temperature: 37.2 centigrade. Chest x-ray: unremarkable. CRP (normal range: less than 5.0): 18.5 mg/l. Echocardiogram findings: LVEF 63%, increased patchy echogenicity of the myocardium, normal left ventricular systolic function. LVEF: 63 %. Electrocardiogram findings: ST segment elevation in lateral leads, left axis deviation, normal left ventricular function throughout the hospitalisation. Electrocardiogram findings: improved, but continued mild ST segment elevation. Complete blood count: notable for neutrophilia without leukocytosis. Heart rate: 116 beats per minute. Inflammatory markers: mildly elevated. Cardiac MRI: unknown results. Cardiac enzymes: elevated. NT-proBNP (normal range: 0-125): 108 pg/mL at presentation, 498 pg/mL peak. SpO2 in room air: 96%. Procalcitonin (normal range: less than 0.10): 0.15 ng/ml. ESR (normal range: 0-15): 7 mm/hr. Respiratory rate: 18. Respiratory viral panel PCR: Negative. SARS-CoV-2 IgG (Normal range: less than 1.40 index): Negative (0.24). SARS-CoV-2 RT-PCR: Negative. Troponin T (normal range: less than 20): 304 ng/L at presentation, 832 ng/L peak. The patient received treatment of intravenous immunoglobulin for event myocarditis. The outcome of event myocarditis was resolved, outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on known drug safety profile and plausible temporal relationship, a possible causal association between the event "myocarditis" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021881937 same article, product, different patient, similar event


VAERS ID: 1497534 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Hawaii  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
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 pressure measurement, Body temperature, C-reactive protein, Cardiac function test, Chest X-ray, Echocardiogram, Ejection fraction, Electrocardiogram, Full blood count, Heart rate, Inflammatory marker test, Magnetic resonance imaging heart, Myocardial necrosis marker, Myocarditis, N-terminal prohormone brain natriuretic peptide, PO2, Procalcitonin, Red blood cell sedimentation rate, Respiratory rate, Respiratory viral panel, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin T, Vital signs measurement
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CKMB; Result Unstructured Data: Test Result:39.3 IU/l; Comments: At presentation; Test Name: CKMB; Result Unstructured Data: Test Result:39.3 IU/l; Comments: Peak; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/91 mmHg; Comments: at presentation; Test Name: Temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: at presentation; Test Name: cardiac exam; Result Unstructured Data: Test Result:normal, without a murmur or friction rub; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unremarkable; Test Name: CRP; Result Unstructured Data: Test Result:24.3 mg/l; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:LVEF 60%; Comments: Both patients had normal left ventricular systolic function.; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:improved, but continued mild ST segment elevation; Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:continued to show normal left ventricular function; Test Name: LVEF; Test Result: 60 %; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:ST segment elevation in inferolateral; Comments: ST segment elevation in inferolateral leads, T wave inversion Electrocardiogram shows ST segment elevation, especially in the lateral leads; Test Name: Complete blood count; Result Unstructured Data: Test Result:notable for neutrophilia without leukocytosis; Test Name: Heart rate; Result Unstructured Data: Test Result:108; Comments: units: beats per minute; at presentation; Test Name: Inflammatory markers; Result Unstructured Data: Test Result:mildly elevated; Test Name: Cardiac MRI findings; Result Unstructured Data: Test Result:Early gadolinium enhancement; Comments: Early gadolinium enhancement(4 minutes) of the myocardium; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:elevated; Test Name: NT-proBNP; Result Unstructured Data: Test Result:325 pg/mL; Comments: At presentation; Test Name: NT-proBNP; Result Unstructured Data: Test Result:364 pg/mL; Comments: Peak; Test Name: SpO2 in room air; Test Result: 100 %; Test Name: Procalcitonin; Result Unstructured Data: Test Result:less than 0.06 ng/ml; Test Name: ESR; Result Unstructured Data: Test Result:31; Comments: units: mm/hr; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Test Name: Respiratory viral panel PCR; Test Result: Negative ; Test Name: SARS-CoV-2 IgG; Test Result: Negative ; Comments: Result: 0.03. Normal range: less than 1.40 index; Test Name: SARS-CoV-2 RT-PCR; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:431 ng/L; Comments: At presentation; Test Name: Troponin T; Result Unstructured Data: Test Result:1210 ng/L; Comments: Peak; Test Name: Vital signs; Result Unstructured Data: Test Result:notable for sinus tachycardia; Comments: initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure Heart rate, beats per minute 108, Blood pressure, mmHg 131/91, Temperature, degree Celsius 37.2, Respiratory rate 20, SpO2 in room air, % 100.
CDC Split Type: USPFIZER INC2021881937

Write-up: myocarditis; This is a Literature report from Cardiology in the Young, 2021, DOI: 10.1017/S1047951121002547, entitled "Self-limited myocarditis presenting with chest pain and ST segment elevation in adolescents after vaccination with the BNT162b2 mRNA vaccine". This reporter reported 2 reports; this is the 2 of 2 reports. We describe, for the first time, adolescents presenting with chest pain and imaging evidence of myocarditis in close temporal association with the BNT162b2 vaccination. Two adolescent males, aged 15-16 years of age, presented in the Emergency Department with chest pain within 3 days of BNT162b2 vaccine administration, one of them after the first, the other (patient of this case) after the second dose of the vaccine. One patient noted mild and typical vaccine-related symptoms including tactile fever, headache, and tender vaccination site within a day of vaccine administration, while the other patient (patient of this case) had no such symptoms. Within a couple of days after vaccination, both patients developed acute onset, mid-sternal, non-radiating chest pain associated with chest tightness. One patient (not patient of this case) had a history of mild intermittent asthma, otherwise, they had no known medical conditions and no prior surgeries. Their initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure. They had a normal cardiac exam without a murmur or friction rub. Inflammatory markers were mildly elevated (Table 1). Complete blood count was notable for neutrophilia without leukocytosis. Cardiac enzymes were elevated in both cases at presentation (Table 1). Infectious workup including immunoglobulin G and real-time reverse transcription polymerase chain reaction for SARS-CoV-2 and respiratory viral panel polymerase chain reaction containing the most common aetiologic agents of viral myocarditis were negative in both patients. Chest X-rays were unremarkable. Electrocardiograms showed ST elevation and T wave inversion in lateral leads (Fig 1). Both patients had normal left ventricular systolic function on echocardiogram (Table 1). Small areas of increased echogenicity could be detected throughout the myocardium in one of the patients, especially in the interventricular septum and lateral wall of the left ventricle (Fig 1). Cardiac MRI with early gadolinium enhancement using electrocardiogram- gated turbo spin echo T1-weighted sequences showed mild global early enhancement of the myocardium, with pronounced enhancement in the subendocardial layer of the left ventricle (Fig 1), findings consistent with inflammation of the myocardium without evidence of myocardial necrosis, fibrosis, or oedema. Cardiac catheterisation was not performed as there was low suspicion for acute coronary syndrome and the cardiac MRI was consistent with myocarditis. One patient received intravenous immunoglobulin, while the other patient (patient in this case) improved without any treatment. Echocardiograms continued to show normal left ventricular function throughout the hospitalisation. Troponin T peaked at 832 and 1210 ng/L, but creatine kinase myocardial band did not increase beyond initial levels (Table 1). Chest pain resolved a day after admission and both patients were discharged from the hospital within 4 days of admission. Electrocardiograms showed improved, but continued mild ST segment elevation at discharge. Discussion: We present two adolescents with evidence of myocarditis shortly after BNT162b2 vaccination. The presentation of these adolescents were consistent with myocarditis based on clinical, imaging, and laboratory findings, and no other alternative aetiology was found. We excluded acute or recent COVID-19 infection and did not find evidence of other viral aetiologies. The temporal association with the preceding COVID-19 vaccine raised the suspicion of a vaccinerelated self-limited myocarditis. Our case series suggests that chest pain within a week of COVID- 19 vaccination with an mRNA vaccine should raise the suspicion of focal myocarditis. Table 1. Demographics, clinical findings, and diagnostic test results of the patients with myocarditis following BNT162b2 vaccine administration: Patient B: Demographics: Age, years: 16; Sex Male; Ethnicity/race:[redacted]; History of cardiac conditions: None; BNT162b2 vaccine: Number of doses given: 2; Days after last vaccine administration to onset of chest pain: 2; Vital signs at presentation: Heart rate, beats per minute: 108; Blood pressure, mmHg: 131/91; Temperature, degree celsius: 37.2; Respiratory rate: 20; SpO2 in room air, %: 100; Cardiac markers (normal range): Troponin T, ng/L (<20 ng/L): At presentation: 431, Peak: 1210; CKMB, U/L (<4.1 U/L): At presentation: 39.3, Peak: 39.3; NT-proBNP, pg/mL (0-125 pg/mL): At presentation: 325, Peak: 364; Other laboratory results (normal range): ESR, mm/hr (0-15 mm/hr): 31; Procalcitonin (<0.10 ng/mL): <0.06; CRP, mg/L (<5.0 mg/L): 24.3; SARS-CoV-2 RT-PCR: Negative; SARS-CoV-2 IgG (<1.40 index): Negative (0.03); Respiratory viral panel PCR: Negative; Electrocardiogram findings: ST segment elevation in inferolateral leads, T wave inversion; Echocardiogram findings: LVEF 60%; Cardiac MRI findings: Early gadolinium enhancement (4 minutes) of the myocardium. Figure 1. Electrocardiogram, echocardiogram, and cardiac MRI findings associated with myocarditis after BNT162b2 vaccination. (a) Electrocardiogram shows ST segment elevation, especially in the lateral leads. (b) The echocardiogram shows patchy echogenic foci in the left ventricle with intact left ventricular systolic function. Arrow indicates echogenic areas in the interventricular septum. (c) Cardiac MRI with gadolinium enhancement using electrocardiogram-gated turbo spin echo T1-weighted sequences demonstrates early enhancement of the myocardium of the left ventricle, especially in the subendocardial layer, but no necrosis or significant oedema, consistent with myocarditis. Arrow indicates bright, enhanced areas of the left ventricular myocardium. Insert shows pre-gadolinium image with no myocardial enhancement. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocarditis due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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-2021881859 same article, product, different patient, event


VAERS ID: 1500664 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Indiana  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021877608

Write-up: Developed myocarditis two days after his second Pfizer vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient''s mother) reported for son that, A 18-year-old male adolescent patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Jun2021 as a DOSE 2, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZ-ER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18May2021 as a DOSE 1, SINGLE for covid-19 immunization. Patient had sore arm after dose 1. The patient developed myocarditis two days after his second pfizer vaccine on 10Jun2021. The patient was hospitalized for developing myocarditis two days after his second pfizer vaccine from 10Jun2021 to an unknown date. Patient was hospitalized with myocarditis on 10Jun2021 two days after his second dose of Pfizer''s COVID vaccine. Felt pressured at work by his employer and co-workers to get vaccinated. "They were uncomfortable that he wasn''t vaccinated" reporter stated. "So he got the COVID vaccine without telling me." Withheld other son, now 16, had an adverse reaction to his measlesmumps rubella (MMR) vaccine when he was younger, and has not been vaccinated since. After first Pfizer dose on May18 he experienced a sore arm but was otherwise ok. Teen suffers severe heart damage after second Pfizer Dose, mother Says Hospital ''Clueless'' About Reporting to VAERS Withheld whose 18-year-old son developed myocarditis two days after his second Pfizer vaccine, said she would never have connected the dots between the vaccine and patient''s symptoms if she hadn''t read about the condition. Dataset of 53 records, Found were sore arm. adverse reaction. COVID, myocarditis, measles, measles mumps, rubella, sore, MMR vaccine. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected


VAERS ID: 1500666 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021880126

Write-up: His whole heart was inflamed, he had inflammation around his heart, so he was in the hospital; His whole heart was inflamed, he had inflammation around his heart, so he was in the hospital; This is a spontaneous report from a contactable consumer (husband). A 49-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: was not reported), via unspecified route of administration, as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient''s whole heart was inflamed, he had inflammation around his heart and he was hospitalized. Reporter stated that the patient was admitted in the hospital and before that he had a clean bill of record no cholesterol, no diabetes and he is not over weight. And she was assuming that the hospital was supposed to report it. Reporter stated that the only problem for calling was because she can''t, bills keep coming and it was ridiculous, she cannot afford to pay all these bills that vaccine gave him this illness. The patient would like Pfizer to convince her why the rest of my family should go get a vaccine. The reporter stated that she was noticed on the news they keep saying teenagers, young teenagers, but somebody needs to tell the truth out there. Reporter was informed that the information was captured to file a safety report and if in case a follow-up is requested then it can be done by this information. The outcome of the events was unknown. Information about lot/batch number has been requested.


VAERS ID: 1509017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-09
Onset:2021-06-08
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9269 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Biopsy, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMBRUVICA; LEVOXYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukemia; Lobectomy (thyroid); Thyroid cancer
Allergies:
Diagnostic Lab Data: Test Name: biopsy; Result Unstructured Data: Test Result:unknown results
CDC Split Type: USPFIZER INC2021888272

Write-up: Pericarditis; a-fib; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 09Feb2021 as single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukemia, thyroid cancer, right lobe was removed. Concomitant medications included ibrutinib (IMBRUVICA) for chronic lymphocytic leukaemia, levothyroxine sodium (LEVOXYL) for thyroid cancer, vitamins. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) in the left arm on 19Jan2021 for Covid-19 immunization, with 0.3mg on the card. On 08Jun2021, the patient developed atrial fibrillation and pericarditis. 4 months after the second COVID 19 vaccine, she developed pericarditis. Like the male guys get from the vaccine. She was just curious. The patient had heard that these can be side effects for young boys. She wanted to know if there''s a report on atrial fibrillation and pericarditis for people belonging to her age group. At first they thought she had A-fib from one of her other pills, but they also had to pull 16oz bloody fluid off of her heart. They put her on pills for the A-fib. They think the A-Fib could be related to her other pill, but they couldn''t figure out the fluid. The biopsy didn''t answer the question. She was not on the medication that caused the A-fib anymore. That medication was Imbruvica for her CLL, Chronic lymphocytic leukemia. On that medication 5% of people can get A-fib. She was on it 2.5 years. Her Imbruvica was 140mg. She was no longer on it. She wanted to donate the ones she didn''t use, but they wouldn''t let her. Outcome of the event pericarditis was recovered in 2021, of the event a-fib was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1509217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Myocarditis
SMQs:, Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), 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 INC2021907736

Write-up: myocarditis; had three miscarriages following the pfizer vaccine; became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer from a Pfizer sponsored Program. This consumer reported for a female patient (wife''s friend). A pregnant female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection batch/lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, reporter stated that his wife''s friend had three miscarriages following the Pfizer vaccine, the first one in the first trimester they could not find baby''s heart beat. 2nd one had miscarriage a couple weeks after and then she conceived again and was in the hospital with myocarditis, her doctor said it was due to genetics and she lost the third one also. Reporter reports his wife''s female friend had her first miscarriage, after the second vaccine and also reports that 82% of people, that got the vaccine experienced miscarriage and spontaneous abortion. Reporter states, his wife''s friend had a total of 3 miscarriages and clarifies, that the first miscarriage occurred after both doses of the Pfizer Covid vaccine, reporter also states that she was also diagnosed with myocarditis and has spent hundreds of dollars on her medical bills. Reporter stated that this woman''s doctor, said it was not caused from the vaccine, that it was genetic, and he did not report this to the VAERS website. The mother reported she became pregnant while taking BNT162B2. The reporter assessed the events as non-serious. The outcome of the events was unknown. Information about lot/batch number has been requested.


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