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From the 1/14/2022 release of VAERS data:

Found 8,620 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

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Case Details

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VAERS ID: 1827504 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-29
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 INC202101381331

Write-up: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number was not reported) dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis on an unspecified date. The reporting physician requested information on incidence of myocarditis with Covid-19 vaccine. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event "Myocarditis" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1839203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-03
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? Yes
   Date died: 0000-00-00
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 INC202101482369

Write-up: Died from heart inflammation two months after receiving his Pfizer Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A male patient (Reporter''s uncle) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. He had died from heart inflammation two months after receiving his Pfizer COVID-19 vaccine. It is unknown if autopsy was done. Outcome of the event was fatal. Reporter implied that the two were related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart inflammation


VAERS ID: 1845386 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101439524

Write-up: Myocarditis; Pericarditis; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program with Regulatory Authority Support. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis, pericarditis with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1848141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-06
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: USJNJFOC20211109933

Write-up: MYOCARDITIS; PERICARDITIS; .This spontaneous report received from a consumer via a company representative concerned a 33 year old male of unknown 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 and expiry: Unknown) 1 total, dose, 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, it was reported that the patient developed myocarditis, and pericarditis. However, the doctor told that there was no correlation between the vaccine and these conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. The reporter causality of the event myocarditis, and pericarditis was not related to covid-19 vaccine ad26.cov2.s and company causality was not related to covid-19 vaccine ad26.cov2.s. This report was serious (Other Medically Important Condition) This case, from the same reporter is linked to 20211110332. .; Sender''s Comments: V0- 20211109933- 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: 1850058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac valve disease, Cardiac valve vegetation, Catheterisation cardiac, Culture, Death, Disseminated intravascular coagulation, Myocarditis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Comments: The patient never had any health problems
Allergies:
Diagnostic Lab Data: Test Name: Cardiac catheterisation; Result Unstructured Data: Negative; Test Name: Culture; Result Unstructured Data: Negative for bacteria; Test Name: Cardiac catheterisation; Result Unstructured Data: Found vegetation on pulmonic valve
CDC Split Type: USJNJFOC20211103061

Write-up: SUCCUMBING; VEGETATION ON PULMONIC VALVE; DISSEMINATED INTRAVASCULAR COAGULATION; VALVE COMPLETELY DESTROYED AFTER ONE WEEK; MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female patient. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient never had any health problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was 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, post 10 days of vaccination, patient experienced the chest pain and then patient had the cardiac workup (results were negative). A week later patient experienced the same symptoms and had another cardiac workup which showed the vegetation on pulmonic valve. On an unspecified date, patient had an surgery to replace the valve. Valve was cultured and negative for bacteria. On an unspecified date, just a week later, the valve was completely destroyed. On an unspecified date, patient experienced the myocarditis and the fluid permeated to the lungs. Patient had chest tube insertion, pericardiocentesis (1.8 L) and thoracotomy. On an unspecified date, patient experienced the disseminated intravascular coagulation (DIC). Consumer reported that, patient went through four weeks of torture before succumbing (death). It was unspecified if an autopsy was performed. Date of death was not reported. Laboratory data (dates unspecified) included: Cardiac catheterization (NR: not provided) Negative, Found vegetation on pulmonic valve, and Valve culture (NR: not provided) Negative for bacteria. On an unspecified date, the patient died from succumbing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vegetation on pulmonic valve, valve completely destroyed after one week, myocarditis and disseminated intravascular coagulation was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20211103061- covid-19 vaccine ad26.cov2.s- succumbing,vegetation on pulmonic valve, myocarditis ,disseminated intravascular coagulation, valve completely destroyed after one week -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).; Reported Cause(s) of Death: SUCCUMBING


VAERS ID: 1856592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Cardiac valve disease, Cardiac valve vegetation, Cardiovascular evaluation, Death, Disseminated intravascular coagulation, Myocarditis, Pericardial effusion, Pleural effusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Comments: The patient never had any health problem.
Allergies:
Diagnostic Lab Data: Test Name: Cardiovascular evaluation; Result Unstructured Data: Negative; Test Name: Bacterial culture; Result Unstructured Data: Negative; Comments: valve was cultured and neg for bacteria; Test Name: Cardiovascular evaluation; Result Unstructured Data: vegetation on pulmonic valve
CDC Split Type: USJNJFOC20211110984

Write-up: SUCCUMBING; MYOCARDITIS; VEGETATION ON PULMONIC VALVE; VALVE DESTROYED; FLUID PERMEATED LUNGS; PERICARDIAL CENTESIS; DISSEMINATED INTRAVASCULAR COAGULATION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient never had any health problem. 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, 10 days post vaccination patient experienced chest pain and performed cardiac workup which result came negative, a week later patient had same symptoms and performed cardiac workup which showed vegetation on pulmonic valve. On an unspecified date patient had surgery and valve was cultured with result negative for bacteria. It was reported that valve completely destroyed after one week and developed myocarditis, fluid permeated lungs and performed chest tubes, pericardial centesis (1.8 Liter), and thoracotomy. On an unspecified date, patient had disseminated intravascular coagulation (DIC). The patient went through four weeks of torture before succumbing. On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of succumbing on an unspecified date, had not recovered from vegetation on pulmonic valve, and valve destroyed, and the outcome of myocarditis, disseminated intravascular coagulation, pericardial centesis and fluid permeated lungs was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211104021.; Sender''s Comments: V0: 20211110984-covid-19 vaccine ad26.cov2.s-myocarditis, succumbing, vegetation on pulmonic valve, valve destroyed, fluid permeated lungs, pericardial centesis, disseminated intravascular coagulation. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1856594 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       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: USJNJFOC20211114655

Write-up: PERICARDITIS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin.. 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 administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 total administered 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, the patient stated that experienced pericarditis after got the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211114655- COVID-19 VACCINE AD26.COV2.S- Pericarditis. This event is considered unassessable. The event 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.


VAERS ID: 1863719 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Carditis, Loss of consciousness, Renal disorder, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: passed out; blood clots; heart inflammation; kidney troubles; 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 LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots) and CARDITIS (heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), THROMBOSIS (blood clots) (seriousness criterion medically significant), CARDITIS (heart inflammation) (seriousness criterion medically significant) and RENAL DISORDER (kidney troubles). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots), CARDITIS (heart inflammation) and RENAL DISORDER (kidney troubles) outcome was unknown. No concomitant medication were reported. No treatment medication were reported. No lab data reported. This case was linked to MOD-2021-376600 (Patient Link).; Sender''s Comments: This case concerns patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected serious events of loss of consciousness, thrombosis (AESI) and carditis. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.


VAERS ID: 1864376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2020-08-13
Onset:2020-11-16
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Atrial flutter, Blood culture, Blood potassium, Blood thyroid stimulating hormone, Blood urea, C-reactive protein, Cardiovascular examination, Chest X-ray, Computerised tomogram, Echocardiogram, Fibrin D dimer, HIV test, Heart rate, Monocyte count, Pericardial effusion, Pericarditis, Pleural effusion, Pleural fluid analysis, Procalcitonin, Prothrombin time, Red blood cell count, Red blood cell sedimentation rate, SARS-CoV-2 test, Thyroxine free, Troponin, Viral test, White blood cell count
SMQs:, Systemic lupus erythematosus (narrow), Supraventricular tachyarrhythmias (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NAPROXEN; PROVENTIL [SALBUTAMOL]; FLUTICASONE
Current Illness: Aortic ectasia (THORACIC); Asthma (MILD); Knee arthritis (RIGHT); Migraine headache; Postmenopause; Ptosis of eyelid (interfering with vision); Seasonal allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm enlargement (ENLARGED DESCENDING AORTA); Basal cell carcinoma (NOSE); Basal cell carcinoma (CHEST); Bell''s palsy; Joint pain (MIGRATORY PAINS IN JOINTS OF KNEES, LEGS (SAW RHEMATOLOGIST, NO DIAGNOSIS)); Joint swelling of hand (MIDDLE FINGER OF LEFT HAND JOINT SWELLING, NO KNOWN CAUSE); Knee replacement ((DUE TO OSTEOARTHRITIS)); Leg pain (MIGRATORY PAINS IN JOINTS OF KNEES, LEGS (SAW RHEMATOLOGIST, NO DIAGNOSIS)); Osteoarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20200915; Test Name: PTT; Result Unstructured Data: 33; Test Date: 20201128; Test Name: PTT; Result Unstructured Data: 50; Test Date: 20201201; Test Name: ANA; Result Unstructured Data: Negative; Test Date: 20201127; Test Name: Blood culture; Result Unstructured Data: No growth; Test Date: 20200915; Test Name: Potassium; Result Unstructured Data: 3.4mmol/l; Test Date: 20201128; Test Name: TSH; Result Unstructured Data: 3.16uIU/mL; Test Date: 20200915; Test Name: Blood Urea Nitrogen; Result Unstructured Data: 28; Test Date: 20210114; Test Name: Cardiologist exam; Result Unstructured Data: no pericardial rub; Test Date: 20200915; Test Name: Chest x-ray; Result Unstructured Data: No evidence of PE or pericardial effusion. No pneumothorax. Pulmonary vasculature within normal limits. Cardiac and mediastinal silhouettes within normal limits. Lungs are clear. Osseous structures intact. No acute process.; Test Date: 20201126; Test Name: CT WITH CONTRAST; Result Unstructured Data: No pulmonary embolism present, no lung consolidation, mild to moderate left and right-sided pleural effusion, underlying compressive atelectasis in the lungs, mild to moderate pericardial effusion present.; Test Date: 20201117; Test Name: CTA; Result Unstructured Data: New small bilateral pericardial effusions, left greater than right and moderate pericardial effusion, stable minimal to mild dilatation of the ascending aorta.; Test Date: 20201127; Test Name: C-reactive protein; Result Unstructured Data: 24.4 High; Test Date: 20201204; Test Name: C-reactive protein; Result Unstructured Data: 2.2High; Test Date: 20201118; Test Name: Echocardiogram; Result Unstructured Data: Normal left ventricular ejection fraction, small pericardial effusion was present circumferentially around the entire heart, evidence of cardiac tamponade was absent.; Test Date: 20201127; Test Name: Echocardiogram; Result Unstructured Data: pericardial effusion was better.; Test Date: 20200915; Test Name: D-DIMER; Result Unstructured Data: 1.01; Test Date: 20201115; Test Name: Heart rate; Result Unstructured Data: 84-117; Test Date: 20201116; Test Name: Heart rate; Result Unstructured Data: 114; Test Date: 20201127; Test Name: HIV antigen/antibody; Result Unstructured Data: Nonreactive; Test Date: 20200915; Test Name: Monocytes, Absolute; Result Unstructured Data: 1.10; Test Date: 20201130; Test Name: Pleural fluid; Result Unstructured Data: Negative for bacteria or fungi. LDH 78 IU/L (<220) and protein consistent with transudative fluid.; Test Date: 20201126; Test Name: Procalcitonin; Result Unstructured Data: 0.38High; Test Date: 20200915; Test Name: PT; Result Unstructured Data: 12.9; Test Date: 20201128; Test Name: PT; Result Unstructured Data: 16; Test Date: 20200915; Test Name: RBC count; Result Unstructured Data: 4.79M/uL; Test Date: 20201118; Test Name: ESR; Result Unstructured Data: 34High; Test Date: 20201126; Test Name: ESR; Result Unstructured Data: 101High; Test Date: 20201205; Test Name: ESR; Result Unstructured Data: 49High; Test Date: 20201123; Test Name: SARS-CoV-2 RT-PCR; Result Unstructured Data: Negative; Test Date: 20201128; Test Name: Free T4; Result Unstructured Data: 1.05; Test Date: 20200915; Test Name: Troponin; Result Unstructured Data: <18; Test Date: 20201126; Test Name: Troponin; Result Unstructured Data: <4; Test Date: 20201128; Test Name: Respiratory virus panel; Result Unstructured Data: Negative(Does not rule out SARS-CoV-2); Nasopharyngeal; Test Date: 20200915; Test Name: WBC count; Result Unstructured Data: 10.4; Test Date: 20201126; Test Name: WBC count; Result Unstructured Data: 20.0High
CDC Split Type: USAUS1312020MRNA1273P3010

Write-up: EPISODIC ATRIAL FLUTTER; PLEURAL EFFUSIONS (BILATERAL); PERICARDIAL EFFUSION; PERICARDITIS; This 59-year-old, female was participating in a Study and experienced pericardial effusion, pericarditis, pleural effusions (bilateral), and episodic atrial flutter. The subject''s medical history, as provided by the investigator, included migratory pains in joints of knees and legs, post menopause, knee replacement surgery (due to osteoarthritis), seasonal allergies, mild asthma, right knee arthritis, basal cell carcinoma nose and chest, Bell''s palsy, migraine headaches, enlarged descending aorta, thoracic aorta ectasia, middle finger of left hand joint swelling, and droopy eyelids interfering with vision. Concomitant medications reported included naproxen, salbutamol, and fluticasone. The patient was allocated to receive intramuscular mRNA-1273 or placebo for SARS-CoV-2 vaccination. The subject received the first dose of blinded study drug on 13 Aug 2020. The patient''s last dose of study drug prior to event onset was on 10 Sep 2020. On 15 Sep 2020, the patient experienced acute shortness of breath along with chest discomfort and visited the emergency room. Laboratory results included white blood cell (WBC) 10.4 K/uL (3.8-10.6), red blood cell count 4.79 M/uL (4.15-5.55), absolute monocytes 1.0 K/ul (0.00-0.80), potassium 3.4 mmol/l (3.5-5.0), blood urea nitrogen 28 mg/dl (10-25), quantitative D-dimer 1.01 ug/ml FEU (<0.59), troponin <18 ng/L (<19), prothrombin time (PT) 12.9 sec (12.1-14.5), and partial thromboplastin time (PTT) 33 seconds (22-36). Chest x-ray revealed no pneumothorax, pulmonary vasculature cardiac and mediastinal silhouettes were within normal limits, lungs were clear, osseous structures were intact, no evidence of pulmonary embolism or pericardial effusion with no acute process. The subject was discharged from the emergency room. On 05 Oct 2020, the patient developed sinus congestion. On 13 Oct 2020, the patient received Flublok RIV4 vaccination for influenza prophylaxis. On 15 Nov 2020, the patient experienced chest heaviness and pain and also felt chest pressure when leaning forward. She had a nausea spell and "passed out" after kneeling on the floor. The subject reported that her heart rate was between 84-117 beats per minute. On 16 Nov 2020, the patient visited her primary care physician concerning the symptoms she had been experiencing (later diagnosed as medically significant events of pericardial effusion and pericarditis). Her heart rate was 114 beats per minute. She was referred to a cardiologist for additional work-up. On 17 Nov 2020, computed tomography (CT) angiography scan showed stable minimal to mild dilatation of the ascending aorta and new small bilateral pleural effusions, left greater than right, and moderate pericardial effusion with diffuse pericardial enhancement; correlate for pericarditis. On 18 Nov 2020, echocardiogram showed normal left ventricular ejection fraction of 60-65%, small pericardial effusion circumferentially around the entire heart with no evidence of cardiac tamponade. Etiology was suspected to be reactive (viral or inflammatory). Erythrocyte sedimentation rate (ESR) was 34 mm/hr (0-20). Treatment included high dose acetylsalicylic acid and colchicine. On 23 Nov 2020, SARS-CoV-2 real time reverse transcription polymerase chain reaction testing was negative. On 26 Nov 2020, the patient went the emergency room for chest pain, epigastric pain and rising fatigue. Episodic atrial flutter was noted, which was considered secondary to pericarditis. A CT showed no pulmonary embolism present, no lung consolidation, mild to moderate left and right-sided pleural effusions, underlying compressive atelectasis in the lungs and mild to moderate pericardial effusion present. Laboratory results included ESR 101 mm/hr, procalcitonin 0.38 ng/mL (<0.25), antinuclear antibodies were negative, platelets 492 k/uL (150-450), troponin <4, brain natriuretic peptide 112 pg/mL (<50), and WBC 20.0 K/uL. The subject was admitted to the hospital. On 27 Nov 2020, echocardiogram showed improvement in the pericardial effusion. Relevant laboratory results included C-reactive protein 24.4 mg/dl (<0.5), WBC 14.3 k/uL, hemoglobin (Hgb) 10.8 g/dL (12-15), hematocrit (Hct) 32.9% (36-46), platelets 454, human immunodeficiency virus antigen and antibody testing was nonreactive, urine histoplasma antigen testing was negative, and blood cultures showed no growth. Respiratory virus panel polymerase chain reaction testing on a nasopharyngeal sample, which included adenovirus, respiratory syncytial virus, parainfluenza, coronavirus (excluding COVID-19), and influenza, was negative for all pathogens tested. Treatment with methocarbamol and paracetamol were started for pericarditis. On 28 Nov 2020, free thyroxine was 1.05 ng/dl (0.61-1.44), thyroid stimulating hormone was 3.16 uIU/mL (0.45-5.33), PT was 16 sec, and PTT was 50 sec. On 30 Nov 2020, laboratory results revealed WBC 9.6 k/uL, Hgb 10.7 g/dL, Hct 30.5% and platelets 474 K/uL. A left-side thoracentesis was performed, removing 450 mL of clear yellow fluid. Results of pleural fluid analyses were consistent with transudate and included cultures negative for bacteria and fungi, lactate dehydrogenase of 78 IU/L (<220) and protein of 3.3 g/dL (<8.3). Infectious disease was consulted and did not have a strong suspicion for infection. She was given ketorolac and prednisone for pericarditis. On 01 Dec 2020, the patient was feeling better, sitting upright with no conversational dyspnea, on room air. She still had fatigue, but she was improving, overall. Vital signs included blood pressure 129/74 mmHg, pulse 67 beats per minute, temperature 36.4 degrees Celsius, respiratory rate 18 breaths per minute, and oxygen saturation 96%. The subject was discharged home in stable condition. The subject was treated with diphenhydramine. Treatment for the events continued on discharge included metoprolol tartrate for atrial flutter, colchicine and prednisone for pericarditis. On 02 Dec 2020, she started low dose acetylsalicylic acid for pericarditis. On 04 Dec 2020, during her post-hospitalization follow-up, atrial flutter was not observed. She was not reporting any shortness of breath or pleurodynia. Relevant laboratory results included WBC 14 K/uL, Hgb 11.7 g/dL, Hct 35.5%, platelets 555 K/uL, C-reactive protein 2.2 mg/dl, and ESR 49 mm/hr. Cardiology follow up was scheduled for 16 Dec 2020. On 07 Dec 2020, the patient remained on a prednisone taper for pericarditis. On 13 Jan 2021, the patient had a follow-up visit with cardiology. The patient had not experienced any symptoms related to atrial flutter since hospitalization but remained on metoprolol as a precaution. The cardiologist believed the irritation from the pericarditis caused the atrial flutter and that it had now resolved. There was no pericardial rub on exam, however she had occasional chest and upper abdominal pain that was likely related to the pericardial fluid. Prednisone tapering was continued. She was instructed to follow-up with rheumatology in Jan 2021 and cardiology again in Apr 2021. On 18 Jan 2021, during a follow-up visit, the physician noted the subject remained with serositis (pericarditis and small bilateral pleural effusion). On 22 Feb 2021, patient was weaned off prednisone. Subject was asymptomatic with no shortness of breath or chest pain. No pulmonology follow up appointment was scheduled. Action taken with study drug in response to the events of pericardial effusion, pericarditis, pleural effusion (bilateral), and episodic atrial flutter, was not applicable, as the subject had already received both scheduled doses. The events, pericardial effusion, pericarditis and pleural effusions (bilateral), were considered resolved on 22 Feb 2021. The event of episodic atrial flutter was considered resolved on 01 Dec 2020. The investigator assessed the events, pericardial effusion, pericarditis, and pleural effusions (bilateral) as related to study drug, based on the timing of chest pain after the study dosing and diagnosis with etiology matching an inflammatory response. The event of episodic atrial flutter was assessed as not related to the study drug. The events of pericardial effusion, pericarditis, pleural effusion (bilateral), and episodic atrial flutter were assessed as not related to study procedure. Follow-up information received on 02 Dec 2020 and 04 Dec 2020 included updated causality, seriousness criteria, severity, action taken, onset dates, hospital admission and discharge dates. Follow-up information received on 07 Dec 2020, 08 Dec 2020, 10 Dec 2020 and 14 Dec 2020 included additional events of pleural effusions (bilateral) and episodic atrial flutter, event details and outcomes, updated action taken with study drug, investigator''s rationale for causality assessment, additional lab results, and treatment medications. Follow-up information received on 16 Dec 2020 included no new information. Follow-up information received on 28 Dec 2020 included no new information. Follow-up information received on 30 Dec 2020 included updated laboratory and diagnostic exam data. Follow-up information received on 14 Jan 2021 included updated medical history, cardiologist follow-up information, and end date and outcome for event of episodic atrial flutter. Follow-up information received on 02 Feb 2021 included updated outcomes for the events of pericardial effusion and pericarditis, updated severity for the event of pericarditis, updated treatment medications and updated event details. Follow-up information received on 26 Feb 2021 included no new information. Follow-up information received on 05 Mar 2021 and 09 Mar 2021 included updated event end date, event outcome, event details and additional medical history. Follow-up information received on 06 Apr 2021 included final outcome and event end dated of the events, pericardial effusion and pericarditis. Analysis of Similar Events: On 16-Dec-2020, the safety database was searched for events similar to Pericarditis, Pericardial effusion, and Pleural effusion using the following search criteria: PT: Pericarditis, Pericardial effusion, Pleural effusion; SMQ: Immune-mediated/autoimmune disorders (Broad/Narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (Broad/Narrow), Haemodynamic oedema, effusions, and fluid overload. As of 16-Dec-2020, under IND 019745 for mRNA-1273, the database search retrieved 44 events, including the three events in the current index case. Three of these events were previously submitted in IND Safety Reports: Angioedema (1) MOD-2020-000921, Swelling face (2) MOD-2020-000515, MOD-2020-000656. These three events were similar to one another, but differed from the index case, as all three events involved cosmetic dermal filler injections in the face and lips. The following four events were similar in presentation but could be explained by other more likely etiologies: Pericarditis (3) MOD-2020-000302, MOD-2020-000643, MOD-2020-000811; and Pleural effusion (1) MOD-2020-000355. In MOD-2020-000811, pericarditis occurred 3 weeks after myocardial infarction; in MOD-2020-000302, the subject had a medical history significant for myocardial infarction; and in MOD-2020-000643 the subject had the relevant medical history of antiphospholipid syndrome and rheumatoid arthritis, suggesting autoimmune predisposition; In MOD-2020-000355, the subject developed pleural effusion after having undergone a recent coronary artery bypass graft procedure. The following events were not similar in presentation, however, were reviewed per the database search strategy and were confirmed as more likely related to alternate etiologies: Angioedema (1) MOD-2020-000315: The event was determined to be due to lisinopril and resolved upon discontinuation of the medication. Swelling face (1) MOD-2020-000323: The subject had undergone a recent dental procedure on the side of swelling. Rash vesicular (1) and Rash (1) MOD-2020-000753: The events occurred 1.5 months after the second dose and recovered in a few days, which is unlikely suggestive of relationship with the study vaccination. Hepatic enzyme increased (2) MOD-2020-000753, MOD-2020-001140: The events occurred 1.5 and 3 months, respectively, after receiving the second study drug dose, which is unlikely suggestive of relationship with the study vaccination. Dermatitis bullous (1) MOD-2020-000325: This event occurred in a subject with chronic lymphocytic leukemia, exhibiting symptoms of disease progression. The remainder of the events were not considered similar, as these could be explained by underlying etiologies related to infection or preexisting comorbidities: Acute kidney injury (5); Encephalopathy (1); Oedema peripheral (1); Pancreatitis (1); Multiple organ dysfunction syndrome (1); Pancreatitis acute (1); Pneumonia (16); and Thrombocytopenia (1). Assessment of Relationship: Based on review of available data, the Sponsor cannot rule out a possible cause and effect relationship between administration of mRNA-1273 or placebo and the occurrence of pericardial effusion, pericarditis, and pleural effusion, considering acute shortness of breath, along with chest discomfort, five days following the second dose of study drug could possibly have represented the earliest manifestations of the reported events; however, no effusion was noted on CT at that time. Thus, the actual date of onset of the events remains unclear, as it is unknown whether the episode of shortness of breath with chest discomfort, five days after the second dose of IP is representing the first signs of onset of the events versus a later date. Concomitant Flubloc RIV4 vaccination and sinus congestion indicating possible viral infection, which both occurred a month before diagnosis of the events, and history of dilatation of the ascending aorta remain confounders. The event of episodic atrial flutter was considered unrelated to IP in agreement with the Investigator. After review of the clinical details and investigator comments pertaining to this adverse event, and based upon experience to date, the Sponsor does not believe that changes to the conduct of this clinical trial are warranted. The Company will continue to monitor these, and other serious adverse events reported in association with the IMP and will communicate any relevant changes to the protocol, Informed Consent Form, Investigator''s Brochure, and/or Core Safety Information.; Reporter''s Comments: This case concerns a 59-year-old, White, female subject with a medical history of mild asthma, who experienced the unlisted events of pericardial effusion, pericarditis, pleural effusion, and episodic atrial flutter. The events of pericardial effusion, pericarditis, and pleural effusion were diagnosed two months and one week after the second dose of IP, and the event of episodic atrial flutter was diagnosed 2 months 17 days after the second dose of IP. The events of pericardial effusion, pericarditis, and pleural effusion were considered related to IP in agreement with the Investigator. Acute shortness of breath, along with chest discomfort, five days following the second dose of study drug might have been the earliest manifestations of the reported events; however, no effusion was noted on CT at that time. Thus, the actual date of onset of the events remains unclear, as it is unknown whether the episode of shortness of breath with chest discomfort, five days after the second dose of IP is representing the first signs of onset of the events versus a later date. Concomitant Flublok RIV4 vaccination and sinus congestion indicating viral infection, which both occurred a month before diagnosis of the events, and history of dilatation of the ascending aorta remain confounders. The event of episodic atrial flutter was considered unrelated to IP in agreement with the Investigator.


VAERS ID: 1872216 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Illinois  
Vaccinated:2021-03-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Disease recurrence, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disease (open heart surgery cardiac tamponade stent (1st)); Emphysema; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Coronary artery disease (Stent in RCA (2nd)); Diabetes; Heart disease, unspecified; Immune system disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101281068

Write-up: symptoms of myocarditis; COPD flare ups after each dose; COPD flare ups after each dose; The initial safety information received on 28Sep2021 and 20Oct2021 was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 01Nov2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (the patient). This consumer provided information for two reports. This is the first of two reports. This currently 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 17Feb2021 (Lot Number: EL9269; Expiration Date: 31May2021) as Dose 1, single for COVID-19 immunisation, and via an intramuscular route of administration on 10Mar2021 (Lot Number: EN6203; Expiration Date: 30Jun2021) as Dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and ongoing COPD emphysema since 2007, ongoing coronary artery disease since 2014 with open heart surgery cardiac tamponade stent (1st), coronary artery disease from 2018 with Stent in RCA (2nd), weakened immune system, and ongoing hypertension since 2021. Family Medical History Relevant included: heart disease, diabetes, hypertension, and coronary artery disease. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient''s concomitant medications were not reported. On an unspecified date in 2021, the patient experienced COPD flare ups after each dose. The flare up lasted 6 months and was treated with oral prednisone for COPD flare ups from an unspecified date in 2021. It took 6 months to get control of COPD after the 1st and 2nd doses. On an unspecified date in 2021, the patient experienced symptoms of myocarditis. As of 01Nov2021, the patient stated, "I believe I have symptoms of myocarditis. I am currently seeking a doctor to give me tests to confirm myocarditis. This is very serious." The clinical outcome of the events "COPD flare up after each dose" was resolved in 2021 while the outcome of the "symptoms of myocarditis" was unknown.; Sender''s Comments: Linked Report(s) : PFIZER INC-202101284220 same patient/reporter, different AE/vaccine dose


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