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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: 1733861 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Troponin
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: Test Date: 2021; Test Name: Troponin; Result Unstructured Data: significantly elevated cardiac troponin levels
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines 2021. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) significantly elevated cardiac troponin levels. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. This case concerns an adult male (age not reported) subject who experienced the serious event of myocarditis. The event occurred after receipt of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient''s medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report. Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associatedand vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-245527, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284002 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. This case concerns an adult male (age not reported) subject who experienced the serious event of myocarditis. The event occurred after receipt of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient''s medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1733867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Troponin
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: Test Date: 2021; Test Name: Troponin; Result Unstructured Data: elevated
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines. 2021 No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain. Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Author commentclinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-245527, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284007 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1733868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Troponin
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: Test Date: 2021; Test Name: Troponin; Result Unstructured Data: Elevated
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) Elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain. Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-245527, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015, MOD-2021-245527 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated. Hence new reports generated. On 05-Jul-2021: Follow up received 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received 08-Jul-2021 included the full text article added with no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1733988 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Myocardial infarction, Palpitations, Pericarditis, Systemic lupus erythematosus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Systemic lupus erythematosus (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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: Heart rate; Result Unstructured Data: high heart rate.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: heart attack who were hospitalized; lupus flare up; Swelling around heart; high palpitations; severe hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack who were hospitalized), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up), PERICARDITIS (Swelling around heart), PALPITATIONS (high palpitations) and URTICARIA (severe hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack who were hospitalized) (seriousness criteria hospitalization, medically significant and life threatening), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), PERICARDITIS (Swelling around heart) (seriousness criterion medically significant), PALPITATIONS (high palpitations) (seriousness criterion medically significant) and URTICARIA (severe hives) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack who were hospitalized), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up), PERICARDITIS (Swelling around heart), PALPITATIONS (high palpitations) and URTICARIA (severe hives) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high heart rate. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Company Comment: This case concerns subject with no reported medical history, who experienced the unexpected events of myocardial infarction, systemic lupus erythematosus, urticaria and palpitations and the expected event of pericarditis. Time to onset from vaccination was not reported for the events. The rechallenge was unknown, as there''s no information about vaccination doses, either dates or dose number. The event pericarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report. Further information is expected.; Sender''s Comments: This case concerns subject with no reported medical history, who experienced the unexpected events of myocardial infarction, systemic lupus erythematosus, urticaria and palpitations and the expected event of pericarditis. Time to onset from vaccination was not reported for the events. The rechallenge was unknown, as there''s no information about vaccination doses, either dates or dose number. The event pericarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report. Further information is expected.


VAERS ID: 1734151 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:elevated; Comments: at the time of admission; Test Name: echocardiogram; Result Unstructured Data: Test Result:unremarkable; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unremarkable; Test Name: troponin I; Result Unstructured Data: Test Result:elevated; Comments: at the time of admission
CDC Split Type: USPFIZER INC202101192972

Write-up: myocarditis; chest pain; This is a literature report. A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1734189 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, Myocarditis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101211727

Write-up: a family friend whose son had myocarditis; almost had a heart attack; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date consumer reported that, a family friend whose son had myocarditis, and almost had a heart attack. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1740161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspepsia, Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: USPFIZER INC202101198335

Write-up: Myocarditis/pericarditis; Myocarditis/pericarditis; Chest pain; Heart burn; This is a spontaneous report from a non-contactable consumer received from a Pfizer sponsored program. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (1 or 2 days after receiving the first dose) the patient experienced chest pain and heart burn. The patient was not evaluated by a doctor at the time of the chest pains so was unclear if it was myocarditis/pericarditis. The patient 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: 1743514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Troponin
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? Yes
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 Date: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: significantly elevated
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. 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. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-245527, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for clinic so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1743712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
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:
CDC Split Type: USPFIZER INC202101211413

Write-up: myocarditis; In the Emergency truck she had to get and then connect to restart her heart again.; She didn''t even wait for 5 months from Moderna and got another vaccine from Pfizer; She didn''t even wait for 5 months from Moderna and got another vaccine from Pfizer; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received MODERNA COVID-19 VACCINE in Apr2021 for COVID-19 immunization. The reporter stated that initially in Apr2021 and the patient was hospitalized and out from Hospital with nursing facility for Apr2021, May2021, Jun2021, Jul2021 because she has been in different Hospital. She didn''t even wait for 5 months from Moderna and got another vaccine from Pfizer, she got vaccinated by Pfizer on an unspecified date in 2021 and in that time period she got myocarditis. She ended up in the intensive care unit. In the Emergency truck she had to get and then connect to restart her heart again. She never had myocarditis issue before she was been given multiple tablets of sodium (treatment) by her medical doctor. Doctors were treating with morphine but they were giving her multiple tablets but at the end of the day, so what is the combination of Moderna and then getting the Pfizer vaccine within 2 months. 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: 1747671 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial rupture, Catheterisation cardiac, Myocardial infarction, Myocarditis, Reproductive tract disorder, Troponin
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no pre-existing conditions. Patient never had coronavirus.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Troponin; Result Unstructured Data: 7.3 ng/mL; Test Date: 202107; Test Name: Cardiac catheterization; Result Unstructured Data: Normal, no blockages were found
CDC Split Type: USJNJFOC20210953105

Write-up: APPARENT HEART ATTACK; MYOPERICARDITIS AND INFLAMED HEART; CORONARY TEAR; GYNECOLOGICAL PROBLEMS; This spontaneous report received from a Company representative concerned a 34 year old female of unknown race and ethnic origin. The patient''s height, and weight were not reported. The patient had no pre-existing conditions. The patient never had coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose was not reported, 1 total, administered on 12-APR-2021 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. The patient did not notice complications until three months later on 09-JUL-2021 the pain started with what felt like heartburn or indigestion, but three days later on 12-JUL-2021 pain intensified to the point that she was breathing into a paper bag for relief and body aches kept her up at night. After three days on 12-JUL-2021, the patient experienced apparent heart attack. By the time patient went to an emergency room, where the amount of troponin in her blood was 7.3 nanograms per milliliter (normal range between 0 to 0.04.), which indicates heart injury. They asked her to get done cardiac catheterization. They sent her by ambulance to hospital for treatment. Catheterization was done and they did not find any blockages and it was normal. The patient also experienced inflamed heart (myopericarditis and inflamed heart) and a coronary tear that will take six to eight months to heal. She met the next day with an infectious diseases team, which recommended additional testing before noting on her admissions paperwork. In addition to continuing to heal, she said she has also developed gynecological problems and her doctors have mentioned the potential for a hysterectomy. On an unspecified date patient was hospitalized. Number of days hospitalized was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myopericarditis and inflamed heart and coronary tear and the outcome of apparent heart attack, gynecological problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953564.; Sender''s Comments: V0: 20210953105 -COVID-19 VACCINE AD26.COV2.S-Apparant Heart attack, Myopericarditis and inflamed heart ,Coronary tear. 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).


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