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From the 1/21/2022 release of VAERS data:

Found 192 cases where Vaccine is COVID19 and Manufacturer is JANSSEN and Symptom is Aortic thrombosis or Arterial thrombosis or Arterial thrombosis limb or Atrial thrombosis or Axillary vein thrombosis or Basilar artery thrombosis or Brachiocephalic vein thrombosis or Carotid artery thrombosis or Cavernous sinus thrombosis or Cerebral artery thrombosis or Cerebral thrombosis or Cerebral venous sinus thrombosis or Cerebral venous thrombosis or Coronary artery thrombosis or Deep vein thrombosis or Hepatic vein thrombosis or Iliac artery thrombosis or Injection site thrombosis or Intracranial venous sinus thrombosis or Jugular vein thrombosis or Mesenteric vein thrombosis or Ophthalmic artery thrombosis or Ophthalmic vein thrombosis or Pelvic venous thrombosis or Peripheral artery thrombosis or Portal vein thrombosis or Postpartum venous thrombosis or Pulmonary artery thrombosis or Pulmonary thrombosis or Retinal artery thrombosis or Retinal vascular thrombosis or Retinal vein thrombosis or Spinal artery thrombosis or Splenic vein thrombosis or Subclavian vein thrombosis or Superior sagittal sinus thrombosis or Thrombosis or Thrombosis in device or Transverse sinus thrombosis or Truncus coeliacus thrombosis or Umbilical cord thrombosis or Vena cava thrombosis or Venous thrombosis or Venous thrombosis limb and Patient Died

Government Disclaimer on use of this data

Table

   
AgeCountPercent
17-44 Years126.25%
44-65 Years2613.54%
65-75 Years2010.42%
75+ Years147.29%
Unknown12062.5%
TOTAL192100%



Case Details

VAERS ID: 1114806 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-03-06
Onset:2021-03-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: School       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Brain death, Brain herniation, Cerebral haematoma, Cerebral haemorrhage, Cerebral mass effect, Cerebral venous thrombosis, Cerebral ventricle dilatation, Computerised tomogram head abnormal, Endotracheal intubation, Headache, Hemiparesis, Mental status changes, Posturing, Retching, Thrombocytopenia
SMQs:, Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine
Current Illness: Depression
Preexisting Conditions:
Allergies: NKMA, No allergies
Diagnostic Lab Data: CT Angiogram of the head 3/17/21: "The supraclinoid ICAs are patent bilaterally. The right MCA is elevated by the large right hemispheric hematoma. There is no occlusion or significant stenosis involving the right MCA. The left MCA and bilateral ACAs are within normal limits. The intracranial vertebral arteries, left PICA, basilar artery and both PCAs are patent. There is no aneurysm or AVM. The evaluation of the venous structures is limited on this CTA but there is no opacification of the right transverse and sigmoid sinuses, suggestive of dural sinus thrombosis. Large right hemispheric hematoma is demonstrated with significant right-to-left midline shift measuring approximately 16 mm. Effacement of the right lateral ventricle and dilation of the left lateral ventricle. Right-sided transtentorial herniation is noted. IMPRESSION: 1. Suspect right transverse and sigmoid sinus dural sinus thrombosis. This can be confirmed with CTV if clinically necessary 2. No evidence of aneurysm or AVM to account for the right hemispheric intraparenchymal hematoma. Significant right-to-left midline shift and downward transtentorial herniation is noted."
CDC Split Type:

Write-up: Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia. Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and L sided weakness. Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift. She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing. Repeat imaging revealed worsening midline shift to 1.6cm. CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021.


VAERS ID: 1195850 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-03-01
Onset:2021-03-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood glucose increased, Cerebrovascular accident, Computerised tomogram head normal, Death, Dysphagia, Gastrointestinal tube insertion, Neurological symptom, Surgery, Thrombosis, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: None
Current Illness: Rash/ allergy on arms, face chest and back . Approximate 1 month prior to vaccine, dermatologist placed him in antibodies, did not work, eventually placed on me drop back, and completed before johnson and johnson vaccine and was cleared by cop to get vaccine even thou rash was still present and not resolved.
Preexisting Conditions: Diabetic, atrial fib. After receiving vaccine, my dad was found unresponsive, glucose elevated, unable to swallow, NG feeding tube placed and then spec tube on April , 2021. Shortly after returning ing to room after surgery, he died of blood clots! This man was eating and drinking before vaccine, CT of head shown no strokes on admission. The vaccine caused his glucose to elevate a lot, neurological changes happened, causing the swallowing reflexes to cease and then death by stroke!!!
Allergies: Environmental, penicillin, erythromycin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death by clot


VAERS ID: 1198162 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-03-13
Onset:2021-03-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Brain death, Cerebral venous sinus thrombosis, Death, Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 7
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: My sister received the Janssen vaccine on March 13, 2021. One week later, March 20, 2021, she started complaining of severe headaches, dizziness and vomiting. This continued so she visited the ER on Wednesday, March 24, 2021, where she suffered a cerebral venous sinus thrombosis. She was pronounced brain dead on March 27, 2021, which is also the same day she was pronounced dead.


VAERS ID: 1201543 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-03-03
Onset:2021-03-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cerebral infarction, Computerised tomogram head abnormal, Computerised tomogram thorax abnormal, Death, Deep vein thrombosis, Pulmonary embolism, Renal infarct, Splenic infarction, Thrombophlebitis superficial, Ultrasound scan abnormal, Venous occlusion
SMQs:, Ischaemic 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), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Renovascular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diamox Unsure of other meications
Current Illness: unknown
Preexisting Conditions: Hypertension, Type2 DM, Idopathic Intercranial Hypertension, Obesity, Chronic back pain
Allergies: Unknown
Diagnostic Lab Data: CT of Head=Subacute left MCA territory infarct, Chest CT=Acute pulmonary embolism, right kidney and splenic infarcts, Upper extremity U/S=occlusive & nonocclusive deep vein thrombosis in the bilateral upper extremities, occlusive superficial venous thrombosis within the bilateral cephalic veins
CDC Split Type:

Write-up: Death


VAERS ID: 1201835 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-12
Onset:2021-03-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1 / 1 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cerebrovascular accident, Chills, Death, Pain, Pyrexia, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 3
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: BP, thyroid, cholesterol, headaches
Current Illness: Sleep Apnea
Preexisting Conditions: Thyroid, headaches
Allergies: None
Diagnostic Lab Data: Network will have this information. I do not at this time.
CDC Split Type:

Write-up: Low grade fever, aches & chills on 3/13/21 & 3/14/21. Felt better 3/15/21 through 3/18/21. Side effects ( fever, aches, chills ) returned on 3/19/21 & 3/20/21. Suffered stroke on 3/21/21 at 3:30 AM due to blood clots. Passed away on 3/22/21.


VAERS ID: 1202482 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / IM

Administered by: Pharmacy       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: 2021-04-12
   Days after onset: 0
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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: nka
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: blood clots


VAERS ID: 1203902 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-03-13
Onset:2021-04-07
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Death, Pneumonia, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: insulin methotrexate amlodipine hydralazine hydroxychlororoquine lisinopril folic acid
Current Illness: diabetes, rheumatoid arthritis
Preexisting Conditions:
Allergies: penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blood Clot which led to Pulmonary Embolism, Pneumonia, and death.


VAERS ID: 1207377 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Blood test, Death, Intensive care, Multiple organ dysfunction syndrome, Pain in extremity, Scan, Thrombosis, X-ray normal
SMQs:, 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, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Irwin 3 in 1 joint formula with Glucosamine, Chondroitin, Turmeric. Take 6 caps daily ALTERNATIVE MEDICINE, Vitamin B12 Oral 100 MCG 1 Tab(s) Once daily HEMATOPOIETIC AGENTS, Breztri Aerosphere Inhalation 160-9-4.8 MCG/ACT 1 Once daily ANTI
Current Illness: HTN, HLD, CHF, Vitamin Deficiencies, Anemia, RLS, Osteoarthritis, Fibromyalgia, Presence of cardiac pacemaker, colostomy status
Preexisting Conditions: HTN, HLD, CHF, Vitamin Deficiencies, Anemia, RLS, Osteoarthritis, Fibromyalgia, Presence of cardiac pacemaker, colostomy status
Allergies: No Known Drug Allergies
Diagnostic Lab Data: Patient had complete blood work ups and scans while admitted to ICU.
CDC Split Type:

Write-up: Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021.


VAERS ID: 1207401 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-30
Onset:2021-04-10
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Deep vein thrombosis, Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: NONE
Current Illness: NONE
Preexisting Conditions: TOBACCO ABUSE, ALCOHOL ABUSE
Allergies: NONE
Diagnostic Lab Data: DEATH - MEDICAL EXAMINER AUTOPSY
CDC Split Type:

Write-up: SUDDEN DEATH - PULMONARY EMBOLUS DUE TO DEEP VEIN THROMBOSIS RIGHT POPLITEAL VEIN


VAERS ID: 1207994 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-26
Onset:2021-03-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       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: 2021-04-09
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cyst on Groin, shingles
Preexisting Conditions: HBB, stage IV Kidney Failure, Diabetes
Allergies: No
Diagnostic Lab Data: Death
CDC Split Type:

Write-up: Blood Clot on back of leg


VAERS ID: 1210630 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-03-04
Onset:2021-03-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Death, Gait inability, Headache, Impaired driving ability, Loss of consciousness, Mechanical ventilation, Muscle spasms, Thrombosis, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2021-04-04
   Days after onset: 28
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: N/A
Preexisting Conditions: N/A
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21. She stated that on 3/6/21 he started having headaches, weakness and leg cramps. He went to the hospital two times with complaints. On 3/15/21 he was unable to walk/drive because headaches were severe. On 3/30/21 he passed out, squad was called. He was not responsive and was put on a vent at the hospital. A "scan" showed blood clots in brain and heart. This individual passed away on 4/4/21.


VAERS ID: 1213131 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-03-29
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Fall, Hip fracture, Spinal fracture, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diabetic Medications (Pills)
Current Illness: broke 3 back bones and hip chip due to fall 3/22/2021 a store parking lot
Preexisting Conditions: Diabetic
Allergies: none
Diagnostic Lab Data: AUTOPSY PERFORMED AND CONFIRMED
CDC Split Type:

Write-up: PATIENT DIED FROM BLOOD CLOT 3/29/2021 - AUTOPSY PERFORMED AND CONFIRMED


VAERS ID: 1215435 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Delaware  
Vaccinated:2021-03-07
Onset:2021-03-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Death, Epistaxis, Haemoptysis, Increased viscosity of upper respiratory secretion, Secretion discharge, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: High Blood Pressure, Kidney disease
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient began experiencing back pain on March 14 and on or around March 18 he started coughing up blood clots according to a coworker. Patient lived alone and was unable to be reached on Sunday March 21. I went over to his house and found him deceased in his bed. Patient had a trashcan beside his bed and it appeared to have some blood in it. Patient had thick mucus coming out of his mouth and blood coming out of his nose. According to paramedics he had passed a few hours before finding him. Unfortunately Patient has been cremated so there is no way to say that this was related to the Covid 19 shot from Johnson and Johnson, however there are new reports that blood clots have been a side effect. I would like to speak with someone from the Department of Health to discuss this further. I feel this could be related to the vaccination and I would to know how long the Health Department knew about this possible side effect. If patient would have known sooner that the blood clots were a side effect I feel he would have gone to the Emergency Room. Patient had no health insurance and he was trying to prevent getting Covid. This has caused our family so much heartache and we are all very apprehensive about getting the Covid Vaccine ourselves. Please contact me as soon as possible, I am also patient''s executor so I am able to speak to you on behalf of patient and our family. Thank you.


VAERS ID: 1216189 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Brain natriuretic peptide increased, Echocardiogram abnormal, Emphysema, Gait inability, Haemoglobin decreased, Heart rate increased, Hypoxia, Intracardiac thrombus, Leukocytosis, Lumbar vertebral fracture, Peripheral artery thrombosis, Platelet count decreased, Procalcitonin normal, Pulmonary hypertension, Thrombosis prophylaxis, Tricuspid valve incompetence, Troponin increased, White blood cell count increased
SMQs:, Cardiac failure (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
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: Prednisone, Metoprolol, amlodipine, furosemide
Current Illness: To ED with acute back pain, constipation, recent root canal, had received tramadol and Medrol dosepak at Urgent Care
Preexisting Conditions: Hypertension, congestive heart failure, obesity, back pain, chronic kidney disease not requiring dialysis
Allergies: Penicillin, Sulfa
Diagnostic Lab Data: Hg dropped from 9.3 on admission to 6.8 and subsequently 6.4 with no apparent bleeding source. Platelets dropped from 130K to 61K to 59K. WBC on admission was 22.9; troponin rose on day 2 from 0.067 to 0.174. Procalcitonin 0.95 on admission increased to 1.40 on day 2. BNP on day 2 was 157.
CDC Split Type:

Write-up: 78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient''s Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source. PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient''s heart rate dropped into the 60''s and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient''s right atrium and a mural thrombus in her femoral artery.


VAERS ID: 1227130 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-12
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Pneumonia, Thrombosis, X-ray
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 12
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: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Congestive heart failure; Dementia; Groin hernia
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: CAT scan; Result Unstructured Data: Saddle PE; Test Date: 20210314; Test Name: X-ray; Result Unstructured Data: Saddle PE
CDC Split Type: USJNJFOC20210424686

Write-up: PNEUMONIA; BLOOD CLOTS; This spontaneous report received from a consumer concerned an 89 year old male. Initial information was received on 13-APR-2021 and processed with additional information received on 15-APR-2021. The patient''s height, and weight were not reported. The patient''s past medical history included congestive heart failure (ejection fraction 20%), large lower left groin hernia, atrial fibrillation, and dementia. No known drug allergies was reported. There was no history of blood clots. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. Batch number was not reported, will be requested. Concomitant medications included apixaban twice a day for atrial fibrillation. On 11-MAR-2021, the patient was taken to Emergency Room (ER) and diagnosed with pneumonia. Patient was awake over 48 hours ''felt due to dementia and illness''. On 14-MAR-2021, the patient was taken back to hospital and X-ray and CAT scan showed saddle pulmonary embolism. On 15-MAR-2021, the patient was discharged to a home with hospice. On 23-MAR-2021, the patient deceased. 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, Hospitalization Caused / Prolonged).; Sender''s Comments: V0: An 89-year old man experienced fatal saddle pulmonary embolism 10 days after vaccine. Relevant medical history included congestive heart failure with ejection fraction 20%, atrial fibrillation (A Fib), and dementia. Relevant concomitant medication (others not reported) included Eliquis for A fib. The patient was diagnosed with pneumonia in the Emergency Department 7 days after vaccine, and 3 days later was brought back to the hospital and diagnosed with saddle pulmonary embolus. He was discharged home on hospice the next day and died 19 days after vaccine. There was no reported thrombocytopenia. The patient''s age, concurrent pneumonia, and complicated past medical history are confounders. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including attempts to contact the patient''s treating physicians.; Reported Cause(s) of Death: PNEUMONIA; BLOOD CLOTS


VAERS ID: 1227818 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: Clot blood (She was prone to blood clots her entire life, but managed it.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210420170

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via media by a company representative concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient was prone to blood clots her entire life, but managed it. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) 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 developed a blood clot. A day after the vaccination, the patient died from the blood clot. 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, and Other Medically Important Condition).; Sender''s Comments: This anecdotal report from media involves a female patient of unspecified age who was prone to blood clots her entire life and on an unspecified date developed a blood clot and died from the blood clot a day after received the Janssen COVID-19 Vaccine Ad26.COV2. Concomitant medications, and details of the event were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT


VAERS ID: 1227922 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Skeletal injury, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Gravida/Para: 1/1. The patient was 4 weeks post-partum.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427241

Write-up: BLOOD CLOT; BROKE TAIL BONE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report was received from a pharmacist via a company representative, and concerned an approximately 40 year old female. The patient''s height, weight, and medical history were not reported. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of administration not reported, batch number: unknown) dose and vaccination site were not reported, administered in 2021 for prophylactic vaccination. No concomitant medications were reported. In 2021, the patient experienced vaccine exposure during pregnancy. The date of the patient''s last menstrual period and expected delivery date were not provided. In 2021, the patient experienced broke tail bone during labor and gave birth (live birth). On an unspecified date in 2021, the patient experienced a blood clot and died. It was noted that she was at high risk for clots because she was 4 weeks post partum (gravida 1, para 1). Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. The patient died of a blood clot and broke tail bone in 2021; the outcome of vaccine exposure during pregnancy was not reported. It was unspecified if an autopsy was performed. This report was serious (Death). This case, from the same reporter is linked to 20210430297.; Sender''s Comments: V0: The case concerns a pregnant female subject around age of 40, who developed thrombosis, skeletal injury and exposure during pregnancy an unspecified time after Janssen COVID-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The subject''s past medial history, last menstrual period, estimated date of delivery and concomitant medications were not provided. Per the reporter (pharmacist) the patient was at a high risk for blood clots because she was 4 weeks post-partum. The patient broke her tail bone during the labor, gave a birth, and later died of a blood clot. No additional information was provided. It is not known whether the autopsy was performed. Given alternative explanation and risk factors of pregnancy, labor and skeletal injury (trauma) the event of thrombosis is considered inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization. Events of skeletal injury was result of an accident and therefore not considered related. Company causality for event of thrombosis is considered not related to Janssen COVID-19 vaccine (Level 4 -Insufficient information available to confirm a possible, probable or a definitive case of venous thrombosis, per the Brighton Collaboration case definition); Reported Cause(s) of Death: BLOOD CLOTS; BROKE TAIL BONE


VAERS ID: 1227926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210428310

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via a company representative and concerned a male 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, a week or so after the Covid-19 vaccination the patient passed away in his sleep. The patient had no underlying condition. An autopsy was performed on an unspecified date and the patient was found to have blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: A male patient of unspecified age passed away in his sleep an unspecified time after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection. It stated that the patient had no underlying condition. A blood clot was found by autopsy; no further details are provided. There is insufficient information to make a meaningful medical assessment. Additional information is being sought.; Reported Cause(s) of Death: BLOOD CLOT; Autopsy-determined Cause(s) of Death: BLOOD CLOT


VAERS ID: 1228903 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram head, Magnetic resonance imaging head
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 1
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: albuterol amiodarone asa digoxin diltiazem esomeprazole heparin sq ipratropium lactulose ativan metoprolol seroquel
Current Illness: covid19
Preexisting Conditions: rheumatoid arthritis gibleed afib hx cva hx recurrent uti
Allergies: none
Diagnostic Lab Data: ct and cta head 4/9/21 mri brain 4/9/21
CDC Split Type:

Write-up: patient had massive intracerebral hemorrhage 3 days after vaccination. family claims patient was doing well until vaccination. there is a suspicion that patient might have had sinus venous thrombosis that lead to the the ICH.


VAERS ID: 1233510 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-08
Onset:2021-04-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: Morbid obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death. Multiple pulmonary thrombi.


VAERS ID: 1234046 (history)  
Form: Version 2.0  
Age: 103.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-07
Onset:2021-04-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebrovascular accident, Hemiparesis, Paralysis, Thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 15
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None. Used to take daily Claritin up until a bout 3 years ago.
Current Illness: None.
Preexisting Conditions: None; has been bedridden for about 3 years.
Allergies: Slight allergy to pollen.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Received a Janssen vaccination on 4/7/21 from a home visiting nurse from the County Health Department. On approximately 4/13/21, the family noticed slight signs of an issue, with patient slumping towards the right, and showing some signs of weakness on right side of body. Family contacted the PCP, who advised to take her to the ED. Family was hesitant to do that because patient had been bedridden for past few years. She seemed to improve somewhat on 4/15/21. Then the morning of 4/16/21, the family found her on the floor of her bedroom. She appeared to have had a moderate to severe stroke. Right side of body paralyzed, cannot speak. Uncertain whether mental faculties further deteriorated. PCP ordered a hospice facility for care. Stroke likely caused by blood clot but unsure if related to JJ vaccine. She has not been evaluated in person by her health care providers.


VAERS ID: 1234152 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-03-12
Onset:2021-03-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time normal, Anticoagulant therapy, Cerebral venous sinus thrombosis, Computerised tomogram head, Condition aggravated, Death, Fibrin D dimer normal, Generalised tonic-clonic seizure, Influenza A virus test negative, Influenza B virus test, International normalised ratio normal, N-terminal prohormone brain natriuretic peptide increased, Platelet count normal, Pneumonia aspiration, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Seizure, Status epilepticus
SMQs:, Cardiac failure (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 10
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: SEE PAGE 2
Current Illness: MS
Preexisting Conditions: MS
Allergies: NONE
Diagnostic Lab Data: unable to get medical records from hospital
CDC Split Type:

Write-up: Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th. On Sunday, March 21st, 911 had to be called as his seizure did not end. He had a grand male. He was seizing for several hours. At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily). He passed 1 week later, March 28 at approx 6:45pm at the Clinic. I am unable to get any information on his medical report for that week. Statement from his Nurologists is on second page. Additional information for Item 18: Statement: 47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram. Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don''t hesitate to email me Pt. med list at the time of this incident Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM


VAERS ID: 1237704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Montana  
Vaccinated:2021-03-10
Onset:2021-03-25
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram, Death, Echocardiogram, Hepatic vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   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: Ferrous Sulfate; Omeprazole
Current Illness: None
Preexisting Conditions: Lupus; Depressive Disorder; Myalgia
Allergies: NKDA
Diagnostic Lab Data: TEE 4/12/19 CXR multiple 4/11, 4/12 Echo 4/17 CT 3/26
CDC Split Type:

Write-up: Death, blood clots in liver


VAERS ID: 1237947 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-04-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Acute kidney injury, Angiogram normal, Computerised tomogram abdomen, Condition aggravated, Death, Dialysis, Electroencephalogram abnormal, Encephalopathy, Endotracheal intubation, Fatigue, Hepatic steatosis, Hyperammonaemia, Hypotension, Lethargy, Magnetic resonance imaging head normal, Pelvic venous thrombosis, Platelet count decreased, Renal impairment, Respiratory failure, Thrombocytopenia, Ultrasound Doppler abnormal, Ultrasound abdomen normal, Urinary tract infection, Venogram normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), 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), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Losartan, pantoprazole, deferasirox, insulin, levothyroxine, simvastatin, Cymbalta
Current Illness: Aplastic anemia
Preexisting Conditions: Aplastic anemia
Allergies:
Diagnostic Lab Data: As above 4/14/21 CT abdomen and pelvis - normal 4/15/21 MRI/MRA/MRV - no acute findings 4/15/21 RUQ US - no thrombosis, fatty liver 4/18/21 MRI brain - no change 4/18/21 EEG - generalized encephalopathy 4/19/21 Lower extremity dopplers - left common femoral DVT Platelets: 228 on admission, down to 31 on 4/17/21
CDC Split Type:

Write-up: Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.


VAERS ID: 1246863 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-24
Onset:2021-04-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortness of breath, blood clot in lungs


VAERS ID: 1246956 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Thrombosis
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), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glimepiride
Current Illness:
Preexisting Conditions: Diabetes
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Stroke and blood clot in right leg.


VAERS ID: 1248051 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-05
Onset:2021-04-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Clostridium difficile colitis, Clostridium test positive, Colitis ischaemic, Death, Deep vein thrombosis, Endotracheal intubation, Hypoglycaemia, Intensive care, Jugular vein thrombosis, Pulseless electrical activity, Resuscitation, Subclavian vein thrombosis, Thrombophlebitis superficial, Ultrasound Doppler abnormal
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA, Plavix, Flexeril, Cymbalta, Flonase, gabapentin, HCTZ, Norco, Novolog, Tresiba, Zestril, Glucophage, Zofran, and zocor
Current Illness:
Preexisting Conditions: DM, HTN
Allergies: codeine
Diagnostic Lab Data: US of upper extremity on 4/18
CDC Split Type:

Write-up: Patient was admitted with ischemic colitis and hypoglycemia. She also tested positive for C.diff during her hospitalization, unclear if this was from prior antibiotics in March. She did not receive DVT prophylaxis for 2 days. She developed a nonocclusive DVT in the right internal jugular and subclavian veins and a Nonocclusive superficial thrombosis in the right basilic vein on 4/18. She went into PEA and was revived, intubated, and transferred to the ICU. She went into PEA again and was revived after 5 rounds of CPR. The family decided to make the patient comfort care and expired on 4/19


VAERS ID: 1276430 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Platelet count, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
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: Test Date: 202104; Test Name: Platelet count; Result Unstructured Data: Low platelets
CDC Split Type: USJNJFOC20210446964

Write-up: RARE BLOOD CLOT; LOW PLATELETS; This spontaneous report received from a consumer concerned about 50 years old female. The reporter obtained the information from news/media. 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 APR-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 unknown date in APR-2021 after vaccination, the patient experienced severe headache, abdominal pain, leg pain and shortness of breath. The patient developed a rare blood clot and low platelets on an unspecified date in APR-2021, within two weeks of receiving JANSSEN COVID-19 vaccine. The patient was hospitalized on an unspecified date in APR-2021. On APR-2021, the patient died from blood clot. The reporter was not sure whether the events was related to the vaccination. 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 rare blood clot on APR-2021, and had not recovered from low platelets. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This female patient in her 50s was reported to have developed a rare blood clot and low platelets within two weeks of receiving JANSSEN COVID-19 vaccine. On an unspecified date, symptoms reported were severe headache, abdominal pain, leg pain and shortness of breath. The patient was hospitalized on an unspecified date and subsequently died from blood clot. It was not known if autopsy was performed. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.; Reported Cause(s) of Death: BLOOD CLOT


VAERS ID: 1276530 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-01
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210453777

Write-up: DEATH; BLOOD CLOT; This spontaneous report received from a consumer news/social media platform concerned a 5 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient developed a rare blood clot and died within two weeks of getting the Janssen covid vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to.; Sender''s Comments: V0-covid-19 vaccine ad26.cov2.s-This case concerns with 5 decade old female. Death, Blood clot. 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: 1284660 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210456400

Write-up: CLOTS; This spontaneous report received from a physician 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 administration not reported, batch number: Unknown) frequency one total, 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. On an unspecified date, the patient died due to clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died to clots on an unspecified date. This report was serious (Death). This case, from the same reporter is linked to 20210457363.; Sender''s Comments: V0: 20210456400-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: CLOTS


VAERS ID: 1285193 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-04-08
Onset:2021-04-25
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Intracardiac thrombus, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 5
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: Carvedilol, Doxazosin, Benicar, Lasix, Rosuvastatin, Bupropion, Hydralazine
Current Illness: Stage 4 kidney failure
Preexisting Conditions: Kidney Failure
Allergies: Morphine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Multiple Blood Clots in Right Lung, clots passed through his heart and caused his death


VAERS ID: 1285510 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Autopsy, Death, Deep vein thrombosis, Pulmonary embolism, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 6
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: obstructive uropathy of undetermined origin
Preexisting Conditions: vodka x 2-3 bottles per day, BMI 30,
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 60 yo male with BMI 30 and vodka x 2-3 bottles per day. In hospital 4/9-14 for obstructive uropathy of undetermined origin. In hospital on 4/12 and got J & J there. 4/13 with no prior history developed a DVT. D/C''d on 4/14 on Eliquis. Found unresponsive 4/19. At autopsy, found pulmonary thromboemboli


VAERS ID: 1304956 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210510772

Write-up: BLOOD CLOT; This spontaneous report received from a company representative concerned a 42 year 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 and expiry were unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, between three to ten days later after vaccination the patient died due to blood clots. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0;20210510772-covid-19 vaccine ad26.cov2.s-Thrombosis. 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: BLOOD CLOT


VAERS ID: 1312771 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-13
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210510294

Write-up: FEMALE ISSUES; BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients. 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 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the consumer called and reported that he had read in newspaper that women had gotten blood clots and 3 passed away with female issues. 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 female issues on an unspecified date, and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0. 20210510294 -COVID-19 VACCINE AD26.COV2.S- Female issues, Blood clot. 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: 1315725 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-13
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210517449

Write-up: PASSED AWAY BECAUSE OF CLOT; This spontaneous report received from a consumer concerned a patient of Unspecified Race, ethnic origin, 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 not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patient passed away because of clot. 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: 20210517449- covid-19 vaccine ad26.cov2.s-thrombosis. 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: CLOT


VAERS ID: 1316349 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210514012

Write-up: This spontaneous report received from a consumer 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 and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from blood clot. 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. 20210514012-COVID-19 VACCINE AD26.COV2.S-Blood clot. 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 CLOT


VAERS ID: 1319778 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-28
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Laboratory test, 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: 2021-05-04
   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:
Current Illness: Abstains from alcohol; Blood pressure high; Diabetes; High cholesterol; Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies, no drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data: Test Name: Laboratory test; Result Unstructured Data: Unknown; Comments: Done 3-4 months ago (results of which were unavailable at that time)
CDC Split Type: USJNJFOC20210509157

Write-up: DEATH; BLOOD CLOT; This spontaneous report received from a health care professional concerned a 66 year old White and not Hispanic or Latino female. Initial information received from the health care professional on 05-MAY-2021 was processed with additional information obtained from live follow up with health care professional on 06-MAY-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure, diabetes, high cholesterol, non smoker, non alcohol user and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug use. Lab work was done 3-4 months ago, the results of which were unavailable. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 possibly left arm for prophylactic vaccination. Unspecified concomitant medications were reported. On 28-APR-2021, the patient developed right leg pain and right leg swelling also began around this time as well. On 04-MAY-2021, the patient died from blood clot. An autopsy was not performed. The reporter stated that the patient''s death was related to Janssen covid-19 vaccination and blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on 04-MAY-2021. This report was serious (Death).; Sender''s Comments: V0:20210509157-JANSSEN COVID-19 VACCINE- Death, blood clot - 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: BLOOD CLOT


VAERS ID: 1322563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210522533

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer who reported hearing a news report concerned a male 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 not reported, expiry not reported frequency one total, dose, therapy start date were not reported 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 had blood clots. On an unspecified date in 2021, the patient was died due to blood clots. it was not reported whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to blood clot on an unspecified date in 2021. This report was serious (Death). This case, from the same reporter is linked to 20210523500.; Sender''s Comments: V0. 20210522533-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: 1326951 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dyspnoea, Malaise, Myocardial infarction, Thrombosis
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: High blood pressure
Current Illness:
Preexisting Conditions: High blood pressure
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: She been feels ill slightly ill ever since the shot. Always short of breathe. Now she died of a blood clot / heart attack while at night in her chair.


VAERS ID: 1329662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-19
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210530454

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer concerned 3 women with 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 and expiry was unknown) 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. On an unspecified date,3 women died from blood clots after getting (Janssen) covid 19 vaccine. It was unknown whether 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 : 20210530454-COVID-19 VACCINE AD26.COV2.S-Blood clots . This event is considered unassessable. The event 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.; Reported Cause(s) of Death: BLOOD CLOT


VAERS ID: 1345947 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
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: 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: USJNJFOC20210545044

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer by a other manufacturer company (Pfizer Inc.) received on14-MAY-2021 and concerned multiple (few) patients. 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) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Reporter stated that Johnson and Johnson vaccine caused blood clots and few people died. It was not reported whether autopsy was performed. On an unspecified date, the patients experienced blood clots. On an unspecified date, the patients died from blood clots. 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; 20210545044-covid-19 vaccine ad26.cov2. s Blood clots. 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: BLOOD CLOTS


VAERS ID: 1349042 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
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: Brain injury, Cardiac disorder, Cerebrovascular accident, Death, Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: USJNJFOC20210544901

Write-up: DROPPING DEAD; HEART ATTACKS; BLOOD CLOTS; STROKES; BRAIN DAMAGE; HEART CONDITIONS; This spontaneous report received from a consumer who reported reading from many personal social media accounts which concerned multiple patients of unspecified age and sex. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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. It was reported that, the patients were suffering from blood clots, dropping dead, had strokes, heart attacks, heart conditions and brain damage after vaccination. It was also reported that, the patients were perfectly healthy before and now they would never be the same. 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 patients died of unknown cause on an unspecified date, and the outcome of blood clots, strokes, heart attacks, heart conditions and brain damage was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210534943.; Sender''s Comments: V0: 20210544901-covid-19 vaccine ad26.cov2.s -Dropping dead, brain damage, blood clots, heart attacks and strokes. This event(s) are 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: 1350433 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-08
Onset:2021-05-08
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Anticoagulant therapy, Bacterial infection, Bilevel positive airway pressure, Blood culture positive, COVID-19, Cardiac arrest, Catheter placement, Condition aggravated, Cough, Death, Diarrhoea, Disseminated intravascular coagulation, Dyspnoea, Endotracheal intubation, Fibrin D dimer increased, Fluid replacement, General physical health deterioration, Gram stain positive, Haemodynamic instability, Heparin-induced thrombocytopenia test, Hypoxia, Intensive care, Lung assist device therapy, Mechanical ventilation, Packed red blood cell transfusion, Peripheral artery thrombosis, Peripheral coldness, Platelet transfusion, Prone position, Pulseless electrical activity, SARS-CoV-2 test positive, Septic shock, Transfusion, Ultrasound Doppler abnormal, Vasopressive therapy, Vena cava thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Infective pneumonia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 12
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: albuterol HFA (PROVENTIL HFA, VENTOLIN HFA, PROAIR HFA) 108 (90 Base) MCG/ACT inhaler ALPRAZolam (XANAX) 0.5 MG tablet Aromatic Inhalants (VICKS BABYRUB EXT) atorvastatin (LIPITOR) 40 MG tablet cetirizine (ZYRTEC) 10 MG tablet citalopram (C
Current Illness:
Preexisting Conditions: Respiratory Acute respiratory failure with hypoxemia (HCC) Pneumonia due to COVID-19 virus Circulatory Arterial embolism and thrombosis of lower extremity (HCC) Hematologic Elevated d-dimer Endocrine/Metabolic Electrolyte imbalance
Allergies: No Known Allergies
Diagnostic Lab Data: D-dimer was normal on 5/13 and elevated to 32400 on 5/18. Dopplers negative. CT angio not done due to clinical instability. Treated initially with heparin and changed empirically to argatroban when it was concerning that she had developed arterial thrombus on heparin.
CDC Split Type:

Write-up: Presented 5/13 to Hospital. Presented to Hospital on 5/13 with one week of symptoms including cough, dyspnea, diarrhea. COVID-19 testing was positive on 5/8. Treatments prior to arrival included remdesivir and dexamethasone, started 5/13. She was also placed on pulse dose steroids 1000 mg/day methylprednisolone given her history of ground glass lung opacities in 2018. Progressed to high-flow nasal cannula, then BiPAP on 5/14, and was intubated on 5/17. Paralysis and proning initiated. Transferred to another hospital for possible VV ecmo candidacy. Patient with severe acute respiratory failure d/t covid who has failed treatment with the ventilator despite paralysis and proning. CTS asked to place patient on VV ECMO. 5/20/21 1135am initiated ECMO Patient is a 50yr old female with past medical history of hypertension, asthma, OSA and obesity BMI 41.5 who presented to hospital on 5/13 with progressive cough and shortness of breath for about a week. Of note, patient also has a history of respiratory failure presenting with ground glass opacities on CT scan in 2018 with unclear etiology despite bronchoscopy and serologic studies which resolved with high dose corticosteroids. Patient recently tested positive for COVID on 5/8 and received johnson and johnson vaccine in April. Patient was admitted on 5/13 and treated with decadron, remdesivir and tocilizumab. Course complicated by progressive respiratory failure requiring HFNC followed by Bipap and ultimately intubation on 5/17. Due to elevated d-dimer, lower extremity dopplers were obtained which were negative, however a heparin gtt was initiated. Course further complicated by cold left lower extremity; arterial duplex demonstrated distal popliteal artery thormbus extending into the peroneal, anterior tibial and dorsalis pedis arteries. therefore heparin was switched to argatroban and a HIT panel was sent. On 5/19 patient continued to decline despite paralytic and pronning. Patient transferred to ICU for further level of care and VV ECMO evaluation. On arrival patient was started on veletri; however due to continued respiratory decline a shock call was placed for VV ECMO and patient cannulated for VV @ 1200. Cannulation was difficult and patient was felt to have an IVC thrombus as clot was seen going into the ECMO circuit during cannulation. Post cannulation she developed worsening septic shock and DIC. She received 2uprbc, 1unit cryo, 1 platelet, 2 FFP, 5 liters crystalloid and 1L albumin. Blood cultures positive for GPC in clusters. Escalating vasopressors (Epi/NE/vaso) and ongoing hypoxia family opted to change code status to DNR. Patient then continue to have worsening hemodynamic instability and went into PEA and ultimately asystole. She was pronounced deceased at 1815. Family was en route already due to her instability thus will be notified of her passing once they arrive. Dr. was notified of patients death.


VAERS ID: 1357434 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
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, 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: USJNJFOC20210550011

Write-up: DEATHS; BLOOD CLOTS; This spontaneous report received from a consumer who reported reading and seeing on the news concerned a patient of unspecified age, race, ethnic origin 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 admin not reported, batch number not reported, expiry not reported) frequency one total, dose, therapy start date were not reported 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. On an unspecified date, the consumer stated that he read and saw on the news that this vaccine causes patient''s deaths, and blood clots. On an unspecified date, the patient died from unknown cause of death. It was not reported whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of deaths on an unspecified date, and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210550011-covid-19 vaccine ad26.cov2.s-deaths, 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1363773 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy soft tissue, Brain compression, Brain scan abnormal, Brain stem haemorrhage, Brain stem syndrome, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Haemorrhage, Haemorrhagic stroke, Headache, Hemiplegia, Pathology test, Platelet count, Platelet count decreased, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 7
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: Pre-diabetic
Preexisting Conditions: Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Platelet count; Result Unstructured Data: alarmingly low platelet count; Test Date: 20210406; Test Name: Brain scan abnormal; Result Unstructured Data: Abnormal, multi-focal brain bleeds and increased compression of brain.; Test Date: 20210407; Test Name: Brain scan abnormal; Result Unstructured Data: increased bleeding and brain stem injury; Test Name: Platelet count; Result Unstructured Data: decreased; Test Name: Biopsy soft tissue; Result Unstructured Data: unknown; Test Name: Pathology test; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210500861

Write-up: CONTINUED TO BLEED; HAEMORRHAGIC STROKE; VOMITING; HEADACHE; PLATELET COUNT DECREASED; BIOPSY SOFT TISSUE; BRAIN SCAN ABNORMAL; POSSIBLE CEREBRAL VENOUS SINUS THROMBOSIS; BRAIN COMPRESSION; BRAIN STEM HAEMORRHAGE; BRAIN STEM SYNDROME; CEREBRAL HAEMORRHAGE; HEMIPLEGIA; SEIZURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1244328 and 1199143) concerned a 59 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included pre-diabetic. It was unknown if patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at the time of vaccination. No allergies to medications, food, or other products was reported. The patient was not pregnant at the time of vaccination. The patient did not have an adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 (also reported as 27-MAR-2021) for prophylactic vaccination. Anatomical vaccination site were not reported. No concomitant medications were reported. On 03-APR-2021, one week after vaccination, the patient had headache and vomiting. On 05-APR-2021, the patient had seizure due to hemorrhagic stroke. On an unspecified date, the patient experienced brain compression, brain stem haemorrhage, brain stem syndrome, cerebral haemorrhage, hemiplegia, possible cerebral venous sinus thrombosis, biopsy soft tissue, and brain scan abnormal, and was hospitalized. On 06-APR-2021, the patient had a surgery to remove pressure on brain and brain stem (craniectomy). The surgeon noted alarmingly low platelet counts (results unspecified). The patient had platelet transfusion. The patient was hospitalized for ''4 days''. The patient continued to bleed on 06-APR-2021 and 07-APR-2021. The patient was removed from life support on 08-APR-2021. The patient died on 08-APR-2021. It was unknown if autopsy was performed. Laboratory data reported following: Brain scan was abnormal and showed abnormal, multi-focal brain bleeds and increased compression of brain. On 07-APR-2021, Brain scan abnormal which showed increased bleeding and brain stem injury. On 08-APR-2021, the patient died from possible cerebral venous sinus thrombosis. Laboratory data (dates unspecified) included: Biopsy soft tissue (NR: not provided) unknown, Pathology test (NR: not provided) unknown. On 08-APR-2021, the subject died from possible cerebral venous sinus thrombosis. 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 possible cerebral venous sinus thrombosis, brain compression, brain stem haemorrhage, brain stem syndrome, cerebral haemorrhage, hemiplegia, seizure, haemorrhagic stroke and continued to bleed on 08-APR-2021, had not recovered from headache, vomiting, and platelet count decreased, and the outcome of biopsy soft tissue and brain scan abnormal was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210441454. Additional information was received on 24-MAY-2021. Following information was added and incorporated into the narrative. Additional events of haemorrhagic stroke and continued to bleed were added, seriousness of events platelet count, vomiting, and headache was updated, additional reference numbers were added, additional vaccination date added in narrative, labeling updated, and course of event and laboratory data updated. It was determined that Manufacturer Case Number 20210441454 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210500861. Upon review, the following information was amended: events biopsy soft tissue and brain scan abnormal was updated from non-serious to serious as this was on the earlier VAERS report.; Sender''s Comments: V2: Additional information received regarding updates in seriousness of events, labeling, course of events, case identifier; and additional evets of hemorrhagic stroke and "continued to bleed" did not alter prior assessment. This fatal spontaneous report (VAERS ID 1244328) concerned a 59- year- old female who experienced vomiting, headache and seizures and was hospitalized for brain compression, brain stem hemorrhage, brain stem syndrome, cerebral hemorrhage, hemorrhagic stroke, hemiplegia, possible cerebral venous sinus thrombosis 16 days after Janssen COVID-19 vaccine was administered for prevention of symptomatic SARS-CoV-2 virus infection. The patient''s height, and weight were not reported. The patient was pre-diabetic with no known allergies. Concomitant medications were not reported. Biopsy soft tissue was done (results not reported) and brain scan showed multi-focal brain bleeds and increased compression of brain; the patient underwent neurosurgery. The platelet count was decreased (result not reported) and received platelet transfusion. Follow-up scan next day showed increased/continued bleeding and brain stem injury and a day later she died from possible cerebral venous sinus thrombosis. It was unknown if an autopsy was performed. Although the subject''s pre-diabetic status may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration - BC) and considering the low platelet count and temporal relationship to vaccination (BC Criteria level 5), the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: POSSIBLE CEREBRAL VENOUS SINUS THROMBOSIS


VAERS ID: 1375369 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-05-05
Onset:2021-05-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN N/A / 1 AR / SC

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Catheterisation cardiac abnormal, Cerebrovascular accident, Coronary arterial stent insertion, Deep vein thrombosis, Leg amputation, Mechanical ventilation, Pneumonia, Pneumonia staphylococcal, Weaning failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (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) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No home medications
Current Illness: None
Preexisting Conditions: Hypertension
Allergies: No known allergies
Diagnostic Lab Data: Cardiac Catherization on 5/19/2021 after cardiac arrest. Stent to RCA. AKA amputation Stroke Mechanical Ventilation unable to wean Staph Aureus Pneumonia -VAP/CAP DVT of limb
CDC Split Type:

Write-up: Cardiac Arrest, DVT, AKA, Stroke


VAERS ID: 1397724 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Thrombosis of LAD, death


VAERS ID: 1406251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210626581

Write-up: BLOOD CLOT; This spontaneous report received from a physician concerned a 21 year old male of unspecified 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) 1 total 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. On an unspecified date, the patient had blood clot at some point following vaccination and died due to it. It was not reported, if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is linked to 20210456400 and 20210457370 (same reporter). .; Sender''s Comments: V0: 20210626581-covid-19 vaccine ad26.cov2.s-This case concerns a 21 year old male, Blood Clot. 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 CLOT


VAERS ID: 1411025 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-18
Onset:2021-05-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Anticoagulant therapy, Death, Headache, Hypotension, Thrombosis, Vitamin K, Volume blood decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: Not sure what medications my mom was on at the time as she was in the hospital and they were changing her medications around
Current Illness: My mom had a sepsis infection ,
Preexisting Conditions: My mom had many health issues. AFib, arthritis, She had to have blood transfusions , I have been trying to get her medical records with no luck so far
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The hospital gave my mom the Johnson shot on May 18,21.( I was not informed about it until my my told me on May 20th ) she said she had a headache and stomach, My mom was scheduled for an angiogram that day but they couldn''t do it then because the doctor had an emergency. So they schedule it for Saturday but they couldn''t do it because my mom had an upset stomach. They then schedule it for the 24th but they couldn''t do it because her vitamin k and plasma level''s were off. So they gave her vitamin k and plasma in the morning of the 25th and said they could do the angiogram. When she came back to the room her blood pressure was extremely low and she was very bloated. I was told they couldn''t do the procedure because she had blood clots in her leg. And the bloating was due to fluids they gave her to flush out the heparin they gave her. Later that evening she passed away


VAERS ID: 1412223 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
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: USJNJFOC20210627096

Write-up: BLOOD CLOT; This spontaneous report received from a patient via social media via a company representative 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 admin not reported, batch number: 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, the patient had blood clot and died.The cause of death is blood clot. It was unknown whether an 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 20210627090.; Sender''s Comments: V0: 20210627096-covid-19 vaccine ad26.cov2.s-blood clot. 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: BLOOD CLOT


VAERS ID: 1416708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
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: USJNJFOC20210628291

Write-up: BLOOD CLOT IN AORTIC ARTERY; This spontaneous report received from a consumer via a company representative 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: Unk) dose not reported, 1 total administered on 27-MAR-202 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a massive blood clot in her aortic artery blocking all the blood flow to her legs then, pieces broke off and went to her brain and heart. On 28-MAY-2021 13:45 in afternoon the patient''s life support was stopped. On 29-MAY-2021 at 2:01, 9 weeks after vaccination the patient died from blood clot in aortic artery. 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: This spontaneous report from consumer concerns a female patient of unspecified age/race/ethnicity who developed "massive blood clot in her aortic artery blocking all the blood flow to her legs then, pieces broke off and went to her brain and heart" 62 days after receiving Janssen COVID-19 vaccine. The patient died on 63rd day post vaccination. No other details reported. The information available precludes a complete and meaningful assessment. Considering the temporal relationship, the events are assessed to have an indeterminate relationship with the vaccination.; Reported Cause(s) of Death: BLOOD CLOT IN AORTIC ARTERY


VAERS ID: 1423010 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: USJNJFOC20210637172

Write-up: DEATH; COMA; BLOOD CLOTS ON BRAIN; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced death, coma, and blood clots on brain. On an unspecified date, the patient died from blood clots on brain, and coma. 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: V0-20210637172-COVID VACCINE AD26.COV2.S-Death, Coma, Blood clots on brain. This events are considered un-assessable. 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: BLOOD CLOTS ON BRAIN; COMA


VAERS ID: 1430600 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-12
Onset:2021-04-08
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Acute kidney injury, Acute respiratory failure, Angiogram pulmonary abnormal, Anticoagulant therapy, Asthenia, Biopsy, COVID-19, Cardiac valve vegetation, Chemotherapy, Cholangiocarcinoma, Computerised tomogram abdomen, Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Critical illness, Death, Deep vein thrombosis, Depressed level of consciousness, Dyspnoea, Echocardiogram, Echocardiogram abnormal, Electrocardiogram, Encephalopathy, Fatigue, Hepatic mass, Hypotension, Intracardiac mass, Laparoscopic surgery, Myocardial ischaemia, Oliguria, Ovarian vein thrombosis, Pain in extremity, Paracentesis, Platelet count decreased, Platelet transfusion, Pulmonary embolism, SARS-CoV-2 test positive, Scan with contrast, Shock, Thrombocytopenia, Troponin increased, Ultrasound Doppler abnormal, Ultrasound abdomen abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (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 (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Biliary malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension
Allergies: None
Diagnostic Lab Data: No PF4 collected, admission platelets 65, lowest platelets 21 Novel Coronavirus PCR- SARS-CoV-2 detected (6/9/2021)
CDC Split Type:

Write-up: 69 YO female received one dose of J&J vaccination on 3/12/21. 4/8: Patient complaint of epigastric abdominal pain almost nightly since March 12 (coincided with her COVID vaccination) described as 10/10, crampy and without radiation. CT abdominal and pelvis with contrast showed infiltrating mass in the left hepatic lobe concerning for intrahepatic cholangiocarcinoma with reactive adenopathy. Additionally, left mid ovarian vein thrombus found. No thrombus in the renal veins or IVC. 4/28: Venous duplex demonstrated bilateral leg acute DVT. Eliquis was started. 5/7: Pt underwent laparoscopic biopsy/paracentesis. Eliquis was held 2 days prior to laparoscope...5/11: Pt presented to hospital with complaints of generalized weakness, fatigue and leg pain. CTPA showed bilateral PE. Pt received heparin drip and was switched back to Eliquis on discharge. Echocardiogram on 5/12 noted mobile round mass in RV junction, right atrial mass; presumed to be a thrombus. Pt additionally with elevated troponin, determined to likely demand ischemia related to PE; EKG without any acute changes. Discharged on 5/24. 5/27: Patient started on chemotherapy with gemcitabine/cisplatin for metastatic intrahepatic cholangiocarcinoma. 6/4: Presented to the ED again due to worsening dyspnea and home pulse ox readings in the 70s. CT chest showed moderate burden of bilateral obstructive pulmonary emboli with no overt RV strain. EKOS and clot retrieval was contraindicated d/t thrombocytopenia. Was noted to have demand ischemia, and transitioned from eliquis to heparin gtt. Vascular was consulted for eval of her ischemic right foot, and deemed that it needed amputation, but would be a high risk surgery. 6/8: Patient was transferred to this reporting institution for second opinion requested by the family. Upon arrival, patient was found to be obtunded and hypotensive requiring heated high flow nasal cannula and vasopressor with norepinephrine. Code status was deemed DNRCCA/Do not intubate per family. Bedside ultrasound was concerning for an LV mass. Cardiology and Vascular surgery were consulted and recommended that the foot be amputated as well, but requested further workup with ECHO and CTA chest/abdomen/pelvis to further evaluate the LV mass. During admission workup, she was incidentally found to be COVID PCR positive. She was started on DEXA-ARDS prednisone dosing, remdesivir, and placed in enhanced droplet isolation. Her hospital course was complicated by acute hypoxemic respiratory failure due to pulmonary emboli, COVID-19 infection, and underlying malignancy requiring heated high flow nasal cannula. Empiric cefepime was started to treat any underlying superimposed pneumonia. Due to extensive clot burden with limb ischemia, as well as + COVID, she was systemically anticoagulated with a heparin drip despite her thrombocytopenia. She was intermittently given platelet transfusions in order to keep platelet count $g30. TTE was obtained on 6/11 which showed large masses in right ventricle and right atrium, vegetations on mitral valve, aortic valve, and tricuspid valve, and probable mass in IVC. She also developed AKI with oliguria related to shock and critical illness. Medical oncology was consulted and she unfortunately was not a candidate for further chemotherapy at the time due to critical illness, as well as ischemic limb. (If further treatment was pursued, she would need a left leg amputation, then would require 4-6 weeks of recovery before additional chemotherapy could be given.) She slowly became more encephalopathic and had increased oxygen requirements, requiring continuous heated high flow nasal cannula. Goals of care were discussed with her family. Given her advanced cancer, it was decided to transition to comfort-focused care. Her code status was changed to DNRCC. Symptoms were controlled with IV pain and anxiety medication. She expired on 6/13/2021 at 0225.


VAERS ID: 1432774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), 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: USJNJFOC20210648060

Write-up: HEART ATTACK; MULTIPLE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative 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, 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. The reporter stated that, On an unspecified date her mother had multiple blood clots due to which she had heart attack. Patient was on blood thinners and did not survive. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from heart attack and had not recovered from multiple blood clots. This report was serious (Death).; Sender''s Comments: V0: 20210648060-covid-19 vaccine ad26.cov2.s -multiple blood clots , 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: 1442349 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210666397

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a Business partner (Pfizer Inc.) on 25-JUN-2021 concerned three patients of unspecified age and gender. 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 and expiry date: unknown) dose was not reported, 1 total, 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, three patients were developed blood clot after vaccination. The patient died from blood clots 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. This report was serious (Death).; Sender''s Comments: V0:20210666397-Covid-19 vaccine ad26.cov2.s -Blood clots. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: BLOOD CLOTS


VAERS ID: 1456619 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Angiogram pulmonary, Angiogram pulmonary abnormal, Brain injury, Brain oedema, Computerised tomogram head, Computerised tomogram head abnormal, Continuous haemodiafiltration, Death, Deep vein thrombosis, Dyspnoea, Endotracheal intubation, Hepatic steatosis, Hypotension, Hypoxia, Hypoxic-ischaemic encephalopathy, Lung assist device therapy, Mental impairment, Multiple organ dysfunction syndrome, Pain in extremity, Peripheral swelling, Pulmonary embolism, Pulmonary infarction, Right ventricular dysfunction, Thrombectomy, Ultrasound Doppler, Ultrasound Doppler abnormal, Withdrawal of life support
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Ischaemic 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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 14
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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Comments: The patient had no known drug allergies. The patient had no known other illness at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient had not taken any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient had no adverse event following any previous vaccine.
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Angiogram pulmonary; Result Unstructured Data: Abnormal; Test Date: 20210510; Test Name: Ultrasound Doppler; Result Unstructured Data: Abnormal; Test Date: 20210513; Test Name: Computerised tomogram head; Result Unstructured Data: Abnormal (Findings consistent with a hypoxic anoxic injury)
CDC Split Type: USJNJFOC20210625722

Write-up: DEATH; COMPUTERISED TOMOGRAM HEAD ABNORMAL; MULTIPLE ORGAN DYSFUNCTION SYNDROME; HYPOXIA; HYPOTENSION; CONTINUOUS HAEMODIAFILTRATION; ENDOTRACHEAL INTUBATION; DEEP VEIN THROMBOSIS; ULTRASOUND DOPPLER ABNORMAL; LUNG ASSIST DEVICE THERAPY; DYSPNOEA; PAIN IN EXTREMITY; PERIPHERAL SWELLING; HYPOXIC-ISCHAEMIC ENCEPHALOPATHY; BRAIN INJURY; BRAIN OEDEMA; ACUTE KIDNEY INJURY; MENTAL IMPAIRMENT; HEPATIC STEATOSIS; THROMBECTOMY; PULMONARY EMBOLISM; PULMONARY INFARCTION; RIGHT VENTRICULAR DYSFUNCTION; ANGIOGRAM PULMONARY ABNORMAL; WITHDRAWAL OF LIFE SUPPORT; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System), concerned a 55 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included ethyl alcohol abuse, and concurrent conditions included hypertension. The patient had no known drug allergies. The patient had no known other illness at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient had not taken any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient''s laboratory data included CT (computed tomography) angiography of chest showed severe burden of acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis and interventional radiology (IR) thrombectomy procedure showed large bilateral pulmonary emboli. On 09-MAY-2021 (approximately 3 weeks after vaccination), the patient was presented to the emergency room due to progressively worsening shortness of breath. The patient also had pain and swelling in the left calf and leg. On the same day, the patient experienced brain injury, brain oedema, acute kidney injury, hypoxic-ischaemic encephalopathy, mental impairment, pain in extremity, peripheral swelling and had lung assist device therapy. The patient was hospitalized on an unspecified date. On 10-MAY-2021, the patient''s ultrasound venous Doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy, however, on 11-MAY-2021 (the next morning), she became more hypoxic and hypotensive and was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). The patient developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for oliguric renal failure. On 13-MAY-2021, CT computerised tomogram (CT) scan of the patient''s head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status over the course of the next few days, the patient was taken off life support and died on 15-MAY-2021 due to unknown cause. The patient was in hospital for 7 days. 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, multiple organ dysfunction syndrome, hypoxic-ischaemic encephalopathy, brain injury, brain oedema, acute kidney injury, mental impairment, deep vein thrombosis, pulmonary embolism, pulmonary infarction, hypoxia, dyspnoea, pain in extremity, peripheral swelling, hepatic steatosis, hypotension, right ventricular dysfunction, continuous haemodiafiltration, endotracheal intubation, thrombectomy, lung assist device therapy, withdrawal of life support, angiogram pulmonary abnormal, computerised tomogram head abnormal and ultrasound doppler abnormal on 15-MAY-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210542597. Additional information was received from patient on 01-JUN-2021. The following information was updated and incorporated in to the case narrative: Patient demographics (race, ethnic origin), added patient history, added ethyl alcohol abuse in disease tab, added batch number, added facility type and other identification numbers updated.; Sender''s Comments: V1: This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), concerns a 55 year old female patient, who was noted to experience acute pulmonary embolism (PE), with severe right heart strain, 18 days after receiving the Janssen Covid-19 vaccine. The patient sought consult at the emergency room due to worsening of the shortness of breath. The patient also had pain and swelling in the left calf and leg. Computed Tomography Angiography (CTA) of chest showed acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis. Venous doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy. However, she became more hypoxic and hypotensive, was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). Later, she developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for renal failure. Nineteen (19) days after receiving the vaccine, Computerised tomogram (CT) scan of the patient''s head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status, life support was said to be taken off which resulted to death. It was unknown if autopsy was performed. Patient''s height and weight were not reported. The patient''s past medical history included ethyl alcohol abuse and concurrent conditions included hypertension. The patient had no known drug allergies. The patient was not pregnant at the time of vaccination. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and the relationship is considered indeterminate. Additional information has been requested.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1463008 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-05-21
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Brain death, Fall, Incorrect dose administered, Intracranial aneurysm, Needle issue, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 4
Permanent Disability? Yes
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:
Current Illness: Blind; Cancer; Congestive heart failure; Diabetes; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Glucose; Result Unstructured Data: glucose 112; Test Name: Blood pressure; Result Unstructured Data: BP 120/75
CDC Split Type: USJNJFOC20210708201

Write-up: BRAIN ANEURYSM; BRAIN DEAD; BLOOD CLOT; FALL; NEEDLE BROKE OFF THE SYRINGE; NEEDLE BROKE OFF THE SYRINGE UNSURE OF THE FULL VOLUME THAT WAS INJECTED; This spontaneous report received from a consumer concerned a 57 year old White Hispanic/Latino male.. The patient''s height, and weight were not reported. The patient''s concurrent conditions included blind, diabetes, cancer, congestive heart failure, and penicillin allergy. Nurse came to patients house to administer the vaccine due to patient disability, patient usually does have a home aid. 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 and has been requested. No concomitant medications were reported. Upon administering the vaccine, the needle broke off the syringe, unsure of the full volume that was injected. On 21-MAY-2021 patient experienced dizziness, vomiting, and fall. Blood pressure and sugar was fine after the wife had checked it (BP 120/75, glucose 112). They called the ambulance because the symptoms were unrelenting and a headache began on 21-MAY-2021. Patient required and emergency surgery to relieve pressure on the brain, drilling of the skull where ultimately patient was pronounced brain dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain aneurysm due to blood clot and brain dead on 25-MAY-2021, and the outcome of fall, blood clot, needle broke off the syringe, needle broke off the syringe unsure of the full volume that was injected was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender''s Comments: V0: 20210708201-COVID-19 VACCINE AD26.COV2.S-Brain Aneurysm, Brain Dead, Blood Clot, Fall. 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: BRAIN ANEURYSM DUE TO BLOOD CLOT


VAERS ID: 1486784 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Death, Deep vein thrombosis, Pulmonary thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Developmental delay since birth with limited speech and inability to read, Cardiac patent foramen ovale
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, death


VAERS ID: 1490599 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-04
Onset:2021-04-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Sepsis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 28
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: 30 days after receiving the vaccination, patient passed away due to blood clots and being sepsis.


VAERS ID: 1533998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210810431

Write-up: DIED; BLOOD CLOT; This spontaneous report received from a consumer 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 not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had blood clot and died. The patient died from unknown cause of death and blood clot. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died and the outcome of blood clot was fatal. This report was serious (Death).; Sender''s Comments: V0:20210810431-Covid-19 vaccine ad26.cov2.s-Death, Blood Clot. 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; BLOOD CLOT


VAERS ID: 1542115 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-11
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210815346

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned multiple (3) patients. The patients` weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 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 patients experienced blood clots and died from blood clot. It was unknown whether the 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: V0:20210815346-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 CLOT


VAERS ID: 1545923 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-05-15
Onset:2021-06-07
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 038C21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Computerised tomogram abnormal, Death, Deep vein thrombosis, Gastrointestinal necrosis, Intestinal resection, Portal vein thrombosis, Surgery, Visceral venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Thrombophlebitis (broad), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   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:
Current Illness: History of DVT and recently diagnosed colon cancer.
Preexisting Conditions: Coronary artery disease, DVT, anemia
Allergies:
Diagnostic Lab Data: CT abdomen and pelvis showed extensive portal and femoral thrombosis on 6-9-2021.
CDC Split Type:

Write-up: Patient presented 3 weeks after vaccination with massive bilateral femoral and portal visceral thrombosis. Taken to surgery and resected dead bowel. Thrombosis progressed and patient died after 2 days.


VAERS ID: 1550081 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis
SMQs:, Ischaemic 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: 2021-03-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210815363

Write-up: BLOOD CLOTS IN BRAIN; This spontaneous report received from a patient via a company representative concerned a female 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, 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. Two weeks later on an unknown date in MAR-2021, the patient experienced blood clots in brain and died from blood clot in her brain. It was reported that, the plug was pulled after one week. 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: This spontaneous report received from a patient via a company representative concerned a female of unspecified age and ethnicity, who experienced blood clots in brain two weeks after receiving Janssen Covid-19 vaccine Ad26.COV2.S. It was reported that, the plug was pulled after one week. The patient died from blood clots in brain. It was unspecified if an autopsy was performed. The patient''s height, and weight were not reported. No past medical history, concurrent conditions, and concomitant medications were reported. Information is limited in this case, and the occurrence of blood clots in brain could represent background incidence of such events in the general population. Hence, the relationship to the vaccination is considered unclassifiable. Additional information has been requested.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN


VAERS ID: 1550084 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210818401

Write-up: DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via social media concerned multiple patients (6 or 7) with unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patients 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced blood clots and died from unknown cause of death. It was unspecified if was an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210818227, 20210818107, 20210817805 and 20210818021.; Sender''s Comments: V0: 20210818401 -covid-19 vaccine ad26.cov2.s- death, 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1577472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Thrombosis
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), 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: USJNJFOC20210810396

Write-up: BRAIN HAEMORRHAGING; BLOOD CLOT; This spontaneous report received from a consumer who reported hearing a news report which 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 was not reported, 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 patient experienced brain haemorrhaging and blood clot. On an unspecified date, the patient died from brain hemorrhage and blood clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain haemorrhaging and blood clot on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210810396- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Brain haemorrhaging, Blood clot. 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: BRAIN HEMORRHAGE; BLOOD CLOT


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: 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: 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: 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: 1691360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-06-06
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Internal haemorrhage, Myocardial infarction, Pulmonary thrombosis, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210916075

Write-up: BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LIVER; INTERNAL BLEEDING; HEART ATTACK; DEATH; This spontaneous report received from a consumer via a company representative concerned a 52 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, and expiry: Unknown) dose was not reported, 1 total, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-JUN-2021, 3 days after vaccination the patient had heart attack on the golf course. On an unspecified date, the patient had internal bleeding and blood clots in his liver and lungs. The patient was in intensive care for 13 weeks and was put on liver transplant list but they could not stop the internal bleeding. The patient hospitalized for unspecified date and days. 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. The outcome of heart attack, internal bleeding, blood clots in lungs and blood clots in liver was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210916075-COVID-19 VACCINE AD26.COV2.S-Death, Heart attack, Blood clots in lungs, Blood clots in liver, Internal bleeding. 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: 1691361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Utah  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
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: USJNJFOC20210916087

Write-up: BLOOD CLOT; This spontaneous report received from a consumer. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On an unspecified date, the patient experienced blood clot and died (due to blood clot). 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). This case, from the same reporter is linked to 20210428051.; Sender''s Comments: V0: 20210916087-covid-19 vaccine ad26.cov2.s ? Blood Clot. 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 CLOT


VAERS ID: 1703530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210918407

Write-up: DEATH; THROMBOSIS; This spontaneous report received from a consumer concerned a female over the age of 50 with an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose not reported with frequency 1 total, start therapy date were not reported used for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the consumer saw a video on you tube (social media) where the patient developed thrombosis post vaccination and also died from an 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 an unspecified date, and the outcome of thrombosis was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210918494. . .; Sender''s Comments: V0- 20210918407-Covid-19 vaccine ad26.cov2.s- Death, Thrombosis. 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: 1706528 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210924012

Write-up: DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned three patients of unspecified age, sex, race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total was 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. On an unspecified date, (days after getting vaccine) the 3 patient''s had blood clots and they died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine was not applicable. The patient''s died from unknown cause of death, and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210924012-COVID-19 VACCINE -Death, 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1706571 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210925910

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative from social media 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 not reported, batch number: Unknown) dose were 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, it was reported as ''''Hi Scientist! Explain why a friend of mine died a week after getting the J & J Vax with blood clots..'''' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210925910-COVID-19 VACCINE AD26.COV2.S-Blood Clots(Fatal). This event is considered un-assessable. The event 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.; Reported Cause(s) of Death: BLOOD CLOT


VAERS ID: 1714502 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-20
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210928799

Write-up: PASSED AWAY DUE TO BLOOD CLOTS; This spontaneous report received from a consumer via media concerned a couple of multiple patients. The patients'' 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: not reported) dose was 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 dates, a couple of patients passed away due to blood clots. As per the reporter, "The called did mention that she was aware of a couple of patients who passed away due to the blood clots as reported by the media (on an unknown date)". On an unspecified dates, the couple of patients died from blood clots. It was unspecified if an 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 20210928678, 20210929077 and 20210929648.; Sender''s Comments: V0:20210928799-covid-19 vaccine ad26.cov2.s-Passed away due to 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: 1721485 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Thrombosis
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210935207

Write-up: DIED; SUDDEN HEART FAILURE; BLOOD CLOT; This spontaneous report received from a consumer (patient''s friend) via a company representative and via social media concerned a patient of unspecified age, sex, race and ethnic origin. 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 administration was not reported, batch number: unknown and expiry: unknown) dose, therapy start 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 "A friend of mine died 4 days after getting the J and J. Sudden heart failure brought on by a blood clot." The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event ''died'' was fatal, and the outcome of sudden heart failure and blood clot was not reported at the time of death. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210935207-covid-19 vaccine ad26.cov2.s-Died, sudden heart failure and blood clot. 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: 1731745 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-06-19
Onset:2021-07-16
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 15
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: hospitalization
CDC Split Type:

Write-up: Was taken to pharmacy for Janssen Covid-19 shot, she passed away after hospitalization for bilateral blood clots in lungs and blood clout in leg. Date of death July 31, 2021. (Cause of death per death certificate: pulmonary thromboembolism and deep venous thrombosis.)


VAERS ID: 1736821 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-26
Onset:2021-09-23
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Acute respiratory failure, Anticoagulant therapy, COVID-19 pneumonia, Cardiac arrest, Computerised tomogram thorax abnormal, Death, Dialysis, Echocardiogram abnormal, Endotracheal intubation, Fungal test, General physical health deterioration, Haemofiltration, Hypoxia, Mechanical ventilation, Pulse absent, Right ventricular dilatation, Thrombosis, Ultrasound Doppler normal, Vascular catheterisation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   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:
Preexisting Conditions: Obesity
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: 42-year-old lady with a history of obesity who was recently admitted to outside hospital with COVID-19 pneumonia and associated complications including acute hypoxemic respiratory failure, ARDS, and AKI. During the course of her hospitalization, she was treated with dexamethasone, remdesivir, tofacitinib, Plaquenil, and ivermectin. She required intubation on 9/10 and developed cardiac arrest after a prolonged period of hypoxia on 9/12. She was transferred for higher level care and treatment with CRRT. She had a vascular catheter placed on 9/15 initiated dialysis that same night. She had an echocardiogram on 9/15 that most notably showed RV was mildly dilated with moderately reduced function therefore she was started on therapeutic heparin given the concern for possible PE in the setting of Covid. Patient underwent dialysis again on 9/17. Lower extremity Dopplers were negative for DVTs on 9/16. From a respiratory standpoint, she is being treated with flolan and has been continued on zosyn and zyvox since admission. She was started on voriconazole on 9/17 and fungal labs (fungitel, galactomannan, blaso/histo Ag) were ordered for concern of possible underlying fungal infection. CT PE studay showed two RV thrombus. Therapeutic heparin was changed to argatroban to reduce fluid intake. Unfortunately, despite our best efforts including maximizing ventilator settings and multiple rounds of hemodialysis patient continued to decline without improvement. After discussion with family on 9/22 decision was made to transition patient to comfort care but to keep her on the ventilator. On the morning of 9/23 at 0655 patient lost pulse and was pronounced dead.


VAERS ID: 1740529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-28
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: 2021-07-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210951234

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer (patient''s niece) 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 and expiry: unknown) dose, therapy start date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021 (two months prior), the patient experienced blood clots and died. 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: V0.20210951234-Covid-19 vaccine ad26.cov2.s -Blood clot. 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: 1760669 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Pain in extremity, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-04
   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: unknown
Current Illness: unknown
Preexisting Conditions: none reported
Allergies: none
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Per niece a couple hours after getting the vaccine started to have issues with arm and his wife took him to the hospital to get checked out. It was took late by the time getting to the hospital and patient passed away around 1 pm. Per the coroner the preliminary cause of death is a blood clot. This information was provided to the pharmacy by the patients niece around 3 pm.


VAERS ID: 1764890 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-04-05
Onset:2021-06-20
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Chest X-ray normal, Cough, Death, Deep vein thrombosis, Dyspnoea, Pain in extremity, Pulmonary embolism, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen as needed. Famotidine as needed.
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: He had chest X-ray the week before he passed which was normal. He had normal vital signs at his PCP visit the week before he passed. He had a negative PCR COVID test the week before and a negative rapid test from the EMT people on site that tried to save him.
CDC Split Type:

Write-up: Started w/ shortness of breath mid to late June 2021. This was intermittent x 6-8 weeks. Started with upper calf pain end of July 2021. This was also intermittent. Started with cough and had increased shortness of breath first week in August. Went to his PCP. She thought it was asthma. Started on albuterol. This did not help. I found him 8/9/21 on our bed when I came home from work and he had passed away. Verbal autopsy report from Coroners office told me DVT in R calf and 2 pulmonary emboli. My husband was a non-smoker and worked out 7 days a week including long distance running, gym twice a week, playing basketball and hiking 14,000 ft mountains. No one can explain to me why he developed clots. No history or family history of any clotting disorders.


VAERS ID: 1767280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-07
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211009196

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. 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 and expiry: unknown) dose, frequency one 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 blood clot after receiving vaccine and died from blood clot on an unspecified date. 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: 20211009196-COVID-19 VACCINE AD26.COV2.S-Blood clot. 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: BLOOD CLOT


VAERS ID: 1767722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Brain oedema, Cerebral venous sinus thrombosis, Haemorrhagic cerebral infarction
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), Embolic and thrombotic events, venous (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210921; Test Name: Autopsy; Result Unstructured Data: Hemorrhagic cerebral infarct
CDC Split Type: USJNJFOC20211006297

Write-up: CEREBRAL VENOUS SINUS THROMBOSIS; HEMORRHAGIC CEREBRAL INFARCT; BRAIN SWELLING; This spontaneous report received from a consumer via social media (news reporter) 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 was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient had complications of hemorrhagic cerebral infarct and brain swelling due to cerebral venous sinus thrombosis. On 21-APR-2021, the patient died from cerebral venous sinus thrombosis, hemorrhagic cerebral infarct and brain swelling. It was reported that she was working on a story about a woman, who died on an unspecified date on 21-APR-2021. The autopsy report was completed on 21-SEP-2021. The pathologist concluded her death was caused by complications of hemorrhagic cerebral infarct and brain swelling due to cerebral venous sinus thrombosis complicating administration of human adenoviral vector vaccine for coronavirus 2019 disease. The doctor deemed the manner of death natural. It may also be considered a therapeutic complication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20211006297-covid-19 vaccine ad26.cov2.s-cerebral venous sinus thrombosis, hemorrhagic cerebral infarct, brain swelling. 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: CEREBRAL VENOUS SINUS THROMBOSIS; HEMORRHAGIC CEREBRAL INFARCT; BRAIN SWELLING


VAERS ID: 1771072 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-08
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: USJNJFOC20211009011

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a female 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, with frequency time 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had a blood clot and died from the blood clot. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from blood clot. This report was serious (Death).; Sender''s Comments: V0: 20211009011-COVID-19 VACCINE AD26.COV2.S-blood clot. 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: BLOOD CLOT


VAERS ID: 1773394 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: USJNJFOC20211010045

Write-up: BLOOD CLOT; This spontaneous report received from a physician via a company representative 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 admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from blood clot. 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). This case, from the same reporter is linked to 20211009193 and 20211010279.; Sender''s Comments: V0:20211010045- covid-19 vaccine ad26.cov2.s -blood clot. 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: BLOOD CLOT


VAERS ID: 1776028 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: USJNJFOC20211012640

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via social media via company representative concerned multiple patients (2 patients) of unspecified sex and age. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the multiple patient developed blood clots and died from blood clot. It was unknown if autopsy was performed. As per the reporter," The CDC (Centers for Disease Control and Prevention) has reported only two other confirmed deaths nationwide". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died from blood clot on an unspecified date. This report was serious (Death). This case, from the same reporter is linked to 20211009011.; Sender''s Comments: V0: 20211012640-COVID-19 VACCINE AD26.COV2.S-blood clot. 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 CLOT


VAERS ID: 1789873 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: USJNJFOC20211011609

Write-up: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA; This spontaneous report was received from literature with VITT following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. Blood advances. 29-SEP-2021. This report concerned multiple patients (3) of unspecified age, sex, race and ethnic origin. The objective of this literature was to describe vaccine-induced immune thrombotic thrombocytopenia (VITT) following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. No past medical history or concurrent conditions were reported. The patients (over 8.7 million) 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, 01 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 3 patients (11 percent) experienced vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia following vaccination. On an unspecified date, unfortunately the patients died. It was not specified whether patients autopsy were performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia on an unspecified date. The author commented that this literature highlighted the critical importance of knowing Covid-19 vaccine history. The author emphasized as on timely recognition that would be essential to prevent catastrophic complications and would require knowing the patient''s vaccine history. This report was serious (Death). This case, from same literature article was linked to 20211004121 and 20211006771.; Sender''s Comments: V0: 20211011609- COVID-19 VACCINE AD26.COV2.S- Vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA


VAERS ID: 1790083 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 15
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: USJNJFOC20211027314

Write-up: DEATH; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1731745) concerned a 88 year old female of 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 administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 19-JUN-2021 for an unknown indication. 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 16-JUL-2021, the patient had deep vein thrombosis (blood clot in leg) and pulmonary embolism (bilateral blood clots in the lungs). On an unspecified date, the patient was hospitalized for events. Number of days hospitalized and discharge information was not reported. On 31-JUL-2021, the patient died from deep vein thrombosis and pulmonary embolism (thromboembolism). It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from deep vein thrombosis and pulmonary embolism (thromboembolism) on 31-JUL-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211016947. Additional information was received from health care professional on 08-Oct-2021. Following receipt of additional information, it was determined that nullification and deletion was required for Manufacturer Report Number 20211016947. The information indicated that Manufacturer Report Number 20211016947 had E2B submission failure, due to incorrect format of VAERS ID. Therefore, this case was created to correct VAERS ID format. All relevant information will be submitted under Manufacturer Report Number 20211027314.; Sender''s Comments: V0: Additional information was received from health care professional on 08-Oct-2021. The information indicated that Manufacturer Report Number 20211016947 had E2B submission failure, due to incorrect format of VAERS ID. Therefore, this case was created to correct VAERS ID format. 20211027314- Covid-19 vaccine ad26.cov2.s- Death, deep vein thrombosis and pulmonary embolism. 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: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM


VAERS ID: 1794526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-18
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: USJNJFOC20211028523

Write-up: BLOOD CLOT COMPLICATIONS; This spontaneous report received from a consumer who reported she read a news article on 05-OCT-2021 which 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 was not reported, 1 total, administered on 01-AUG-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 an unspecified date, reporter stated that a local woman died from a rare blood clot complications due to the Janssen vaccine. 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: 20211028523-COVID-19 VACCINE AD26.COV2.S-blood clot complications. 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 CLOT COMPLICATIONS


VAERS ID: 1795256 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiomyopathy, Coronary artery thrombosis, Death, Dyspnoea, Ejection fraction decreased, Intensive care, PO2 decreased, Percutaneous coronary intervention, Pulmonary embolism, Pulseless electrical activity, Seizure, Syncope, Thrombectomy
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   Days after onset: 55
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: Obesity ,
Preexisting Conditions: Obesity
Allergies: NKDA
Diagnostic Lab Data: see above
CDC Split Type:

Write-up: Patietn recived J & J vaccine early August and within 2 weeks became SOB. He presented to Medical center after syncopal episode and had acute thrombosis of RCA on 9/25 /21 . He underwent PCI and thrombectomy . He was noted to have Cardiomyopathy at this time with EF < 20% . Several hours later while in the ICU he had siexzure followed by PEA arrest with ABG Po2 28 ( presumed pulmonary embolus ) and was pronounced dead at that time


VAERS ID: 1803505 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: USJNJFOC20211034195

Write-up: COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a consumer 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 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patients experienced covid-19 vaccine-induced thrombotic thrombocytopenia, On an unspecified date, the patient died from covid-19 vaccine-induced thrombotic thrombocytopenia. 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 20211034157.; Sender''s Comments: V0: 20211034195-COVID-19 VACCINE AD26.COV2.S-COVID-19 vaccine-induced thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA


VAERS ID: 1807886 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-05
Onset:2021-10-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Brain death, Cerebral haemorrhage, Computerised tomogram head normal, Dizziness, Headache, Nausea, Seizure, Subarachnoid haemorrhage, Superior sagittal sinus thrombosis, Urinary tract infection, Vertigo, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-20
   Days after onset: 2
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: Flonase, Melatonin, Vitamin D, biotin, diclofenac sodium, Lexapro, Ferrous sulfate, multivitamin, Tri-Sprintec, Protonix, Linzess, medical marijuana
Current Illness: none
Preexisting Conditions: obesity, hypothyroidism, GERD, anxiety, depression
Allergies: nsaids
Diagnostic Lab Data: Patient was immediately taken for cerebral angiogram and no interventions were able to be performed, it was a non survivable injury. Patient was pronounced brain dead on 10/20/21 at 11:37pm
CDC Split Type:

Write-up: Patient started with headache, dizziness, blurred vision, nausea and vomiting which she went to an urgent care facility on 10/18. On 10/19 she presented to an outside ER for the same symptoms, had a negative head CT and was sent home with antibiotics for a suspected UTI and meclizine for suspected vertigo. On 10/20 she returned to that same ER with no improvement in symptoms, she experienced a seizure in their ER and Head CTa showed near complete thrombosis of superior sagittal sinus, with acute parasagittal frontal parenchymal and subarachnoid hemorrhage. Patient arrived at our facility.


VAERS ID: 1817190 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
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: USJNJFOC20211043203

Write-up: THROMBOSIS; THROMBOCYTOPENIA; This spontaneous report received from a consumer via social media (media report) via a company representative concerned a 37 year old female of unspecified race and ethnicity. The patient''s height, and weight 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis, and thrombocytopenia and on 07-SEP-2021, the patient died from thrombosis and thrombocytopenia. 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 thrombosis, and thrombocytopenia. This report was serious (Death). This case, from the same reporter is linked to 20211043449, 20211042919 and 20211043850.; Sender''s Comments: V0- 20211043203 - covid-19 vaccine ad26.cov2.s ? Thrombosis, Thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: THROMBOSIS; THROMBOCYTOPENIA


VAERS ID: 1817192 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: USJNJFOC20211043449

Write-up: THROMBOSIS; THROMBOCYTOPENIA SYNDROME; This spontaneous report received from a consumer via a company representative via social media (news report) concerned multiple patients (three patients) of unspecified age, sex race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) doses were not reported, 1 total, start therapy dates were not reported for prophylactic vaccination. The batch numbers were not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. It was reported in news report that, "according to the CDC, there had been three other confirmed deaths of thrombosis with thrombocytopenia syndrome (TTS) after patients received the Johnson and Johnson vaccine, administered to more than 15 million people." On an unspecified date, the patients died from thrombosis, and thrombocytopenia syndrome. 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 20211042990, 20211043203, 20211043850 and 20211042919.; Sender''s Comments: V0: 20211043449-covid-19 vaccine ad26.cov2.s-thrombosis and thrombocytopenia syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: THROMBOSIS; THROMBOCYTOPENIA SYNDROME


VAERS ID: 1817491 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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, SARS-CoV-2 test positive, Septic shock, Vaccination failure, Vena cava thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Lack of efficacy/effect (narrow), 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: 29
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: Congestive heart failure; Hyperlipidemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Comments: The patient had no known allergies
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: COVID-19 PCR test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20210920491

Write-up: DEATH; ACUTE RESPIRATORY FAILURE; PULMONARY EMBOLISM; SEPTIC SHOCK; VENA CAVA THROMBOSIS; ACUTE KIDNEY INJURY; COVID-19 PNEUMONIA; COVID-19; DIZZINESS; COUGH; ENDOTRACHEAL INTUBATION; RENAL REPLACEMENT THERAPY; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; DYSPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1655956),concerned a 68 year old male. Initial information was processed with additional information received on 13-SEP-2021. The patient''s height, and weight were not reported. The patient''s past medical history included: Sorin Perceval S (S/P) aortic valve replacement, and concurrent conditions included: hypertension, congestive heart failure, and hyperlipidemia. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 in total, administered on 27-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam, atorvastatin, and carvedilol. On 13-AUG-2021, the patient arrived at the emergency room (ER) due to shortness of breath (dyspnoea) which he had since 1 week ago. Associated symptoms include dry cough and dizziness. The patient was intubated (endotracheal intubation) in the emergency room(ER). On the same day, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive. Finally, the patient was diagnosed with acute hypoxic respiratory failure, covid-19 (confirmed clinical vaccination failure), covid-19 pneumonia, septic shock, oliguric acute kidney injury (AKI) which required continuous renal replacement therapy (CRRT). The patient was also diagnosed with partial proximal inferior vena cava (IVC) thrombosis and emboli in the lingual (pulmonary embolism) and due to these events the patient was hospitalized (dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event confirmed clinical vaccination failure was not reported. On 30-AUG-2021, the patient died from acute kidney injury, acute respiratory failure, covid-19, covid-19 pneumonia, cough, dizziness, dyspnoea, pulmonary embolism, septic shock, vena cava thrombosis, renal replacement therapy, endotracheal intubation, death, sars-cov-2 test positive. It was unspecified if an autopsy was performed. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000193188. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 22-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender''s Comments: V1:This follow up adds- Product quality complaint investigation result. This new information does not alter prior causality assessment. 20210920491-covid-19 vaccine ad26.cov2.s- Death, acute kidney injury, acute respiratory failure, covid-19, covid-19 pneumonia, cough, dizziness, dyspnoea, pulmonary embolism, septic shock, vena cava thrombosis, renal replacement therapy, endotracheal intubation, sars-cov-2 test positive. 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. 20210920491-covid-19 vaccine ad26.cov2.s- confirmed 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: ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; COVID-19; COVID-19 PNEUMONIA; COUGH; DIZZINESS; DYSPNOEA; PULMONARY EMBOLISM; SEPTIC SHOCK; VENA CAVA THROMBOSIS; RENAL REPLACEMENT THERAPY; ENDOTRACHEAL INTUBATION; DEATH


VAERS ID: 1823353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Cerebral venous sinus thrombosis, Chills, Dizziness, Fatigue, Headache, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Chronic migraine; Gastrointestinal disorder; Multiple sclerosis (Diagnosed more than 20 years ago); Obesity (Body-mass index of 33.3. (Healthy is 18.5 to 24.9))
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Body mass index; Result Unstructured Data: 33.3; Comments: Healthy is 18.5 to 24.9
CDC Split Type: USJNJFOC20211042919

Write-up: CONSTANT HEADACHE; COMPLICATIONS OF CEREBRAL VENOUS SINUS THROMBOSIS; DIZZINESS; CHILLS; NOT FEELING WELL; TIRED AND FATIGUE; NAUSEA; This spontaneous report received from a consumer via a company representative via social media concerned a 60-year-old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: obese with a body-mass index of 33.3, high blood pressure, chronic migraines, common colon condition, and diagnosed more than 20 years ago with multiple sclerosis, a potentially disabling disease of the brain, for which the patient took medication. 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 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. It was reported that "The patient died 13 days after she received the single-shot vaccine on 08-April-2021, just five days before federal health agencies temporarily paused the vaccine administration while they examined an unusual blood-clotting disorder". The patient "appears to have succumbed" to a "rare but nevertheless documented" complication associated with the viral vector vaccine, cerebral venous sinus thrombosis. According to the Regulatory Authority, the condition is characterized by a blood clot in the venous sinuses, part of the brain''s blood drainage system". "In the days after the shot, the patient was not feeling well, she was tired. The autopsy report documents constant headache, fatigue, chills, dizziness and nausea. The reporter stated that the patient did not looked well, but the next week, she went to work". On 17-Apr-2021, the reporter mentioned that the patient stated "her head hurt", and reported suggested her to rest. The patient contacted her doctor, who recommended Motrin and prescribed an anti-nausea medication. The reporter stated that "People were offering to take patient to the hospital, but she assured them sleep would make it better. She would give it another day. On 21-April-2021, the patient, divorced and was living alone, did not go to the office. She stopped responding to messages, inciting panic. A friend with a key was enlisted to check on patient. She found the patient was dead on her bed." The autopsy report lists the cause as "complications of cerebral venous sinus thrombosis" and "recent administration" of a COVID-19 vaccine as the contributing condition. The report, however, notes "no definitive identifiable neuropathological features" of the disease. On 21-APR-2021, the patient died from complications of cerebral venous sinus thrombosis. An autopsy was performed on 20-SEP-2021. It was also reported that "As of 22-Oct-2021, more than 15 million Americans have gotten the J&J vaccine. There are believed to be five confirmed deaths, including the patient". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, tired and fatigue, chills, dizziness, nausea and constant headache was not reported. This report was serious (Death). This case, from the same reporter is linked to 20211043203, 20211043850, 20211043449 and 20211042990.; Sender''s Comments: V0: 20211042919-COVID-19 VACCINE AD26.COV2.S-Complications of cerebral venous sinus thrombosis. 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: COMPLICATIONS OF CEREBRAL VENOUS SINUS THROMBOSIS


VAERS ID: 1831721 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-06
Onset:2021-05-25
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Deep vein thrombosis, Intracardiac thrombus, Pulmonary embolism, Sudden death, Superficial vein thrombosis, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

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: Remicade, Amitriptyline, Hydroxyzine, Oxycodone, Duloxetine.
Current Illness: Chrohn''s Disease
Preexisting Conditions: Fibromyalgia
Allergies: None
Diagnostic Lab Data: Bilateral pulmonary thromboemboli extending deeply into both lungs. Adherent thromboli in right atrium Deep vein thromboli of superficial veins of Left Lower leg. Lead to instantaneous death on 5-25-2021.
CDC Split Type:

Write-up: Blood clot induced death.


VAERS ID: 1840261 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-01
Onset:2021-10-09
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain lower, Angiogram, Asthma, Atrial fibrillation, COVID-19, Death, Deep vein thrombosis, Dyspnoea, Echocardiogram abnormal, Hypoxia, Pleural effusion, Pulmonary embolism, Thrombocytopenia, Ultrasound scan abnormal, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortness of Breath diabetes, hypertension presenting by ambulance for left lower quadrant abdominal pain. Patient reports that the pain is intermittent when he gets "strong" he feels short of breath. He denies URI symptoms. No chest pain. Denies fever. Noted to be febrile here however. No urinary symptoms. No diarrhea. Hospital Course and Significant Findings: Patient was a 65-year-old male vaccinated for Covid-19 (tested positive for Covid-19 on 10/9/2021), type II diabetic, hypertension admitted on 10/20/2021 with worsening shortness of breath. Asthma Hospital course: -In emergency room--- $g presented with ST elevation/DKA. Insulin drip protocol started and patient taken to Cath Lab: 100% LAD occlusion/received DES -Admitted to ICU: Started on remdesivir/Decadron, insulin drip continued (thrombocytopenia noted/consistent with DIC and no TOCI given)/requiring high flow oxygen--- $g transferred out of ICU -(10/21/2021) echocardiogram showing LVEF 20-25%, DVT ultrasound showing right distal femoral to entire popliteal DVT (started on enoxaparin -(10/23/2021 developed A. fib/RVR-initially treated with digoxin and then amiodarone drip/more shortness of breath-transferred to ICU/then downgraded to med telemetry on 10/24/2021 in early a.m. -(10/24/2021) CT angiogram chest showing bilateral lower lobe pulmonary emboli/consolidations bilaterally/bilateral pleural effusions--- $g started on Eliquis/ongoing high flow oxygen needs. -(10/25/2021) repeat echocardiogram with similar LVEF: 25% -(10/26/2021) started on empiric ceftriaxone/doxycycline -(10/28/2021) transferred to ICU for work of breathing/hypoxia (intolerant of BiPAP)/pt able to come off Bipap in evening to high flow O2--- $gable to take in some po''s During the course of the night, patient experienced deasaturations despite Bipap. After D/W patient, he was intubated. Unfortunately patient exp''d PEA arrest later in am. Despite several rounds of CPR, patient expired at 3:05 am.


VAERS ID: 1854042 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-03-16
Onset:2021-09-11
   Days after vaccination:179
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Death, Dyspnoea, Endotracheal intubation, General physical health deterioration, Hypoxia, Intensive care, Jugular vein thrombosis, Mechanical ventilation, SARS-CoV-2 test positive, Subclavian vein thrombosis, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   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: Multiple myeloma with chemo treatments, ESRD with hemodialysis, morbid obesity
Allergies: NSAID''s, Thorazine, Ultran
Diagnostic Lab Data:
CDC Split Type: 11895

Write-up: Had been previously admitted from 8/27-8/31 with +COVID and acute hypoxemia and discharged with good oxygenation on dexamethasone and levoquin for UTI. Admitted again on 9/2 due to worsening dyspnea from covid pneumonia. Treated with zyvox and zosyn on high flow oxygen. Continued to decline and admitted to ICU on 9/3 and intubated. Given remdesevir and continues steroids. Found bilateral IJ and subclavian vein thrombosis. Transitioned from eliquis to lovenox. Unable to be weaned from the ventilator. Family involved in care and transitioned patient to comfort care and patient was extubated and passed on 9/11/21.


VAERS ID: 1856602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis
SMQs:, Ischaemic 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211116416

Write-up: BRAIN BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a 35 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced massive brain blood clot and died from brain blood clot. 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: 20211116416-covid-19 vaccine ad26.cov2.s-brain blood clot. This case concerned to a 35 year old female. 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: BRAIN BLOOD CLOT


VAERS ID: 1856604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), 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: USJNJFOC20211116646

Write-up: HEART ATTACK; HUGE BLOOD CLOTS; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnic origin. 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 and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Consumer reported that on an unspecified date, the patient got the shot and shortly he was dead from a heart attack caused by huge blood clots of the size of a tennis ball. 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 heart attack and huge blood clots on an unspecified date. This report was serious (Death).; Sender''s Comments: V0 20211116646-COVID-19 VACCINE AD26.COV2.S- Heart attack, huge 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: HEART ATTACK; HUGE BLOOD CLOTS


VAERS ID: 1860101 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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: USJNJFOC20211108240

Write-up: CEREBRAL VENOUS SINUS THROMBOSIS; This is spontaneous report received from a patient via a company representative via social media (news report) concerned an adult patient (between 18 to 59 years old) of unspecified 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 admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from cerebral venous sinus thrombosis. It was unspecified if an 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 20211108282, 20211105314, 20211107849, 20211107924, 20211107704, 20211108139, 20211111163 and 20211109684.; Sender''s Comments: V0: 20211108240- COVID-19 VACCINE AD26.COV2.S- cerebral venous sinus thrombosis. 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: CEREBRAL VENOUS SINUS THROMBOSIS


VAERS ID: 1863368 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intracardiac thrombus, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211122792

Write-up: LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN LUNGS; LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN HEART; This spontaneous report received from a consumer concerned multiple patients of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient''s 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the consumer lost two family members from blood clots in lungs and heart. The reporter stated I lost two family members from blood clots after this shot in the heart and lungs. 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: 20211122792-COVID-19 VACCINE AD26.COV2.S- lost two family members from blood clots in lungs , lost two family members from blood clots in heart.. 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: LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN LUNGS; LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN HEART


VAERS ID: 1866972 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-13
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: USJNJFOC20211124990

Write-up: BLOOD CLOTS/ 3 OR 4 WOMEN THAT DIED FROM BLOOD CLOTS; This spontaneous report received from a patient via a company representative via a social media post concerned 3 or 4 female patients of unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. These patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the reporter stated that "I really Hope you do not get the J and J there have been 3 or 4 Women that Died from Blood Clots". On an unspecified date, the patients died from blood clots. 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). This case, from the same reporter is linked to 20211125101.; Sender''s Comments: V0: 20211124990-covid-19 vaccine ad26.cov2.s -blood clots/ 3 or 4 women that died from 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: 1880780 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-05-01
Onset:2021-10-06
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, COVID-19 pneumonia, Cardiac arrest, Chest tube insertion, Condition aggravated, Death, Deep vein thrombosis, Echocardiogram abnormal, Ejection fraction decreased, Fraction of inspired oxygen, Gastrostomy, Mechanical ventilation, Pneumonia necrotising, Pneumonia pseudomonal, Pneumothorax, Positive end-expiratory pressure, Pulmonary embolism, Pulseless electrical activity, Renal tubular necrosis, Resuscitation, SARS-CoV-2 test positive, Sepsis, Tidal volume, Tracheostomy
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Renovascular disorders (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), 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: 2021-11-12
   Days after onset: 37
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: COPD, Pulmonary Embolism, Hyperlipidemia, Gastroesophageal Reflux Disease, Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 74yr old male admitted on 11/3/2021 from Medical Center. The patient had a past medical history of COPD, PE, Hyperlipidemia, Gastroesophageal reflux disease, Hypothyroidism, Cholecystectomy, R knee replacement, PEG on 10/29/2021 and a Percutaneous tracheostomy on 10/27/2021. Pt was vaccinated with Johnson and Johnson vaccine in May 2021. Pt''s son passed away from COVID-19 infection. The patient tested positive on 10/5/2021. The patient was transferred to bigger hospital from smaller Hospital with COVID-19 pneumonia and sepsis. When the patient arrived to bigger hospital the patient had a pulseless electrical activity cardiac arrest requiring chest compressions and 1 dose of epinephrine prior to returning to spontaneous circulation. The patients post cardiac echocardiogram showed an ejection fraction decreased to 23%, the pt. also developed acute kidney injury related to acute tubular necrosis. The patient was given tocilizumab, remdesivir and steroids. The patient''s hospital course was further complicated by DVT and pulmonary embolism. Pt was noted to also have right upper lobe necrotizing pneumonia due to Pseudomonas. Pt was seen and was on Meropenem. Pt was unable to be weaned off of the ventilator and underwent a tracheostomy on 10/27/2021 and a PEG placement on 10/29/2021. The patient''s family met with palliative care and they wanted to continue current care. On admission to Select the patient was on assit-control mode of ventilation with a tidal volume of 380, PEEP of 5, respiratory rate of 14 and FiO2 of 40%. The pt. had also had pneumothoraxes and on admission to Select the pt. had 2 right sided chest tubes and a chest tube on the left. Pt''s condition worsened and on 11/12/2021 Pulmonary noted that he had a long discussion with the family, discussed with them the surgical additional chest tube placement needed, but family decided on comfort cares at that time. Pt was placed on comfort cares and expired on 11/12/2021 at 1500.


VAERS ID: 1892677 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Death, Imaging procedure, Nausea, Platelet count, Portal vein thrombosis, Thrombosis with thrombocytopenia syndrome, Visceral venous thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Immune-mediated/autoimmune disorders (narrow), 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: Test Name: Platelet count; Result Unstructured Data: ranging from 10000 to 127000; Test Name: Imaging procedure; Result Unstructured Data: Cerebral Venous Sinus Thrombosis
CDC Split Type: USJNJFOC20211138044

Write-up: THROMBOTIC THROMBOCYTOPENIA; CEREBRAL VENOUS SINUS THROMBOSIS; SPLANCHNIC VEIN THROMBOSIS; PORTAL VEIN THROMBOSIS; INTRAPARENCHYMAL BRAIN HAEMORRHAGE; ABDOMINAL PAIN; BACK PAIN; NAUSEA; VOMITING; DEATH; This spontaneous report received from a consumer concerned multiple patients (6) of unspecified age and sex. The patients'' height, and weight were not reported. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, five patients presented with initial symptoms of headache and back pain in the sixth patient who subsequently developed headache (subsumed under CVST). It was reported that one patient also had abdominal pain, nausea, and vomiting. The four patients developed focal neurological symptoms focal weakness, aphasia, visual disturbance (subsumed under CVST) prompting presentation for emergency care. The median days from vaccination to hospital admission was 15 days (range 10 to 17 days). All were eventually diagnosed with cerebral venous sinus thrombosis (CVST) by intracranial imaging. The two patients were also diagnosed with splanchnic and portal vein thrombosis. It was unusual for patients presenting with thrombotic events, all six patients showed evidence of thrombocytopenia (less than 150,000 platelets per microliter of blood), consistent with a condition known as thrombotic thrombocytopenia, with platelet nadir counts ranging from 10,000 to 127,000 during their hospitalizations. It was reported that four patients developed intraparenchymal brain hemorrhage and one subsequently died. Laboratory data (dates unspecified) included: Imaging procedure (NR: not provided) Cerebral Venous Sinus Thrombosis, and Platelet count (NR: not provided) ranging from 10000 to 127000. On an unspecified date, one patient died from unknown cause of death. It was unspecified if an autopsy was performed. The outcomes for the multiple patients with cerebral venous sinus thrombosis, thrombotic thrombocytopenia, back pain, abdominal pain, nausea, vomiting, splanchnic vein thrombosis, portal vein thrombosis and intraparenchymal brain haemorrhage was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210340967.; Sender''s Comments: V0: 20211138044- covid-19 vaccine ad26.cov2.s-thrombotic thrombocytopenia, Cerebral venous sinus thrombosis, splanchnic vein thrombosis, portal vein thrombosis. This event(s) is labeled per RSI and is therefore considered potentially related. 20211138044- covid-19 vaccine ad26.cov2.s-Death, intraparenchymal brain haemorrhage. 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: 1892683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-23
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: USJNJFOC20211140935

Write-up: RARE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned an adult female (older than 50 years) of 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: Unknown expiry: unknown) dose, therapy start date not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had rare blood clots (Clot blood) and died. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare blood clots was reported as fatal. This report was serious (Death). This case, from the same reporter is linked to 20210654540, 20211010045, 20210446964 and 20211023372.; Sender''s Comments: V0:20211140935- covid-19 vaccine ad26.cov2.s -rare 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).; Reported Cause(s) of Death: RARE BLOOD CLOTS


VAERS ID: 1899233 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: USJNJFOC20211143972

Write-up: RARE BLOOD CLOTS; This spontaneous report received from a consumer via a news article concerned two female patients of age over 50 years. No past medical history or concurrent conditions were 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 was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patients experienced rare blood clots and died. 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). This case, from the same reporter is linked to 20211023372, 20211010045 and 20211140935.; Sender''s Comments: V0: 20211143972-COVID-19 VACCINE AD26.COV2.S- Rare blood clots. 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: RARE BLOOD CLOTS


VAERS ID: 1901540 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-10-09
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Angiogram, Asthma, Atrial fibrillation, COVID-19, Death, Deep vein thrombosis, Dyspnoea, Echocardiogram, Echocardiogram abnormal, Hypoxia, Pleural effusion, Pulmonary embolism, SARS-CoV-2 test, Thrombocytopenia, Ultrasound scan, Ultrasound scan abnormal, Vaccination failure, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2021-10-29
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Type II diabetes mellitus
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20211009; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20211021; Test Name: Diagnostic ultrasound; Result Unstructured Data: Deep Vein Thrombosis; Test Date: 20211021; Test Name: Echocardiogram; Result Unstructured Data: LVEF 20-25%; Test Date: 20211024; Test Name: CT angiography; Result Unstructured Data: pulmonary emboli; Test Date: 20211025; Test Name: Echocardiogram; Result Unstructured Data: LVEF 25%
CDC Split Type: USJNJFOC20211130291

Write-up: DEATH; HYPOXIA; PULMONARY EMBOLISM; PLEURAL EFFUSION; ANGIOGRAM; ATRIAL FIBRILLATION; ULTRASOUND SCAN ABNORMAL; DEEP VEIN THROMBOSIS; ECHOCARDIOGRAM ABNORMAL; ASTHMA; THROMBOCYTOPENIA; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; VACCINE BREAKTHROUGH INFECTION; ABDOMINAL PAIN LOWER; DYSPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 65 year old male of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 19-Nov-2021 and from Central Complaint Vigilance department on 23-Nov-2021. The patient''s height and weight were not reported. The patient concurrent conditions include hypertension and type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 to left arm for an unspecified indication. No concomitant medications were reported. On 09-OCT-2021, the patient tested positive for Covid-19 (confirmed clinical vaccination failure). On 20-OCT-2021, the patient was admitted to hospital with worsening shortness of breath and asthma. In emergency room patient presented with ST elevation DKA (diabetic ketoacidosis). Insulin drip protocol was started and patient was taken to lab where 100% LAD (left anterior descending) occlusion was observed and received DES (drug-eluting stent). Later admitted to intensive care unit (ICU) started on remdesivir, Decadron, insulin drip. Continued thrombocytopenia was noted consistent with DIC (disseminated intravascular coagulation) and no "TOCI" given requiring high flow oxygen, transferred out of ICU. On 21-OCT-2021 echocardiogram showed left ventricular ejection fraction (LVEF) 20-25%, DVT (Deep vein thrombosis) ultrasound showed right distal femoral to entire popliteal DVT. The patient was started on enoxaparin. On 23-OCT-2021, the patient developed atrial fibrillation with rapid ventricular response (A fib RVR) and was initially treated with digoxin and then with amiodarone drip, patient developed more shortness of breath and was then transferred to ICU, downgraded to med telemetry on 24-OCT-2021 in early morning. On 24-OCT-2021, chest computed tomography angiogram showed bilateral lower lobe pulmonary emboli consolidations and bilaterally bilateral pleural effusions and was started on Eliquis. The patient required ongoing high flow oxygen need. On 25-OCT-2021 repeat echocardiogram was done with similar results of LVEF of 25%. On 26-OCT-2021 the patient was started on empiric treatment of ceftriaxone and doxycycline. On 28-OCT-2021, patient was transferred to ICU for work of breathing hypoxia intolerant of BiPAP (bilevel positive airway pressure) and was able to come off Bipap in the evening to high flow oxygen, able to take in some through oral. During the course of the night on the same day the patient experienced desaturations despite Bipap. The patient was intubated. Unfortunately, patient expired, PEA (Pulseless electrical activity) arrest later in the morning on 29-OCT-2021. Despite several rounds of cardiopulmonary resuscitation, patient expired at 3:05 am on 29-OCT-2021 from an 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 from an unknown cause of death on 29-OCT-2021, and the outcome of abdominal pain lower, angiogram, asthma, atrial fibrillation, covid-19, deep vein thrombosis, dyspnoea, echocardiogram abnormal, hypoxia, pleural effusion, pulmonary embolism, thrombocytopenia, ultrasound scan abnormal, vaccine breakthrough infection was fatal and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000203205. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 24-NOV-2021. The following information was updated and incorporated into the case narrative: PQMS number and Product quality complaint investigation result added.; Sender''s Comments: V1:Additional information received updates: PQMS number and Product Quality complaint investigation result. This updated information does not alter prior causality assessment of reported events. 20211130291-COVID-19 VACCINE AD26.COV2.S - deep venous thrombosis, thrombocytopenia, pulmonary embolism, ultrasound scan abnormal . This event(s) is labeled per RSI and is therefore considered potentially related. 20211130291-COVID-19 VACCINE AD26.COV2.S -asthma, atrial fibrillation, echocardiogram abnormal, covid-19, vaccine breakthrough infection, death, dyspnoea, hypoxia, pleural effusion, abdominal pain lower, angiogram. 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). 20211130291-COVID-19 VACCINE AD26.COV2.S -confirmed clinical vaccine 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: 1913465 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-16
Onset:2021-03-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Acute myocardial infarction, Ammonia increased, Computerised tomogram abnormal, Computerised tomogram spine, Death, Electrocardiogram, Intensive care, Magnetic resonance imaging, Malaise, Near death experience, Nonalcoholic fatty liver disease, Portal vein thrombosis, Rectal haemorrhage, Ultrasound kidney, Unresponsive to stimuli
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 85
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: laxics, neurontin, licinopril, pottasium citrate, spironolactone, tresiba, inhaler
Current Illness:
Preexisting Conditions: diabetes, aneurisms repair, copd, heart mermer, chs, peripheral neuropathy, liver issues
Allergies: sulfa
Diagnostic Lab Data: cat scan - large blood clot blocking portal vein, only small amount of blood going to liver mri - inconclusive renal ultrasound cervical spine ct upper gi ekg
CDC Split Type:

Write-up: immediately became very ill, 9 days later (03/25/21) patient was found nearly dead, rarced to hospital, on the way there he became unresponsive, ambulance carried him the rest of the way 8 days in icu, 4 days on the floor, discharged with acute non- alcoholic liver non-stem heart attack, DOES NOT DRINK, he exibited a typical behavior, therefor they couldnt get his elevated amonia down, never medically responded,was discharged home, 8 days later condition worsened, he was not medically responding as expected, rectal bleeding, discharged on hospice diagnosed with portal vein thrombosis never went back to normal self. died in 8 weeks


VAERS ID: 1923992 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-12
Onset:2021-11-29
   Days after vaccination:262
Submitted: 0000-00-00
Entered: 2021-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / SC

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Death, General physical health deterioration, Intensive care, Positive airway pressure therapy, Respiratory failure, Thrombosis
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, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-11-29
   Days after onset: 0
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt admitted on 11/22 from nursing home with respiratory failure secondary to COVID19 infection. He was admitted to the ICU and placed on NIV. Pt continued to require more oxygen and was unable to come off BIPAP. He did express that he did not want to be placed on ventilator and did not want any intervention in regards to his own blood clot. The patient was made a DNR/DNI. His family was contacted. Pt continued to decline over the next couple of days. Family was called in. Pt was transitioned to comfort measures. He did pass away on 11/29/2021 @ 1846.


VAERS ID: 1932483 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Acute myocardial infarction, Anticoagulant therapy, Arrhythmia, Asthenia, Atrial fibrillation, Blood glucose increased, Bradycardia, Cardiac arrest, Cardiac failure acute, Cardiac pacemaker insertion, Cardiomegaly, Catheterisation cardiac abnormal, Computerised tomogram thorax abnormal, Coronary angioplasty, Coronary artery disease, Death, Decreased appetite, Deep vein thrombosis, Diabetic ketoacidosis, End stage renal disease, Fall, Fatigue, Haemodialysis, Hyperglycaemia, Hypophagia, Hypotension, Iliac artery occlusion, Iliac artery stenosis, Intensive care, Left ventricular failure, Lethargy, Leukocytosis, Pneumonia, Pulmonary embolism, Pulmonary oedema, Rhabdomyolysis, Shock, Sinus arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-12-01
   Days after onset: 76
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Possibly Diclofenac and Metformin-patient was lethargic
Current Illness:
Preexisting Conditions: DM2, HTN
Allergies: NKA
Diagnostic Lab Data: 9/22/21: BGL in hospital: 911.2 mg/dL
CDC Split Type:

Write-up: Of note, the patient is not in state registry. Date taken from nursing flowsheet in medical records. This date may not be an estimate. 9/22/21: Pt received covid vaccine 1 week ago, since then has been c/o weakness, fatigue, loss of appetite, fell today NOBT. BGL 523 pt hasn''t been taking metformin bc he ran out. hypotensive in route given 1L NS. a&ox3, clear speech. pt lethargic. Per patient''s significant other, he had not taken his Metformin for 4-5 days because he complains that his medications make him sick and sleepy. She also mentions that patient has generalized fatigue and weakness with decreased p.o. intake since he stopped taking his medications. 10/15/21: Discharge summary: This is the care of 62 year old male who has a medical history of DM2 and HTN presenting with generalized fatigue. Patient was lethargic during interview and was mostly responding with "I''m tired". Patient was found to have hyperglycemia, AKI and leukocytosis. Patient was admitted to ICU with DKA and DKA protocol was started. Patient was also found to have bilateral pneumonia and was started on Abx. His AKI developed to ESRD and he was started on HD with midodrine for hypotension. Upon admission and during the course of his stay he was found to have NSTEMI, pulmonary edema, acute on chronic systolic CHF, and LLL pulmonary embolism. His ARF resolved and he was started on Eliquis. Patient was also seen by vascular surgery for lower extremity DVT and near occlusion of left common iliac, internal iliac and external iliac arteries, 50% narrowing of right common iliac artery, no indication of surgical intervention at this time. Patient was discharged to facility after HD chair was secured. Patient will follow up with PCP, cardiology and vascular surgery as outpatient. He maximized his benefit from his inpatient stay. 10/20/21: Patient was recently hospitalized for several weeks last month and was discharged only 5 days ago. He was initially hospitalized for diabetic ketoacidosis, however patient then developed rhabdomyolysis with acute renal failure and NSTEMI. He had multiple arrhythmias during a hospitalization including AFib with RVR and bradycardia with sinus pauses. He did receive cardiac catheterization with Dr. on September 24th which revealed diffuse coronary artery disease. He had PTCA of the circumflex with incomplete revascularization. Leadless pacemaker was placed on September 30. Patient was discharged on oral amiodarone and anticoagulation with Eliquis. 10/21/21: Cardiomegaly noted on chest CT. Prior imaging notes normal heart size. Admitted 10/20 for cardiac arrest. 12/1/2021: Pt expired. Major medical illness: shock.


VAERS ID: 1941718 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intracardiac thrombus, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211222177

Write-up: BLOOD CLOTS IN THE LUNGS; BLOOD CLOTS IN THE HEART; This spontaneous report received from a consumer via social media concerned multiple patients of unspecified age, sex, 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, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced "blood clots in the lungs, and blood clots in the heart". On an unspecified date, the patient died from "blood clots in the lungs, and blood clots in the heart". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, and blood clots in the heart was fatal. This report was serious (Death).; Sender''s Comments: V0: 20211222177-covid-19 vaccine ad26.cov2.s-blood clots in the lungs, and blood clots in the heart. 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 IN THE LUNGS; BLOOD CLOTS IN THE HEART


VAERS ID: 1947958 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-08
Onset:2021-11-26
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Angiogram cerebral abnormal, Aphasia, COVID-19 pneumonia, Carotid artery occlusion, Carotid artery thrombosis, Cerebrovascular accident, Cough, Death, Electrocardiogram ST segment elevation, Endotracheal intubation, Exposure to SARS-CoV-2, Gaze palsy, Haematocrit normal, Hemiparesis, Hypoxia, Intensive care, Ischaemic stroke, Magnetic resonance imaging head abnormal, Mechanical ventilation, Neurological examination abnormal, Perfusion brain scan abnormal, Pneumonia, Prone position, Pulmonary oedema, Respiratory symptom, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-12-04
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amLODIPine (NORVASC) 10 MG tablet atorvastatin (LIPITOR) 80 MG tablet clopidogrel (PLAVIX) 75 MG tablet glipiZIDE CR (GLUCOTROL) 2.5 MG 24 hr tablet metoprolol succinate-XL (TOPROL-XL) 100 MG 24 hr tablet pantoprazole (PROTONIX) 40 MG table
Current Illness:
Preexisting Conditions: Acute respiratory failure Cardiomyopathy, ischemic Coronary artery disease involving native coronary artery of native heart without angina pectoris Essential hypertension PVD (peripheral vascular disease) Left-sided carotid artery disease Acute systolic heart failure Acute right MCA stroke Anemia in chronic kidney disease Kidney disorder Stage 3 chronic kidney disease Renal osteodystrophy Gout Diabetes mellitus
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Deceased 12/4/2021; Hospitalized 11/26/2021; COVID-19 exposed unclear if test done; fully vaccinated BRIEF OVERVIEW: Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 11/26/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute right MCA stroke [I63.511] Ischemic stroke [I63.9] HOSPITAL COURSE Patient is a 67 yo male, history of PVD, HTN, CAD, cardiomyopathy, DM, CKD, tobacco use, and recent COVID exposure, who was admitted to Medical ICU from ED for concern of stroke in the presence of COVID pneumonia. Neuro ICU was consulted for stroke. To review, patient was found unresponsive on 11/26. He was last known well on the evening of 11/25. Down time is unknown. Patient has multiple family members at home who are COVID positive. Per ED report, patient was having some cough and respiratory symptoms while at home. EMS reportedly found patient unresponsive with a right sided gaze and left sided weakness. Patient was hypoxic with O2 sat in the 60''s and a respiratory rate in the 40''s. On arrival to outside ED, patients exam was documented as non verbal but following commands. Patient was stroke coded at 1130 on 11/26; initial NIH 32. Stat HCT was negative for hemorrhage. Due to unknown down time, patient was outside the window for TPA. CTA shows a left cervical ICA occlusion and a incompletely occlusive right cervical ICA thrombus. No intracranial occlusions reported. CTP showed a 7 ml core and 5 ml penumbra. Patient was showing some ST elevation in V1, V2 and lead 3 concerning for STEMI. He was given rectal aspirin. Per outside report, ED physician contacted both BW cardiology and stroke neurology for recommendations. Per cardiology, did not feel this was a STEMI, no acute need for heparin gtt from cardiac standpoint at this time. Stroke neurology recommended STAT MRI brain. There was no documented discussion regarding whether or not patient''s candidacy for mechanical thrombectomy was discussed. It was assumed that patient was not a candidate. Patient was satting 90% on NRB. It was ultimately decided to admit to Medical ICU and patient was intubated for airway protection. On 11/27an MRI brain was obtained and showed right MCA and watershed territory strokes, Left MCA/ACA watershed strokes, and possible small left petechial ICH. Throughout his ICU course his pulmonary status continued to decline and he developed severe ARDS, pneumonia, and pulmonary edema. Despite maximum medical efforts, including high dose sedation, paralytics, and prone positioning, the patient failed to make significant improvement from a pulmonary standpoint. Given his poor neurological exam in conjunction with his multiple bihemispheric strokes seen on brain MRI, as well as failure to improve on the ventilator, multiple family meetiings were held to discuss goals of care. It was decided that the current level of care and anticipated poor recovery did not align with the patients prior wishes. As such, the family elected to transition him to comfort measures. After all family was able to say their goodbyes, the patient was terminally extubated on 12/4/21. He passed away with family at his bedside at 3:53PM.


VAERS ID: 1950879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), 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: USJNJFOC20211229627

Write-up: BLOOD CLOT; HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a 59 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). 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 stated that, "Second vax death in my family. My 33 year old brother died from a blood clot causing a stroke. 2 months after his 2nd pfz shot. Now my 59 year old uncle died from a blood clot causing a heart attack. 3 months after his only J&J shot. When will people realise that it''s not safe?". It was unspecified if an autopsy was performed. On an unspecified date, the patient died from blood clot, and heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: 20211229627-Covid-19 vaccine ad26.cov2.s -Blood clot, 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: BLOOD CLOT; HEART ATTACK


VAERS ID: 1954111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211225334

Write-up: BLOOD CLOTS ALL OVER HER BODY; This spontaneous report received from a consumer via social media via a company representative concerned a female 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 (Janssen series 1 dose) (suspension for injection, route of admin, batch number and expiry were not reported) dose not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots all over her body. Reporter stated that "I just learned from my bd that his daughters man grandma recently days ago after taking the Johnson and Johnson covid vaccine in that same day. I''m not anti vax but no major coincidence these two women and other people all over the world is dying due to the shots causing blood clots." On an unspecified date, the patient died from blood clots all over her body. 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 20211225157 and 20211225561.; Sender''s Comments: V0 20211225334-COVID-19 VACCINE AD26.COV2.S-blood clots all over her body. 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 ALL OVER HER BODY


VAERS ID: 1954454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Medical History/Concurrent Conditions: Surgery (Was in rehab from surgery.); Comments: The patient was very healthy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211232634

Write-up: DIED; BLOOD CLOTS; 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. The patient''s past medical history included: surgery, and other pre-existing medical conditions included: The patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total, dose number series 1, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots. The patient died from unknown cause of death one day after he was forced to take the vaccine. According to reporter patient was very anti vaccine and very healthy. He was there in a rehab from a surgery. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20211232634- covid-19 vaccine ad26.cov2.s- Died, 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1955766 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-17
Onset:2021-11-01
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / SYR

Administered by: Public       Purchased by: ?
Symptoms: Death, Pulmonary thrombosis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-11-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: I AM WRITING THIS ON BEHALF OF MY BROTHER. MY BROTHER PASSED AWAY 11/14/21 DUE TO BLOOD CLOTS THAT TRAVELED FROM HIS LEGS TO HIS LUNGS. MY BROTHER WAS PERFECTLY HEALTHY. I HAVE NO DOUBT IN MY MIND THAT THE J&J VACCINATION CAUSED HIS DEATH. AS I WRITE THIS TODAY I RECEVIED A NOTIFICATION STATING THAT THE CDC RECOMMENDS MODERNA OR PFIZER OVER THE J&J VACCINATION DUE TO BLOOD CLOTS. NO ONE WILL BE ABLE TO CHANGE MY MIND AND TELL ME IT WAS DUE TO SOMETHING ELSE. THE MEDICAL EXAMINER HAS NO EXPLANATION AS TO WHY HE GOT BLOOD CLOTS WITH NO UNDERLYING CONDITION AND IS COMPLETELY DUMBFOUNDED BY IT. MY BROTHER PASSED AWAY AT THE AGE OF 44. RIP
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: MY BROTHER AT THE AGE OF 44 PASSED AWAY FROM BLOOD CLOTS THAT TRAVELED FROM HIS LEGS TO HIS LUNGS.


VAERS ID: 1963728 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-04-07
Onset:2021-04-19
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       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: 2021-05-07
   Days after onset: 18
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: None
Preexisting Conditions: COPD (not on Oxygen)
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type: 1808982

Write-up: Death (Blood Clots) Died at Hospital 5/7/2021


VAERS ID: 1966610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-12-01
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Thrombosis
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), 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 totally healthy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211237435

Write-up: STROKE; BLOOD CLOT; This spontaneous report received from a consumer via social media concerned a 5 decade old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient was totally healthy. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On DEC-2021, the patient experienced blood clot. On DEC-2021, the patient experienced stroke and died. It was unspecified if autopsy was performed. As per the reporter, "Totally healthy woman in her 40s just about died in our office earlier this week after having a stroke. The blood clot they just ruled was a direct result of the J&J vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20211237435-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Stroke, Blood clot. 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: STROKE


VAERS ID: 1972052 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-28
Onset:2021-04-19
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anticoagulant therapy, Autopsy, Cardiac disorder, Death, Dehydration, Pain in extremity, Pulmonary embolism, Pulmonary thrombosis, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: After drinking, awoke feeling dehydrated and with leg pain. Called 911 after having a syncopal episode. Taken to hospital with likely pulmonary thromboembolus treated with aggressive resuscitation including tPA. Died a few hours after admission. Went to tissue donation, small pulmonary thrombus and lymphocytic aggregates in heart at autopsy.


VAERS ID: 1973954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal behaviour, Decubitus ulcer, Speech disorder, Thrombosis
SMQs:, Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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: USJNJFOC20211225157

Write-up: MAJOR BLOOD CLOTS; BEDSORES; MAJOR CHANGE IN BEHAVIOR; NOT ABLE TO TALK NORMAL; This spontaneous report received from a consumer via social media 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. On an unspecified date, after the patient was given vaccine everything went down hill for her (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter said that cause of patient''s death was not just her bedsores. The second shot did complete damage to patient. She was not able to talk normal, had major change in behavior and what was found in her as well was blood. As per the physician, she would had survived her bedsores if she didn''t had some major blood clots. Reporter also stated, reporter is not antivax but no major coincidence these two women and other people all over the world are dying due to the shots causing blood clots (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major blood clots and bedsores was fatal, and not able to talk normal and major change in behavior was not reported. This report was serious (Death). This case, involving the same patient is linked to 20211236359 (dose number in series 1 case). This case, from the same reporter is linked to 20211225334 and 20211225561.; Sender''s Comments: V0: 20211225157-covid-19 vaccine ad26.cov2.s-major blood clots and bedsores. 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: BEDSORES; MAJOR BLOOD CLOTS


VAERS ID: 1973966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, Thrombosis
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), 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: USJNJFOC20211237517

Write-up: DEATH; BLOOD CLOT; STROKE; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. (Dose number in series:1). No concomitant medications were reported. The consumer reported that "3 weeks post vaccination, the patient experienced blood clot, stroke, and died". 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. The patient died of death on an unspecified date, and the outcome of blood clot and stroke was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20211237517 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Blood clot, 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: 1973978 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211240528

Write-up: DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via social media concerned adult (30-59 years) multiple patients of an unspecified age, sex, race and ethnic origin. The patients height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, and batch number: unknown, expiry: unknown) dose, 01 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that "the patients in their late 30-59 years experienced blood clots and death due to the vaccine". On an unspecified date, the patients died from an 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. The outcome for event death was reported as fatal, and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20211240528- COVID-19 VACCINE AD26.COV2.S- Death, 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1973981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211241004

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via social media (local channel) concerned 7 female patients of unspecified ages, races and ethnic origins. The patient''s weight, height, and medical history were not reported. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, and batch number: unknown, expiry: unknown) dose, 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. It was reported that "The caller mentioned the news referenced 9 fatalities total, of which 7 were female due to the blood clots." On unspecified dates, the patients died from blood clots. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes of the event blood clots was fatal. This report was serious (Death). This case, from the same reporter is linked to 20211244852.; Sender''s Comments: V0: 20211241004-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: 1973983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: The patient was healthy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211242178

Write-up: DROPPED DEAD OF BLOOD CLOTS; This spontaneous report received from a consumer via social media via company representative concerned a 4 decade old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, therapy start date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, reporter said that "my coworker was a healthy woman in her 30''s and dropped dead of blood clots two weeks later". 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: 20211242178-COVID-19 VACCINE AD26.COV2.S-Dropped dead of blood clots. 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: BLOOD CLOTS


VAERS ID: 1973986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), 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: Patient had perfect health at the time of vaccination.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211243010

Write-up: BLOOD CLOTS; HEART ATTACK; FEELING BAD; This spontaneous report received from a consumer through company representative via social media concerned a 63 year old male unspecified race and ethic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient had perfect health at the time of vaccination. 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, 1 total administered on AUG-2021 for prophylactic vaccination. (Dose series in number 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Consumer reported that "A buddy of mine got the jab about 4 months ago. He almost immediately started feeling bad ever since. Perfect health, and just dropped dead from blood clots and a heart attack". (Dose series in number 1). On an unspecified date, the patient died from blood clots, and heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling bad. This report was serious (Death).; Sender''s Comments: V0:20211201290 - COVID-19 VACCINE AD26.COV2.S- Blood clot, Heart attack. This event is considered Un assessable. 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: BLOOD CLOTS; HEART ATTACK


VAERS ID: 1978471 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211244852

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via social media (local news channel) concerned 2 patients of unspecified ages, sexes, races and ethnic origins. The patients'' weight, and height were not reported. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown, and expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On unspecified dates, the patients died from blood clots. It was unknown if an autopsy was performed. As per the reporter, "The caller mentioned the news referenced 9 fatalities total, of which 7 were female due to the blood clots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This outcomes of the event blood clots was fatal. This report was serious (Death). This case, from the same reporter is linked to 20211241004.; Sender''s Comments: V0: 20211244852-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 CLOT


VAERS ID: 1984099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -

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: 2021-08-04
   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: USJNJFOC20211254542

Write-up: DIED; BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a 44 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that, on 03-AUG-2021, the patient experienced blood clot and next day on 04-AUG-2021, she died from unknown cause of death (dose number in series was 1). It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 04-AUG-2021 from unknown cause of death, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20211254542 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Blood clot. 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: 1988205 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / OT

Administered by: Unknown       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211247547

Write-up: DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media (Johnson and Johnson Corporate) concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was vaccinated with covid-19 vaccine ad26. cov2. s (manufacturer not specified) (dose number series 1) (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number, and expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Following booster administration, the patient came home and died (captured as death). On an unspecified date, an autopsy was performed and according to the autopsy result the patient had developed blood clots. On an unspecified date, the patient died (cause of death unknown) (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clots was not reported (dose number in series 2). This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20211247547-covid-19 vaccine ad26.cov2.s -Death, 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: UNKNOWN CAUSE OF DEATH; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1988207 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: USJNJFOC20211248720

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via social media concerned a 19 year old of unspecified 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) 1 total dose, start therapy date were not reported for prophylactic vaccination (dose series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter stated that "My next door neighbor, 19 years old, died from a blood clot after getting the J&J shot. Thousands died after the astra zeneca shot. Don''t live in an echo chamber and only seek out validating news. Its difficult but search for facts. The studies are out there." On an unspecified date, the patient died from blood clot. It was unspecified whether 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: 20211248720-covid-19 vaccine ad26.cov2.s- blood clot. 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 CLOT


VAERS ID: 1994521 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death, Pulmonary thrombosis, Thrombosis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Infective pneumonia (narrow), 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: USJNJFOC20211249023

Write-up: DIED IN THREE WEEKS TIME AFTER SUFFERING TERRIBLY; COVID PNEUMONIA; THREE BLOOD CLOT IN LEGS; SIX BLOOD CLOTS IN LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media from a company representative 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. On an unspecified date in /FEB/2020, the patient was previously treated with covid-19 vaccine from an unspecified manufacturer (form of admin, route of admin, and batch number were not reported), dose was not reported for prophylactic vaccination.(Dose number in series 1). No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.(Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following covid-19 vaccine ad26.cov2.s vaccination, the patient experienced covid, which was followed by covid pneumonia (Suspected clinical vaccination failure), six blood clots in lungs and three blood clots in legs. It was reported that the patient died in three weeks time after suffering terribly. The cause and date of death was unspecified. It was unknown whether an autopsy was performed.(Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died in three weeks time after suffering terribly on an unspecified date, and the outcome of covid pneumonia, Suspected clinical vaccination failure, six blood clots in lungs and three blood clot in legs was not reported. This report was serious (Death, and Other Medically Important Condition). This case is associated with Product Quality Complaint number 90000208090.; Sender''s Comments: V0: 20211249023-covid-19 vaccine ad26.cov2.s-died in three weeks time after suffering terribly, covid pneumonia, six blood clots in lungs and three blood clot in legs. 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). 20211249023-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: 1994564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral thrombosis, Death, Vertigo
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Vestibular disorders (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: USJNJFOC20211261664

Write-up: DIED; BRAIN FILLED WITH BLOOD CLOTS; VERTIGO LIKE SYMPTOMS; This spontaneous report received from a consumer via a company representative 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 and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced brain filled with blood clots, vertigo like symptoms and died from unknown cause of death. Reporter Stated as " My brother died after receiving the jab! He developed Vertigo like Systems. His brain was filled with Blood clots" It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo like symptoms and brain filled with blood clots was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211260953 and 20211260743.; Sender''s Comments: V0: 20211261664-covid-19 vaccine ad26.cov2.s- Died, Brain filled with 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1996758 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: USJNJFOC20211265808

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex of an 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 administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, reporter stated that patient died after the J&J vaccine from blood clots. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was fatal. This report was serious (Death).; Sender''s Comments: V0: 20211265808- 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: 2005918 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-04-08
Onset:2021-12-20
   Days after vaccination:256
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atelectasis, Blood lactic acid increased, COVID-19, Cardiac arrest, Chest X-ray abnormal, Chest tube insertion, Continuous haemodiafiltration, Cough, Death, Decreased appetite, Hypertension, Life support, Lung opacity, Oxygen saturation decreased, Pain, Pneumothorax, Renal impairment, SARS-CoV-2 test positive, Sepsis, Septic shock, Somnolence, Thrombosis, Ultrasound Doppler abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2022-01-04
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine, aspirin, atorvastatin, clopidogrel, vitamin B12, ferrous sulfate, furosemide, isosorbide dinitrate, losartan, metoprolol tartrate,l multivitamin, nifedipine, nitro PRN, omeprazole, pramipexole, sildenafil, testosterone, tramadol
Current Illness:
Preexisting Conditions: Past Medical History Positives Diagnosis Date ? CAD (coronary artery disease) ? CVA (cerebral vascular accident) 9/4/2020 ? GERD (gastroesophageal reflux disease) ? Hyperlipidemia ? Hypertension ? RLS (restless legs syndrome) ? Sleep apnea ? Stroke
Allergies: None
Diagnostic Lab Data: 12/20/21 COVID 19: positive 12/22/21 chest xray: Areas of patchy opacification in the left mid and lower lung and right lower lung. Some of this may be infectious/inflammatory such as pneumonia. Some of this may be atelectatic. 12/27/21 US: Study positive for nonocclusive calf vein thrombus right lower extremity posterior tibial and peroneal distributions.
CDC Split Type:

Write-up: Presented to ER on 12/22/21. Positive for COVID on 12/20/21. on Thursday he began to develop achy pains and feeling sleepy. When his symptoms did not improve he decided to call his primary care doctor on Monday. Patient thought he had a urinary tract infection. He was tested for COVID and was positive. He states since that time he has been monitoring his O2 saturations. On his pulse ox at home his O2 saturations are dropping below 90%. Patient arrived into the emergency room at 88% on room air. He was requiring 5 L nasal cannula to maintain his O2 saturations greater than 92%. He states that he has had decreased appetite, a nonproductive cough. He reports that he took his a.m. medications. Placed on dexamethasone, ceftriaxone, azithromycin and remdesivir. On 1/4/21, patient continued to be hypertensive overnight and required increased pressor therapy. He also had a small right-sided pneumothorax that was treated with a right-sided chest tube yesterday with resolution of the pneumothorax.He continued to be hemodynamically unstable from the COVID sepsis/septic shock also possible PE with elevated lactate. His kidney function worsened and he needed CVVH overnight. In the morning of 1/4/21 he had cardiac arrest with ROSC after 3 cycles of ACLS. Passed away on 1/4/21


VAERS ID: 2006349 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-07
Onset:2021-09-03
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN NO LOT # AVAILA / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Confusional state, Cough, Death, Deep vein thrombosis, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN; RA; GERD; restless leg syndrome, hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt brought to ED with increasing SOB, confusion, on O2 via NC; found to have a DVT left upper extremity and PE right lower lung; positive for COVID; coughing; placed on Airvo 55L/91% FiO2; given remdesivir, solu-medrol, baricitinib; pt''s condition worsened and she was placed on comfort measures without aggressive treatments; pt died in the hospital


VAERS ID: 2017502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiopathy, Cerebral haemorrhage, Pulmonary embolism, Thrombosis
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), Embolic and thrombotic events, 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: USJNJFOC20220100724

Write-up: DIED FROM PULMONARY EMBOLISM; BRAIN BLEEDS; BLOOD CLOTS; DESTROYED VASCULAR SYSTEM; This spontaneous report received from a consumer via social media via a company representative 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, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). 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 stated that "The J&J killed my father. Brain bleeds and blood clots until he died from a pulmonary embolism. From the day he got he, he felt it. Took 6 months to destroy his vascular system". On an unspecified date, the patient died from pulmonary embolism. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain bleeds, blood clots and destroyed vascular system was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20220100724 - Covid-19 vaccine ad26.cov2.s- Died from pulmonary embolism, Brain bleeds, 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: PULMONARY EMBOLISM


VAERS ID: 2017512 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: USJNJFOC20220102272

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from blood clots. As per the reporter "My friend is dead from blood clots after j&j". 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: 20220102272 - 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: 2017586 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: Patient was older but healthy men.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20220107619

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient was older but healthy men. 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, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, it was reported that "My father in law died from sudden blood clots after they got vaxxed. Older but healthy men." 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 20220108012.; Sender''s Comments: V0: 20220107619 - 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: 2017589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: The patient was older but healthy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20220108012

Write-up: BLOOD CLOTS; 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. The patient''s pre-existing medical conditions included: The patient was older but healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series was 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from blood clots. It was unknown if an autopsy was performed. The consumer reported as " My grandfather died from sudden blood clots after they got vaxxed. Older but healthy men." 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 20220107619.; Sender''s Comments: V0- 20220108012 -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: 2017595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20220108362

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer through social media via a company representative concerned a female of unspecified age, race and ethnic origin. 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 administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that, on an unspecified date "patient (friend) died from blood clots after receiving Janssen and Janssen vaccine (dose number in series was 1)." It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event blood clots was fatal. This report was serious (Death).; Sender''s Comments: V0: 20220108362- 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: 2024033 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20220113612

Write-up: BLOOD CLOTS IN LUNGS; 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 (Dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, reporter stated that " Death of friend from blood clots in lungs just days after J&J shot." On an unspecified date, the patient died from blood clots in lungs. 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: 20220113612-COVID-19 VACCINE AD26.COV2.S-blood clots in lungs. 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 IN LUNGS


VAERS ID: 2027099 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: USJNJFOC20220112761

Write-up: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of 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. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots and died from blood clots. It was reported that, "My Immediate Family knows of 2 Direct Vaccine Deaths & ZERO COVID DEATHS. 1 was Blood Clots=J&J." 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). This case, from the same reporter is linked to 20220112624.; Sender''s Comments: V0: 20220112761-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 CLOT


VAERS ID: 2027103 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: USJNJFOC20220113987

Write-up: BLOOD CLOTS; This spontaneous report received from a patient 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 admin, and batch number were not reported, expiry: unknown) dose, 1 total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from blood clot. Reporter stated, "My friend died from blood clots after J and J". 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: 20220113987-COVID-19 VACCINE AD26.COV2.S-Blood clots. 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: BLOOD CLOTS


VAERS ID: 2034104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), 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: USJNJFOC20220118705

Write-up: HEART ATTACK; BLOOD CLOT; This spontaneous report received from a consumer via social media through a company representative 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) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter stated "My cousin died from a heart attack because the johnson and johnson vaccine caused a blood clot. Because she trusted people like you". On an unspecified date, the patient died from heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0.20220118705-covid-19 vaccine ad26.cov2.s -Heart attack, Blood clot. 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: 2039031 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       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: USJNJFOC20220114550

Write-up: BLOOD CLOT TO BRAIN; This spontaneous report received from a consumer via a company representative via Social Media concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter stated "Other friends moms died from a blood clot to the brain. Said it was rare." 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). This case, from the same reporter is linked to 20220113983 and 20220113829.; Sender''s Comments: V0- 20220114550 -COVID-19 VACCINE AD26.COV2.S-Blood Clot to brain. 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 CLOT TO BRAIN


VAERS ID: 2041969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -

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: USJNJFOC20220123691

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via a 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from blood clot. Reporter stated that "This is absolutely horrible! Whoever is doing this bullying or suggesting people to do the mocking is about as much of a moral guide. My mom died from a clot caused by the JNJ vaccine and we are holding off till Novavax is ready. This person should step down". It was unspecified if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 20220100327-COVID-19 VACCINE AD26.COV2.S-Blood clot. 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 CLOT


VAERS ID: 2050258 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac disorder, Death, Off label use, Product administered to patient of inappropriate age, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Medication errors (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: USJNJFOC20220112461

Write-up: DEATH; BLOOD CLOT; INFLAMMATION AROUND HEART; OFF LABEL USE; INAPPROPRIATE AGE AT THE TIME OF VACCINATION; This spontaneous report received from a consumer via social media (News) concerned a 13 year old male of unspecified 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, batch number: unknown and expiry: unknown) dose was not reported, dose number in series was 1, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had blood clot and inflammation around heart (off label use and inappropriate age at the time of vaccination). Reporter stated that how we could continue with our vaccine whether there have been reports of inflammation around heart, blood clot and death. On an unspecified date, the patient died from unknown cause of death (dose number in series was 1). 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 death on an unspecified date, and the outcome of inflammation around heart, blood clot, off label use and inappropriate age at the time of vaccination was not reported. This report was serious (Death, and Other Medically Important Condition). Additional information was received from reporter on 13-JAN-2022. The following information was updated and incorporated into the case narrative: Age, sex, added extra events (off label use and inappropriate age at the time of vaccination).; Sender''s Comments: V1: Follow up information in this version updated : Age, sex, added extra events (off label use and inappropriate age at the time of vaccination). The follow up information does not change the causality of the previous reported events. 20220112461-Covid-19 vaccine ad26.cov2.s- Death, Blood clot. 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: 2053692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Angiogram, Antibody test, Aspartate aminotransferase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood fibrinogen, Blood urea, Body mass index, Brain herniation, Cerebral venous sinus thrombosis, Coma scale, Computerised tomogram, Computerised tomogram head, Fibrin D dimer, Haemoglobin, Haemorrhage intracranial, International normalised ratio, Laboratory test, Magnetic resonance imaging, Neurological examination, Physical examination, Platelet count, Prothrombin time, Subarachnoid haemorrhage, Thrombocytopenia, Venogram, White blood cell count
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic thrombocytopenia; Migraine
Preexisting Conditions: Comments: The patient was not pregnant, had no history of hypercoagulability, and no use of hormone replacement therapy.
Allergies:
Diagnostic Lab Data: Test Name: Physical examination; Result Unstructured Data: mild neck stiffness; Test Name: Laboratory test; Result Unstructured Data: 6 mm; Test Name: Venogram; Result Unstructured Data: no cerebral venous thrombosis; Test Name: Neurological examination; Result Unstructured Data: not reported; Test Name: Glasgow coma scale; Result Unstructured Data: 3; Test Name: Head CT; Result Unstructured Data: haemorrhage; Test Name: Angiogram; Result Unstructured Data: thrombosis; Test Name: Venogram; Result Unstructured Data: thrombosis; Test Name: Platelet count; Result Unstructured Data: 16400 mm3; Test Name: Platelet count; Result Unstructured Data: 114000 mm3; Test Name: Platelet count; Result Unstructured Data: 10000 mm3; Test Name: Platelet count; Result Unstructured Data: 16000 mm3; Test Name: Haemoglobin; Result Unstructured Data: 11.2 g/dL; Test Name: Haemoglobin; Result Unstructured Data: 11.0 g/dL; Test Name: Haemoglobin; Result Unstructured Data: 12.2 g/dL; Test Name: Haemoglobin; Result Unstructured Data: 10.7 g/dL; Test Name: White blood cell count; Result Unstructured Data: 6650 mm; Test Name: White blood cell count; Result Unstructured Data: 9700 mm; Test Name: White blood cell count; Result Unstructured Data: 9900 mm; Test Name: White blood cell count; Result Unstructured Data: 20700 mm; Test Name: International normalized ratio; Result Unstructured Data: 1.2; Test Name: International normalized ratio; Result Unstructured Data: 1,8; Test Name: Prothrombin time; Result Unstructured Data: 14.0 s; Test Name: Prothrombin time; Result Unstructured Data: 21.4 s; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 24.4 s; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 30.5 s; Test Name: Fibrin D dimer; Result Unstructured Data: 13476 ng/mL; Test Name: Fibrinogen; Result Unstructured Data: 128 mg/dL; Test Name: Fibrinogen; Result Unstructured Data: 319 mg/dL; Test Name: Blood urea nitrogen; Result Unstructured Data: 16 mg/dL; Test Name: Blood urea nitrogen; Result Unstructured Data: 14 mg/dL; Test Name: Blood urea nitrogen; Result Unstructured Data: 12 mg/dL; Test Name: Blood urea nitrogen; Result Unstructured Data: 13 mg/dL; Test Name: Creatinine; Result Unstructured Data: 0.9 mg/dL; Test Name: Creatinine; Result Unstructured Data: 0.8 mg/dL; Test Name: Creatinine; Result Unstructured Data: 0.6 mg/dL; Test Name: Creatinine; Result Unstructured Data: 1.6 mg/dL; Test Name: Bicarbonate; Result Unstructured Data: 22 mmol/L; Test Name: Bicarbonate; Result Unstructured Data: 19 mmol/L; Test Name: Bicarbonate; Result Unstructured Data: 16 mmol/L; Test Name: Bicarbonate; Result Unstructured Data: 19 mmol/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 17 IU/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 24 IU/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 17 IU/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 56 IU/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 20 IU/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 30 IU/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 24 IU/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 35 IU/L; Test Name: Bilirubin total; Result Unstructured Data: 0.2 mg/dL, less than; Test Name: Bilirubin total; Result Unstructured Data: 0.2 mg/dL; Test Name: Bilirubin total; Result Unstructured Data: 0.3 mg/dL; Test Name: Bilirubin total; Result Unstructured Data: 1.0 mg/dL; Test Name: Antibody test; Result Unstructured Data: 2.240 OD; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: absence of cerebral perfusion; Test Name: Body mass index; Result Unstructured Data: 36.6; Test Name: CT scan; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20220117124

Write-up: CEREBRAL VENOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; RIGHT TEMPORAL INTRAPARENCHYMAL HEMORRHAGE; EXTENSIVE SUBARACHNOID HEMORRHAGE; TRANSTENTORIAL HERNIATION WITH OBLITERATION OF THE BASILAR CISTERNS; This spontaneous report was received from literature. This report concerned a 35 year old female of unspecified race and ethnicity. The objective of this study is to report one of those fatalities in a 35-year-old woman who developed CVST with thrombocytopenia after vaccination with the J&J vaccine. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: migraine headaches, and chronic thrombocytopenia, and other pre-existing medical conditions included: The patient was not pregnant, had no history of hypercoagulability, and no use of hormone replacement therapy. On an unspecified date, three months prior the laboratory date included: Platelet count (NR: 140000 - 450000) 16400 mm3, Blood urea nitrogen (NR: 7 - 24) 16 mg/dL, Creatinine (NR: 0.5 - 1.5) 0.9 mg/dL, Aspartate aminotransferase (NR: 12 - 32) 24 IU/L, Alanine aminotransferase (NR: 12 - 39) 30 IU/L, , Bilirubin total (NR: 0.3 - 1.2) < 0.2 mg/dL, Haemoglobin (NR: 12 - 16) 11.2g/dL, White blood cell count (NR: 4000 - 100000) 6650 mm. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (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 and has been requested. No concomitant medications were reported. On an unspecified date, seven days after vaccination, the patient went to emergency department (ED) with severe headache. She described her headache as being more severe and retro-orbital compared with her typical migraine. Physical examination was remarkable only for mild neck stiffness. Laboratory evaluation revealed a platelet count of 114K/ ul (106 K/ul in 2015, although January 2021 was up to 164 K/uL; Table 1). Non contrast head computerized tomography (CT) was normal, and a CT venogram head did not reveal any evidence of cerebral venous thrombosis. She was discharged to home with improvement in symptoms after migraine treatment. Laboratory data included: Platelet count (NR: 140000 - 450000) 114000 mm3, Alanine aminotransferase (NR: 12 - 39) 30 IU/L, Aspartate aminotransferase (NR: 12 - 32) 24 IU/L, Bicarbonate (NR: 21 - 39) 19 mmol/L, Bilirubin total (NR: 0.3 - 1.2) 0.2 mg/dL, Blood urea nitrogen (NR: 7 - 24) 12 mg/dL, Creatinine (NR: 0.5 - 1.5) 1.6 mg/dL, 0.8 mg/dL, Haemoglobin (NR: 12 - 16) 11 g/dL, White blood cell count (NR: 4000 - 100000) 9700 mm. 20 hours later, she returned to a separate ED with persistent headache. No repeat imaging or laboratory studies were completed. The patient continued to have a normal neurologic examination. She was again discharged after symptomatic relief. On an unspecified date, Fourty-eight hours after initial ED visit and 16 hours after discharge from the second ED visit, the patient experienced an acute loss of consciousness with an onset of generalized tonic-clonic seizure activity. On arrival to the ED, she was unresponsive with no purposeful movements. Neurologic examination revealed a Glasgow coma score of 3 with corneal, gag, and cough reflexes absent. Pupils were 6 mm and fixed. Non contrast head CT revealed right temporal intra parenchymal hemorrhage and extensive subarachnoid hemorrhage. There was also evidence of elevated intracranial pressure (sulci effacement) and resultant trans tentorial herniation with obliteration of the basilar cisterns. A hyper density involving the superior sagittal sinus, right transverse sinus, and right sigmoid sinus suggested cerebral venous thrombosis. Subsequent CT angiogram and venogram of the head revealed findings consistent with superior sagittal, transverse, and sigmoid sinus thrombosis. Laboratory evaluation revealed a platelet count of 10 K/uL, fibrinogen of 128 mg/dL, and D-dimer of 13476 ng/dL. Heparin-induced thrombocytopenia antibody assay was very elevated at 2.240 OD (normal <0.4) The patient had no exposure to heparin products. Evaluation by neurology and neurosurgery did not recommend any neurosurgical intervention secondary to futility. The patient had an ongoing absence of cortical activity with the absence of all cortical and brainstem reflexes. Nuclear medicine perfusion imaging documented the absence of cerebral perfusion. On an unspecified date, the patient also experienced thrombocytopenia. On an unspecified date, the patient died due to cerebral venous sinus thrombosis and thrombocytopenia. It was unknown if any autopsy was performed. On first day, laboratory data included: White blood cell count (NR: 4000 - 100000) 9900 mm, Prothrombin time (NR: 10.5 - 13) 14.0 s, Platelet count (NR: 140000 - 450000) 10000 mm3, Haemoglobin (NR: 12 - 16) 12.2 g/dL, International normalized ratio (NR: not provided) 1.2, Activated partial thromboplastin time (NR: 26.0 - 36.0) 24.4 s, Fibrinogen (NR: 210 - 450) 128 mg/dL, , Blood urea nitrogen (NR: 7 - 24) 12 mg/dL, , Bicarbonate (NR: 21 - 39) 19 mmol/L, Creatinine (NR: 0.5 - 1.5) 0.6 mg/dL, Alanine aminotransferase (NR: 12 - 39) 24 IU/L, Aspartate aminotransferase (NR: 12 - 32) 17 IU/L, Bilirubin total (NR: 0.3 - 1.2) 0.3 mg/dL, Antibody test (NR: not provided) 2.240 OD. On second day, Laboratory data (dates unspecified) included: Activated partial thromboplastin time (NR: 26.0 - 36.0) 30.5 s, Alanine aminotransferase (NR: 12 - 39) 35 IU/L, Aspartate aminotransferase (NR: 12 - 32) 56 IU/L, Bicarbonate (NR: 21 - 39) 19 mmol/L, Bilirubin total (NR: 0.3 - 1.2) 0.1 mg/dL, Blood urea nitrogen (NR: 7 - 24) 13 mg/dL, Creatinine (NR: 0.5 - 1.5) 1.6 mg/dL, Fibrin D dimer (NR: not provided) 13476 ng/mL, Fibrinogen (NR: 210 - 450) 319 mg/dL, Haemoglobin (NR: 12 - 16) 10.7 g/dL, International normalized ratio (NR: not provided) 1, 8, Platelet count (NR: 140000 - 450000) 16000 mm3, Prothrombin time (NR: 10.5 - 13) 21.4 s, White blood cell count (NR: 4000 - 100000) 20700 mm. Other laboratory data included: Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, Glasgow coma scale (NR: not provided) 3, Head CT (NR: not provided) haemorrhage, Neurological examination (NR: not provided) not reported, Nuclear magnetic resonance imaging (NR: not provided) absence of cerebral perfusion, Physical examination (NR: not provided) mild neck stiffness, Body mass index (NR: not provided) 36.6, pupils (laboratory test) (NR: not provided) 6mm, Venogram (NR: not provided) no cerebral venous thrombosis, thrombosis (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of cerebral venous sinus thrombosis and thrombocytopenia on an unspecified date, and the outcome of right temporal intraparenchymal hemorrhage, extensive subarachnoid hemorrhage and transtentorial herniation with obliteration of the basilar cisterns was not reported. The author concluded that, the development of thrombosis with severe thrombocytopenia points toward activation of platelet aggregation. The clinical similarities of TTS to heparin-induced thrombocytopenia are striking. Rapid laboratory and radiographic evaluation are necessary for appropriate management. Platelet count, D-dimer, fibrinogen, Heparin-induced thrombocytopenia (HIT) antibody assay, and CT or magnetic resonance imaging (MRI) venogram are necessary for the evaluation of high-risk patients recently vaccinated with an adenovirus vector vaccine against SARS-CoV-2. It is necessary for clinicians to recognize this entity as platelet transfusion or heparin-based anticoagulation could have devastating effects. Timely treatment with intravenous immunoglobulin and anticoagulation with non-heparin therapies (argatroban or bivalrudin) is essential for effective management. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220122480, 20220122504 and 20220122419.; Sender''s Comments: V0- 20220117124 -Covid-19 vaccine ad26.CoV-2.s- Right temporal intraparenchymal hemorrhage, Extensive subarachnoid hemorrhage, Transtentorial herniation with obliteration of basilar cisterns . 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). 20220117124 -Covid-19 vaccine ad26.CoV-2.s- Cerebral Venous sinus thrombosis, Thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: CEREBRAL VENOUS SINUS THROMBOSIS; THROMBOCYTOPENIA


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: 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: 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: 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: