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From the 11/19/2021 release of VAERS data:

Found 5,451 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: 1797226 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2; Test Result: Negative ; Result Unstructured Data: All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.. 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 relevant concomitant medications were reported. No treatment information was provided. They calculated incidence rates and 95% confidence intervals (CIs) of myocarditis using vaccine administration as the denominator and compared it with the incidence of myocarditis in unexposed individuals between 14-Dec-202 and 20-Jul-2020; and with vaccinated individuals during a 10 day period 1 year prior to vaccination. There were 15 cases of confirmed myocarditis in the vaccinated group (2 after the first dose and 13 after the second). Of the patients with myocarditis post vaccination, no one had prior cardiac disease. Fourteen (93%) reported chest pain between 1 to 5 days after vaccination. Symptoms resolved with conservative management in all cases; no patients required intensive care unit admission or readmission after discharge. Author concluded that In this population-based cohort study of 2,392,924 individuals who received at least 1 dose ofCOVID-19mRNAvaccines, acute myocarditis was rare, at an incidence of 5.8 cases per 1 million individuals after the second dose (1 case per 172,414 fully vaccinated individuals). The signal of increased myocarditis in young men warrants further investigation. This vaccinated cohort is unique in its racial and ethnic diversity and in receiving care at community hospitals with treatment reflective of real-world practice. Limitations of this study include the observational design; short follow-up time; absence of myocardial biopsy for definitive diagnosis; lack of uniform testing of all cases; possible more extensive workup of chest pain in vaccinated individuals during the immediate post-vaccination period; and possible under-diagnosis of subclinical cases. No relationship between COVID-19 mRNA vaccination and post-vaccination myocarditis can been established given the observational nature of this study. This case was linked to MOD-2021-350207, MOD-2021-353153, MOD-2021-353154, MOD-2021-353156, MOD-2021-353157, MOD-2021-353158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 has Email with a regulatory authority and does not contain any new information.; Sender''s Comments: This case concerns an adult male patient with no relevant medical history, who experienced the expected event of myocarditis, which required hospitalization. The event occurred on an unknown date after the dose of Moderna COVID-19 Vaccine. Symptoms resolved with conservative management and did not require intensive care unit admission or readmission after discharge. Myocardial biopsy for definitive diagnosis was not performed. The rechallenge was not applicable as no information regarding dose number was provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1797227 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2; Test Result: Negative ; Result Unstructured Data: All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) had resolved. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.. 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 relevant concomitant medications were reported. No treatment information was provided. They calculated incidence rates and 95% confidence intervals (CIs) of myocarditis using vaccine administration as the denominator and compared it with the incidence of myocarditis in unexposed individuals between 14-Dec-202 and 20-Jul-2020; and with vaccinated individuals during a 10 day period 1 year prior to vaccination. There were 15 cases of confirmed myocarditis in the vaccinated group (2 after the first dose and 13 after the second). Of the patients with myocarditis post vaccination, no one had prior cardiac disease. Fourteen (93%) reported chest pain between 1 to 5 days after vaccination. Symptoms resolved with conservative management in all cases; no patients required intensive care unit admission or readmission after discharge. Author concluded that In this population-based cohort study of 2,392,924 individuals who received at least 1 dose ofCOVID-19mRNAvaccines, acute myocarditis was rare, at an incidence of 5.8 cases per 1 million individuals after the second dose (1 case per 172,414 fully vaccinated individuals). The signal of increased myocarditis in young men warrants further investigation. This vaccinated cohort is unique in its racial and ethnic diversity and in receiving care at community hospitals with treatment reflective of real-world practice. Limitations of this study include the observational design; short follow-up time; absence of myocardial biopsy for definitive diagnosis; lack of uniform testing of all cases; possible more extensive workup of chest pain in vaccinated individuals during the immediate post-vaccination period; and possible under-diagnosis of subclinical cases. No relationship between COVID-19 mRNA vaccination and post-vaccination myocarditis can been established given the observational nature of this study. This case was linked to MOD-2021-350207, MOD-2021-353153, MOD-2021-353154, MOD-2021-353155, MOD-2021-353157, MOD-2021-353158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 has Email and does not contain any new information.; Sender''s Comments: This is a literature case concerning a young male adult patient with no previous relevant medical history, who experienced the expected serious event/AESI of Myocarditis after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the event occurred during the week following the dose of Spikevax, dose number unknown. Electrocardiogram and echocardiogram were performed and Troponin I was measured, with unknown results. The rechallenge is not applicable, since dose number is unknown. The benefit-risk relationship of Spikevax vaccine is not affected by this report.


VAERS ID: 1797228 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2; Test Result: Negative ; Result Unstructured Data: All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) had resolved. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.. 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 relevant concomitant medications were reported. No treatment information was provided. They calculated incidence rates and 95% confidence intervals (CIs) of myocarditis using vaccine administration as the denominator and compared it with the incidence of myocarditis in unexposed individuals between 14-Dec-202 and 20-Jul-2020; and with vaccinated individuals during a 10 day period 1 year prior to vaccination. There were 15 cases of confirmed myocarditis in the vaccinated group (2 after the first dose and 13 after the second). Of the patients with myocarditis post vaccination, no one had prior cardiac disease. Fourteen (93%) reported chest pain between 1 to 5 days after vaccination. Symptoms resolved with conservative management in all cases; no patients required intensive care unit admission or readmission after discharge. Author concluded that In this population-based cohort study of 2,392,924 individuals who received at least 1 dose ofCOVID-19mRNAvaccines, acute myocarditis was rare, at an incidence of 5.8 cases per 1 million individuals after the second dose (1 case per 172,414 fully vaccinated individuals). The signal of increased myocarditis in young men warrants further investigation. This vaccinated cohort is unique in its racial and ethnic diversity and in receiving care at community hospitals with treatment reflective of real-world practice. Limitations of this study include the observational design; short follow-up time; absence of myocardial biopsy for definitive diagnosis; lack of uniform testing of all cases; possible more extensive workup of chest pain in vaccinated individuals during the immediate post-vaccination period; and possible under-diagnosis of subclinical cases. No relationship between COVID-19 mRNA vaccination and post-vaccination myocarditis can been established given the observational nature of this study. This case was linked to MOD-2021-350207, MOD-2021-353153, MOD-2021-353154, MOD-2021-353155, MOD-2021-353156, MOD-2021-353158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 has Email with report received from Research team and does not contain any new information.; Sender''s Comments: This case concerns an adult male patient with no relevant medical history, who experienced the expected event of myocarditis, which required hospitalization. The event occurred on an unknown date after the dose of Moderna COVID-19 Vaccine. Symptoms resolved with conservative management and did not require intensive care unit admission or readmission after discharge. Myocardial biopsy for definitive diagnosis was not performed. The rechallenge was not applicable as no information regarding dose number was provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1797229 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2; Test Result: Negative ; Result Unstructured Data: All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) had resolved. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.. 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 relevant concomitant medications were reported. No treatment information was provided. They calculated incidence rates and 95% confidence intervals (CIs) of myocarditis using vaccine administration as the denominator and compared it with the incidence of myocarditis in unexposed individuals between 14-Dec-202 and 20-Jul-2020; and with vaccinated individuals during a 10 day period 1 year prior to vaccination. There were 15 cases of confirmed myocarditis in the vaccinated group (2 after the first dose and 13 after the second). Of the patients with myocarditis post vaccination, no one had prior cardiac disease. Fourteen (93%) reported chest pain between 1 to 5 days after vaccination. Symptoms resolved with conservative management in all cases; no patients required intensive care unit admission or readmission after discharge. Author concluded that In this population-based cohort study of 2,392,924 individuals who received at least 1 dose ofCOVID-19mRNAvaccines, acute myocarditis was rare, at an incidence of 5.8 cases per 1 million individuals after the second dose (1 case per 172,414 fully vaccinated individuals). The signal of increased myocarditis in young men warrants further investigation. This vaccinated cohort is unique in its racial and ethnic diversity and in receiving care at community hospitals with treatment reflective of real-world practice. Limitations of this study include the observational design; short follow-up time; absence of myocardial biopsy for definitive diagnosis; lack of uniform testing of all cases; possible more extensive workup of chest pain in vaccinated individuals during the immediate post-vaccination period; and possible under-diagnosis of subclinical cases. No relationship between COVID-19 mRNA vaccination and post-vaccination myocarditis can been established given the observational nature of this study. This case was linked to MOD-2021-350207, MOD-2021-353153, MOD-2021-353154, MOD-2021-353155, MOD-2021-353156, MOD-2021-353157 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 has Email with agency received from team and does not contain any new information.; Sender''s Comments: This literature-study case concerns an adult male patient of unknown age, with no relevant medical history, who experienced the expected serious AESI event of myocarditis. The event occurred at an unknown date after a dose of Spikevax. The rechallenge was unknown since no information about other doses was available. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1800231 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       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: USJNJFOC20211033613

Write-up: MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, as per reporter "Your shot gave my wife myocarditis" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211033613-covid-19 vaccine ad26.cov2.s-myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1800255 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Myocarditis; Pericarditis; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) outcome was unknown. Possible The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) to be possibly related. No relevant concomitant medications were reported. Two patients received a second vaccination after onset of myocarditis; neither had worsening of symptoms. All patients were discharged after a median of 2 days (IQR, 2-3 days). There were no readmissions or deaths. At last available follow-up (median, 23.5 days [IQR, 4.8-41.3 days] after symptom onset), 13 patients (65%; 95% CI, 43%- 82%) had symptom resolution and 7 (35%; 95% CI, 18%-57%) were improving. Pericarditis developed after the first immunization in 15 cases (40.5%; 95% CI, 26%-57%) and after the second immunization in 22 cases (59.5%; 95% CI, 44%-74%) (mRNA-1273 vaccine, 12 cases (32%). No treatment information was provided. Very limited information provided since in the report information of the case is only given as percentage without individual patient data. Medical query raised to author Company Comment: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the expected serious adverse events of special interest of myocarditis and pericarditis. The events occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case, so relevant data is requested. Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 included an Email and does not contain any new information.; Sender''s Comments: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the expected serious adverse events of special interest of myocarditis and pericarditis. The events occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case, so relevant data is requested.


VAERS ID: 1800280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2; Test Result: Negative ; Result Unstructured Data: All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Acute myocarditis following COVID-19 mRNA vaccination in adults aged 18 years or older. JAMA Intern Med. 2021 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 MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) had resolved. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) All were hospitalized and tested negative for SARS-CoV-2 by polymerase chain reaction on admission.. 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 relevant concomitant medications were reported. No treatment information was provided. They calculated incidence rates and 95% confidence intervals (CIs) of myocarditis using vaccine administration as the denominator and compared it with the incidence of myocarditis in unexposed individuals between 14-Dec-202 and 20-Jul-2020; and with vaccinated individuals during a 10 day period 1 year prior to vaccination. There were 15 cases of confirmed myocarditis in the vaccinated group (2 after the first dose and 13 after the second). Of the patients with myocarditis post vaccination, no one had prior cardiac disease. Fourteen (93%) reported chest pain between 1 to 5 days after vaccination. Symptoms resolved with conservative management in all cases; no patients required intensive care unit admission or readmission after discharge. Author concluded that In this population-based cohort study of 2,392,924 individuals who received at least 1 dose ofCOVID-19mRNAvaccines, acute myocarditis was rare, at an incidence of 5.8 cases per 1 million individuals after the second dose (1 case per 172,414 fully vaccinated individuals). The signal of increased myocarditis in young men warrants further investigation. This vaccinated cohort is unique in its racial and ethnic diversity and in receiving care at community hospitals with treatment reflective of real-world practice. Limitations of this study include the observational design; short follow-up time; absence of myocardial biopsy for definitive diagnosis; lack of uniform testing of all cases; possible more extensive workup of chest pain in vaccinated individuals during the immediate post-vaccination period; and possible under-diagnosis of subclinical cases. No relationship between COVID-19 mRNA vaccination and post-vaccination myocarditis can been established given the observational nature of this study. This case was linked to MOD-2021-353153, MOD-2021-353154, MOD-2021-353155, MOD-2021-353156, MOD-2021-353157, MOD-2021-353158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 has Email with FTA received from SARA team and does not contain any new information.; Sender''s Comments: This is a literature case concerning a young male adult patient with no previous relevant medical history, who experienced the expected serious event/AESI of Myocarditis after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the event occurred during the week following the dose of Spikevax, dose number unknown. Electrocardiogram and echocardiogram were performed and Troponin I was measured. The rechallenge is not applicable, since dose number is unknown. The benefit-risk relationship of Spikevax vaccine is not affected by this report.


VAERS ID: 1807539 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial necrosis marker, Myocarditis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: cardiac enzymes; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC202101334341

Write-up: myocarditis-heart muscle inflammation; syncopal episode; This is a spontaneous report from a contactable nurse. A male patient in his 40''s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number was not reported), via an unspecified route of administration on 20Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. HCP reported that the patient received the Pfizer Covid-19 vaccine on 20Aug2021, had a syncopal episode on 21Aug2021, and on 23Aug2021 his cardiac enzymes were elevated and was diagnosed with myocarditis-heart muscle inflammation. HCP is asking if there were any incidences with stroke after a delay of time after the administration of the Pfizer Covid-19 vaccine? The outcome of the events was unknown. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1810178 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211035322

Write-up: PERICARDITIS; MYOCARDITIS; This spontaneous report received from a patient via a company representative 161 patients of unspecified age, sex, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch numbers: unknown, Expiry: unknown) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patients experienced pericarditis, and myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pericarditis and myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- 20211035322- covid-19 vaccine ad26.cov2.s ?Myocarditis, Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1810626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101377481

Write-up: heart inflammation/myocarditis; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. The consumer reported similar events for three patients. This is the second report. A 32-year-old female patient received bnt162b2 (COMIRNATY Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech Covid-19 vaccine and was in observation at the hospital for 8 hours, then admitted for 3 days, again with heart inflammation, he specifically said myocarditis. The outcome of the events was unknown. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101375428 same reporter and drug, different patient and similar event;US-PFIZER INC-202101377482 same reporter and drug, different patient and similar event


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