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

Found 5,176 cases where Age is Unknown and Vaccine targets COVID-19 (COVID19) and Symptom is Acute endocarditis or Atypical mycobacterium pericarditis or Autoimmune myocarditis or Bacterial pericarditis or Carditis or Endocarditis or Endocarditis bacterial or Endocarditis enterococcal or Endocarditis noninfective or Endocarditis staphylococcal or Endocarditis viral or Eosinophilic myocarditis or Fungal endocarditis or Giant cell myocarditis or Immune-mediated myocarditis or Lupus endocarditis or Lyme carditis or Meningococcal carditis or Myocarditis or Myocarditis bacterial or Myocarditis infectious or Myocarditis septic or Myopericarditis or Pericarditis or Pericarditis constrictive or Pericarditis infective or Pericarditis lupus or Pericarditis meningococcal or Pericarditis rheumatic or Pericarditis tuberculous or Pleuropericarditis or Purulent pericarditis or Streptococcal endocarditis or Subacute endocarditis or Viral myocarditis or Viral pericarditis

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1645896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Nevada  
Vaccinated:2021-07-09
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Cholecystitis, Gallbladder disorder, Pericarditis, Pericarditis constrictive, Ultrasound biliary tract
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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: Autoimmune disorder; SLE
Allergies:
Diagnostic Lab Data: Test Name: CP of her heart pericarditis; Result Unstructured Data: Test Result:Unknown; Test Name: ultrasound of her gall bladder; Result Unstructured Data: Test Result:Inflammed; Comments: it was inflamed and it was full of sludge
CDC Split Type: USPFIZER INC202100969917

Write-up: gall bladder issues/gall bladder was inflamed and it was full of sludge; pericarditis; gall bladder inflammation; extreme stomach pain; This is a spontaneous report from a contactable consumer via Medical information team. A 42 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included autoimmune issue and lupus from an unknown date and unknown if ongoing. The patient previously had BNT162B2 dose 1 for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient started experiencing some pains turned out to be gall bladder issues and she is in the hospital right now to get her gall bladder removed. The patient''s husband was aware about the usual side effect, the pericarditis and also the inflammation of the gall bladder. The patient''s husband concern was, is it possible that the spike protein invalidated into her gall bladder, that caused the autoimmune reaction or the inflammation to the gall bladder. He wants to know if we are doing tests on gall bladders that have been removed, and if his wife body is continuing to manufacture the spike protein and with her autoimmune condition related, will it be transmitted to another organ, or will it cause pericarditis. He is asking if we have procedure or testing spike protein concentration and other organs. The patient had gall bladder inflammation and pericarditis issue. The patient went through gall bladder surgery and had her gall bladder removed. The patient woke with extreme stomach pain and went to the emergency room that was last two days in Jul2021. The patient had CP of her heart pericarditis and they did an ultrasound of her gall bladder and told it was inflamed and it was full of sludge and then they sent her home and told her to schedule with a surgeon because he said it was a (Distorted voice). When probed if the result of test were normal: Reporter stated, No, the ultrasounds showed that her gall bladder had sludge in it and it was inflamed. It progressively got that worse over the next couple of days until the patient had surgery this morning to have her gall bladder removed. The outcome of events was unknown. Information about lot/batch number has been requested.


VAERS ID: 1646328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100994432

Write-up: chest pain; suspicious of myocarditis; This is a spontaneous report. A non-contactable female consumer (patient''s mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 2 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chest pain and suspicious of myocarditis (medically significant). The patient got second dose (of bnt162b2) and got chest pain and went to ER who were suspicious of myocarditis. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1646354 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase, Angiogram, Antibody test, Aspartate aminotransferase, Biopsy heart, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood cholesterol, Blood creatinine, Blood folate, Blood glucose, Blood immunoglobulin G, Blood immunoglobulin M, Blood iron, Blood magnesium, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood thyroid stimulating hormone, Blood urea, Body mass index, Body temperature, Brain natriuretic peptide, C-reactive protein, Catheterisation cardiac, Chest X-ray, Coxsackie virus test, Echocardiogram, Ejection fraction, Electrocardiogram, Fibrin D dimer, Haematocrit, Haemoglobin, Heart rate, High density lipoprotein, International normalised ratio, Iron binding capacity total, Low density lipoprotein, Lymphocyte count, Magnetic resonance imaging, Mean cell volume, Myocarditis, Neutrophil count, Oxygen saturation, Physical examination, Platelet count, Polymerase chain reaction, Protein total normal, Prothrombin time, Red blood cell count, Red blood cell sedimentation rate, Respiratory rate, SARS-CoV-2 test, Serum ferritin, Transferrin saturation, Troponin increased, Very low density lipoprotein, White blood cell count
SMQs:, Myocardial infarction (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from recreational drugs; Alcohol use; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: partial thromboplastin time; Test Result: 30 s; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:9 IU/l; Test Name: CT angiography; Result Unstructured Data: Test Result:unremarkable; Test Name: antibodies; Result Unstructured Data: Test Result:No antibodies against coxsackievirus B2, B3, B4, B; Comments: No antibodies against coxsackievirus B2, B3, B4, B5 and B6 serotypes were detected.; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:22 IU/l; Test Name: endomyocardial biopsy; Result Unstructured Data: Test Result:was not performed due; Comments: was not performed due to the patient''s improving symptoms and lack of ventricular arrhythmias or significant cardiac wall motion abnormalities; Test Name: albumin; Result Unstructured Data: Test Result:4.4 g/dl; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:54 IU/l; Test Name: bicarbonate; Result Unstructured Data: Test Result:23 mEq/l; Test Name: bilirubin; Test Result: 0.5 mg/dl; Test Name: calcium; Test Result: 8.8 mg/dl; Test Name: chloride; Result Unstructured Data: Test Result:102 mEq/l; Test Name: cholesterol; Test Result: 109 mg/dl; Test Name: creatinine kinase; Result Unstructured Data: Test Result:450 IU/l; Test Name: serum creatinine; Test Result: 0.83 mg/dl; Test Name: folate; Result Unstructured Data: Test Result:19.6 ng/ml; Test Name: glucose; Test Result: 93 mg/dl; Test Name: IgG; Result Unstructured Data: Test Result:0.3; Test Name: IgG antibodies; Result Unstructured Data: Test Result:each positive with a titre of 1:400 where the norm; Comments: each positive with a titre of 1:400 where the normal value is <1:100) against coxsackie A7, A9, A16 and A24 serotypes but was negative for IgM antibodies, suggesting past infection.; Test Name: Parvo B19 IgM; Result Unstructured Data: Test Result:0.2; Test Name: iron level; Result Unstructured Data: Test Result:43 ug/dL; Test Name: magnesium; Test Result: 1.9 mg/dl; Test Name: phosphorus; Test Result: 3 mg/dl; Test Name: potassium; Result Unstructured Data: Test Result:3.6 mEq/l; Test Name: blood pressure; Result Unstructured Data: Test Result:91/52 mmHg; Test Name: thyroid stimulating hormone; Result Unstructured Data: Test Result:1.415 MiU/mL; Test Name: blood urea nitrogen; Test Result: 13 mg/dl; Test Name: body mass index; Result Unstructured Data: Test Result:27.7; Comments: kg/m2; Test Name: Temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:42 pg/mL; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:Showed normal coronary arteries; Test Name: Chest x-ray; Result Unstructured Data: Test Result:unremarkable; Test Name: Coxsackievirus B1 antibody titre; Result Unstructured Data: Test Result:1:8; Test Name: C-reactive protein; Result Unstructured Data: Test Result:24.8 mg/l; Test Name: echocardiogram; Result Unstructured Data: Test Result:showed an ejection fraction of 55% percent; Test Name: ejection fraction; Test Result: 55 %; Test Name: electrocardiogram; Result Unstructured Data: Test Result:showed normal sinus rhythm, a normal axis, 76 beat; Comments: showed normal sinus rhythm, a normal axis, 76 beats per minute, and a 1-mm ST-depression in lead III; Test Name: D-dimer; Result Unstructured Data: Test Result:0.33 ug/ml; Test Name: haematocrit; Test Result: 38.7 %; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.9 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:92; Comments: beats per minute; Test Name: HDL; Test Result: 37 mg/dl; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.1; Test Name: total iron binding capacity; Result Unstructured Data: Test Result:274 ug/ml; Test Name: LDL; Test Result: 50 mg/dl; Test Name: absolute lymphocyte count; Result Unstructured Data: Test Result:1.14 x10 3/mm3; Test Name: Cardiac magnetic resonance; Result Unstructured Data: Test Result:with and without contrast showed linear sub-epicar; Comments: with and without contrast showed linear sub-epicardial enhancement involving the lateral wall of the left ventricle consistent with acute myocarditis; Test Name: MCV; Result Unstructured Data: Test Result:89; Comments: fl; Test Name: absolute neutrophil count; Result Unstructured Data: Test Result:5.0 x10 3/mm3; Test Name: oxygen saturation; Test Result: 98 %; Comments: percent on room air; Test Name: Physical examination; Result Unstructured Data: Test Result:was unremarkable.; Test Name: platelets; Result Unstructured Data: Test Result:161; Comments: K/mm3; Test Name: PCR panel; Result Unstructured Data: Test Result:was negative for adenovirus, human metapneumovirus; Comments: was negative for adenovirus, human metapneumovirus, rhinovirus, enterovirus, influenza A, influenza B, parainfluenza virus 1, 2, 3 and 4, respiratory syncytial virus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, HH6 and Lyme disease. HIV, Hep B and C were also negative; Test Name: total protein; Result Unstructured Data: Test Result:6.9 g/dl; Test Name: prothrombin time; Test Result: 14.2 s; Test Name: RDW; Test Result: 12.5 %; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:21; Comments: mm/hr; Test Name: respiratory rate; Result Unstructured Data: Test Result:18; Comments: breaths per minute; Test Name: SARS-CoV-2 antigen; Test Result: Negative ; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Name: ferritin; Result Unstructured Data: Test Result:108.0 ng/ml; Test Name: iron saturation; Test Result: 16 %; Test Name: high-sensitivity troponin I initial value; Result Unstructured Data: Test Result:2,529 pg/mL; Test Name: high-sensitivity troponin I initial value; Result Unstructured Data: Test Result:6803 pg/mL; Test Name: VLDL; Test Result: 15 mg/dl; Test Name: total leucocyte count; Result Unstructured Data: Test Result:7.3 x10 3/mm3
CDC Split Type: USPFIZER INC202100996340

Write-up: consistent with acute myocarditis; This is a literature report. The authors describe the case of a 24-year-old (race) man with no past medical history who presented to the Emergency Department (ED) with chest pain which had woken him from sleep. The pain was left-sided, severe, constant, non-radiating, was associated with headache and had started 30 min before arrival in the ED. The patient denied taking any over-the-counter medications for pain relief. The patient had received his second dose of BNT162b2 (Pfizer-BioNTech COVID-19 vaccine) 3 days before the episode. On the day he received the second dose, he developed subjective fever, chills, fatigue, headache and lower back pain, which resolved over the next 24 hours. The night before presenting to the hospital, he had shovelled snow for about 30 minutes. The next morning, he developed chest pain which prompted him to come to the ED. A review of symptoms was negative for nausea, vomiting, diaphoresis, dizziness, light-headedness, vision changes, orthopnoea, shortness of breath and paroxysmal nocturnal dyspnoea. The patient was born and raised in the state and works as a maintenance custodian. He denied recent sick contacts or travel. He drinks alcohol socially and has never used tobacco products or illicit drugs such as cocaine or amphetamines. His parents are alive and healthy, and there was no family history of sudden cardiac death, other cardiac disease or autoimmune disease. On presentation, the patient''s temperature was 37.6 degree C, blood pressure was 91/52 mmHg, heart rate was 92 beats per minute, respiratory rate was 18 breaths per minute, oxygen saturation was 98% on room air and his body mass index was 27.7 kg/m2. Physical examination was unremarkable. On laboratory evaluation, the following values were noted: haemoglobin 12.9 g/dl (13.5-17.5 g/dl), haematocrit 38.7% (41-53%), total leucocyte count 7.3x103/mm3 (4.5-11x103/mm3), absolute neutrophil count 5.0x103/mm3 (1.3-7.8x103/mm3), absolute lymphocyte count 1.14x103/mm3 (0.9-4.6x103/mm3), platelets 161 K/mm3 (140-440 K/mm3), MCV 89 fl (80-100 fl), RDW 12.5% (0.5-16.5%), blood urea nitrogen 13 mg/dl (7-23 mg/dl), serum creatinine 0.83 mg/dl (0.60-1.30 mg/dl), high-sensitivity troponin I initial value 2,529 pg/ml (3-23 pg/ml), high-sensitivity troponin I peak value 6,803 pg/ml, brain natriuretic peptide 42 pg/ml (1-100 pg/ml), D-dimer 0.33 ug/ml (=0.50 ug/ ml), erythrocyte sedimentation rate 21 mm/hr (0-10 mm/hr), C-reactive protein 24.8 mg/l (=9.9 mg/l), creatinine kinase 450 U/l (30-223 U/l), prothrombin time 14.2 s (12.2-14.9 s), international normalized ratio 1.1 (0.9-1.1), partial thromboplastin time 30 s (21.3-35.1 s), iron level 43 ug/dl (50-212 ug/dl), total iron binding capacity 274 ug/dl (150-450 ug/dl), iron saturation 16% (15-50%), ferritin 108.0 ng/ ml (18.7-323.0 ng/ml), folate 19.6 ng/ml (=4.1 ng/ml), thyroid stimulating hormone 1.415 mIU/ml (0.450-5.330 mIU/ml), sodium 136 mEq/l (135-145 mEq/l), potassium 3.6 mEq/l (3.5-5 mEq/l), chloride 102 mEq/l (98-107 mEq/l), bicarbonate 23 mEq/l (21-31 mEq/l), glucose 93 mg/dl (70-110 mg/dl), calcium 8.8 mg/dl (8.6-10.3 mg/dl), bilirubin 0.5 mg/dl (0.3-1.1 mg/dl), total protein 6.9 g/dl (6.4-8.4 g/dl), albumin 4.4 g/dl (3.5-5.7 g/dl), alkaline phosphatase 54 U/l (34-104 U/l), aspartate aminotransferase 22 U/l (13-39 U/l), alanine aminotransferase 9 U/l (7-52 U/l), phosphorus 3 mg/dl (2.5-5 mg/dl), magnesium 1.9 mg/dl (1.7-2.5 mg/dl), cholesterol 109 mg/dl (=199 mg/dl), triglycerides 73 mg/dl (=149 mg/dl), VLDL 15 mg/dl (=49 mg/dl), HDL 37 mg/dl (30-74 mg/dl) , and LDL 50 mg/dl (=129 mg/dl). SARS-CoV-2 antigen and a PCR test were negative. Coxsackievirus B1 antibody titre was 1:8 (<1:8 titre) and so essentially negative. No antibodies against coxsackievirus B2, B3, B4, B5 and B6 serotypes were detected. Notably, the patient had IgG antibodies (each positive with a titre of 1:400 where the normal value is <1:100) against coxsackie A7, A9, A16 and A24 serotypes but was negative for IgM antibodies, suggesting past infection. Parvo B19 IgM 0.2 (0-0.8) and IgG 0.3 (0-0.8) were also negative. The PCR panel was negative for adenovirus, human metapneumovirus, rhinovirus, enterovirus, influenza A, influenza B, parainfluenza virus 1, 2, 3 and 4, respiratory syncytial virus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, HH6 and Lyme disease. HIV, Hep B and C were also negative. Chest x-ray and CT angiography were unremarkable. An electrocardiogram (EKG) showed normal sinus rhythm, a normal axis, 76 beats per minute, and a 1-mm ST-depression in lead III (Electrocardiogram showing normal sinus rhythm, a normal axis, 76 beats per minute and a 1-mm ST-depression in lead III). An echocardiogram showed an ejection fraction of 55%. Cardiac catheterization showed normal coronary arteries. Cardiac magnetic resonance imaging (MRI) with and without contrast showed linear sub-epicardial enhancement involving the lateral wall of the left ventricle consistent with acute myocarditis (Cardiac magnetic resonance imaging (MRI) with and without contrast showed linear sub-epicardial enhancement involving the lateral wall of the left ventricle consistent with acute myocarditis: STIR image and T2 image.). An endomyocardial biopsy was not performed due to the patient''s improving symptoms and lack of ventricular arrhythmias or significant cardiac wall motion abnormalities. The patient was hospitalized for 4 days and discharged in a stable condition. He was seen in an outpatient clinic 6 weeks later, is doing well and is back at work. An increasing number of cases of myocarditis and pericarditis after mRNA COVID-19 vaccination have been reported in the Vaccine Adverse Event Reporting System (VAERS). Most cases are in male adolescents, typically within several days of COVID-19 vaccination and more commonly after the second dose. Literature identified 110 cases of myocarditis among 5 million people who were [ administered two doses of the Pfizer-BioNTech vaccine in the month before their myocarditis diagnosis and 90% of cases were in men. Among the vaccinated young men, the rate was 5-25 times the background rate for myocarditis. The patient was also young (24 years old), presented with chest pain 3 days after receiving his second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine, and was diagnosed with myocarditis. Extensive work-up was done to exclude other possible causes of myocarditis in the patient. Healthcare providers should maintain a high index of suspicion regarding myocarditis after COVID-19 vaccination in the appropriate clinical situation. It was concluded that the case of 24-year-old male patient who developed chest pain after receiving the second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine and who was diagnosed with myocarditis. Healthcare providers should maintain a high index of suspicion regarding myocarditis after COVID-19 vaccination in the appropriate clinical situation. The authors emphasize that the benefits of vaccination far outweigh the risk given COVID-19 infection can cause multisystem organ dysfunction leading to morbidity and mortality and given that reported cases of myocarditis are mild and rare and most patients recover. Vaccination is a vital, very effective and life-saving measure against COVID-19 infection.; Sender''s Comments: There is reasonable possibility that the event myocarditis was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1646355 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100996652

Write-up: Myopericarditis; This is a spontaneous report from a contactable consumer. An adolescent patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number, unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. On an unspecified date, patient experienced myopericarditis after the 2nd COVID 19 dose. Event took place after use of product. The outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected. Sender''s Comments: Limited information precludes a comprehensive causality assessment however with known safety profile of the drug the causal role of BNT162B2 vaccine cannot be excluded for the reported event of myocarditis. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.


VAERS ID: 1646363 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100997718

Write-up: association with myopericarditis after getting the vaccine; This is a spontaneous report from a contactable physician. This physician reported for a patient that: A patient of an unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry 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 was not reported. The patient concomitant medications were not reported. The patient had association with myopericarditis after getting the vaccine. On an unspecified date patient experienced myopericarditis (myocarditis). Pfizer employee states that she gave the physician the name of the person at the state and that is why she was cc''d on the email. Physician was emailing the (State withheld), asking about the vaccine and its association with myopericarditis. There is no patient specific information to provide or product information to provide. In the email, the physician asked if he were to provide the names of individuals who developed temporary associated myopericarditis after getting the vaccine, could he be provided with the lot numbers used. They are putting together a case series from that patients did well, and many pediatricians are now hesitant to vaccinate. It was reported that she has no other information and does not know this physician. It was reported again clarified that she has no patient information, just that she knows the patients are adolescents. Again, clarified the details previously stated from the email. They are putting together a case series at (name withheld). They all did well thankfully. He needs information to help move the needle on this. The data will show he assumes that the incidence is very low, outcome is very good, and no specific lot number was a problem. The physician had asked if there was a website or specific literature. Pfizer employee states she has no other information to provide. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported event of myocarditis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1646740 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Carditis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
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 INC202101016381

Write-up: Patient failed to wake in the morning. Suspected heart inflammation.; This is a spontaneous report from a non-contactable consumer. An adult male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. There was no other vaccine in four weeks. The patient failed to wake in the morning on 02Aug2021. suspected heart inflammation. The patient died on 02Aug2021. death cause was heart Inflammation. It was unknown if treatment was received. Case was reported serious due to Results in death. It was not reported if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Heart Inflammation


VAERS ID: 1646758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-01
Onset:2021-03-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac disorder, Gait disturbance, Lung disorder, Myocarditis, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEURONTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Concussion; COVID-19; Milk allergy (Known allergies: Some food the patient think they don''t test you here. when little milk); Sinusitis; Trigeminal neuralgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101021870

Write-up: vomited; could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they KILL ME OR POISON; could not see, walk and having trouble at every level; MYOCARDITIS; LUNGS AND HEART FAILING; LUNGS AND HEART FAILING; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 10:30 AM (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was hospital. Medical history included Allergies to little milk (Known allergies: Some food the patient think they don''t test you here. when little milk), sinus, concussion, trigeminal neuralgia, had covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks: take low dose of Nuerontinin. Concomitant medication included gabapentin (NEURONTIN). The patient previously took Sulphur and experienced allergy, motrin experienced allergy, penicillin and experienced allergy. The reported event started on 26Mar2021 10:00 AM, the course was reported as that nurse laughed I did nothing while I vomited, could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they kill me or poison me. I am sick...getting worse...I have myocarditis now and lungs and heart failing...going to lose my job my health care everything cause you all lied you are liars. I asked what was in it I did not want it but from media pressure and my job got it. now I am about to die and lose everything I worked for cdc is liars and Dr. you all a bunch of liars killed me or it will. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received and was reported as medical clinic did it said. The event outcome was not recovered. No covid tested post vaccination. Follow-up (11Aug2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101022994

Write-up: Pericarditis; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer reported herself that a female patient received the BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on an unspecified in 2021 (Batch/Lot Number: not provided) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient had been hospitalized twice due to fluid on heart and lung, chest pains and difficulty in breathing. These issues were ongoing. The patient had been diagnosed with pericarditis from cardiologist where the outer wall of heart was damaged because of the COVID vaccine. The patient stated that because of this shot, her life has changed and now she was susceptible to more breathing issues and chronic chest/heart pains. The patient did not recover. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Troponin I
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ejection fraction; Test Result: 53 %; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm with diffuse ST; Comments: Sinus rhythm with diffuse ST elevation; Test Name: CMR; Result Unstructured Data: Test Result:revealed patchy midmyocardial increased T2 signal; Comments: revealed patchy midmyocardial increased T2 signal; Test Name: nasopharyngeal SARS-CoV-2 PCR testing; Test Result: Negative ; Test Name: Peak cardiac troponin I; Result Unstructured Data: Test Result:38.3 ng/ml
CDC Split Type: USPFIZER INC202101048345

Write-up: myocarditis following SARS-CoV-2 vaccination; This is a literature report. This author reported similar events for five patients. This is the second of five reports. An adult male patient (age reported as 16-20 years) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient developed Cardiac Magnetic Resonance Imaging (CMR)-proven myocarditis shortly after vaccination on an unspecified date. The patient with no infectious prodrome developed severe chest pain and elevated troponin I within 2 days-4 days of second vaccination. The patient did not develop any other complications and was discharged home. Lag between vaccination and presentation was 3 days. The patient had fever, 3 days into hospitalization. The symptoms at presentation included pleuritic and positional chest pain; rhinorrhea; headache. The patient underwent lab tests and procedures which included ejection fraction: 53 % (normal $g 55%), electrocardiogram: sinus rhythm with diffuse ST elevation, Cardiac Magnetic Resonance Imaging (CMR): revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis. (Short-axis and 4-chamber views demonstrating increased T2 signal and LGE in the midwall and subepicardial layer throughout the left ventricle (arrowheads) in a patient who received their second SARS-CoV-2 vaccination 7 days earlier), nasopharyngeal SARS-CoV-2 PCR testing: negative and troponin I: 38.3 ng/ml. The outcome of the event was unknown. Large clinical trials of both BNT162b2 and mRNA1273 in more than 70,000 individuals showed good safety profiles for both of the mRNA-based vaccines and no reports of myocarditis. However, myocarditis has been described after other vaccinations, such as seasonal influenza and smallpox and regulatory agencies are evaluating the risk of COVID-19 vaccine-associated myocarditis based on post-Emergency Use Authorization reports. CMR findings in the patient with suspected COVID-19 vaccine-associated myocarditis have not been well described in published reports, and the author''s report tried to document some of these changes. Although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: A contributory role of BNT162B2 to the event myocarditis cannot be fully excluded based on temporal relationship and since it is part of the product safety profile. This case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202100999284 Same article/drug/event; Different patient


VAERS ID: 1647205 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Troponin I
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ejection fraction; Test Result: 48 %; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm with diffuse ST elevation; Comments: and PR depression; non-sustained ventricular tachycardia.; Test Name: CMR; Result Unstructured Data: Test Result:revealed patchy midmyocardial increased T2 signal; Comments: with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis; Test Name: nasopharyngeal SARS-CoV-2 PCR testing; Test Result: Negative ; Test Name: Peak cardiac troponin I; Result Unstructured Data: Test Result:13.4 ng/ml
CDC Split Type: USPFIZER INC202101048365

Write-up: myocarditis following SARS-CoV-2 vaccination; This is a literature report. This author reported similar events for five patients. This is the third of five reports. An adult male patient (age range 20-25 years) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown), 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 did not have an infectious prodrome. The patient developed severe chest pain and elevated troponin I. The patient developed CMR-proven myocarditis shortly after vaccination. The patient experienced myocarditis following sars-cov-2 vaccination, 2 days after the second vaccination. Lag between vaccination and presentation: 2 days. Symptoms at presentation included non-positional chest pain radiating to back; myalgia and; malaise. The patient had fever on presentation. Electrocardiogram showed sinus rhythm with diffuse ST elevation and PR depression; non-sustained ventricular tachycardia. Peak cardiac troponin 1 was 13.4 ng/mL. Ejection fraction (normal $g55%) was 48%. The patient had negative nasopharyngeal SARS-CoV-2 PCR testing. CMR revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis. The patient did not develop any other complications and was discharged home. The outcome of the event was unknown. Although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, the authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any 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-202100999284 same article/drug/event, different patient


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