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From the 11/12/2021 release of VAERS data:

Found 5,176 cases where Age is Unknown and Vaccine targets COVID-19 (COVID19) and Symptom is Acute endocarditis or Atypical mycobacterium pericarditis or Autoimmune myocarditis or Bacterial pericarditis or Carditis or Endocarditis or Endocarditis bacterial or Endocarditis enterococcal or Endocarditis noninfective or Endocarditis staphylococcal or Endocarditis viral or Eosinophilic myocarditis or Fungal endocarditis or Giant cell myocarditis or Immune-mediated myocarditis or Lupus endocarditis or Lyme carditis or Meningococcal carditis or Myocarditis or Myocarditis bacterial or Myocarditis infectious or Myocarditis septic or Myopericarditis or Pericarditis or Pericarditis constrictive or Pericarditis infective or Pericarditis lupus or Pericarditis meningococcal or Pericarditis rheumatic or Pericarditis tuberculous or Pleuropericarditis or Purulent pericarditis or Streptococcal endocarditis or Subacute endocarditis or Viral myocarditis or Viral pericarditis

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1711627 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101146047

Write-up: Her friend has had both Covid 19 vaccines and has developed pericarditis; This is a spontaneous report from a contactable consumer (patient''s friend) via the Pfizer-sponsored Program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 1, SINGLE and received the second dose of 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 immunization. The patient''s medical history and concomitant medications were not reported. The consumer reported that her friend has had both COVID-19 vaccines and has developed pericarditis on an unspecified date. Her friend will have some tests next week. The outcome of the event pericarditis was unknown. The batch/lot numbers for BNT162B2 were not provided and will be requested during follow-up.


VAERS ID: 1711904 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-17
Onset:2021-09-06
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate increased, Pericarditis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: HR; Result Unstructured Data: Test Result: over 100 resting.
CDC Split Type: USPFIZER INC202101176877

Write-up: acute pericarditis; My HR was over 100 resting, I am an athlete and normally my HR is 60 at rest; chest pain; SOB; This is a spontaneous report from a non-contactable consumer or other non hcp. A 54-years-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 17Apr2021 as 2nddose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute pericarditis on an unspecified date, chest pain on 06Sep2021, sob on 06Sep2021, my HR was over 100 resting, I am an athlete and normally my HR is 60 at rest on an unspecified date. Patient stated I was in the hospital with pericarditis, asked me if I had received the Pfizer BT Covid vaccine. Patient states he may have gotten the pericarditis, maybe it was the vaccine. The patient underwent lab tests and procedures which included heart rate over 100 resting on. Therapeutic measures were taken as a result of acute pericarditis, chest pain, sob, my hr was over 100 resting, am an athlete and normally my hr is 60 at rest. Outcome of the patient experienced acute pericarditis, chest pain, sob was unknown, my hr was over 100 resting, am an athlete and normally my hr is 60 at rest on was recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1712059 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cervical radiculopathy, Chest pain, Pain in extremity, Pericarditis, Rash
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101197630

Write-up: acute pericarditis; pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy; pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy; bubble in her chest and was in pain so went to the ER; Covid arm/rash; This is a spontaneous report from a non-contactable consumer (patient). A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced acute pericarditis, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, bubble in her chest and was in pain so went to the er, covid arm/rash. The patient received the first dose on 06Aug2021 and was wondering if she should receive the second dose due to side effects. The patient was required to receive the vaccine for her job or she will be terminated. A few days after the first dose she developed Covid arm/rash, then she felt a bubble in her chest and was in pain so went to the emergency room (ER). She was diagnosed with acute pericarditis and was told it would go away in a couple of days and it did. She then developed pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy. It just started going away a week and a half ago but was still having tingling in the right had from time to time. She actually was waiting to receive the second dose but wanted to call and see if she should. Her doctor did give her a note that she shouldn''t receive the vaccine until further notice but she had to get the vaccine or she will be terminated. Her doctor recommended her to see a neurologist. They prescribed gabapentin, toradol and another medication but it didn''t help her. The events resulted in visit to the emergency room. The patient was hospitalized due the events acute pericarditis, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, bubble in her chest and was in pain so went to the er. The outcome of acute pericarditis was recovered and outcome of the event pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy (cervical radiculopathy) was not recovered while outcome of rest of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1721536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Troponin; Result Unstructured Data: elevated
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain. Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram. 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. Further information has been requested to the author. Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-245527, MOD-2021-284014, MOD-2021-284015, MOD-2021-284013, MOD-2021-284013 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for a regulatory authority so Incorrect E2B Company Number was removed. Hence new reports generated with correct E2B Number. 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. Further information has been requested to the author.


VAERS ID: 1721537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: significantly elevated
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness 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 and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-245527 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284015 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1721775 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-02-18
Onset:2021-02-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: did have mycarditis og the heart; 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 (did have mycarditis og the heart) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYOCARDITIS (did have mycarditis og the heart) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (did have mycarditis og the heart) outcome was unknown. No concomitant medication details was provided. No treatment medication details was provided. Action taken was not applicable. This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report


VAERS ID: 1721907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Feeling abnormal, Myocarditis
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: Test Name: EKG; Result Unstructured Data: Test Result:Abnormal; Comments: received an EKG that was abnormal
CDC Split Type: USPFIZER INC202101169446

Write-up: Caller thinks it is Myocarditis.; Chest pain; Shortness of breath; felt like her lungs couldn''t fill up; This is a spontaneous report from a contactable Nurse (patient) A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. Immediately after receiving the vaccine patient began having chest pain, shortness of breath and felt like her lungs couldn''t fill up. She has not gotten better in two weeks. She thought it sounds like Myocarditis (as reported). The patient went to urgent care center, they told her not to go to the Emergency Room for risk of getting Covid.Stated they did an office EKG and said they would send it to cardiologist. (as reported). The patient underwent lab tests and procedures which included electrocardiogram abnormal on an unspecified date. At the time of the reporting the patient had not yet recovered from chest pain and Shortness of breath, outcome of other reported events was unknown.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event Myocarditis cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate


VAERS ID: 1725498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101177862

Write-up: pericarditis; This is a spontaneous report from a non-contactable consumer reported for another male patient (reporter''s boss''s husband). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed pericarditis months after his second dose. The 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: 1725551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac disorder, Endocarditis
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy smoker; Pericardial window (she had a pericardial window placed in her heart)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101213572

Write-up: infectious endocarditis; cardiac symptoms; This is a spontaneous report received from a contactable Pharmacist reported for a female patient. A female patient of late 50''s-early 60''s received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) received via unspecified route of administration on 30Dec2020 as dose 1, single for covid-19 immunization and bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) received via unspecified route of administration on 20Jan2021 as dose 2, single for covid-19 immunization. Patient medical history included heavy smoker and she had a pericardial window placed in her heart. It was reported that patient experienced cardiac symptoms approximately 2 months following the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine. Patient was hospitalized due to events caused and she was admitted to the ICU and placed on a ventilator. Patient had a pericardial window placed in her heart and she received antibiotics at one point during her care and for what they thought could be an infectious Endocarditis, but no organism grew on culture. Treatment received for the events caused. Event took place after use of product. 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: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1730435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2021-01-25
Onset:2021-07-16
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Antinuclear Antibody; Test Result: Positive ; Comments: First test was positive; Test Date: 20210615; Test Name: Antinuclear Antibody; Test Result: Negative ; Comments: repeat test was negative
CDC Split Type: USPFIZER INC202101190833

Write-up: Pericarditis; This is a spontaneous report from a non-contactable physician (patient). A female patient of unknown age received the second dose of bnt162b2 on 25Jan2021 (lot number: unknown) via unknown route of administration in Arm Right at single dose for COVID-19 immunization. Medical history and concomitant medications were reported none. Historical vaccine included the first dose of bnt162b2 on 04Jan2021 around 2Pm -3PM (lot number: unknown) for Covid-19 Immunization. Prior Vaccinations (within 4 weeks) there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE following prior vaccinations were reported as None. Family Medical History Relevant to AE was reported as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported None. Patient Had a problem and doctor told her to report this, did not know if it was related to the vaccine or not, wanted to know if there had been any other reports like this. Patient got pericarditis in mid Jun2021 that lasted until or around Aug2021. She did not know, maybe lasted until the second week in Aug2021. Clarified pericarditis started middle of Jul2021 on 16Jul2021. Patient did not have Pericarditis at the moment. Patient wanted to know whether it was ok to get the booster. Patient had No new medications, nothing changed in her life. Investigations included: Developed a positive Antinuclear Antibody, the autoimmune marker, around that time period after the pericarditis. First test was positive on 15Jun2021, repeat test was negative on 15Jun2021. The adverse event required a visit to Physician Office and Had tests done. The causality assessment between the event Pericarditis and the suspect drug was reported as unknown. The outcome of the event was recovered on 10Aug2021. No follow-up attempts are possible; information about lot batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event Pericarditis due to temporal relationship. However, current information is limited and does not allow a full medical assessment. 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.


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=15&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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