National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

From the 10/8/2021 release of VAERS data:

Found 3,741 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

This is page 3 out of 375

Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12   next


VAERS ID: 1370818 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:2021-01-23
Onset:2021-02-23
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029K20A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20211

Write-up: Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Feb-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with CLONIDINE for Symptomatic treatment, at an unspecified dose and frequency and MORPHINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was not provided by the reporter. The patient had a pace maker put in on 23-Feb-2021 and had pericarditis the same day. About two weeks before Easter, the patient had pain every time she took a breath like she was going to have a heart attack. Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.


VAERS ID: 1381123 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-04-16
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Palpitations, Pericarditis, Polymerase chain reaction
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROTEIN; MULTIVITAMIN [VITAMINS NOS]; VITAMIN D3
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210421; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC2021585137

Write-up: pericarditis; shortness of breath; heart palpitations; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included protein (whey protein isolate); multivitamin [vitamins nos]; vitamin d3. The patient experienced pericarditis, shortness of breath, heart palpitations, chest tightness on 16Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the adverse event included indomethacin and colchicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) with Nasal Swab was negative on 17Apr2021; negative on 21Apr2021. The outcome of the event pericarditis was unknown, the outcome of the other events was not resolved. No follow up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1390934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myocarditis, Ventricular extrasystoles
SMQs:, Ventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
CDC Split Type: USPFIZER INC2021609376

Write-up: she may have myocarditis; symptomatic ventricular ectopy; fatigue; headache; This is a spontaneous report received from a contactable consumer for a female patient (our young, female physician) of unspecified age 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 2ND DOSE, SINGLE for covid-19 immunisation . The patient medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 1ST DOSE, SINGLE DOSE for covid-19 immunisation on unknown date. The patient''s concomitant medications were not reported. The patient who was with no major medical problems developed symptomatic ventricular ectopy that she stated to begin 10 days after her second vaccine dose (Pfizer). She is currently under the care of a cardiologist who believed she might have myocarditis. She also experienced fatigue and headache with her second vaccine dose. She was started on ibuprofen and is feeling "a little better". She denied fever or other systemic manifestations. The outcome of the events was unknown. Therapeutic measures were taken as a result of she may have myocarditis (myocarditis). Information on the batch number has been requested.


VAERS ID: 1390967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Disease recurrence, 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? Yes
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: Pericarditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021615654

Write-up: episode of pericarditis; episode of pericarditis; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included pericarditis. The patient''s concomitant medications were not reported. Patient who had medical history of pericarditis had another episode of pericarditis and was brought to the hospital after receiving the COVID vaccine. He received ketorolac (TORADOL) and was discharged. Outcome of the event was recovered. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a causal association between the reported event pericarditis and BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1392581 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Anticoagulant therapy, Blood test, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Headache, Injection site pain, Musculoskeletal stiffness, Myocarditis, Pericarditis, Troponin increased, Ultrasound bladder, Ultrasound kidney, Urine analysis
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (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), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 05-JUN-21 - Emergency department - blood tests (6 vials taken) - elevated troponin level - urine sample - ECG - ultrasound - heart - ultrasound - kidney - ultrasound - bladder - xray - chest 06-JUN-21 - Inpatient - ultrasound - heart - ECG - blood tests (~8 vials) elevated troponin level 07-JUN-21 - Inpatient - chewable asprin - blood tests (~3 vials) elevated troponin level
CDC Split Type:

Write-up: symptoms: acute chest pain, headache, stiff neck, pain at the injection site treatment: morphine (bolus), IV heparin (bolus plus drip), tylenol, asprin, IV fluids diagnosis: myocarditis and pericarditis


VAERS ID: 1394140 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 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? Yes
   Date died: 2021-05-14
   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: PFIZER INC2021664604

Write-up: the cause of death is myocarditis; This is a spontaneous report from a contactable consumer reporting for her father. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 13May2021 (Batch/Lot Number: EX8679) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient died from myocarditis on 14May2021. The patient died on 14May2021. It was not reported if an autopsy was performed. Course of the event. The woman reported that her father, who was vaccinated in out of country, died after the second dose. He got his second dose on 13May2021 and died the next day (14May2021). The cause of death is myocarditis. Follow up information has been requested.; Reported Cause(s) of Death: the cause of death is myocarditis


VAERS ID: 1398521 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, Chest pain, Chills, Electrocardiogram, Magnetic resonance imaging, Myalgia, Myocarditis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: catheter angiogram; Result Unstructured Data: Unknown; Test Date: 20210524; Test Name: EKG; Result Unstructured Data: Abnormal; Test Date: 20210524; Test Name: MRI; Result Unstructured Data: Unknown
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown 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 21-May-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown. Concomitant product use was not reported. It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries. Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1400320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Myocarditis, Troponin increased
SMQs:, Myocardial infarction (narrow), 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: Elevated Troponin
CDC Split Type:

Write-up: Myocarditis suspected


VAERS ID: 1409686 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-02
Onset:2021-03-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8982 / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN; TELMISARTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021651215

Write-up: Pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) via unspecified route of administration in left arm on 02Feb2021 01:00 PM as 2nd dose, single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at hospital (facility type). The patient''s medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient''s concomitant medications received within two weeks of vaccination included simvastatin and telmisartan both from unspecified date. The patient previously took levofloxacin (LEVAQUIN) and it was reported as known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via unspecified route of administration in left arm on 12Jan2021 12:00 PM (at the age of 73-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On unspecified date in Mar2021 the patient experienced pericarditis treated with unspecified medication and resulted in doctor or other healthcare professional office/clinic visit. The had patient been tested for COVID-19 on unspecified date in May2021 with nasal swab test and a negative result was reported. The outcome of the event was not resolved.


VAERS ID: 1412501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Adenovirus test, Alanine aminotransferase, Antibody test, Aspartate aminotransferase, Blood albumin, Brain natriuretic peptide increased, Brain natriuretic peptide normal, C-reactive protein, C-reactive protein increased, Cytomegalovirus test, Echocardiogram, Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Inflammatory marker test, International normalised ratio, Investigation, Lymphocyte count, Magnetic resonance imaging heart, Myocarditis, N-terminal prohormone brain natriuretic peptide, N-terminal prohormone brain natriuretic peptide increased, Neutrophil count, Platelet count, Polymerase chain reaction, Prothrombin time, Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test negative, Serum ferritin, Troponin, Troponin decreased, Troponin increased, White blood cell count
SMQs:, Cardiac failure (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Pulmonary hypertension (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? 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: Partial thromboplastin time; Test Result: 22.3 s; Test Name: Adenovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:30; Comments: (units/L); Test Name: COVID-19 spike antibody; Result Unstructured Data: Test Result:unknown results; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:54; Comments: (units/L); Test Name: Albumin; Result Unstructured Data: Test Result:3.9 g/dl; Test Name: Highest BNP; Result Unstructured Data: Test Result:unknown results; Test Name: Brain natriuretic; Result Unstructured Data: Test Result:(normal < 100) pg/mL; Comments: (normal < 100); Test Name: C-reactive protein; Test Result: 0.99 mg/dl; Test Name: Highest C-reactive protien; Test Result: 12.3 mg/dl; Test Name: Cytomegalovirus; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST elevation; Comments: Atrioventricular dissociation with junctional escape rhythm, ST elevation; Test Name: Enterovirus diagnostics; Test Result: Negative ; Comments: Negative serum PCR; Test Name: Epstein-Barr virus; Result Unstructured Data: Test Result:unknown results; Test Name: Inflammatory markers; Result Unstructured Data: Test Result:mildly elevated with D-dimer 1.52 ug/mL; Test Name: INR; Result Unstructured Data: Test Result:1.11; Test Name: viral diagnostic studies; Test Result: Negative ; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result:1.69; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:myocardial edema; Comments: LGE (subepicardial) involving lateral LV apex, myocardial edema of lateral LV wall, left axillary adenopathy; Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:4.65; Test Name: NT pro-BNP; Result Unstructured Data: Test Result:428 pg/mL; Test Name: Highest NT-pro BNP; Result Unstructured Data: Test Result:482 pg/mL; Test Name: Platelet count; Result Unstructured Data: Test Result:198; Test Name: PCR; Test Result: Negative ; Test Name: Prothrombin time; Result Unstructured Data: Test Result:unknown results seconds; Test Name: fever; Result Unstructured Data: Test Result:38.3 oC; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:18; Comments: mm/hr; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:43; Comments: mm/hr; Test Name: COVID-19 PCR; Test Result: Negative ; Test Name: SARS-CoV-2; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: Test Result:70 ug/L; Test Name: Troponin; Result Unstructured Data: Test Result:2.59 ng/ml; Test Name: Lowest troponin prior; Result Unstructured Data: Test Result:1.42 ng/ml; Test Name: Highest troponin; Result Unstructured Data: Test Result:12.43 ng/ml; Test Name: Peripheral white blood cell count; Result Unstructured Data: Test Result:6.97; Test Name: troponin; Result Unstructured Data: Test Result:returned to normal
CDC Split Type: USPFIZER INC2021665013

Write-up: acute myocarditis or myopericarditis; This is a literature report 2021. Additionally reported 2021, via contactable Physicians. This Physician reported similar events for seven patients. This is the first of seven reports. Introduction: On 11Dec2020, the FDA issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 mRNA vaccine for prevention of COVID-19 for individuals 16 years of age and older.1. On 10May2021, the FDA revised the EUA for this vaccine to include children 12 years and older. The Pfizer vaccine remains the only vaccine with an EUA for 12-to 17-year-old children. This vaccine demonstrated 94-95% efficacy in preventing COVID-19 infection in 16- 55-year-old participants, and 100% efficacy in the 12-15 year old age group. Systemic reactogenicity occurred more commonly in younger patients and after the second dose of vaccine. Post-immunization myocarditis is a known rare adverse event following other vaccinations, particularly following smallpox vaccination. Recently the news media has highlighted reports of myocarditis after COVID-19 mRNA vaccination involving military patients and patients. The cohort identified a male predominance with an incidence of 1/20,000 (men aged 18 to 30 years old). However, a conclusive causal link to vaccination has not been confirmed at this time. Additionally, two recently published case reports describe myocarditis after COVID-19 mRNA vaccination in a 56-year-old man with previous COVID-19 and a 39-year-old man with no history of COVID-19. This report summarizes case histories of 7 healthy male adolescents 14 to 19 years of age who developed acute myocarditis or myopericarditis within 4 days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine, none of whom met criteria for MIS-C. All 7 patients were vaccinated in April and May of 2021 and have been reported to VAERS. Patient 1: A previously well 16-year-old male presented to an emergency department (ED) with fatigue, poor appetite, fever of 38.3o C, and pain in the chest and both arms two days after his second Pfizer-BioNTech COVID-19 vaccine. He had no history of recent viral illness symptoms and no known COVID-19 exposures. Evaluation included an electrocardiogram (ECG) that showed atrioventricular dissociation with junctional escape and ST elevation and an elevated troponin I (2.59 ng/ml, normal range for this hospital, < 0.03 ng/mL). He was transferred to the Pediatric Intensive Care Unit of a tertiary care hospital for suspected myo-carditis. Inflammatory markers were mildly elevated with D-dimer 1.52 ug/mL, erythrocyte sedimentation rate (ESR) of 43 mm/hr, and maximum C-reactive protein (CRP) of 12.3 mg/L (normal range, <1.0 mg/dL). Cardiac MRI demonstrated late gadolinium enhancement characteristic for myocarditis. Echocardiogram was normal. Troponin I peaked at 12.43 ng/mL (normal range for this hospital, <0.80 ng/mL). A nasopharyngeal swab for SARS-CoV-2 PCR was negative as was his serum SARS-CoV-2 nucleocapsid anti-body. All other viral diagnostic studies were negative. He remained well appearing, hemodynamically stable and in normal sinus rhythm throughout the six-day hospitalization. Partial thromboplastin time: 22.3 seconds, Adenovirus diagnostics: Negative serum PCR, Alanine transaminase: 30 (units/L), COVID-19 spike antibody: unknown results, Aspartate transaminase: 54 (units/L), Albumin: 3.9 g/dl, Highest BNP: unknown results, Brain natriuretic: (normal<100) pg/ml, C-reactive protein: 0.99 mg/dl, Cytomegalovirus: Negative serum PCR, Electrocardiogram: Atrioventricular dissociation with junctional escape rhythm, ST elevation, Enterovirus diagnostics: Negative serum PCR, Epstein-Barr virus: unknown results, INR: 1.11, Absolute lymphocyte count:1.69, Cardiac MRI: LGE (subepicardial) involving lateral LV apex, myocardial edema of lateral LV wall, left axillary adenopathy, Absolute neutrophil count: 4.65, NT pro-BNP: 428 pg/ml, Highest NT-pro BNP: 482 pg/mL, Platelet count: 198, PCR: negative, Prothrombin time: unknown results, fever: 38.3 oC, Erythrocyte sedimentation rate: 18 mm/hr, COVID-19 PCR: negative, Ferritin: 70 ug/l, Troponin: 2.59 ng/ml, Lowest troponin prior: 1.42 ng/ml, Peripheral white blood cell count: 6.97. He received 100 grams (1.5 grams/kg) IVIG, then 10 mg/kg methylprednisolone intra-venously on three consecutive days followed by a planned 12-week oral prednisone taper began. He also received 3 15-30 mg doses of intravenous ketorolac for pain. By 3 weeks after presentation, troponin had returned to normal. Author report 7 cases of clinical myocarditis or myopericarditis that developed in 14 to 19-year-old males within 4 days of receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine with no evidence of acute SARS-CoV-2 infection and who did not fulfill criteria for MIS-C. Extensive diagnostic evaluation for other myocarditis etiologies was negative, including respiratory pathogens from nasopharyngeal swabs, serum PCR tests, and infectious serologies. Additionally, all cardiac MRIs were diagnostic for myocarditis based on the modified Lake Louise criteria rather than MIS-C characteristics described by (withheld) et al (diffuse myocardial edema without evidence of late gadolinium enhancement). There was some suggestion of abnormal left ventricular myocardial echocardiographic strain corresponding to regions of myocardial necrosis on cardiac MRI. All patients in this series had myocarditis or myopericarditis, which is the term for diagnosis of both myocardial and pericardial inflammation. These terms are often used interchangeably, which can make surveillance of these diseases challenging. Myocarditis and pericarditis are rare diseases. The true baseline incidence of myocarditis is unknown and varies by season, geography, and age: it has been reported to occur in 1.95/100,000 person- years in children <15 years of age in Finland and in 2.16 cases per 100,000 US military service members in a 30-day period. It is more common in males, and among children demonstrates a bimodal incidence pattern, with peaks at <2 years of age and in adolescence. An evaluation for potential viral causes is recommended, although a cause is usually not found. There have been prior reports of myocarditis following smallpox vaccination10. In patients with myocarditis, restriction from competitive sports is recommended for at least 3 months until cleared by a cardiologist in order to avoid sudden cardiac events while the heart muscle recovers. Less is known about the true incidence of pericarditis. Pericarditis can occur in the setting of a variety of infectious and non-infectious illnesses. In a study of patients more than16 years of age in Finland, the incidence rate of hospitalizations for acute pericarditis was 3.32/100,000 person-years, with males at higher risk than females and in 2007, the incidence of acute pericarditis in one study was 27.2 cases per 100,000 per year. Treatment for myocarditis and pericarditis may vary considerably depending on the patient characteristics, clinical condition, underlying cause, and physician preference. Consistent with a known male preponderance of myocarditis and pericarditis, all seven of our cases were male. The Pfizer-BioNTech clinical trials demonstrated an increased systemic reactogenicity and immunogenicity in younger study participants following mRNA vaccine. For example, 41.5% of adolescents developed chills after dose #2, compared to 35.1% of subjects 18-55 years of age. In terms of immunogenicity, an analysis of SARS-CoV-2 50% neutralizing titers 1 month after dose#2 demonstrated higher geometric mean titer (GMT) in children 12-15 years of age (GMT=1,239.5), compared to subjects 16-25 years of age (GMT=705.1). Adverse events often occurred more frequently after dose #2 and within 2 days following vaccination and included injection site pain, fatigue, myalgia, chills, arthralgia, fever, injection site swelling or redness, nausea, malaise, and lymphadenopathy. It is possible that myocarditis or myopericarditis may be an additional rare adverse event related to systemic reactogenicity, but currently no causal association has been established between this vaccine and myopericarditis. In our case series, 6 patients received non-steroidal anti-inflammatory drug (NSAID) treatment. Four patients received IVIG and oral prednisone; one of these four patients also initially received high-dose methylprednisolone. The recognition of a possible temporal relationship of COVID-19 vaccine and myocarditis is critical, because the correct diagnosis may spare healthy adolescents and young adults presenting with chest pain and ECG ST elevation from undergoing unnecessary invasive medical procedures such as cardiac catheterization. It is unclear if treatment with intravenous immunoglobulin and/or corticosteroids, in the absence of MIS-C criteria, is warranted with all cases of myocarditis that develop temporally after COVID-19 vaccination. Notably, 3 patients recovered with NSAID therapy alone. Myocarditis and myopericarditis after COVID-19 vaccination appear rare. As of 23May2021, the Centers for Disease Control and Prevention (CDC) reports that 1,560,652 people <18 years of age have completed a two-dose series of COVID-19 vaccine17. Of these, 652, 758 adolescents received their second dose more than fourteen days ago17. Currently, the Pfizer-BioNTech COVID-19 vaccine is the only COVID-19 vaccine authorized for children <18 years of age in the US. We urge physicians and healthcare providers to consider myocarditis in the evaluation of adolescents and young adults who develop chest pain after COVID-19 vaccination. All cases of myocarditis in patients with recent COVID-19 vaccination should be reported promptly to VAERS. Our case series has inherent limitations. We compiled cases through personal communications between colleagues rather than using a systematic surveillance system to identify cases. It was not possible to exclude all alternative etiologies including idiopathic and other infectious etiologies, and there was not a systematic diagnostic evaluation for other viral etiologies. Cardiac biopsy was not performed on any patients, because they were all clinically stable during hospitalization. However, no patient had evidence of a preceding or concurrent symptomatic viral illness to implicate as an etiology of myocarditis, and the lack of eosinophilia dissuades a hypersensitivity reaction. The pathophysiology of myocarditis in these patients is indeterminate and we do not know if it is the same or different than classic myopericarditis or myopericarditis following other vaccines, associated with acute COVID-19, or MIS-C. Given the nature of a case series, we cannot determine the incidence rate of myocarditis/myopericarditis following COVID-19 mRNA vaccination. Finally, a negative nucleocapsid antibody does not conclusively rule out the possibility of natural infection. This report summarizes a series of US cases of myocarditis and myopericarditis following the Pfizer BioNTech COVID-19 mRNA vaccine in adolescent males. All cases in this report occurred after the second vaccine dose. Fortunately, none of our patients was critically ill and each was discharged home. At present, there is no definite causal relationship between these cases and vaccine administration. 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 acute myocarditis due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and viral serologies 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-2021665014 Same reporter, drug, event but different patient;US-PFIZER INC-2021665016 Same reporter, drug, event but different patient;US-PFIZER INC-2021665017 Same reporter, drug, event but different patient;US-PFIZER INC-2021665018 Same reporter, drug, event but different patient;US-PFIZER INC-2021665019 Same reporter, drug, event but different patient;US-PFIZER INC-2021665020 Same reporter, drug, event but different patient


Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=3&SYMPTOMS[]=Acute_endocarditis_%2810049001%29&SYMPTOMS[]=Atypical_mycobacterium_pericarditis_%2810055036%29&SYMPTOMS[]=Autoimmune_myocarditis_%2810064539%29&SYMPTOMS[]=Bacterial_pericarditis_%2810004050%29&SYMPTOMS[]=Carditis_%2810062746%29&SYMPTOMS[]=Endocarditis_%2810014665%29&SYMPTOMS[]=Endocarditis_bacterial_%2810014666%29&SYMPTOMS[]=Endocarditis_enterococcal_%2810014671%29&SYMPTOMS[]=Endocarditis_noninfective_%2810062608%29&SYMPTOMS[]=Endocarditis_staphylococcal_%2810014684%29&SYMPTOMS[]=Endocarditis_viral_%2810061837%29&SYMPTOMS[]=Eosinophilic_myocarditis_%2810014961%29&SYMPTOMS[]=Fungal_endocarditis_%2810017529%29&SYMPTOMS[]=Giant_cell_myocarditis_%2810083635%29&SYMPTOMS[]=Immune-mediated_myocarditis_%2810082606%29&SYMPTOMS[]=Lupus_endocarditis_%2810058225%29&SYMPTOMS[]=Lyme_carditis_%2810078417%29&SYMPTOMS[]=Meningococcal_carditis_%2810027270%29&SYMPTOMS[]=Myocarditis_%2810028606%29&SYMPTOMS[]=Myocarditis_bacterial_%2810065218%29&SYMPTOMS[]=Myocarditis_infectious_%2810066857%29&SYMPTOMS[]=Myocarditis_septic_%2810028615%29&SYMPTOMS[]=Myopericarditis_%2810028650%29&SYMPTOMS[]=Pericarditis_%2810034484%29&SYMPTOMS[]=Pericarditis_constrictive_%2810034487%29&SYMPTOMS[]=Pericarditis_infective_%2810062491%29&SYMPTOMS[]=Pericarditis_lupus_%2810058149%29&SYMPTOMS[]=Pericarditis_meningococcal_%2810034492%29&SYMPTOMS[]=Pericarditis_rheumatic_%2810034496%29&SYMPTOMS[]=Pericarditis_tuberculous_%2810055069%29&SYMPTOMS[]=Pleuropericarditis_%2810059361%29&SYMPTOMS[]=Purulent_pericarditis_%2810051071%29&SYMPTOMS[]=Streptococcal_endocarditis_%2810073742%29&SYMPTOMS[]=Subacute_endocarditis_%2810042276%29&SYMPTOMS[]=Viral_myocarditis_%2810047470%29&SYMPTOMS[]=Viral_pericarditis_%2810047472%29&VAX=COVID19&VAXTYPES=COVID-19&WhichAge=range&LOWAGE=(-1)&HIGHAGE=(-1)

Government Disclaimer on use of this data


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166