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From the 9/10/2021 release of VAERS data:

Found 988 cases where Vaccine is COVID19 and Manufacturer is JANSSEN and Patient Died



Case Details

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VAERS ID: 1591702 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-03-11
Onset:2021-06-30
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018HRSA / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Cough, Death, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 19
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: UNK
Current Illness: NO
Preexisting Conditions: chronic lung disease, high blood pressure
Allergies: UNK
Diagnostic Lab Data: 7/6/2021 COVID-19 PCR positive
CDC Split Type:

Write-up: 6/30/2021 symptoms: cough, 7/6/2021 Positive COVID-19 7/19/2021 died


VAERS ID: 1591750 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-05-04
Onset:2021-08-15
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Respiratory distress, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 3
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: SMALL CELL LUNG CANCER--METASTATIC TO LIVER AND BONE. ON CHEMOTHERAPY. CHRONIC OBSTRUCTIVE PULMONARY DISEASE. CORONARY ARTERY DISEASE.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT RECEIVED SINGLE DOSE OF JANSSEN COVID19 VACCINE ON 5/04/2021. ADMITTED TO MEDICAL CENTER ON 08/15/2021 WITH WORSENING SHORTNESS OF BREATH. TESTED POSITIVE FOR COVID19 ON 08/10/2021 AFTER STARTING CHEMOTHERAPY FOR SMALL CELL LUNG CANCER THE WEEK PRIOR. REQUIRED HI FLOW O2 IN ED, STARTED ON DECADRON, REMDESIVIR, CEFTRIAXONE, AND LASIX. PATIENT HAD PROGRESSIVE RESPIRATORY DECLINE. FAMILY ELECTED TO PURSUE COMFORT MEASURES. PATIENT EXPIRED ON 08/18/2021.


VAERS ID: 1594327 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: Unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210829146

Write-up: This spontaneous report received from a consumer concerned a patient of an 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 admin not reported, batch number: unknown expiry: unknown) with frequency 1 total administered, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. According to the hearsay on an unspecified date, one patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210829146-Covid-19 vaccine ad26.cov2.s-Death. 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: 1594329 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Suspected COVID-19, Thrombosis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: Unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210829189

Write-up: DEATH; BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; COVID RELATED ISSUES; This spontaneous report received from a company representative concerned a 50year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. According to the hearsay, a patient died after taking the Janssen Covid 19 shot some time ago. On an unspecified date, the patient died with Covid related issues (suspected clinical vaccination failure) and he had blood clots. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of covid related issues, blood clots and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210829189-COVID-19 VACCINE AD26.COV2.S-death, blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210829189-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1594357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

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: It was reported that, the patient was fit.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210832457

Write-up: SUSPECTED HEART ATTACK; This spontaneous report received from a company representative concerned a 60 year old male patient. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: It was reported that, the patient was fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknow) with frequency as 1 total for prophylactic vaccination. Dose and therapy start date were not reported. The batch number was not reported. Per Procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was suspected with heart attack. On an unspecified date, the patient died from suspected heart attack. It was reported that, the patient died within 30 days of receiving vaccine and cause of death was unknown however suspected as heart attack. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210832457- covid-19 vaccine ad26.cov2.s-suspected heart attack. 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: SUSPECTED HEART ATTACK


VAERS ID: 1594386 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19 pneumonia, Coma, Dehydration, Multiple organ dysfunction syndrome, Oxygen saturation, SARS-CoV-2 test, Sepsis, Severe acute respiratory syndrome, Suspected COVID-19, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 24
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: ENBREL
Current Illness: Abstains from alcohol; Non-smoker; Rheumatoid arthritis (Enbrel).
Preexisting Conditions: Comments: Patient had no known allergies and no drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: COVID-19 antigen test; Result Unstructured Data: positive to Covid-19; Test Date: 20210717; Test Name: Oxygen saturation; Result Unstructured Data: low.
CDC Split Type: USJNJFOC20210834830

Write-up: COMA; COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; MULTIPLE ORGAN FAILURE; SUSPECTED COVID-19; ACUTE KIDNEY INJURY; THROMBOCYTOPENIA; SEVERELY DEHYDRATED; This spontaneous report received from a consumer concerned a 62 year old White, Not Hispanic or Latino male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol user. The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis. On 17-JUL-2021, the patient started feeling chills, fever and throwing up. The oximeter showed that his oxygen levels were low. On The patient was admitted to the hospital and on 18-JUL-2021 the patient was diagnosed with covid-19 related pneumonia. On an unspecified date in JUL-2021, it was reported that the patient was severely dehydrated and had an intravenous (IV), had thrombocytopenia and acute kidney injury. The reporter (spouse) stated that the patient was given 4 liters of oxygen but was not getting better, and hence was put on the ventilator. On JUL-2021, the patient experienced suspected covid-19, multiple organ failure. Laboratory data included: covid-19 antigen test (NR: not provided) positive to Covid-19. On an unspecified date, the patient experienced coma. On 25-JUL-2021, the patient died from covid-19 related pneumonia, severe sepsis, acute respiratory syndrome, suspected covid-19, and multiple organ failure. An autopsy was not performed. The duration of hospitalization was unspecified. The death certificate of the patient had severe sepsis, acute respiratory syndrome and covid-19 related pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coma, thrombocytopenia, acute kidney injury, and severely dehydrated. This report was serious (Death and Hospitalization Caused / Prolonged). This case is associated with a Product Quality Complaint.; Sender''s Comments: V0;20210834830; Covid-19 vaccine ad26.cov2. s, Suspected covid-19, Covid-19 related pneumonia, Acute respiratory syndrome, Severe sepsis, Coma, Thrombocytopenia, Multiple organ failure, Acute kidney injury and Severely dehydrated. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; SUSPECTED COVID-19; MULTIPLE ORGAN FAILURE


VAERS ID: 1594405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Headache, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: USJNJFOC20210835168

Write-up: DIED; HEART RACING; HEADACHE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. 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) dose, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient complained of heart racing and headache and the patient died two weeks later. The cause of death was unknown. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause of death on an unspecified date, and the outcome of heart racing and headache was not reported. This report was serious (Death).; Sender''s Comments: V0 20210835168-COVID-19 VACCINE AD26.COV2.S-died. 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: 1602904 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-12
Onset:2021-04-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac stress test, Computerised tomogram, Condition aggravated, Echocardiogram, Fibrin D dimer increased, Hypertension, Renal failure, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 104
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Welbutrin
Current Illness: none
Preexisting Conditions: Hypertension
Allergies: no
Diagnostic Lab Data: HIgh D-dimer, CT scans, echo heart, stress test and others.
CDC Split Type:

Write-up: Patient developed high D-dimer and blood clots immediately after vaccination. Kidney failure followed shortly thereafter. Went into hypertensive cardiac arrest approximately 3 weeks later. All started with vaccination.


VAERS ID: 1617434 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-25
Onset:2021-07-23
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bacterial test positive, COVID-19, Cerebral infarction, Chills, Computerised tomogram head abnormal, Computerised tomogram thorax normal, Death, Endotracheal intubation, Fatigue, Haemoglobin decreased, Infection, Intensive care, Loss of personal independence in daily activities, Lung disorder, Mycetoma mycotic, Oropharyngeal pain, Pneumonia, Post procedural haemorrhage, Pyrexia, Rash, Respiratory failure, SARS-CoV-2 test positive, Staphylococcal infection, Subdural haematoma, Suture insertion, Thrombocytopenia, Tracheostomy, Transfusion, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 29 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: clindamycin (CLEOCIN) 150 MG Oral Capsule Take 3 capsules by mouth 3 times daily at 8 AM, 2 PM, & 10 PM for 10 days cyanocobalamin (VITAMIN B-12) 500 MCG Oral Tablet Take 1 tablet by mouth daily. 5/3/21 folic acid 1 MG Oral Tablet Take
Current Illness:
Preexisting Conditions: Anemia H/H 10.7/34.6 (9/1/20) ? Asthma ? B12 deficiency ? Blood transfusion without reported diagnosis ? Fall 7/25/2020 ? Pulmonary Mycobacterium avium complex (MAC) infection 11/2016 ? Traumatic hematoma of left forearm 07/13/2018
Allergies: Linezolid
Diagnostic Lab Data: SARS-COV-2, NAA, Detected: 08/18/21
CDC Split Type:

Write-up: Patient required hospitalization due to breakthrough infection. She received J&J vaccine on 05/25/21. Hospitalized from 07/23/21 - 08/21/21 (death). Below is copied from discharge (death) summary: Patient 47 y.o. female with PMH of asthma, MAC PNA, and MRSA PNA (treatment course above) admitted to Hospital on 07/24/2021 for evaluation of progressive fatigue of 2 weeks, generalized weakness limiting activities of daily living. Found to be COVID positive. She recived J&J COVID-19 vaccination 5/25/21. Pt also noted to have a fever of 101, chills, and sore throat. Patient has been followed by pulmonary service for pulmonary cavitary lesions, MRSA, and MAC. Pt went to PCP and told her to go to ED. Patient admitted to Hospital North campus. Pulm and ID consulted this admission. CT chest with mycetomas noted. IV abx given per ID recs. BAL done 07/27 cx growing MRSA put on Bactrim, which was transitioned to Vanc, Zosyn, and minocycline given worsening thrombocytopenia. MICU consulted for worsening respiratory status and increasing oxygen requirements. 8/10/2021 ED Intubated in the setting of respiratory failure and transferred to MICU for further management. On 8/12 CT Head showed 3.4mm thickness subdural hematoma in the R frontal with occipital infarcts. S/p BAL with MRSA, started on linezold. 8/15 Transitioned from Zyvox to Bactrim due to rash, for treatment of superimposed pneumonia with MRSA on BAL. Pt transitioned to PS 8/16 and tolerated well. After discussion w family, they would like to proceed with tracheostomy. Pt has increasing WBC this AM. Respiratory cultures. Tracheostomy placed 8/20 with minimal blood loss 8/20, 95/39 MAP 59 200mcg phenylephrine given plus 100 more Pt was found to be bleeding through her tracheostomy tube, surgery consulted and placed sutures, bleeding slightly decrease Hbg 6.8 1U blood trans 8/21/2021: Patient''s family visited at bedside, and then proceeded to the family counseling room. After an extensive discussion regarding the patients status and prognosis, the family (Pt''s mother, father, and daughter) decided to compassionately wean the patient. A morphine drip was started, pressors, and O2 were weaned. The patient expired shortly after.


VAERS ID: 1623771 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-03-25
Onset:2021-08-03
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Covid 19
CDC Split Type:

Write-up: Covid 19 pneumonia


VAERS ID: 1623874 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN JSN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA, Dabigatran, Dexamethasone, Septra
Current Illness: Covid Pneumonia, PE
Preexisting Conditions: DM, AF, HTN, HIV, Hypothyroidism
Allergies: NKA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Died the day after receiving the vaccine


VAERS ID: 1624304 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, COVID-19, Death, Diarrhoea, Pulmonary embolism, SARS-CoV-2 test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-08-09
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dexamethasone, Loxitane, Ativan, Seroquel, Prilosec, Zoloft, Minipress, Prolia (6 mo injection), Potassium Chloride, Vitamin D, Calcium/Magnesium.
Current Illness: None other than clinical diagnoses (see below)
Preexisting Conditions: Congenital Adrenal Hyperplasia$g21-Hydroxylase deficiency, CVA, White Matter Periventricular Infarction, Meningioma, Lung Nodule, Hyperlipidemia, Gastritis and Gastroduodentitis, GI AVM, GI Bleed, Melena, Diverticulosis.
Allergies: Aspirin, Codeine, Escitalopram, Lodine, Olanzapine, Zyprexa, Risperidone.
Diagnostic Lab Data: COVID-19 Positive Autopsy finding: Pulmonary Embolism (Cause of Death).
CDC Split Type:

Write-up: Vomiting and Diarrhea 08/03-08/09. Found dead at residence on 08/09.


VAERS ID: 1627712 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-08-24
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK UN / UN

Administered by: Work       Purchased by: ?
Symptoms: Completed suicide, Immediate post-injection reaction, Suicidal ideation
SMQs:, Suicide/self-injury (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 28
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: type 1 Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Suicidal ideations began immediately. Suicide by gunshot completed July 27, 2021


VAERS ID: 1628006 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-08-14
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Death
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hospitalization 8/14-8/22/2021 for acute respiratory failure/pneumonia due to COVID. Treated with dexamethasone 6 mg IV daily; Remdesivir for 5 days. Expired 8/22/2021


VAERS ID: 1628577 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-04-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / -

Administered by: Private       Purchased by: ?
Symptoms: Choking, Death, Mouth haemorrhage
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not sure
Current Illness: Type 2 diabetes
Preexisting Conditions: Type 2 diabetes
Allergies: None
Diagnostic Lab Data: None. Medical Examiner refused to conduct autopsy even after the family begged for it to be done and the primary wouldn?t sign off on the death cert.
CDC Split Type:

Write-up: Death on 4/16/2021?. Hemorrhaged (mouth), and choked on blood. Family was present at the time of occurrence but nothing could be done to help her. This was 16 days after receiving the J and J shot and would not perform autopsy due to age even when her primary wouldn?t sign off on the death cert.


VAERS ID: 1628604 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-11
Onset:2021-04-11
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, Dyspnoea, Fibrin D dimer increased, Hyponatraemia, Laboratory test abnormal, Lactic acidosis, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin, Celexa, Plavix, Lasix, gabapentin, Norco, Antivert, metformin, Centrum Silver vitamins, Fish oil, Prilosec, Flomax.
Current Illness: Compression fracture of body of thoracic vertebra
Preexisting Conditions: Arthritis, ASHD, basal cell cancer (face), BPH, colon cancer (s/p resection and chemo), cardiac disease, chronic lower back pain, constipation, CAD, CVA, diabetes mellitus with peripheral neuropathy, diffuse large B cell lymphoma, GERD, hard of hearing, hyperlipidemia, leg pain, leg weakness, MALT lymphoma, history of MI, s/p CABGx4 in 2003, spinal stenosis, ulcer, vertigo
Allergies: n/a
Diagnostic Lab Data: COVID-19 by NAA, Limited Use: SARS CoV2 COVID-19 Detected (3/29/2021) D-Dimer: $g10,000 ng/mL FEU (4/11/2021)
CDC Split Type:

Write-up: A 91-year-old gentleman with significant known history for coronary artery disease/CVA/history of B-cell lymphoma/hypertension and significant other medical history, presented to hospital due to shortness of breath; it is noted the patient was saturating at 76% on non-rebreather. The patient was desatting despite being on non-rebreather and therefore it was requested that the patient be transported to the ER. He was evaluated , was on AVAP 80%, alert, however, unable to fully follow any commands. He was placed on AVAP and his oxygenation/pulse ox increased to 90%. Lab workup showed hypernatremia/acute renal failure/lactic acidosis with a D-dimer of more than 10,000. Transitioned to hospice care.


VAERS ID: 1629288 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Malaise, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: THE PATIENT CAME ON 8/16 /2021 WITH COVID SYMPTOMES TESTED WITH PCR THE RESULT CAME POSITIVE FOR COVID THE PATIENT EXPIRED ON 8/21/2021


VAERS ID: 1631068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: USJNJFOC20210843032

Write-up: DEATH; This spontaneous report received from a consumer via social media and concerned two male patients of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died from unknown cause. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died (due to unknown cause) on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210843032- Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1631079 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

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: USJNJFOC20210844140

Write-up: DIED OF HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. 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)1 total frequency, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died of heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 20210844140-COVID-19 VACCINE AD26.COV2.S-died of heart attack. 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: HEART ATTACK


VAERS ID: 1631954 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Idaho  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: USJNJFOC20210842457

Write-up: DIED FROM COMPLICATIONS OF COVID/COVID AFTER VACCINATED; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician via a company representative via social media concerned a 70 year old male. 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: Unk) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from complications of covid/covid after vaccinated (suspected clinical vaccination failure). Patient was fully vaccinated with the J&J vaccine. It was reported that there was lack of guidance about boosting that vaccine led to his death. It was reported that patient was pretty healthy. Cause of death was reported as complications of covid. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died from complications of covid/covid after vaccinated on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210842457-Covid-19 vaccine ad26.cov2.s- died from complications of covid/covid after vaccinated.This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210842457-Covid-19 vaccine ad26.cov2. s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: DIED FROM COMPLICATIONS OF COVID


VAERS ID: 1634859 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210845181

Write-up: DEATH; This spontaneous report received from a consumer via a company representative from social media concerned an 8 decade old of unspecified age, sex, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210844359.; Sender''s Comments: V0: 20210845181-covid-19 vaccine ad26.cov2.s- Death.This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1636956 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-28
Onset:2021-08-22
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN NONE GIVEN FROM / 1 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 0
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: COPD, Diabetes, Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. given dose. NO lot number in our vaccination system, pt. passed from COVID19 on 8/22/2021.


VAERS ID: 1636967 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-07-29
Onset:2021-08-23
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Angiogram abnormal, Aspiration, Central pain syndrome, Cerebellar stroke, Cerebral infarction, Cerebral mass effect, Coma scale abnormal, Computerised tomogram head abnormal, Computerised tomogram neck, Death, Dizziness, Dysarthria, Electroencephalogram, Endotracheal intubation, Heparin-induced thrombocytopenia test, Hydrocephalus, Ischaemic stroke, Magnetic resonance imaging head abnormal, NIH stroke scale abnormal, Paranasal sinus discomfort, Perfusion brain scan, Platelet count normal, Posterior fossa syndrome, Seizure, Seizure like phenomena, Status epilepticus, Thalamic infarction, Tinnitus
SMQs:, Angioedema (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen 650 mg as needed for headache/pain
Current Illness: none
Preexisting Conditions: ADHD and anxiety
Allergies: no known allergies
Diagnostic Lab Data: 8/25: HIT antibody (P4F) negative 8/25: platelets 227 8/25 CT Head: 1. Abnormal low density compatible with infarcts throughout the cerebellum, pons and brainstem, and both of the posterior cerebral artery territories including the bilateral thalami. 2. Mass effect within the posterior fossa results in distortion of the fourth ventricles with what appears to be early developing lateral and third ventricular hydrocephalus. There is marked effacement of the basilar cisterns. 3. Residual intracranial contrast limits assessment but there are no current findings of hemorrhagic conversion or acute intracranial hemorrhage. 4. Paranasal sinus disease.
CDC Split Type:

Write-up: Patient woke up 8/23 morning c/o dizziness, slurred speech and with ringing in his left ear. Shortly afterwards pt exhibited seizure-like activity. Family called 911. EMS witnessed seizure at home and was actively seizing on arrival of EMS. Pt was administered 5mg Versed w/o relief then was given Ketamine and intubated. After airway was secured pt was transported to the ED. Pt was admitted for treatment for status epilepticus. Pt sedated on Propofol gtt, Keppra and placed on cEEG. Initial CT Head w/o contrast negative for any acute findings. cEEG was negative for seizures. Pt treated prophylactically with Rocephin and Vancomycin for suspected aspiration. MRI brain w/o contrast obtained early today at the outside hospital and showed Bilateral cerebellar and thalamic AIS with possible basilar occlusion. Dr was contacted and accepted for transfer for acute stroke evaluation and treatment. Prior to transfer obtained CTA head/neck. Pt transported via helicopter. Upon arrival pt was met in ED CT for stat CT cerebral perfusion and CT Head w/o contrast. Pt arrived 8/24/2021 16:08. NIH 36 and GCS 3T. Pt arrived on Propofol and was stopped. Scans showed a large infarction and no intervention recommended. Of note: pt had just received this Johnson and Johnson COVID vaccination 2 weeks ago.


VAERS ID: 1640748 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-15
Onset:2021-02-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 3726945 / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 1
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:

Write-up: Death


VAERS ID: 1640942 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-15
Onset:2021-04-24
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Confusional state, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD, Cardia cath, cardiomyopathy, pacemaker, internal defibrillator
Allergies: NKA
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: Confusion


VAERS ID: 1641233 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-06
Onset:2021-08-15
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, COVID-19, Death, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Calan, hytrin, seroquel, prilosec, claritin, humalog, lantus, robitussin, Vit. D albuterol, acetaminophen
Current Illness:
Preexisting Conditions: HTN, Peripheral artery disease, chronic atrial fibrillation, DM, Type 2 diabetes, arthritis, peripheral neuropathy, AKI hyperlipidemia,
Allergies:
Diagnostic Lab Data: Tested positive upon admission 8/15/2021
CDC Split Type:

Write-up: Weak and fell Exposed from caregiver who had recently tested positive


VAERS ID: 1641422 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-04
Onset:2021-08-19
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Death, Dyspnoea, Lung opacity, SARS-CoV-2 test positive, Scan with contrast abnormal, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, hypercholesterolemia.
Allergies: NKA
Diagnostic Lab Data: Covid test-positive. Chest xray-moderate diffuse bilateral groundglass and heterogenous opacities. CT chest PE with contrast.
CDC Split Type:

Write-up: Pt came to ER c/o SOB that started earlier that morning. Pt became very winded and could not catch his breath, EMS called and pt sats in the 60-70''s with tachypnea.


VAERS ID: 1641586 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-07-28
Onset:2021-08-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201728146 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 3
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:

Write-up: COVID infection. Specimen collected 8/8/21. Patient died on 8/11/21.


VAERS ID: 1642957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, Laboratory test, Medication error, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BNT 162
Current Illness: Hyperlipidemia; Hypertension; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Hemorrhagic stroke
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Lab test; Result Unstructured Data: Normal; Test Date: 20210801; Test Name: Platelet count; Result Unstructured Data: 4800
CDC Split Type: USJNJFOC20210837606

Write-up: HEMORRHAGIC STROKE; MEDICATION ERROR (RECEIVED A FULL SERIES OF PFIZER FOLLOWED BY JNJ VACCINE); This spontaneous report received from a consumer via a company representative concerned a 48 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: hemorrhagic stroke, and concurrent conditions included: controlled hypertension, hyperlipidemia, and overweight. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination. The patient received a full series of Pfizer sometime between MAR-2021 and MAY-2021. On JUL-2021, Laboratory data included: Lab tests were normal. On 01-AUG-2021, Laboratory data included: Platelet count (NR: not provided) 4800 and the patient had 3 brain bleeds. On 11-AUG-2021, the patient had medication error (received a full series of pfizer followed by JNJ vaccine). On 16-AUG-2021, the patient experienced hemorrhagic stroke and was hospitalized for one day. On 17-AUG-2021, the patient died from hemorrhagic stroke. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error (received a full series of Pfizer followed by JNJ vaccine) was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210837606 -covid-19 vaccine ad26.cov2.s- Hemorrhagic stroke. 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: Hemorrhagic stroke


VAERS ID: 1642962 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hospitalisation
SMQs:

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210846858

Write-up: ENDED UP IN THE HOSPITAL; DEATH; This spontaneous report received from a consumer via a company representative from social media concerned ''multiple patients''. The patient''s height, and weight were not reported. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On an unspecified date, the many patients got vaccinated and ended up in the hospital, and were hospitalized (date unspecified). The number of days of hospitalization were not reported. On an unspecified date, the patients died from an unknown cause of death. It was unspecified if an autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine was not applicable. The patients died of death and ended up in the hospital on an unspecified date. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210844140, 20210844317 and 20210844359.; Sender''s Comments: V0-20210846858-COVID-19 VACCINE AD26.COV2.S-Death and Ended up in the Hospital(Fatal); These events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1655806 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-09
Onset:2021-08-18
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Death, Mechanical ventilation, Vaccine breakthrough infection
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: DM
Preexisting Conditions: DM
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21


VAERS ID: 1655956 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-27
Onset:2021-08-13
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Cough, Death, Dizziness, Dyspnoea, Endotracheal intubation, Pulmonary embolism, Renal replacement therapy, SARS-CoV-2 test positive, Septic shock, Vena cava thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 17
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: atorvastatin, carvedilol, lorazepam
Current Illness:
Preexisting Conditions: Hypertension, CHF, HLD, s/p aortic valve replacement
Allergies: No Known Allergies
Diagnostic Lab Data: COVID-19 PCR + on 8/13/2021
CDC Split Type:

Write-up: 8/13/21: Patient arrived at the ER due to shortness of breath since 1 week ago. Associated symptoms include dry cough and dizziness. Intubated in the ER. Diagnosed with: acute hypoxic resp failure, COVID-19 pneumonia, septic shock, oliguric AKI requiring CRRT, partial proximal IVC thrombosis, emboli in the lingula Note: patient previously vaccinated with J&J COVID-19 vaccine on 4/27/21. 8/30/21: patient died this morning.


VAERS ID: 1656127 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-05
Onset:2021-08-14
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, Anaemia, Brain cancer metastatic, COVID-19, COVID-19 pneumonia, Continuous positive airway pressure, Dyspnoea, Endometrial cancer, Endotracheal intubation, Intracranial mass, Respiratory distress, SARS-CoV-2 test positive, Sepsis, Transfusion, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Uterine and fallopian tube malignant tumours (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 11
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:

Write-up: Result Type: History and Physical Date: August 14, 2021 2:17 Result Status: Auth (Verified) Result Title: Admission H & P Performed By: MD on August 14, 2021 2:21 Verified By: MD on August 14, 2021 2:21 Encounter info: Inpatient, 08/14/2021 - 08/25/2021 * Final Report * Date of Admission 08/14/2021 Chief Complaint for resp distress, COVID+, intubated by EMS and given 4mg versed, 20mg etomidate, 100mg ketamine, 125mg solumedrol History of Present Illness 75-year-old female sent from secondary to respiratory distress. Patient is intubated in the ER therefore history is taken from ER records and chart. Patient had recent admission at hospital rib patient had been initially admitted with symptomatic anemia and abnormal vaginal bleeding. At that time patient was found to have brainstem mass likely metastatic cancer secondary endometrial cancer. Patient required blood transfusion. Patient presents today with acute worsening of shortness of breath at 11:30 a.m. this evening. patient has known covid-19. Per EMS patient''s initial O2 sats were in the 70s. Patient started on CPAP with no improvement. Patient intubated in the field. Course of symptoms constant degree at onset severe degree of present severe. No known exacerbating alleviating factors. No known other associated symptoms. Patient by emergency department patient started IV pressors given IV antibiotics. Pneumonia due to COVID-19 virus U07.1 Acute hypoxemic respiratory failure Respiratory failure J96.90 Severe sepsis R65.20 Recent diagnosis metastatic CA likely endometrial History of Abnormal vaginal bleeding CM Ongoing Assessment AH NEW Patient: Age: 75 years Sex: Female DOB: Associated Diagnoses: None Author: Professional Services CM Contact Information: Discharge Planner . Discharge Planner Phone . Assessment Ongoing Assessment Situation: was advised that pt expired this morning 8/25/21. contacted (ex-spouse) to inform him of this information. Pt was not under hospice services as ex-spouse only returned part of the paperwork..


VAERS ID: 1656560 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-10
Onset:2021-07-31
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, COVID-19, Computerised tomogram thorax abnormal, Death, General physical health deterioration, Lung infiltration, Mechanical ventilation, Pulmonary embolism, SARS-CoV-2 test positive, Troponin increased
SMQs:, Interstitial lung disease (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Multiple sclerosis
Allergies: No known allergies
Diagnostic Lab Data: COVID positive 8/2/2021; CTA revealed bilateral pulmonary embolisms and extensive bilateral pulmonary infiltrates; Troponin 1.33 on 8/6/2021
CDC Split Type:

Write-up: Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 07/10/2021. Patient started having symptoms on 7/31/2021 and presented to ED on 8/2/2021. Patient received dexamethasone and enoxaparin at outside hospital. Patient rapidly declined eventually requiring mechanical ventilation and was then transfered to ED on 8/5/2021. Patient was diagnosed with bilateral pulmonary embolisms. Patient received dexamethasone, enoxaparin, remdesivir, & ceftriaxone. Hospital course progressed without meaningful recovery of lung function ad patient expired on 8/18/2021.


VAERS ID: 1658364 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-12
Onset:2021-08-06
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 36 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, CKD3
Allergies:
Diagnostic Lab Data: covid PCR positive on 7/31/2021
CDC Split Type:

Write-up: Death from Covid Pneumonia


VAERS ID: 1658553 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-17
Onset:2021-08-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 0
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:

Write-up: Janssen on 8/17. Positive 8/29. death at end hospital stay


VAERS ID: 1659134 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Clostridium test positive, Death, Dyspnoea, Hypoxia, Mechanical ventilation, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Pseudomembranous colitis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aripiprazole 10 mg daily, pepto-bismol 262 mg every 6hrs PRN, lisinopril 5 mg daily, omeprazole 20 mg daily, sertraline 25 mg daily, zolpidem 5 mg daily at bedtime, Tylenol #3 1-2 tabs every 6 hours as needed.
Current Illness:
Preexisting Conditions: Diabetes mellitus, Hypertension, Hyperlipidemia, Depression, GERD, cirrhosis
Allergies: No known allergies
Diagnostic Lab Data: COVID positive 8/1/2021, 8/20/2021, and 8/24/2021. Clostridium difficile positive 8/14/2021
CDC Split Type:

Write-up: Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 04/01/2021. Patient presented to ED with complaints of shortness of breath x 3 days. On arrival he was placed on high flow nasal cannula. Patient was mechanically ventilated on 8/5/2021 due to worsening hypoxia. Patient received dexamethasone & remdesivir. Patient was transferred to hospital on 8/5/2021. Patient received methylprednisolone, cefepime, meropenem, metronidazole, & vancomycin IV and PO. Hospital course progressed without meaningful recovery of lung function. On 8/24/2021, family decided to move to comfort care. Patient expired on 8/24/2021.


VAERS ID: 1659476 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-31
Onset:2021-04-24
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Acute myeloid leukaemia, Asthenia, Blood test, Blood urine present, Fatigue, Laboratory test, Platelet count, Urinary tract infection, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Guillain-Barre syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 77
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 28 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril Multi-Vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Full blood work up and when she was transferred to the hospital they did their blood work up on her White Blood Cell counts, Platelet count and everything else that indicated she had Leukemia
CDC Split Type:

Write-up: she became very tired after the shot and never regained her energy and ended up in the ER for a UTI but there was a lot of blood in her urine. After running blood work and multiple tests she was diagnosed with AML just shy of 4 weeks from the time the shot was administered.


VAERS ID: 1659718 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-03-01
Onset:2021-08-16
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, Death, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pulmonary Embolism, Acute Respiratory Failure, and Death


VAERS ID: 1660971 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Haematoma, Internal haemorrhage, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 31
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: Abstains from alcohol; Blood pressure high (Patient was on CPAP machine.); Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies and no drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Name: Oxygen saturation; Result Unstructured Data: Low; Test Name: COVID-19 virus test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210857346

Write-up: DEATH; INTERNAL BLEEDING; HEMATOMA; LOW BLOOD OXYGEN; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID -19 INFECTION; This spontaneous report received from a consumer concerned a 69 year old white non- hispanic or latino male. Initial information was processed along with the additional information received on 30-AUG-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure and was on CPAP (Continuous positive airway pressure ) machine, non-alcohol user, and non-smoker. The patient had no known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 in total administered to left arm on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the patient developed shortness of breath and fever (Suspected covid -19 infection) and was taken to emergency room. There patient tested positive for covid-19 infection (suspected clinical vaccination failure). The patient was transferred to other hospital and was on CPAP machine along with Bi-PAP. The patient had low blood oxygen. The patient was put on oxgyen. On unspecified date the patient become negative for covid-19 infection. The patient had internal bleeding and was on blood thinner. The patient had hematoma and could not breath. On 19-AUG-2021 the patient was again transferred to another hospital and was intubated which made him worse. On 27-AUG-2021 the patient passed away. The number of days hospitalized was 32. It was unknown whether the cause of death was due to covid-19 infection or due to vaccine. It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 27-AUG-2021, recovered from suspected covid -19 infection, had not recovered from hematoma, internal bleeding, and low blood oxygen, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with a product quality complaint 90000191347.; Sender''s Comments: V0: 20210857346-covid-19 vaccine ad26.cov2.s-Death, internal bleeding, suspected covid -19 infection, hematoma and low blood oxygen. 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). 20210857346-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1660988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: USJNJFOC20210860032

Write-up: DEATH; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date spike protein was found in every organ of the patient and patient died after 7 days of vaccination from an unknown cause. It was unknown whether autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210860032-COVID-19 VACCINE AD26.COV2.S-DEATH. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1663204 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-13
Onset:2021-08-06
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Appendicitis, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Death, Dyspnoea, Endotracheal intubation, Headache, Hypoxia, Intensive care, Lung opacity, Pulmonary oedema, Respiratory failure, SARS-CoV-2 test positive
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine 5mg daily, aspirin 81mg daily, atorvastatin 40mg daily, basaglar inject up to 30 units daily, Os-cal 3tabs TID, ceterizine 10mg daily, Vitamin D3 4,000unit 2 tab daily, famotidine 20mg BID, folic acid 1mg daily, Norco 10-325mg q8
Current Illness:
Preexisting Conditions: Anemia, CAD, T2DM, GERD, HTN, RA, obesity, HLD, hypercalcemia, hyperparathyroidism s/p parathyroidectomy
Allergies: NKDA
Diagnostic Lab Data: Covid positive (8/6/21)
CDC Split Type:

Write-up: Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/13/2021. On 8/6/2021, pt presented to ED with increasing diffuse abdominal pain that started 3 days prior. Pt reports he was diagnosed with COVID-19 on 8/5/21 and had increasing shortness of breath with cough and headache which began 8/1/21. CT showed acute uncomplicated appendicitis and confirmed patchy ground-glass opacities within the bilateral lung bases consistent with COVID pneumonia. He was given 1 g of Tylenol, 1 g of IV Rocephin, 6 mg of Decadron, 500 mg of IV Flagyl, 2 doses of 4 mg of morphine, 4 mg of Zofran and 40 mg of IV Protonix in the ED. Pt also received remdesivir. He developled hypoxia on HFNC 50/50 sating 84-87%. pO2 49. Patient was able to maintain sats in the lower 90''s CXR showed worsening pulmonary edema and he was given 20mg IV lasix. Patient transferred to MICU service for worsening respiratory status on 8/13. Patient was intubated and started on proning protocol. He continued to require pressors and sedation with propofol, versed, and dilaudid. Palliative was consulted and discussed with family comfort care. Patient expired on 8/24/21.


VAERS ID: 1663206 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-12
Onset:2021-08-01
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK UN / UN
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Bilevel positive airway pressure, COVID-19, Cough, Death, Dyspnoea, Fibrin D dimer increased, General physical health deterioration, SARS-CoV-2 test positive, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin 81 mg daily, cholecalciferol 50 mcg, clobetasol 0.05% apply to affected area(s) as directed, lotrisone cream apply to affected area(s) as directed for up to 2 weeks at a time, famotidine 20 mg daily, flonase 50 mcg/actuation spray 1
Current Illness:
Preexisting Conditions: Osteoarthritis, diabetes mellitus type 2, insomnia, hypertension, hypercholesterolemia, hypotyhyroidism
Allergies: Sulfa, clarithromycin, penicillin V potassium
Diagnostic Lab Data: COVID positive 8/1/2021 and 8/18/2021; WBC peaked at 35.6 on 8/14/2021; D-dimer peaked at 32.79 on 8/12/2021
CDC Split Type:

Write-up: Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/12/2021 and 04/7/2021. Patient presented to another facility on 8/1/2021 for shortness of breath and cough. Patient received dexamethasone, remdesivir, levofloxacin with continuous BiPAP. Patient was then transfered to hospital on 8/5/2021 for higher level of care. Patient received remdesivir, dexamethasone, methylprednisolone, baricitinib, zinc, vitamin c, and ivermectin. Patient continued to decompensate and expired on 8/19/2021.


VAERS ID: 1663589 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-05
Onset:2021-08-22
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Acute kidney injury, Aortic aneurysm, Apnoea, Atrial fibrillation, Atrioventricular block first degree, Blood creatinine increased, Blood gases abnormal, Blood lactic acid, Blood loss anaemia, Blood test abnormal, Bundle branch block right, COVID-19, Central venous catheterisation, Chest X-ray abnormal, Chronic kidney disease, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Computerised tomogram pelvis abnormal, Computerised tomogram thorax, Condition aggravated, Death, Dependence on respirator, Electrocardiogram normal, Electrolyte imbalance, Endotracheal intubation, Explorative laparotomy, Extubation, Gastric ulcer perforation, Gastrointestinal fistula, Hypotension, Infusion, Inguinal hernia, Intensive care, Interstitial lung disease, Intracranial mass, Ischaemia, Lung opacity, Malaise, Metabolic acidosis, Metabolic encephalopathy, Oxygen saturation increased, Peritonitis, Physical deconditioning, Pleural effusion, Pneumonia bacterial, Pneumoperitoneum, Pulmonary fibrosis, Respiratory distress, Resuscitation, Septic shock, Supraventricular tachycardia, Troponin increased, Unresponsive to stimuli
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal perforation (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine (NORVASC) 2.5 MG tablet ascorbic acid (VITAMIN C) 500 MG tablet aspirin 325 MG tablet Calcium Carb-Cholecalciferol (CALCIUM/VITAMIN D) 600-400 MG-UNIT TABS Camphor-Menthol-Methyl Sal (BEN GAY ULTRA STRENGTH) 4-10-30 % CREA extern
Current Illness: COVID-19 positive BLEPHAROPLASTY 7.28.21 dementia
Preexisting Conditions: Carotid artery narrowings RBBB (right bundle branch block with left anterior fascicular block) Hypothyroidism (acquired) Benign essential hypertension Tension headache Dizziness - light-headed History of CVA (cerebrovascular accident) ED (erectile dysfunction) GERD (gastroesophageal reflux disease) BPH (benign prostatic hyperplasia) Hyperlipidemia LDL goal < 100 CKD (chronic kidney disease), stage III Depression with anxiety Seasonal allergic rhinitis due to other allergic trigger Physical deconditioning COVID-19 virus infection
Allergies: Pravastatin Myalgia Lipitor [Atorvastatin] Myalgia Sulfa Drugs Nausea Only
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hospitalized; COVID-19 positive (fully vaccinated); Expired in hospital (likely due to COVID-19) BRIEF OVERVIEW: Admission Date: 8/22/2021 Discharge Date: 08/28/2021 Discharge Disposition: Deceased DISCHARGE DIAGNOSIS: 1. Deceased 2. Perforated Gastric Ulcer 3. Acute Blood loss anemia 4. COVID19 5. AKI with CKD stage III 6. Acute Metabolic Encephalopathy DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Respiratory distress HOSPITAL COURSE: Patient was a 94-year-old male who was initially hospitalized with signs of septic shock believed to be secondary to COVID-19 and possible bacterial pneumonia; as well as new onset AFib with RVR. Patient was admitted to the intensive care unit, he did have improvement initially with fluid resuscitation and Levophed as well as amiodarone infusion. Further workup did reveal a pneumoperitoneum patient desired aggressive treatment and went forward knowing high risk of death with exploratory laparotomy. This was done on 08/22/2021 and patient was found to have a pre pyloric perforation and peritonitis. Patient was returned back to the intensive care unit and remained intubated along with central line placements. Aggressive treatment continued, patient was extubated on 8/25 but not responding; further findings on repeat CT scans on 08/25 showed continued leaking from stomach as well as findings of a potential cancerous brain mass. On 08/26/21 family, along with son, mutually agreed on comfort care initiation. Today at 0300 patient passed away, attempted son x3 calls, but then did get through to other son who was to notify the family. HISTORY OF PRESENT ILLNESS: Patient is a 94-year-old man with a past medical history significant for CVA and mild dementia, CKD stage 3, hypertension and hypothyroidism who was admitted to intensive care unit on August 22, 2021 for COVID-19 infection and septic shock. The patient was recently hospitalized from April 11th through April 15th for physical deconditioning. During that time he was diagnosed with dementia with a MoCAa score of 6/30. He discharged to Rehab where he has been continued undergo rehabilitation. Today he presented to the emergency department in extremis. He was in profound respiratory distress and shock. He tested positive for COVID at his care facility a couple days prior. This unclear if he had been undergoing any kind of treatment for this. He had significant episodes of nonresponsiveness an apnea while in the ED. Additionally, he was profoundly hypotensive and tachycardia with new onset rapid atrial fibrillation and rapid ventricular response. He was hypothermic and placed on a Bair Hugger. Initial blood work revealed mild electrolyte abnormalities, lactic acid greater than 7, a creatinine of 1.9. Chest x-ray revealed mild scattered interstitial thickening and lung opacities. Patient was started on IV fluid and placed on phenylephrine infusion. Conversation with the patient''s son, as well as his other son reveal that the patient would not want CPR or to be placed on a ventilator but they would want to pursue all other aggressive measures. He was then transitioned up to the emergency department to the intensive care unit for further management. Intensive care unit course: After arrival to the intensive care unit the patient was aggressively fluid resuscitated. His blood pressures responded relatively well. Due to pharmacy shortage of the phenylephrine the patient was transitioned to norepinephrine. His cognitive status drastically improved from when I evaluated him in the emergency department. He is alert and oriented x3. Suspicious for ongoing COVID infection and possible pneumonia the patient''s antibiotics were transitioned to cefepime plus azithromycin plus vancomycin. He is started on remdesivir for COVID 19 treatment. ABG revealed compensated metabolic acidosis. The patient''s lactic acid has improved to 6.5 from 7. Initial troponins are elevated as expected from demand ischemia from septic shock. EKG does not reveal any ST segment changes in the patient does not complain of any chest pain. He is, however complaining of abdominal pain. He has a soft right inguinal hernia which is difficult to reduce and has no overlying skin changes. The patient has had increasing oxygen needs initially requiring 6 L of oxygen in the emergency department now on 100% oxygen via non-rebreather. At approximately 1630 while I was re-evaluating the patient and discussing his care to son the patient entered into a what appeared to be wide complex ventricular tachycardia with an initial heart rate of approximately 240. Nurse was in the room with me. The patient was not feeling well. His Levophed was shut off and fluids were started. A stat amiodarone infusion of 150 mg was begun. Patient was connected to defibrillator pads. Asked the patient and family if he required cardiac defibrillation if he would want that, and he very explicitly said "yes!". His heart rate responded to the amiodarone infusion, however, and he subsequently entered into what appeared to be a narrow complex supraventricular tachycardia with a heart rate of approximately 180. His blood pressure remained stable during this time. As we continued to monitor in supportive care and continued his amiodarone infusion the patient''s heart rate then entered into a normal sinus rhythm with a systolic rate of approximately 90. Unfortunately, strips of these rhythms were unable to be captured. EKG afterwards revealed normal sinus rhythm with a first-degree heart block and previously seen right bundle-branch block. After his amiodarone infusion I did not bolus further or start continued infusion for the patient but plan to continue monitoring. Stat CT of chest abdomen and pelvis was obtained. This revealed many things but specifically a pneumoperitoneum. The case was discussed with the on-call general surgeon who evaluated the patient with me in the intensive care unit. Along with the patient''s son and other son, it was decided the patient would want to pursue aggressive measures including exploratory laparotomy. Risks of surgery including death were shared with the patient. Furthermore was explicitly stated that he would likely return to the intensive care unit ventilator dependent with multiple drains and need for central line and continued resuscitation the ultimate outcome of which being still high likelihood of death. Understanding this the patient and his son still wanted to proceed. Alternatives, including comfort care were offered and declined. Of note additional findings on CT scan include nodular pulmonary opacities right with recommended CT follow-up in 3-6 months, left pleural effusion, and small abdominal aortic aneurysm and mild pulmonary fibrosis.


VAERS ID: 1663606 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-06-18
Onset:2021-08-25
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Anticoagulant therapy, Bilevel positive airway pressure, COVID-19, Chest X-ray normal, Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal, Condition aggravated, Death, Emphysema, Fall, Fat embolism, Femur fracture, Hip fracture, Oxygen saturation decreased, Pulmonary embolism, Renal impairment, Respiratory failure, SARS-CoV-2 test positive, Ventilation/perfusion scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amLODIPine (NORVASC) 10 MG tablet aspirin 81 MG chewable tablet atorvastatin (LIPITOR) 20 MG tablet hydrochlorothiazide (HYDRODIURIL) 50 MG tablet lisinopril (PRINIVIL,ZESTRIL) 40 MG tablet metFORMIN (GLUCOPHAGE) 500 MG tablet omeprazole (P
Current Illness: NA
Preexisting Conditions: Atherosclerosis of native artery of both lower extremities with intermittent claudication COPD (chronic obstructive pulmonary disease) DMII (diabetes mellitus, type 2) Hyperlipidemia HTN (hypertension) Onychomadesis Acute CVA (cerebrovascular accident) AKI (acute kidney injury) Intertrochanteric fracture of right femur, closed, initial encounter Acute respiratory failure with hypoxia
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hospitalized; COVID-19 positive (fully vaccinated); patient expired during hospitalization. Active Hospital Problems Diagnosis Date Noted POA ? Acute respiratory failure with hypoxia 08/30/2021 Unknown ? Intertrochanteric fracture of right femur, closed, initial encounter 08/25/2021 Unknown ? COPD (chronic obstructive pulmonary disease) 06/08/2021 Yes Date of Death: 8/30/21 Time of Death: 10:43 PM Preliminary Cause of Death: COVID-19 Discharge Disposition: expired HOSPITAL COURSE: The patient is an 87 year old male history of emphysema, MCA CVA, vascular dementia, hypertension admitted 8/25 to the orthopedic service for right comminuted hip fracture that occurred after a fall at his living facility. He tested positive for covid 19 on 8/20 after an exposure at his nursing facility. He received his J&J vaccine in June 2021. At the time of admission, he was fairly asymptomatic from covid 19 infection. Patient was initially stable with no significant chest x-ray findings. Patient was scheduled for OR on August 26th. Overnight on 8/25, patient had rapid escalation in his oxygen needs, going from room air to requiring 5-6 liters NC and later to HFNC. Unable to obtain CTA thorax due to kidney function, so CT thorax without contrast performed, only showed severe emphysema. VQ scan obtained which was not suspcious for PE. Patient was started on a heparin gtt due to concern for PE vs. Fat emboli. As V/Q scan came back negative for PE, heparin drip was discontinued. Orthopedic team transferred service to hospitalist team and were waiting for improvement in respiratory status before proceeding with surgery. Patient was started on decadron. As patient''s oxygen requirements increased, patient was placed on BiPAP to help with workup breathing. Code status confirmed with patient''s son wants patient to remain as do not resuscitate. He also reported that guardianship is being pursued patient was made incapacitated at nursing facility. Due to worsening oxygen requirements, Pulmonology was also consulted. Patient was continued on BiPAP with worsening respiratory status and eventually died.


VAERS ID: 1665394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: Parkinson''s disease
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210855586

Write-up: DEATH; SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned an 87 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included Parkinson''s disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was fully vaccinated still got covid-19 (suspected covid-19 infection and suspected clinical vaccine failure). Patient was finally tested negative for covid-19. It was too much for patient''s Parkinson body he died in his sleep. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Death).; Sender''s Comments: V0: 20210855586-COVID-19 VACCINE AD26.COV2.S-Death. 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). 20210855586-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1665438 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210860177

Write-up: DEATH; This spontaneous report received from a consumer via social media (medical journal) concerned multiple patients of unknown race and ethnicity. 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) 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. The reporter read in journal that 22 people died after receiving the vaccine. The cause of death was unknown. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210860032.; Sender''s Comments: V0: 20210860177-Covid-19 vaccine ad26.cov2.s -Death. 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: 1666245 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-02
Onset:2021-08-15
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Small cell lung cancer metastatic
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: cough, dyspnea, small cell lung CA with metastasis


VAERS ID: 1667100 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-09
Onset:2021-09-01
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired on 09/01/2021


VAERS ID: 1667385 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-16
Onset:2021-07-14
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, General symptom, Malaise, Myocarditis, Viral infection
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: 2021-07-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Irbesartan, lipitor, chlorthalidone, ambien, rybelsus, clindaycin
Current Illness: None
Preexisting Conditions: High blood pressure, high cholesterol
Allergies: N/a
Diagnostic Lab Data: Autopsy says myocarditis from viral infection. I wanted to share our story to help research in case it was linked to his recent vaccine.
CDC Split Type:

Write-up: My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case.


VAERS ID: 1669558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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: USJNJFOC20210855833

Write-up: DEATH; SEIZURES; This spontaneous report received from a consumer via a company representative via social media (twitter) concerned a male of an unspecified age. 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) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient developed seizure and then died. As per the reporter, "I know an hour after taking the vaccine this 100 percent healthy kid had seizures. Next thing the patient was dead." It was unknown if an autopsy was performed or not. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of seizures was not reported. This report was serious (Death).; Sender''s Comments: V0: 20210855833-covid-19 vaccine ad26.cov2.s -Death, Seizures. 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: 1669567 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Diabetes (Controlled); Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210858457

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 94 year old male and unspecified race & ethinicity. Initial information was processed along with the additional information received on 27-AUG-2021 The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes, hypertension, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 in total dose was administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer reported that father was in the emergency room on 17-AUG-2021 and was hospitalized. On 18-AUG-2021, the patient was on ventilator and died on 24-AUG-2021 with the delta variant. On an unspecified date, the patient had suspected covid-19 infection, and suspected clinical vaccination failure. On 24-AUG-2021, the patient died from covid-19 infection. The patient was hospitalized for 7 days. It was unspecified if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on 24-AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210858457-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210858457-covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. 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.; Reported Cause(s) of Death: COVID-19 INFECTION


VAERS ID: 1669577 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: USJNJFOC20210860208

Write-up: DEATH; This spontaneous report received from a consumer via company representative concerned 726 patients of unspecified sex, race and ethnic origin. The patients 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 was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died from unknown cause of death. It was unknown that whether autopsy performed for reported patients. This report was serious (Death).; Sender''s Comments: V0: 20210860208-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1669586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210900460

Write-up: TWO STROKES; This spontaneous report received from a consumer via a company representative through social media concerned a female of unspecified age, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the vaccine caused blood clotting throughout the patient''s body resulting in two strokes and ultimately her death on 19-AUG-2021. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 19-AUG-2021, the patient died from two strokes. This report was serious (Death).; Sender''s Comments: V0: 20210900460 - JANSSEN COVID-19 VACCINE Ad26.COV2.S- Two strokes. 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: TWO STROKES


VAERS ID: 1670157 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-07-27
Onset:2021-08-07
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 RL / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, COVID-19 pneumonia, Death, Dehydration, Dyspnoea, Fatigue, Intensive care, Mechanical ventilation
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: MS
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client''s husband reported client received a flu shot on 7/27/21 when symptoms began. ( does not indicate client received the influenza vaccine and last documented shot was given on 8/23/16.) Symptoms included fatigue, aches mostly in hip, dehydration, and breathing difficulties, which continued to get worse throughout the week. On 8/6/21 husband found client on floor in the bathroom. When paramedics arrived, client refused to go to the hospital. On 8/7/21, husband physically brought client to Hospital where she was admitted with COVID pneumonia. She was in the ICU, ventilated and passed away on 8/30/21.


VAERS ID: 1670340 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-24
Onset:2021-09-03
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Computerised tomogram abdomen normal, Computerised tomogram head, Computerised tomogram pelvis, Computerised tomogram thorax normal, Drug screen negative, Endotracheal intubation, Life support, Pulse absent, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (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), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data: CT scan of chest, abdomen, pelvis, brain all negative. Urine drug screen negative.
CDC Split Type:

Write-up: Patient is a prisoner at the county prison. He had a seizure in his cell and went into cardiac arrest. EMS was called. He got back ROSC en route to the ED. Intubated en route. Lost pulses again and again fot ROSC. Drug screen was negative. All CT scans negative. No medical history. Patient is in critical condition on life support and is not expected to survive the day.


VAERS ID: 1674474 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-05-23
Onset:2021-05-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Embolism arterial
SMQs:, Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: A small blockage in his artery, not large enough to do a stent.
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: My father received the shot on Sunday May 23rd in the late afternoon, on Tuesday May 25th he had an artery embolism and passed away that morning.


VAERS ID: 1675012 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-12
Onset:2021-08-18
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Angiogram pulmonary abnormal, Anticoagulant therapy, Anxiety, Bilevel positive airway pressure, Blood gases, Blood pressure decreased, COVID-19, Cardiac arrest, Condition aggravated, Confusional state, Death, Dyspnoea, Echocardiogram, Emphysema, Endotracheal intubation, Gastrointestinal tube insertion, Haemoglobin decreased, Haemoptysis, Infection, Intensive care, Mechanical ventilation, Oxygen saturation decreased, Packed red blood cell transfusion, Patient restraint, Pulmonary embolism, Pulmonary mass, SARS-CoV-2 test positive, Treatment noncompliance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Myelodysplastic syndrome (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PROAIR HFA; VENTOLIN HFA 12/18/15 ELIQUIS 5 MG Information, Historical ZITHROMAX 250 MG 12/21/18 PULMICORT 0.5 MG/2ML 3/10/18 Keflex 500 MG 1/17/20 1/24/20 CeleXA 10 MG 3/5/17 VIBRA-TABS 100 MG 7/29/21 8/8/21 FLONA
Current Illness:
Preexisting Conditions: Chronic anticoagulation Chronic systolic heart failure COPD (chronic obstructive pulmonary disease) History of pulmonary embolism
Allergies: NKDA
Diagnostic Lab Data: SARS-COV-2, NAA, Detected: 08/18/21.
CDC Split Type:

Write-up: Patient required hospitalization due to breakthrough infection. He received J&J vaccine on 03/12/21. Hospitalized from 08/18/21 - 08/30/21. Below is copied from discharge (death) summary: Hospital Course: HPI: Patient is a 70 year old male with a PMHx of COPD / Emphysema with home O2 dependence recently increased to 3L/NC, HFrEF, recent Dx of PE one month ago on Eliquis and depression who presented to the ED for worsening shortness of breath and hemoptysis. He is Covid positive and did receive the J&J vaccine. He was admitted to the Hospitalist''s Service. He has worsening shortness of breath and increased oxygen demand and work of breathing. He is transferred to the ICU for increased level of care. 8/22: CTA Chest negative for PE but showed severe centrilobular emphysema, left lung apex cavitary lesion (infxn vs. Malignancy). Echo pending. Patient on BiPAP 10/5, 70% FiO2. No other concerns. 8/23: Holding off Baricitinib given concern for CAP. Given Lasix 40 IV x 1 and will resume home Lasix BID in AM for HFrEF. Currently on BiPAP 10/6, 80%. Weaning to HFNC +/- NRB as tolerated. 8/24: Pt with high level of anxiety prn yesterday for which Buspar was effective. He has been anxious overnight. Remains on HFNC. 8/25: Over day time transitioned to bipap with improvement in oxygenation. Reports no change in respiratory status. 8/26: Patient had several episodes of removing HFNC or BiPAP. Placed in restraints w/mittens on HFNC + NRB. Patient with more confusion recently as well. Started on Seroquel. Currently on HFNC + NRB 60L/100%. 8/27: Patient with confusion/agitation yesterday. CT head ordered but patient unable to cooperate even w/Ativan. Patient maxed out on Precedex gtt and still agitated. Added ketamine gtt w/improvement in sedation and patient able to tolerate BiPAP. NG placed. 8/28: Patient with increasing O2 demands last night, patient subsequently intubated and placed on PRVC. Today, patient changed from PRVC to PS with improvements in oxygenation. Patient on 14/10 75% PS satting mid 90''s. 8/29: Overnight patients blood pressure dropping despite being on Levo and Vaso infusions. Neosynephrine infusion added. Bedside ultrasound performed showing ~50% collapse of IVC on inspiration - patient bolused 1L IVF with minimal improvement of blood pressure. Patient with increasing O2 requirements. ABG performed showing Hgb 6.5. Patient type & screened, crossmatched, transfused 1u PRBC''s. Vancomycin added for broad spectrum antibiotic coverage. Spoke with patients significant other who came in to the hospital to see patient - she confirms status of DNR with being ok for intubation. 1957: Maxed on 4 vasopressors. GCS 3T. HR trended down to asystole. No heart tones auscultated. Time of death 1957. Significant other notified. Discharged Condition: deceased


VAERS ID: 1675027 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-15
Onset:2021-08-21
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cardiac arrest, Death, Dyspnoea, Dyspnoea exertional, Fatigue, Infection, Life support, Pulse abnormal, Pulse absent, SARS-CoV-2 test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril (unknown) Metformin 500mg BID Pravastatin (unknown) Ammonium Lactate 12% Lotion Apply a moderate amount topically twice daily Fexofenadine 180mg tablets. Take one tablet every day by mouth as needed. Folic acid 1mg tablet. Take
Current Illness:
Preexisting Conditions: HTN, HLD, T2DM
Allergies: Aspirin
Diagnostic Lab Data: SARS-COV-2, NAA, Detected: 08/21/21.
CDC Split Type:

Write-up: Patient required hospitalization due to breakthrough infection. He received J&J vaccine on 03/15/21. Hospitalized from 08/21/21 - 08/27/21. Below is copied from patients discharge (death) summary: Patient lost pulse soon after family visit. 4 rounds of ACLS performed. Asystole on monitor Time of death pronounced at 1719. Alerted by RN that patient regained a weak pulse at 1722. Pressors restarted. Patient again lost pulse soon after and 1 round of ACLS was performed. No ROSC obtained. Asystole on monitor. No cardiac activity noted. Time of death 1734. 75 y.o. male with a PMH of HTN, HLD, COVId diagnosed 1 week ago presents to the ED c/o worsening SOB. Over the past week he has been noticing exertional SOB, fatigue and dyspnea. He had been able to recover with rest , today he was not able to get back to baseline so he decided to come in. At triage he was satting in the 70s on RA. He was placed on a nonrebreather at that time.


VAERS ID: 1675587 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death, Laboratory test, Malaise, Mechanical ventilation
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cabergoline .5 mg 2x/week
Current Illness: Chest congestion, cough, cold/flu symptoms.
Preexisting Conditions: Pituitary gland tumor
Allergies: None
Diagnostic Lab Data: Many tests were done at Hospital
CDC Split Type:

Write-up: Immune response, COVID-19 pneumonia. Patient told the pharmacist giving vaccine he was not feeling well. They did not test him for COVID and gave vaccine anyway. It is unknown if he officially had COVID-19, but he became sick almost immediately after getting the vaccine. Taken to hospital by ambulance on 08/06/2021, put on a ventilator on 08/13/2021 and died on 08/31/2021.


VAERS ID: 1677072 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: USJNJFOC20210902754

Write-up: DIED; This spontaneous report received from consumer social media via a company representative concerned a 20 year old female 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 (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210902775.; Sender''s Comments: V0:20210902754-covid-19 vaccine Died. 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: 1677074 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: USJNJFOC20210903589

Write-up: COVID-19; This spontaneous report received from a company representative concerned multiple patients of unknown race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. It was reported that "529 people had died of COVID-19 since 01-APR-2021. According to the ADPH, this included twenty people who were vaccinated, who did their part in the fight against COVID-19". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210903589- JANSSEN COVID-19 VACCINE Ad26.COV2.S- COVID-19. 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.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1678243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: USJNJFOC20210902860

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative from social media (Twitter) concerned multiple (two female) patients. The patient''s weight, height, and medical histories were not reported. The patients 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. Batch numbers were not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, multiple (two) patients developed blood clots. As per the reporter, "We already know JnJ had to halt Vax distribution temporarily because of 2 reported deaths from blood clots in women". Patients died on unspecified date(s). It was not reported if an autopsy was performed. Action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210902860- covid-19 vaccine ad26.cov2.s-Blood Clots. 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: BLOOD CLOTS


VAERS ID: 1679276 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-23
Onset:2021-08-06
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19 pneumonia, Computerised tomogram thorax abnormal, Death, Laboratory test abnormal, Lung infiltration, Malaise, Sepsis, White blood cell count increased
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TYLENOL, TRAMADOL, METOPROLOL TARTRATE, BENAZEPRIL, CHOLECALCIFEROL, GABAPENTIN, HCTZ, MAGNESIUM, OMEPRAZOLE, ZINE
Current Illness:
Preexisting Conditions: BENIGN HYPERTENSION, CHRONIC LOW BACK PAIN, DM 2, OSTEOARTHRITIS, GERD, MIGRAINE W/AURA, MIXED HYPERLIPIDEMIA, HRT, SYNCOPE
Allergies: PENICILLIN, SULFA, PRAVASTATIN, CODEINE
Diagnostic Lab Data: CHEST CT 08/16 WITH SEVERE BILATERAL PATCHY INTERSITITIAL AND ALVEOLAR INFILTRATES; LAB SHOWS SEPTICIMIA WBC 12.9 H
CDC Split Type:

Write-up: PHYSICIAN STATES PATIENT RECEIVED JOHNSON AND JOHNSON VACCINE ON 07/23/2021. BECAME ILL 08/06/2021, RESULTING IN COVID PNEUMONIA AND PATIENT''S EXPIRATION ON 09/05/2021


VAERS ID: 1679277 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-23
Onset:2021-05-16
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cerebral haemorrhage, Chest X-ray, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Contusion, Death, Extremity contracture, Laboratory test, Loss of consciousness, Neck surgery, Respiration abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine 5mg
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: All tests were conducted on 5/17/2021. -CT scan head/neck -Radiology/chest -CT/Scan/Head and Neck -CT Scan/Chest -Surgery Neck/Throat There were numbers labs run but I do not have the results
CDC Split Type:

Write-up: 1015 , I found my mother on the floor. She had a contusion on her head from hitting a table edge on the way down. Her right hand was curled up near her face. She was unconscious and breathing with a very loud rasping sound. She was taken to the hospital by ambulance. The Dr told us she had a catastrophic event. One side of her brain was filled with blood. Surgery or comfort care was the only choice. At 1317 they removed everything and began comfort care. Approximately 2000 she was moved to the hospice floor and passed away at approximately 2200..


VAERS ID: 1682403 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-03-11
Onset:2021-08-01
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 28
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: unknown
Current Illness: unknown
Preexisting Conditions: None
Allergies: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient tested positive for COVID-19 and is now deceased


VAERS ID: 1683324 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-29
Onset:2021-09-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Antibody test positive, Anticoagulant therapy, Blood fibrinogen decreased, Blood lactate dehydrogenase normal, Brain death, Cerebral haemorrhage, Computerised tomogram head abnormal, Craniotomy, Death, Fibrin D dimer increased, Haemoglobin normal, Haemostasis, Haptoglobin normal, Headache, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Infarction, International normalised ratio increased, Intracranial pressure increased, Neurological decompensation, Ovarian vein thrombosis, Platelet count decreased, Prothrombin time prolonged, Renal vein thrombosis, Thrombocytopenia, Transfusion, Ventricular drainage, White blood cell count increased, Withdrawal of life support
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (broad), Renovascular disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: History of pre-eclampsia (2015)
Allergies: None
Diagnostic Lab Data: WBC 11.77, Hgb 13.2, Plt 31 (nadir). INR 1.4, PT 16.7, PTT 34. D-Dimer $g 40.00. Fibrinogen 74. Haptoglobin 192. LDH 158. HIT panel with strong positive, HIT optical density 2.552 (this was after she had already received IVIG and some transfusions).
CDC Split Type:

Write-up: Patient presented to the ED around 10pm on 4/21, ~one week after her J&J COVID vaccine (exact date of initial vaccination not confirmed but was reportedly 1 week prior) with abdominal pain and headache. She was found to have thrombocytopenia (Plt 38) on presentation as well as renal and ovarian vein thrombosis. CT head showed a large right frontal intraparenchymal hemorrhage. She was taken for urgent craniotomy on 9/5 with EVD placement. Brain tissue was noted to have bleeding spots unresponsive to cautery and requiring local hemostatic agents. Repeat imaging showed worsening infarction. She had continued elevated intracranial pressures, so was taken back to the OR on the morning of 9/6 for bilateral EVD placement to help relieve pressure. Given her thrombocytopenia, thrombosis, significantly elevated D-dimer, low fibrinogen, and +HIT Ab test, she was diagnosed with vaccine-induced thrombocytopenia and thrombosis (VITT). She was started on IVIG 1g/kg daily x 2 days, bivalirudin with supportive transfusions to maintain goal plts $g50K, fibrinogen $g 150. Despite this, her neurologic status deteriorated due to elevated pressures, clotting off of her EVDs, and ultimately was declared brain dead in the afternoon on 9/7. Family withdrew supportive care and patient passed at 3:57PM on 9/7/21.


VAERS ID: 1683449 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-01
Onset:2021-08-28
   Days after vaccination:149
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, COVID-19, Cardiac arrest, Cough, Death, Dyskinesia, Endotracheal intubation, Haemodialysis, Hyponatraemia, Mechanical ventilation, Neutropenia, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test positive, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Atorvastatin 20 mg QD, Calcitriol 0.5 mg TIW, Clonidine 0.1 mg
Current Illness:
Preexisting Conditions: Anemia, Coagulopathy, Dementia, Depression, DM type 1, Dialysis, hearing loss, hyperlipidemia, hypertension,
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Jannsen Vaccine on 4/01/2021 and 3/23/2021. Presented to facility of 8/28/2021 with a chief complaint of cough without SOB, with room sats of 85%, fever, and COVID positive. Patient required intubation on 8/30/2021 during a cardiac arrest. On 8/31/2021 patient transferred to facility. On arrival with air transport, patient is hemodynamically stable, sedated on propofol. Patient is connected to MV with settings CMV 20/450/.70 +10. On 9/2/2021, spontaneous movement but not following commands. Remains in prone position. HD yesterday.


VAERS ID: 1683559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-27
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death, Headache, Seizure
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 4
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210902775

Write-up: COMA; FITTING; SEVERE HEADACHES (WORSEN NEXT DAY); DIED; This spontaneous report received from a patient social media via a company representative concerned a male of unspecified age, 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 admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, frequency time 1 total administered on 27-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-AUG-2021, after vaccination the patient instantly got severe headaches, even worst next day (28-AUG-2021). On 29-AUG-2021, patient started fitting in hospital and on 30-AUG-2021, she was in coma and was hospitalized (days unspecified). On 31-AUG-2021, the patient died from unknown cause of death. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on 31-AUG-2021, and had not recovered from severe headaches (worsen next day), coma, and fitting. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210902754.; Sender''s Comments: V0: 20210902775-covid-19 vaccine ad26.cov2.s-died, coma, fitting. 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). 20210902775-Covid-19 vaccine ad26.cov2.s-severe headache. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1683561 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hospitalisation, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210910577

Write-up: HOSPITALISATION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; DEATH; This spontaneous report received from social media via a company representative concerned multiple patients. 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) dose, start therapy date were not reported,1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the 15,739 patients got COVID-19 among people who were fully vaccinated (suspected covid-19 infection, suspected clinical vaccination failure), Of those, 571 had been hospitalised (for unspecified days), and 131 had died. The patients died due to unknown reason on an unspecified date. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Outcome of suspected covid-19 infection, hospitalisation and suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210902916, 20210909398 and 20210909281. This case was associated with Product Quality Complaint.; Sender''s Comments: V0; 20210910577-covid-19 vaccine ad26.cov2. s-Death, Hospitalization. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. V0: - 20210910577- covid-19 vaccine ad26.cov2 - Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1684882 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-08-12
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN NO LOT # AVAILA / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: POSITIVE COVID TEST IN JULY 2021, SOB WORSENED, SENT BACK TO HOSPITAL DUE TO HYPOXIA,, THEN DISCHARGED TO HOSPICE WHERE HE PASSED AWAY.


VAERS ID: 1685011 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-08-26
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN NO LOT # AVAILA / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cardiac arrest, Dyspnoea, Pyrexia, Respiratory failure, SARS-CoV-2 test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SOB, FEVER, WEAKNESS, POSITIVE COVID TEST, RESPIRATORY FAILURE, CARDIAC ARREST


VAERS ID: 1685155 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-03-16
Onset:2021-08-19
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-06
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: O2 dependent COPD.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient diagnosed and hospitalized with COVID 19. Patient expired.


VAERS ID: 1685567 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-08-12
Onset:2021-08-29
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-03
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: aspirin,lipitor, vitamin B, iron, midodrine, potassium, gluconate, brilinta, vitamin D, nitro
Current Illness:
Preexisting Conditions: hyperlipidemia, hypertension, coronary artery disease, chronic kidney disease, cerebral infarction
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 8/29/2021, decedent presented to the ER with a three day duration of worsening shortness of breath. He was admitted to the hospital and discharged home on 9/1/2021 with COVID pneumonia.


VAERS ID: 1685705 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-11
Onset:2021-08-25
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Bacteraemia, Bacterial test, COVID-19, Chills, Cough, Death, Diarrhoea, Endotracheal intubation, Fatigue, Haemodialysis, Hypoxia, Mechanical ventilation, Myalgia, Pyrexia, Renal impairment, SARS-CoV-2 test positive, Sepsis, Septic shock, Staphylococcus test positive, Ultrasound kidney normal, Vascular catheterisation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine 5 mg QD, Aspirin 81 mg QD, Atorvastatin 40 mg QD, Calcium Acetate QD, Carvedilol 25 mg BID, Cetririzine 10 mg QD PRN, Clopidogrel 75 mg QD, Ergocalciferol 50,000 units QWeek, Fluticasone nasal BID, Insulin aspart 28 units TID, La
Current Illness:
Preexisting Conditions: Type 2 DM, HTN, hyperlipidemia, Obesity, PVD, CKD, GERD, OSA on CPAP, Hypothyroidism.
Allergies: Lisinopril (Cough), Potassium (Nausea)
Diagnostic Lab Data: Covid Positive Test on 8/25/2021 using Roche LIAT SARS Assay platform using PCR or equivalent nucleic acid amplification technology.
CDC Split Type:

Write-up: Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/11/2021. Presented to ED on 8/25/2021 with a 9-10 day history of coughing, fevers, diarrhea, fatigue, hypoxia, myalgiam and chills. She was started on Dexamethasone on 8/26 and continued this through her hospital course. Eventually her oxygen requirements escalated and she required intubation on 8/27/21 due to persistent significant hypoxia despite maximum non-invasive interventions. A trialysis catheter was also placed for her and nephrology was consulted due to urgent need for dialysis as her kidney function continued to deteriorate since admission. Renal ultrasound did not show any hydronephrosis or obstructive processes. On 8/27 she had 3L removed via HD. She required paralytics, sedation, and pain control while on the ventilator. On 8/27/21, her code status was changed to DNAR/COT. Eventually, she developed septic shock and was found later to be bacteremic (GPC in clusters) with a positive MRSA PCR nares. The culture did not have a final result by the time of her passing. She was started on broad spectrum antibiotics on 8/30 at the time of her becoming more septic. On 8/31, the patient''s MAPs and oxygen saturations continued to decrease despite maximal therapy (including four vasopressors). The patient passed away at 0630 on 8/31/21.


VAERS ID: 1186600 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-04-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abdominal tenderness, Acidosis, Acute myocardial infarction, Agitation, Angiogram pulmonary normal, Anxiety, Arteriogram coronary abnormal, Aspartate aminotransferase increased, Asthenia, Blood bicarbonate decreased, Blood calcium decreased, Blood creatine phosphokinase increased, Blood lactic acid, Blood pH decreased, Blood sodium decreased, Blood urea increased, Body temperature normal, Cachexia, Carbon dioxide decreased, Cardiac arrest, Cardiac failure congestive, Cardiac murmur, Cardio-respiratory arrest, Cardiogenic shock, Catheterisation cardiac abnormal, Computerised tomogram abdomen, Confusional state, Coronary artery disease, Cyanosis, Decreased appetite, Dry skin, Dyspnoea, Ecchymosis, Echocardiogram, Echocardiogram abnormal, Electrocardiogram abnormal, Emotional distress, Endotracheal intubation, Essential thrombocythaemia, Fatigue, General physical condition abnormal, Haematocrit increased, Haemoglobin increased, Hypokinesia, Hypotension, Intensive care, International normalised ratio normal, Intra-aortic balloon placement, Jugular vein distension, Liver function test normal, Lymphocyte count increased, Malaise, Multiple organ dysfunction syndrome, Nausea, Pain, Pallor, Pericardial effusion, Platelet count increased, Pneumonia, Pulmonary mass, SARS-CoV-2 test negative, Sepsis, Septic shock, Sinus tachycardia, Speech disorder developmental, Tachycardia, Thoracic operation, Troponin increased, Unresponsive to stimuli, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Blood premalignant disorders (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown. Recent travel history
Preexisting Conditions: HPI: hx of melanoma s/p immunotherapy 2 years ago, chronic thrombocytosis with 7-8 year history on agrelid, followed by Dr.
Allergies: No known allergies
Diagnostic Lab Data: 4/8/21: CTA in all lung fields, no hypoxia or tachypnea on room air. Non tender in all quadrants, no peritoneal signs. No pedal edema or tenderness bilaterally. CTA was negative for PE, revealed multiple pulmonary nodules largest measuring 1 cm in the left upper lobe and additional nodules 0.9 cm in the lateral right middle lobe and 0.9 cm in the inferior lingula. 0.9 nodule in the inferior linear surrounding tree in bud opacity suggestive of atypical infectious process. EKG 4/8/21 at 0113 Rate: 121, Rhythm: sinus tachycardia, no ST elevation. QTC 462, QRS 72. Repeat EKG read at 0341 Rate: 124, Rhythm: sinus tachycardia, no ST elevation, unchagned from prior. Labs at 0120 - Hgb (18.5), Hct (56.9), Plt (940), Immgrans (1.7), Lympohcytes (4.4); Na (132), CO2 (20), BUN (32.0), Createnine GFR (1.12), EGFR (49), Calcium (8.6). LFTs normal except AST (59). INR 1.1, CPK (1,109), Troponin (4.7) Blood work with elevated troponin (4.7 at 0120, 6.272 at 0755), no STEMI criteria, never with CP or SOB evaluated by cardiology , started on DAPT and heparin , CTPA obtained due to high risk factors for PE with melanoma in the past, recent travel and possible adverse reaction/cogulopathy with vaccine, no PE possible infectious/malignant features in lungs. Blood work also with elevated WBC (22.88 at 0532) and lactic acid (7.8 at 0604; 8.5 at 0755), negative beta hydroxy but with a very low ph, tox screen positive for opiates / tylenol/aspirin levels unremarkable. CPK 1,781 at 0830. SARS coronavirus-2 RNA (COVID-19) test negative at 0212. Labs at 0830 - WBC (30.30), Hgb (17.5), Hct (54.4), Plt (884), Na (136), CO2 (14.3), BUN (33.4), Createnine GFR (1.05), Calcium (7.7), CPK (1,781), Troponin (3.973, 4.031) Echo at 0846 - depress EF between 30-40%, with pericardial fluids, possible pericardial tamponade. At 0900 - ordered CTA chest/abd/pelvis for aortic dissection, the risk of CIN was considered but the benefit outweigh the complication. 4/8/21 at 1040 - Perioperative anesthesia eval: 1) Emergent insertion of peripheral percutaneous venous and arterial ECMO cannulae 2) Emergent initiation of veno-arterial extracorporeal membrane oxygenation support 3) Emergent insertion of distal perfusion cannula 4) Ultrasound guided vascular access 5) Lower extremity angiograms 6) Transthoracic and/or transesophageal echocardiogram(s) 7) Left heart catheterization with coronary angiography LHC showed Non obstructive CAD, LVEDP 37 mmHg (Elevated left sided filling pressures) and RHC showed PA pressure 36/30 mmHg, mean 33mmHg; Sat mixed venous 79%, Ao 98%; CO Fick 5.1, CI 3.26. Pertinent Lab Prior to or at Onset of Code: pH 7.12/31/133/10.1/95%
CDC Split Type:

Write-up: ED note: 62 year old patient presented to Main ED on 4/8/21 at 0120. Patient arrived by ambulance and her chief complaint was left sided abdominal pain associated with generalized weakness, malaise, and fatigue x 3 days. HPI: hx of melanoma s/p immunotherapy 2 years ago, chronic thrombocytosis with 7-8 year history on agrelid, followed by Dr. Patient travelled recently. She received her Johnson and Johnson Covid vaccine Sunday afternoon (4/4). The next day she started to feel unwell with malaise, generalized weakness and body aches. with subjective fevers on Monday (4/5), nausea and 1 episode of non bilious vomiting. She refers severe pain that did not improved with ibuprofen, as well as increased fatigue, anorexia and has been unable to drink or eat any food for the past couple of days. As per her husband she also developed SOB with exertion yesterday. No fever, chills, constipation, diarrhea, blurred vision, numbness or paresthesias. Travel 4 days prior and receiving johnson and johnson covid vaccine. No modifying factors. No urinary sx, cough, no sick contacts. Pt denies measured fevers, chills, diarrhea, chest pain, SOB, blood in stool, headache, vision changes, numbness/tingling, focal weakness. No prior hx of MI / PE, no history of similar pain , no abdominal surgeries. PMHx: melanoma, thrombocytosis ; PSHx: none ; Social Hx: (-) tobacco, (-) EtOH, (-) illicit drug use ; Allergies: none ; PCP: in another country NKDA. Family history: Mother CKD. Social history: she is married, originally from another country; has been living in another location for the last 3 months. She is an architect Denies any sick contacts. Her husband has been vaccinated for COVID-19.Travel screening done in the ED: no/unsure if in the last month she may have been in contact with someone who was confirmed or suspected to have COVID-19. Yes (negative result) to "have you had a COVID-19 viral test in the last 14 days. No to "do you have any of the following new or worsening symptoms?" and no to have you traveled internationally in the last month? No documented travel since 03/08/21. No to all high risk personnel screen questions. Physical Exam on 4/8/21 at 0128am: BP 110/58 | Pulse 120 | Temp 97 ?F (36.1 ?C) | Resp (!) 34 | Ht 5'' 2.99" (1.6 m) | Wt 125 lb 10.6 oz (57 kg) | SpO2 97% | BMI 22.27 kg/m? Normal PE in ED: Constitutional: She is oriented to person, place, and time. She appears well , well-developed, well-nourished and appears stated age. Non-toxc appearing, no nystagmus or gaze deviation, no meningismus or rigidity, 2+ equal pulses in all extremities, tachycardic, regular. Code sepsis called at 0250. At 0951 - Dr.at bedside will take patient to the OR for possibly VA ECMO for ischemic cardiomyoptahy. Medications: ASA, brilinta and heparin drip. Started on cefepime, vancomycin and azithromycin (D1) for suspected multifocal pneumonia Patient became hypotensive in the course of the morning and was transferred to the cath lab for urgent cardiac catheterization that showed non-obstructive CAD, elevated filling pressures, normal CO (on levophed). Echo showed LVEF 29%, biventricular failure, global hypokinesis. No valve disease 4/8/21 at 1012 - Cardiothoracic Surgery: Physical Exam positive for: Constitutional: She appears well-developed and well-nourished. She appears toxic. She has a sickly appearance. She appears ill. She appears distressed. Nasal cannula in place. Neck: Normal range of motion. Neck supple. JVD present. Cardiovascular: Regular rhythm. Tachycardia present. Murmur heard. Systolic murmur is present with a grade of 2/6. Pulmonary/Chest: Effort normal. No respiratory distress. She has rales. Abdominal: Soft. She exhibits no distension. There is abdominal tenderness. There is no rebound and no guarding. Neurological: She is alert. She has normal strength. A sensory deficit is present. Skin: Skin is dry and intact. Ecchymosis noted. She is not diaphoretic. There is cyanosis. There is pallor. Psychiatric: Judgment and thought content normal. Her mood appears anxious. Her speech is delayed. She is agitated. Cognition and memory are normal. Assessment: 1) Cardiogenic shock -discussed extensively with patient and husband high likelihood for need for V-A ECMO support 2) NSTEMI -f/u LHC to eval for CAD 3) Essential thrombocytosis - rec heme consult as plts significantly elevated and high risk of thrombus/embolism development 4) Pericardial effusion - rpt echo in AM but no indication for intervention at this time as no evidence of tamponade physiology by echo 4/8/21 at 1230 - Cardiothoracic surgery note: Patient evaluated at bedside with cardiology at time of cardiac cath with decision for no ECMO support as per cardiology recs secondary to shock not thought to be cardiogenic primary in nature with further management as per MICU. 4/8/21 at 1254 - Coronary Care Unit note: CTA abdomen and pelvis showed no acute aortic disease, no ischemic bowel, small linear filling defect in proximal celiac trunk may represent nonocclusive thrombus, stable small mildly hyperdense pericardial effusion. She was taken to the OR for cath and possible ECMO. Found to be agitated and confused. She was intubated in the OR and pressors were started (Levophed and epinephrine). IABP placed during cath, but removed due to good cardiac function. No coronary artery disease on cath. RIJ Swan Ganz placed. During the course of hours WBC increased to 30 and then to 45. Her pressors requirements increased and the acid base status woresened, with depleted bicarb and low pH. Currently on broad spectrum ATB (cefepime, Vancomycin and azithromycin) with infusion of flis and albumin, bicarb pushes (2) and gtt, on Levophed and vasopressin. Currently on broad spectrum ATB (cefepime, Vancomycin and azithromycin) with infusion of IVF and albumin, bicarb pushes (2) and gtt, on Levophed and vasopressin. 4/8/21 at 2127 - Surgery note: We are consulted due to concern for bowel ischemia. The patient is on max dose of Levo, Vaso, Epi with refractory hypotension and acidosis. Her CT shows all mesenteric vessels are patent and no bowel thickening, stranding, or free fluid to suggest bowel ischemia. The abdomen is soft non tender and non distended. In the setting of multiorgan failure and low flow state, non occlusive mesenteric ischemia would be expected but would be diffuse in nature rather than focal. There is no role for surgical resection for diffuse bowel ischemia if it develops--the mainstay of treatment being to improve her overall perfusion to vital organs. She may benefit from ionotropic support in addition to vasopressors. Code Blue called 4/9/2021 at 0045 ? patient found unresponsive, asystole. History: 62 y.o female history of ET, melanoma s/p surgical removal and immunotherapy, presented with septic shock with metabolic acidosis, intubated, sedated on pressors, levophed, epinephrine and vasopressin drip. Pertinent Lab Prior to or at Onset of Code: pH 7.12/31/133/10.1/95%


VAERS ID: 1249184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
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: Medical History/Concurrent Conditions: Cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210422620

Write-up: ACUTE DECOMPENSATION; This spontaneous report received from a consumer via a company representative concerned a 7 decade old female. The patient''s height, and weight were not reported. The patient''s past medical history included oncologic process. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 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 09-APR-2021, the subject experienced acute decompensation. On 09-APR-2021, the subject died from unknown cause of death. The patient had an oncologic process for which she considered traveling to the US to be vaccinated against COVID given that in Argentina and patient would to wait very long. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210422620-Covid-19 Vaccine Ad26.Cov2.S-Acute Decompensation. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1255787 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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 was very healthy
Allergies:
Diagnostic Lab Data:
CDC Split Type: VNJNJFOC20210435630

Write-up: DEATH; BLOOD COAGULATION; This spontaneous report received from a consumer concerned a 21 year old male. The patient''s weight, height, and medical history were not reported. It was noted the patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry :UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported . Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in 2021, the patient developed blood coagulation, reported as "the vaccine caused blood coagulation". The patient subsequently died 10 days after vaccination; the cause of death was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event blood coagulation was not provided. The patient died on an unspecified date 10 days after vaccination. This report was serious (Death and Other Medically Important Condition).; Sender''s Comments: V0: This 21-year-old male patient was reported in social media to have developed "blood coagulation" after an unspecified duration of receiving COVID-19 VACCINE AD26.COV2.S. The patient died from an unspecified cause 10 days after vaccination. No other details was reported. Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.; Reported Cause(s) of Death: DEATH


VAERS ID: 1272743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ARJNJFOC20210455424

Write-up: DEATH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 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 08-APR-2021, the patient died from unknown cause of death three days after vaccination (vaccinated on 05-APR-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender''s Comments: 20210455424-Covid-19 vaccine ad26.cov2.s-death. 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: 1281036 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210455217

Write-up: Arrhythmia; This spontaneous report received from a patient via regulatory authority concerned a 77 year old of unspecified sex. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, on an unspecified anatomical site for prophylactic vaccination. 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 experienced arrhythmia. On an unspecified date, the patient died from arrhythmia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of arrhythmia on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210455217-COVID-19 VACCINE AD26.COV2.S-Arrythmia. This event 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.; Reported Cause(s) of Death: ARRHYTHMIA


VAERS ID: 1342583 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210541498

Write-up: DEATH; This spontaneous report received from a patient via a company representative from news article concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency once total, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was died. The cause of death was not reported. It was unknown whether the autopsy was done or not. It was reported that first forensic investigations did not revealed obvious connections with the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210541498-covid-19 vaccine ad26.cov2.s -death. 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: DEATH


VAERS ID: 1345915 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210541514

Write-up: SUSPICIOUS DEATH; This spontaneous report received from a company representative who reported seeing tweets and news articles concerning a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, therapy start date were not reported, at frequency of one total administered for prophylactic vaccination. The batch number was not reported. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. It was reported in news articles that on unspecified date in MAY-2021, there was suspicious death (cause unknown) of the patient. However, the first forensic investigation did not reveal obvious connection with vaccine. The patient died from unknown cause. It was unknown whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210533585.; Sender''s Comments: V0 -20210541514-covid-19 vaccine ad26.cov2.s-Suspicious death. 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: 1348517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 0
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210533585

Write-up: DEATH; CARDIAC ARREST; This spontaneous report received from a company representatives who reported seeing tweets and news articles concerning a 61 year old male, race and ethnicity unspecified. Initial information was processed with additional information received on 17-MAY-2021 and 18-MAY-2021. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cardiac arrest. On 15-MAY-2021, the patient died after receiving the vaccine (date of vaccination discrepant; as some tweets note the vaccine was inoculated on the morning of death and others state the vaccine was inoculated four days before he died (11-MAY-2021)). The magistrate on duty was informed, who then arranged for his body to be taken to the morgue pending autopsy. The local health unit informed the Regional Crisis Unit of the episode. No other details on the identity of the man were communicated. In recent weeks, there were two other suspicious deaths, in which autopsy ruled out as being related to the vaccination. As the prosecutor opened an investigation into this man''s death, the investigators arranged an autopsy to establish a possible link with the vaccine. It was noted that he did not suffer from particular pathology and as ordered by the prosecutor, the body was currently in the morgue at the hospital awaiting examination. The doctors would have hypothesized a cardiac arrest. The magistrate asked for the seizure of the entire batch of vials, however, had already been almost entirely inoculated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 15-MAY-2021. This report was serious (Death). This case, from the same reporter is linked to 20210541514 and 20210541498.; Sender''s Comments: V0: 20210533585- Covid-19 vaccine ad26.cov2.s-Death, Cardiac arrest. 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: DEATH; CARDIAC ARREST


VAERS ID: 1349719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-24
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210545674

Write-up: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 22-MAY-2021 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. The patient died two days after receiving vaccination cause of death is unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210545674-covid-19 vaccine ad26.cov2.s-Death. 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: 1353707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 0
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210542565

Write-up: MILD MYALGIA ONLY THE DAY AFTER THE VACCINE UPON TAKING PARACETAMOL. THE DAY AFTER GENERAL WELL-BEING. THE FOLLOWING DAY FOUND DEAD WITHOUT APPARENT CAUSE; MILD MYALGIA ONLY THE DAY AFTER THE VACCINE UPON TAKING PARACETAMOL. THE DAY AFTER GENERAL WELL-BEING. THE FOLLOWING DAY FOUND DEAD WITHOUT APPARENT CAUSE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-729631] concerned a 60 year old male. The patient''s weight was 73 kilograms, and height was 175 centimetres. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) .5 ml, administered on 12-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 13-MAY-2021, the patient experienced moderate myalgia without any fever and called the physician and asked if he could take Paracetamol for the same. On 14-MAY-2021, the patient was feeling well, and had no more pain or fever and especially no headache. On 15-MAY-2021, the patient expired and his son found him dead in the early afternoon, leaning over the bath bidet, with a bruised lesion on the nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death and myalgia on 15-MAY-2021. This report was serious (Death). Sender''s Comments: V0: 20210542565-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Myalgia. 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: DEATH


VAERS ID: 1353989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210548196

Write-up: DEATH; BRAIN STROKE; This spontaneous report received from a patient''s husband via a company representative concerned an adult female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain stroke. The patient died from unknown cause of death. It was reported that, death was related to stroke but no official information was reported. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date and outcome of brain stroke was not reported. This report was serious (Death and Other Medically Important Condition).; Sender''s Comments: V0:20210548196-COVID-19 VACCINE AD26.COV2.S-Death ,Brain stroke. 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: 1356975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Administration site pain, Blood fibrinogen, Body temperature, Cerebral haemorrhage, Deep vein thrombosis, Disseminated intravascular coagulation, Electrocardiogram, Fibrin D dimer increased, Influenza like illness, Platelet count, Prothrombin time, Prothrombin time shortened, Superior sagittal sinus thrombosis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: was not on hormonal contraception
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: above 200 g/L; Test Date: 20210514; Test Name: EKG; Result Unstructured Data: not reported; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: 25 g/L; Test Date: 20210519; Test Name: Fibrin D dimer abnormal; Result Unstructured Data: over 35000; Test Date: 20210519; Test Name: Fibrinogen; Result Unstructured Data: 91; Test Date: 20210519; Test Name: APTT; Result Unstructured Data: ratio 1.19; Test Date: 20210519; Test Name: Thrombocyte count; Result Unstructured Data: 50 g/L; Comments: (40 on citrate); Test Date: 20210519; Test Name: Prothrombin time; Result Unstructured Data: 48 %
CDC Split Type: SIJNJFOC20210550911

Write-up: DISSEMINATED INTRAVASCULAR COAGULATION; CEREBRAL HEMORRHAGE; VENOUS THROMBOSIS OF SAGITTAL SINUS THROMBOSIS; Fibrin D dimer increased; Prothrombin time decreased; DEEP VEIN THROMBOSIS IN THE CALF; THROMBOCYTOPENIA; INFLUENZA LIKE ILLNESS; administration site pain; This spontaneous report was received from a physician and pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, SI-JAZMP-NCPHV-2021SI0598_0598, PBE-FAMHP-DHH-N2021-92848] and from online article, and concerned a 37 year old female. The patient''s height, weight, and medical history were not reported. The patient''s was not on hormonal contraception. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, vaccination site not reported, batch number: XD955 expiry: 28/2/2023) 1 dosage form, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 07-MAY-2021, the same day as receiving the vaccine, the patient experienced administration site pain. On 10-MAY-2021, (3 days post vaccine) the patient had flu-like symptoms including chills, sore throat with linings and was diagnosed angina tonsillitis, difficulty swallowing, malaise, myalgia, headache, tiredness, arthralgia, body temperature 39 degrees Celsius. On 14-MAY-2021, the patient had consultation for influenza like illness. She had normal thrombocytes $g 200 g/L and ECG (result not reported). On 17-MAY-2021, detection of a deep vein thrombosis in the calf. Treatment started low molecular weight heparin, Innohep (tinzaparine) 10.000 once a day for 2 injections total despite thrombocytopenia 25 g/L. On 19-MAY-2021, patient was seen at emergency service for disturbance of consciousness and hemiplegia during the night. It was detected that patient had disseminated intravascular coagulation and cerebral hemorrhage (bilateral, intraparenchymatous) facilitated by a venous thrombosis of sagittal sinus thrombosis, thrombocytopenia due to vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) and anticoagulation treatment (coded to thrombocytopenia). Laboratory data included: APTT ratio 1.19, Fibrin D-dimer abnormal over 35000, fibrinogen 91 (fibrogenopenia), prothrombin time 48%, and thrombocyte count 50 g/L (40 on citrate); normal ranges not reported for all results. Patient was admitted to intensive care unit, intubated, placed on mechanical ventilation and sedation. Treatment medications included mannitol 15 g in 15 minutes, polyvalent immunoglobulins 1g/kg/day for 2 days. Innohep (tinzaparine sodium) was discontinued and switch to Orgaran (danaparoid sodium) with monitoring of "anti Xa activity", dexamethasone 40 mg per day for 4 days. Patient died on 20-MAY-2021 (also reported as 21-MAY-2021). The cause of death was not reported. It was unknown whether an autopsy was performed. On 25-MAY-2021, positive test result was received for heparin-induced thrombopenia (HIT II). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient outcome for the events venous thrombosis of sagittal sinus thrombosis, deep vein thrombosis, disseminated intravascular coagulation, cerebral hemorrhage, thrombocytopenia, Fibrin D dimer increased, prothrombin time decreased was fatal. Outcome for influenza like illness and administration site pain was unknown. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This case is linked to duplicate cases 20210550864, 20210550753.; Sender''s Comments: V0: This spontaneous report received from a physician and pharmacist via a regulatory authority and from online article concerned a 37-year-old woman who died after experiencing thrombocytopenia (platelet nadir: 25,000) on day 10 and sagittal sinus thrombosis (CVST) on day 12 after vaccination. Medical history was not reported. Concomitant medications included paracetamol and the patient was not taking hormonal contraception. On day 3 after vaccination, the patient had flu-like symptoms including chills, sore throat, difficulty swallowing, malaise, myalgia, headache, tiredness, arthralgia, and fever. On day 7, the patient had normal platelet count ($g200,000). On day 10, a deep vein thrombosis was detected in the calf. Treatment was initiated with low molecular weight heparin despite new thrombocytopenia (25,000). On day 12, the patient presented to the emergency department for disturbance of consciousness and hemiplegia during the night. The patient had disseminated intravascular coagulation (DIC) and cerebral hemorrhage facilitated by a venous thrombosis of sagittal sinus thrombosis. Laboratory data included: high D-dimer ($g 35000), low fibrinogen (91), low platelet count (50,000; 40,000 on citrate). Patient was intubated and placed on mechanical ventilation. Treatment medications included mannitol and polyvalent immunoglobulins for 2 days and dexamethasone for 4 days; Innohep (tinzaparine) was discontinued and switched to Orgaran (danaparoid). Patient died on day 13 of unreported cause. It was unknown whether an autopsy was performed. On day 18, a positive test result was received for heparin-induced thrombopenia (HIT II). Although the use of heparin may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition) and considering the low platelet count prior to heparin use and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.


VAERS ID: 1357482 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

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: BEJNJFOC20210548097

Write-up: DEATH; This spontaneous report received from a patient via a company representative concerned a 4 decade old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry :Unknown) dose, start therapy date were not reported, total 1 dose was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death around 10 days after receiving the vaccine. It was not reported, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 - 20210548097 - Covid-19 vaccine ad26.cov2.s - DEATH . 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: 1362958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Neurological symptom, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 1
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: Medical History/Concurrent Conditions: Disease Parkinson''s; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210551265

Write-up: SHOCK; NEUROLOGICAL SYMPTOM; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-2021056660] concerned an 80-year-old male. The patient''s weight was 80 kilograms, and height was 170 centimeters. The patient''s past medical history included disease Parkinson''s, and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955) 1 dosage forms, 1 total administered on 30-APR-2021 for covid-19 vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient had neurological symptom. On 02-MAY-2021, he had shock. On the same day, he died from shock, and neurological symptom. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210551265-Covid-19 vaccine ad26.cov2.s-Shock, neurological symptoms. 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: SHOCK; NEUROLOGICAL SYMPTOM


VAERS ID: 1364572 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

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: DEJNJFOC20210557499

Write-up: FLU-LIKE SYMPTOMS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-202100077678] concerned a 79 year old male. 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: XD955 expiry: unknown) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced flu-like symptoms. On an unspecified date, the patient died from flu-like symptoms. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0; 20210557499-COVID-19 VACCINE AD26.COV2.S-Flu-like symptoms. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: FLU-LIKE SYMPTOMS


VAERS ID: 1369919 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-16
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENITRIN 5 MG/24 HOUR TRANSDERMAL PATCH; CONGESCOR 1.25 MG, FILM COATED TABLETS; UROREC 8 MG HARD CAPSULES; LASIX 25 MG TABLET; BREVA? DOSED AEROSOL; MINIAS 2,5 MG/ML ORAL DROPS, SOLUTION; OMEPRAZOLE; COUMADIN 5 MG TABLET; FINASTERIDE
Current Illness: AFib; COPD; Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Basedow''s disease; Cholecystectomy; Hernia inguinal
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210546385

Write-up: DEATH SUDDEN; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-730740] concerned an 89 year old male of unspecified ethnicity. The patient''s weight was 75 kilograms, and height was 165 centimeters. The patient''s past medical history included hernia inguinal surgery in 1970, Basedow''s disease, and cholecystectomy was performed in 1981, and concurrent conditions included atrial fibrillation (AFib), Ischemic heart disease (IHD) and chronic obstructive pulmonary disease (COPD). The patient was previously treated with tapazole for Basedow''s disease from 2015 to August 2020. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: unknown) 1 dosage forms was administered on 13-MAY-2021 for COVID-19 vaccination. Concomitant medications included Venitrin (glyceryl trinitrate) transdermal patch, Congescor (bisoprolol fumarate) film coated tablet, Urorec (silodosin) hard capsules, Lasix (furosemide) tablet, Breva (ipratropium bromide/salbutamol) aerosol, Minias (lormetazepam) oral drops solution, omeprazole, Coumadin (warfarin sodium) tablet and finasteride used for unknown indication. On 15-May-2021, the patient had accidental fall on the landing of his home. The patient called the emergency helpline number and no fractures were reported and the patient refused to visit a hospital. The next day, on 16-MAY-2021, the patient died from unknown cause of death and his body was found. A request for clinical report from the attending physician was made on 18-MAY-2021. It was unknown whether autopsy performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender''s Comments: V0: 20210546385-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1372728 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-23
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: It was not clear whether there was a previous disease or not.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210559467

Write-up: CORONARY THROMBOSIS; This spontaneous report received from a patient via a company representative concerned a 64-year-old male. Initial information was processed with additional information received on 30-MAY-2021 and 31-MAY-2021. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included it was not clear whether there was a previous disease or not. 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 administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-MAY-2021, the patient experienced a coronary thrombosis, and was hospitalized. The patient passed away shortly afterwards. The autopsy revealed that the cause of death was coronary thrombosis On 23-MAY-2021, the patient died from coronary thrombosis. An autopsy was performed on an unspecified date of MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from a patient via a company representative concerned a 64-year-old man who experienced fatal coronary thrombosis 1 day after vaccine. Past medical history was unknown. No concomitant medications were reported. One day after vaccine, the patient was hospitalized for a coronary thrombosis and died shortly after. The autopsy revealed that the cause of death was coronary thrombosis. There was no further available information on risk factors, clinical course, diagnostic or laboratory information. Information in this case is limited precluding a meaningful medical assessment. Additional information will be requested if contact information becomes available.; Reported Cause(s) of Death: CORONARY THROMBOSIS


VAERS ID: 1373957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-25
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Acute myocardial infarction, Coronary artery embolism, Headache, Nausea, Troponin increased
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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: DEJNJFOC20210601135

Write-up: ACUTE MYOCARDIAL INFARCTION, OF ANTERIOR WALL; EMBOLUS CORONARY ARTERY; CARDIAC TROPONIN INCREASED; ABDOMINAL PAIN UPPER; NAUSEA; HEADACHE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-202100079089] concerned a 68 year old male, ethnicity unknown. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-MAY-2021, the patient experienced acute myocardial infarction, of anterior wall, nausea, headache, embolus coronary artery, cardiac troponin increased and abdominal pain upper. On an unspecified date, the patient died from acute myocardial infarction, of anterior wall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute myocardial infarction, of anterior wall, nausea, headache, embolus coronary artery, cardiac troponin increased and abdominal pain upper on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210601135-covid-19 vaccine ad26.cov2.s- acute myocardial infarction, of anterior wall, embolus coronary artery, cardiac troponin increased, abdominal pain upper, nausea, headache. 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: ACUTE MYOCARDIAL INFARCTION, OF ANTERIOR WALL


VAERS ID: 1374049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-17
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Dyspnoea, Embolism, Hypertension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 2
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: MOXOGAMMA; AMLODIPINE;PERINDOPRIL
Current Illness: Allergic reaction to drug (Statins cause urticaria); Hypercholesterolaemia (Statins contraindicated - patient had urticaria when using them); Primary hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVJNJFOC20210606885

Write-up: THROMBOEMBOLISM; ACUTE MYOCARDIAL INFARCTION IN INFERIOR WALL OF LEFT VENTRICLE; HYPERTENSION; SHORTNESS OF BREATH; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, LV-SAM-2021055756] concerned an 86 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included primary hypertension, hypercholesterolaemia, and allergic reaction to drug (experienced urticaria with statins). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 0.5 ml, 1 total, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included amlodipine/perindopril, and moxonidine. On 17-MAY-2021, the patient had thromboembolism, acute myocardial infarction in inferior wall of left ventricle, hypertension, and shortness of breath. The patient was hospitalized (dates and duration unspecified). On 19-MAY-2021, the patient died due to acute myocardial infarction, hypertension, and thromboembolism. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute myocardial infarction in inferior wall of left ventricle, thromboembolism and hypertension on 19-MAY-2021, and the outcome of shortness of breath was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210606885-COVID-19 VACCINE AD26.COV2.S-thromboembolism, acute myocardial infarction in inferior wall of left ventricle, shortness of breath. 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). 20210606885-COVID-19 VACCINE AD26.COV2.S-hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: ACUTE MYOCARDIAL INFARCTION; HYPERTENSION; THROMBOEMBOLISM


VAERS ID: 1380097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death, Ischaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 1
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210606910

Write-up: DEATH; ISCHEMIA; DEEP COMA; This spontaneous report received from a consumer via a company representative concerned a 68 year old male unknown ethnicity and race. The patient''s weight, height, and medical history were not reported. 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, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-JUN-2021, the patient experienced ischemia and went in deep coma. On 03-JUN-2021, the patient died. He died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 03-JUN-2021, had not recovered from deep coma, and the outcome of ischemia was not reported. This report was serious (Death, and Life Threatening). This case, from the same reporter is linked to 20210606849.; Sender''s Comments: V0: 20210606910-covid-19 vaccine ad26.cov2.s-Death, Ischemia, Deep coma. This event(s) is considered un-assessable. The event(s) has an unknown/unclear 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: 1383882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Asthenia, Cerebral haemorrhage, Computerised tomogram, Eye movement disorder, Incontinence, Loss of consciousness, Shift to the left
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; TICLOPIDINE
Current Illness: Anxiodepressive syndrome; Arthrosis; Bronchitic asthma; Hypertension arterial; Prostate adenoma; Tachyarrhythmia; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cytomegalovirus colitis; Diverticula of colon; Haemorrhoids; Polyps; Rectorrhagia
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Computerised tomogram; Result Unstructured Data: unknown; Test Date: 20210529; Test Name: CT angiography; Result Unstructured Data: unknown
CDC Split Type: ITJNJFOC20210611419

Write-up: HEMORRHAGIC STROKE; LOSS OF CONSCIOUSNESS; RIGHT BRACHIOCRURAL HYPOSTHENIA; LEFT OCULOCEPHALIC DEVIATION; SPHINCTER RELEASE; SHIFT TO THE LEFT; This spontaneous report received from a physician via a Regulatory Authority [Regulatory Authority, IT-MINISAL02-737635] concerned a 67 year old male. The patient''s weight was 68 kilograms, and height was 174 centimeters. The patient''s past medical history included diverticula of colon, rectorrhagia, polyps, cytomegalovirus colitis, and haemorrhoids, and concurrent conditions included tachyarrhythmia, anxiodepressive syndrome, hypertension arterial, type 2 diabetes mellitus, bronchitic asthma, arthrosis, and prostate adenoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 24-MAY-2021 for sars-cov-2 vaccination. Non-company suspect drugs included: ticlopidine (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 29-MAY-2021 for antiplatelet therapy. Concomitant medications included metformin for type 2 diabetes mellitus. On 29-MAY-2021, five days after the vaccination, the patient experienced hemorrhagic stroke, loss of consciousness, right brachiocrural hyposthenia, left oculocephalic deviation, sphincter release and shift to the left. On 29-MAY-2021, Laboratory data included: CT angiography (NR: not reported) unknown, and computerized tomogram (NR: not reported) unknown. On 29-MAY-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ticlopidine was withdrawn on 29-MAY-2021. The patient died of hemorrhagic stroke, loss of consciousness, right brachiocrural hyposthenia, left oculocephalic deviation, sphincter release and shift to the left on 29-MAY-2021. This report was serious (Death).; Reporter''s Comments: Sender''s Comments: V0: 20210611419-COVID-19 VACCINE AD26.COV2.S-hemorrhagic stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210611419-COVID-19 VACCINE AD26.COV2.S- loss of consciousness, right brachiocrural hyposthenia, left oculocephalic deviation, sphincter release, shift to the left. 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: 1384817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
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: DEJNJFOC20210607177

Write-up: UNKNOWN CAUSE OF DEATH; This spontaneous report received from a physician via a Regulatory Authority concerned a 71 year old female (unspecified 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 admin not reported, batch number: X0959 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject died from unknown cause of death. It was reported that, the patient death occurred next day after receiving the vaccine. On 22/05/2021 It was not reported, if an autopsy was performed. Last updated patient body was sent for forensic department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210607177- Covid-19 vaccine ad26.cov2.s-unknown cause of death. 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: 1386906 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Headache, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210613817

Write-up: DEATH (4 DAYS AFTER GETTING JANSSEN COVID-19 VACCINE); THROMBOSIS; HEADACHE; TIREDNESS (EXPERIENCING FOR ALL THE ENTIRE WEEKEND); This spontaneous report received from a patient via a company representative via social media concerned a 62-year-old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis, headache, and tiredness (experiencing for all the entire weekend). On an unspecified date (4 days after vaccination), patient died due to unknown cause. Investigation are being carried out to know if the patient suffered from some pathology that patient was unaware. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause and the outcome of headache, tiredness (experiencing for all the entire weekend) and thrombosis was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210613817-COVID-19 VACCINE AD26.COV2.S -Death and thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1389485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-23
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Lumbar scoliosis
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Infection urinary tract
Allergies:
Diagnostic Lab Data: Test Date: 20200402; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20210619012

Write-up: CARDIO-RESPIRATORY ARREST; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-2021062586] concerned an 82 year old female. The patient''s weight was 39 kilograms, and height was 135 centimeters. The patient''s past medical history included infection urinary tract, and covid-19 in APR-2020, and concurrent conditions included lumbar scoliosis, and arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-02 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 22-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 02-APR-2020, the patient''s laboratory data included: SARS-CoV-2 test positive. On 23-MAY-2021, the patient experienced cardio-respiratory arrest. On the same day, the patient died due to cardio-respiratory arrest. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210619012-COVID-19 VACCINE AD26.COV2.S -Cardio-respiratory arrest. 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.; Reported Cause(s) of Death: CARDIO-RESPIRATORY ARREST


VAERS ID: 1391229 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-26
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Diarrhoea, Frequent bowel movements, Intestinal ischaemia, Muscle spasms, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-BISOPROLOL; OXAZEPAM; AMLODIPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Hormone therapy; Lumpectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210616258

Write-up: DEATH; EXTENSIVE ISCHEMIA OF SMALL INTESTINE AND COLON; DIFFUSION ABDOMINAL PAIN; DIFFUSION ABDOMINAL PAIN; FREQUENT BOWEL MOVEMENTS; NAUSEA; CRAMPS; WATERY DIARRHEA; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94284] concerned a 79 year old female of unspecified race and ethnicity. The patient''s weight was 68 kilograms, and height was not reported. The patient''s past medical history included in 2002, lumpectomy followed by post-radiation, hormonal therapy based on Nolvadex (tamoxifen), and on 11-JUN-2007 laparoscopic cholecystectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: unknown) dose was not reported, administered on 26-MAY-2021 for covid-19 immunization. Concomitant medications included Amlodipine, Bisoprolol fumarate/hydrochlorothiazide, and Oxazepam for unknown indication. On 26-MAY-2021, the patient experienced extensive ischemia of small intestine and colon, diffusion abdominal pain (Abdominal pain), diffusion abdominal pain (Diffuse pain), frequent bowel movements, nausea, cramps and watery diarrhea. The patient died from laparoscopic exploration with determination of extensive ischemia of small intestine and colon (treatment received on 30-MAY). It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, extensive ischemia of small intestine and colon, diffusion abdominal pain, diffusion abdominal pain, frequent bowel movements, nausea, cramps and watery diarrhea on 26-MAY-2021. This report was serious (Death).; Reporter''s Comments: Treatment - Ja 30/05 :Evolution of the ADR; Sender''s Comments: V0-20210616258-COVID-19 vaccine ad26.COV2.S-Death, extensive ishchamia of small intestine and colon, diffusion abdominal pain, diffusion abdominal pain, frequent bowel movements, nausea, cramps, watery diarrhea. 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: LAPAROSCOPIC EXPLORATION WITH DETERMINATION OF EXTENSIVE ISCHEMIA OF SMALL INTESTINE AND COLON


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