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From the 11/26/2021 release of VAERS data:

Found 5,645 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: 1790109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / 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? 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: 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 in members of the military. 2021:e212833 No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion 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. Company Comment: This is a literature report of myocarditis in an adult male. 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-2021-284001, 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-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-245527, 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 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: This is a literature report of myocarditis in an adult male. 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: 1790488 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Rare cases of young male adults with symptoms of heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) 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 CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided. Company Comment: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1790889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Rhode Island  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-16
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101288088

Write-up: Myocarditis; This is a spontaneous report from a contactable nurse. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.


VAERS ID: 1790932 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
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 INC202101290842

Write-up: Have myocarditis from Pfizer vaccine; This is a spontaneous report from a contactable consumer. A patient (friend''s children of reporter) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOW, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications was not reported. The patient experienced have myocarditis from pfizer vaccine on an unspecified date with outcome of unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.


VAERS ID: 1791257 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Dizziness, Myocarditis, Nausea, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? 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: myocarditis; Test Result: Negative ; Comments: tested for myocarditis which came back negative
CDC Split Type: USPFIZER INC202101334825

Write-up: seizure; cardiac arrest; nauseous; dizzy; This is a spontaneous report from a contactable consumer (parent) reported for patient (son). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. He has had no prior health issues. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in May2021 at age of 16-years-old for COVID-19 immunization. On 19Jul2021 upon arriving to a friend''s house, the patient suffered a seizure than cardiac arrest. He was resuscitated 3x prior to arriving at the hospital, thankfully getting his pulse back. If he was not where he was reporter would be writing you a very different email as thankfully the house he was at was able to administer CPR. He was airlifted to a hospital where testing began to try to find out what happen. It was ruled his event was cardiac related, not neurological. Prior to the event he was nauseous, and dizzy. He was tested for myocarditis which came back negative. A defibrillator was now in his chest, and her son will never play sports again. For a 14-year-old (as reported), this was a huge hit mentally. She read so much about the effect of the vaccine. The nausea, the dizziness, the cardiac arrest. All signs point to that a child wouls have had chest pains, and that these symptoms occur a certain amount of time ater vaccination. The fact that he was working out after the vaccine too, and an athelet by nature, just make her even more curious. With her son, it happened about 5 weeks post vaccination and no myocarditis that thay have seen to date. The signs and symptoms are so spot on for what happened to him. He could have died, in fact on paer, he did and was resuscitated. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.


VAERS ID: 1791276 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
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 INC202101342025

Write-up: caller has a friend who developed myocarditis after the vaccination; This is a spontaneous report received from a contactable Consumer or other non-health professional (patient''s friend) via Pfizer. A male patient of an unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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 medical history and concomitant medications were not reported. It was reported that caller has a friend (patient), knows the patient personally. On an Unspecified date, patient developed myocarditis after the vaccination with Pfizer covid vaccine, who was a golfer and cannot play golf. As per understand by patient friend myocarditis shortens life and have major structural damage done to the heart. Investigation Assessment was not provided. Outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1794528 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-18
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: 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. 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 This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-245527, 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 -MODERNATX, INC.-MOD-2021-245527 to -MODERNATX, INC.- MOD-2021-284005 On 05-Jul-2021: Follow up received by safety 07-Jul-2021included initial additional document with no new information was received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included 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: 1797224 (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-2021-353154, 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 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: 1797225 (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. LITERATURE REFERENCE: Acute myocarditis following COVID-19 mRNA vaccination in adults aged 18 years or older. 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-2021-353155, 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 received from team and does not contain any new information. Sender''s Comments: This case refers to a male patient of unknown age with no specified medical history who experienced the expected event of Myocarditis on an unknown date after receiving a dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as unknown due to inadequate information. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


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.


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