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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 7 out of 375

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VAERS ID: 1466130 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, 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 Name: echocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: electrocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: Troponin level; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC2021812724

Write-up: Myocarditis; Same event reported for seven patients, this is the fifth of 7 reports. Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger RNA (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Results a total of 23 male patients median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. More than 2.8 million doses of mRNA COVID-19 vaccine administered in this period. While the observed number of myocarditis cases was small, the number was higher than expected after a second vaccine dose. Conclusions and relevance: In this case series, myocarditis occurred in previously healthy patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunization on an unspecified date. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021812011 same reporter/drug/event, different patient


VAERS ID: 1481751 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-23
Onset:2021-05-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 1 LA / OT

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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VITAMIN D [VITAMIN D NOS]; FISH OIL; SIMVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: acute idiopathic myocarditis; 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 MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination. Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. A cardiologist informed to the patient that people experienced acute myocarditis. EKG: abnormal, catheter angiogram on 24-May-2021. MRI on 25-May-2021. 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 was linked to MOD-2021-209351 (Patient Link).; 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: 1482837 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
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 INC2021604586

Write-up: 18 teens in the State, had suffered "heart inflammation"; This case has been considered invalid ICH- Reporter with no first-hand knowledge This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer reported for 18 adolescents approx 12-15 years old, unspecified gender patients that : Suspect Product(s): Name: Pfizer Covid Vaccine (BNT162B2) Verbatim and event description: Please be aware I heard on yesterdays 11:00 o clock pm News Program with PRIVACY and PRIVACY a statement concerning receipt of Pfizer BioNtech COVID-19 vaccine. Among adolescents 12-15 years old who have received Pfizer-BioNtech COVID - 19 vaccine (not sure 1 or 2 doses), 18 teens in the State had suffered "heart inflammation" I have no further information, there was no other background information provided, and I have no first hand knowledge of any of the teens who suffered this adverse event. No follow-up attempts are possible. Information about batch number cannot be obtained. Follow-up (30May2021): This case remains invalid since since the reporter cannot be identified for direct/private contact (internet source) This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer of unspecified age or gender reported that: Suspect Product(s): Name: Pfizer Covid Vaccine (BNT162B2) Verbatim and event description: Could also be caused by an experimental gene therapy "vaccine" No follow-up attempts are possible. Information about batch number cannot be obtained.


VAERS ID: 1482888 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Indiana  
Vaccinated:2021-06-08
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest pain, Myocarditis, Pain
SMQs:, Retroperitoneal fibrosis (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021739594

Write-up: I just worried about if I have like that the a Myocarditis; I have like the pain on the left side of my chest pain and all the way penetrates to the back; I got the sore pain after like the 2 days gone; I have like the pain on the left side of my chest pain and all the way penetrates to the back; I have like the pain on the left side of my chest pain and all the way penetrates to the back; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiry date: unknown) dose 1 via an unspecified route of administration on 08Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, "I just had the first shot of Pfizer on 08Jun2021 and 3 or 4 days after and I had chest pain on the left side and all the way penetrates to the back. So it''s like a pressure pain and but up to now I still had the pain but not as much like 2 or 3 days before. I just worried about Myocarditis. I just want to make sure, that my heart is ok on an unspecified date in Jun2021." The outcome of events i have like the pain on the left side of my chest pain and all the way penetrates to the back is not recovered and for the other events it was unknown. Information about lot/Batch number has been requested.


VAERS ID: 1483169 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Military       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, 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 Name: echocardiogram findings; Result Unstructured Data: Test Result:Unknown Results; Test Name: electrocardiogram findings; Result Unstructured Data: Test Result:Unknown Results; Test Name: Troponin level; Result Unstructured Data: Test Result:Elevated
CDC Split Type: USPFIZER INC2021812722

Write-up: Myocarditis; This is a literature report from the Cardiology, 2021, DOI: 10.1001/jamacardio.2021.2833 entitled Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the Military. The author reported the same event for seven patients, this is the third of 7 reports. Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Objective: To describe myocarditis presenting after COVID-19 vaccination within the Military Health System. This retrospective case series studied patients within the Military Health System who experienced myocarditis after COVID-19 vaccination between Jan and Apr2021. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger RNA (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Results a total of 23 male patients (22 currently serving in the military and 1 retiree; median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All military members were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. The military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. While the observed number of myocarditis cases was small, the number was higher than expected among male military members after a second vaccine dose. Conclusions and relevance: In this case series, myocarditis occurred in previously healthy military patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunization on an unspecified date. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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 appropriated, Linked Report(s) : US-PFIZER INC-2021812011 same reporter/drug/event, different patient


VAERS ID: 1483170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, 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 Name: echocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: electrocardiogram findings; Result Unstructured Data: Test Result: unknown results; Test Name: Troponin level; Result Unstructured Data: Test Result: elevated.
CDC Split Type: USPFIZER INC2021812725

Write-up: Myocarditis; This is a literature report from the Regulatory Authority, 2021, DOI: 10.1001/jamacardio.2021.2833 entitled Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. The author reported the same event for seven patients, this is the sixth of 7 reports. Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Objective: To describe myocarditis presenting after COVID-19 vaccination within the Military Health System. This retrospective case series studied patients within the Military Health System who experienced myocarditis after COVID-19 vaccination between Jan and Apr2021. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Results a total of 23 male patients (22 currently serving in the military and 1 retiree; median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All military members were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. The military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. While the observed number of myocarditis cases was small, the number was higher than expected among male military members after a second vaccine dose. Conclusions and relevance: In this case series, myocarditis occurred in previously healthy military patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunization on an unspecified date. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021812011 same reporter/drug/event, different patient


VAERS ID: 1483171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: Electrocardiogram findings; Result Unstructured Data: Test Result:unknown results; Test Name: Troponin level; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC2021812726

Write-up: Myocarditis; This is a literature report from Agency. The author reported the same event for seven patients, this is the seventh of 7 reports. Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination. Objective: To describe myocarditis presenting after COVID-19 vaccination within the Health System. This retrospective case series studied patients within the Health System who experienced myocarditis after COVID-19 vaccination between Jan and Apr2021. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included. Exposure: Receipt of a messenger RNA (mRNA) COVID-19 vaccine between 01Jan and 30Apr2021. Main outcomes and measures: Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes. Results a total of 23 male patients (22 currently employed and 1 retired; median (range) age, 25 (20-51) years presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All patients were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. The agency administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. While the observed number of myocarditis cases was small, the number was higher than expected among male patients after a second vaccine dose. Conclusions and relevance: In this case series, myocarditis occurred in previously healthy patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunization on an unspecified date. The patient experienced myocarditis in 2021. The patient underwent lab tests and procedures which included echocardiogram findings: unknown results, electrocardiogram findings: unknown results, troponin level: elevated. The patient received brief supportive care and it was unknown if the patient was resolved or resolving at the time of the report. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship. More immunological and biomolecular evidences would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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-2021812011 same reporter/drug/event, different patient


VAERS ID: 1483343 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
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 INC2021823457

Write-up: myocarditis; This is a spontaneous report from a non-contactable consumer (patient) reported for another patient (1st case of two children reports). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He states he would not have taken it. He indicates his brother is a doctor and has conveyed to him it is experimental and per VAERs this is a reported adverse event. Asks how it is being given to kids and he knows two children that have experienced myocarditis. He states is sitting there like a vegetable. States he eats healthy, a vegan and runs. The patient experienced myocarditis on an unspecified date. The outcome of the event was unknown. The response to consumer question was provided as Approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of for up to 24 months, for assessments of safety and efficacy against COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on 11Dec2020. On 7May2021, Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the FDA for approval of the vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency. A submission for the 12 to 15 years group will occur once the required data six months after the second vaccine dose are available. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021823458 as same reporter/drug/AE, different patient


VAERS ID: 1483344 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
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 INC2021823458

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported reporter knows two children who experienced myocarditis. On an unknown date, patient experienced myocarditis. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021823457 as same reporter/drug/AE, different patient


VAERS ID: 1483429 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-18
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: Chantix
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021830721

Write-up: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; varenicline tartrate (CHANTIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient''s medical history included cardiac disorder. The patient''s concomitant medications were not reported. On an unknown date, the patient experienced myocarditis. The patient has a heart condition and need to quit. It''s something that''s going on around the heart. Patient stated that the heart is fine and everything''s fine, have scar tissue and they were calling it myocarditis. The action taken in response to the event for varenicline tartrate was unknown. The outcome of the event was unknown. Follow-up attempts are completed, information about lot/batch number cannot be obtained.


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=7&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)

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