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

Found 93 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

Table

   
AgeCountPercent
17-44 Years66.45%
44-65 Years2122.58%
65-75 Years1313.98%
75+ Years88.6%
Unknown4548.39%
TOTAL93100%



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: 1223789 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Adrenal haemorrhage, Brain injury, Cerebral haemorrhage, Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal, Death, Deep vein thrombosis, Dependence on respirator, Diarrhoea, Headache, Life support, Malaise, Platelet count decreased, Pulmonary embolism, Surgery, Thrombosis, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 100mg, Lisinopril 40mg, Glipizide 5mg, AmLODIPine 5mg, Basaglar 80 units, Rosuvistatin 40mg, Metformin 500mg
Current Illness:
Preexisting Conditions: Type II diabetes, cholesterol, high blood pressure
Allergies:
Diagnostic Lab Data: Abdominal CT Scan 03/16/2021, Head CT 03/16/2021 & 03/17/2021
CDC Split Type:

Write-up: My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a few days afterwards. She then felt better until day nine after the vaccine. On the evening of the ninth day, she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening. Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning. Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands. She was given platelets, pain meds and admitted into the hospital. Later that night staff felt she wasn?t responsive and a head CT was performed. It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point. During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes. On the morning of the 13th day patient was removed from life support and she passed.


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: 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: Death, Fatigue, Headache, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210613817

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


VAERS ID: 1391230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-30
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cerebral haematoma, Cerebral haemorrhage, Coagulopathy, Computerised tomogram, Computerised tomogram head, Death, Hepatic failure, Hypovolaemic shock, Immunology test, Mesenteric vein thrombosis, Multiple organ dysfunction syndrome, Platelet count, Platelet factor 4, Pneumothorax, Portal vein thrombosis, Pulmonary embolism, Renal infarct, Renal vein thrombosis, Shock, Splenic infarction, Splenic vein thrombosis, Thrombocytopenia, Ultrasound scan, Venous occlusion
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (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, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad), Renovascular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 2
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: TARGAXAN; DOBUTAMINE; CALCIUM;COLECALCIFEROL; ALDACTONE [SPIRONOLACTONE]; CLAFORAN [CEFOTAXIME SODIUM]; SUFENTA; OBRACIN; BIFITERAL; VESIPAQUE; OMEPRAZOLE; ATROPINE; MANNITOL; SEVOFLURANE; TRACRIUM; LINISOL; ENALAPRIL; EZETROL; CLAMOXYL [AM
Current Illness: Arterial hypertension; Diabetes; Esophageal varices; Hepatic cirrhosis; Hepatic disease (Decompensation liver disease; late February/early March 2021: 4 day hospital admission. No exposure to heparin or LMWH (low-molecular-weight heparins) at that time.); Hepatic encephalopathy; Idiopathic thrombocytopenic purpura (chronic); Non-alcoholic steatohepatitis; Portal hypertension; Splenomegaly; Thrombopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Splenorenal shunt; Therapeutic embolization
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT scan; Result Unstructured Data: unspecified; Test Date: 2021; Test Name: Head CT; Result Unstructured Data: possible thrombus; Comments: possible thrombus thv torcula, dd artefact). Also active bleeding with voluminous hematoma.; Test Date: 2021; Test Name: Platelet count; Result Unstructured Data: 59000; Test Date: 2021; Test Name: Platelet factor 4; Result Unstructured Data: HIT test negative (0.0 U/ml); Test Date: 2021; Test Name: ELISA; Result Unstructured Data: For anti-PF4 ikv mgl VITT negative; Test Date: 2021; Test Name: CT scan; Result Unstructured Data: brain/thorax/abdomen; Test Date: 202103; Test Name: Diagnostic ultrasound; Result Unstructured Data: no portatrombosis; Test Date: 202104; Test Name: Platelet count; Result Unstructured Data: 64000
CDC Split Type: BEJNJFOC20210615725

Write-up: PORTAL VEIN THROMBOSIS; SPLENIC VEIN THROMBOSIS; PULMONARY EMBOLISM; MESENTERIC VEIN THROMBOSIS; RENAL VEIN THROMBOSIS; THROMBOPENIA; SPLENIC INFARCTION; RENAL INFARCTION; VENOUS OBSTRUCTION; HYPOVOLAEMIC SHOCK; HEPATIC FAILURE; DEATH; CEREBRAL HEMATOMA; CEREBRAL HEMORRHAGE; MULTI ORGAN FAILURE; PULMONARY COLLAPSE; ACUTE KIDNEY FAILURE; SHOCK; COAGULATION DISORDER; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94448] concerned an elderly male, age not specified. The patient''s weight was 100 kilograms, and height was 166 centimeters. The patient''s past medical history included splenorenal shunt and embolization (2020), and concurrent conditions included "NASH Cirrhosis" (captured as non-alcoholic steatohepatitis and cirrhosis) decompensation liver disease, portal hypertension, esophageal varices, hepatic encephalopathy, thrombopenia (2013) (initially attributed to chronic ITP (idiopathic thrombocytopenic purpura), however, also already mild splenomegaly), diabetes, and arterial hypertension. In late FEB/early MAR-2021, the patient was hospitalized for four (4) days due to decompensation liver disease. According to the patient''s chart, no exposure to heparin or LMWH (low-molecular weight heparin) at that time. The last ultrasound performed in MAR-2021 showed no "porta thrombosis". Platelet count of 64000 (no units/normal range provided) noted in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAY-2021 for covid-19 immunisation. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included sufentanil citrate, albumin human, amoxicillin, atracurium besilate, atropine, calcium/colecalciferol, cefotaxime sodium, dobutamine, enalapril, ezetimibe, gluconate sodium/magnesium chloride hexahydrate/potassium chloride/sodium acetate trihydrate/sodium chloride, glucose, insulin, lactulose, lidocaine hydrochloride, mannitol, norepinephrine, nystatin, omeprazole, phenobutiodil, propofol, propranolol, rifaximin, sevoflurane, spironolactone, tobramycin sulfate, and tranexamic acid, all for unspecified indications. Serious adverse events reported by EVHuman, with an onset date of 30-MAY-2021, and a fatal outcome, included: hypovolaemic shock, hepatic failure, death, renal infarction, cerebral hematoma, portal vein thrombosis, venous obstruction, pulmonary embolism, splenic vein thrombosis, cerebral hemorrhage, splenic infarction, multi organ failure, mesenteric vein thrombosis, pulmonary collapse, renal vein thrombosis, thrombopenia, acute kidney failure, shock, and coagulation disorder. Fifteen (15) days after vaccination (30-MAY-2021), the patient was hospitalized for a liver transplant (hospitalization added as a serious criterion to the case). Peroperative diagnosis of again "porta thrombosis" during liver transplantation, for which thrombectomy was performed. Shortly after reperfusion, acute collapse of transplant liver due to pulmonary embolism, with also hyperacute obstruction of venovenous bypass due to thrombus (presumably heparin-coated circuit). Previously stable blood flow through bypass. In case of obstruction of circuit, establish thrombi in pump, afferent and efferent lines. Suspicion of suction of thrombus via circuit rather than circuit thrombosis. Determine recurrence of porta thrombosis for which right thrombectomy with IVIG (in addition to corticoids I.V. transplantation) given. "Seen mgl HIT/VITT. Poly transfusion perioperatively." Postoperatively evolution to acute liver failure, with hypovolemic shock obvious major bleeding, AKI (acute kidney injury). CT brain/thorax/abdomen: bilateral pulmonary emboli, acute complete thrombosis of current gate (extra- and intrahepatic), and disseminated thrombus material in mesenteric veins, left renal vein and multiple collateral veins; disseminated spleen infarcts and bilateral renal infarcts; on CT brain possible thrombus "press dd artefact". Also active bleeding with voluminous hematoma. Revision with hemostasis and packing. Treatment medications (dates unspecified) included: "yes Cf supra IVIG Corticoids. Stop heparin (limited exposure via flush arterial line), vital support, "specific R/ after liver transplantation (immunosuppression, antimicrobial prophylaxis, etc)". Evolution of the ADR - Deceased Examination s - Cf supra: CT images HIT test negative (0.0 U/ml) Additional ELISA for anti-PF4 ikv mgl VITT negative (OD = 0.08, positive when $g0. 4) HIT/VITT test taken shortly after ICU admission (some reserve for interpretation test given possible factor dilution tg intraoperative polytransfusion)* Chronic thrombopenia in patient with cirrhosis, portal hypertension and splenomegaly (preoperative stable platelet count: 59000 vs 64000 in April 2021). Evolution to fulminant liver failure, with persistent shock and MOF (multi-organ failure), with the death of patient on 01-JUN-2021. On 01-JUN-2021, the patient died from the events. 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 Hospitalization).; Reporter''s Comments: Treatment - Ja Cf supra IVIG Corticoiden Stop heparin (limited exposure via flush arterial line) vital support, specific R/ after liver transplant (immunosuppression, antimicrobial prophylaxis)Evolution of the ADR - passed away Examinations - Cf supra: CT images HIT test negative (0.0 U/ml) additional ELISA in front of anti-PF4 ikv mgl VITT negative (OD = 0.08, positive when $g0.4) HIT/VITT test taken shortly after admission ICU (some reserve for interpretation test seen possible). Sender''s Comments: V0: This spontaneous report received from a physician via Regulatory Authority concerns a male patient, age not specified, unknown ethnicity, noted to have pulmonary emboli, thrombosis in multiple sites, infarcts, and possible thrombus in the torcula 15 days after receiving the Janssen Covid-19 vaccine. That day, the patient was hospitalized to undergo liver transplant. Patient has Nonalcoholic Steatohepatitis (NASH) Cirrhosis. Again "portatrombosis" was encountered during the liver transplantation. Shortly after reperfusion, transplanted liver collapsed. There was obstruction of venovenous bypass, which previously had stable blood flow, and pulmonary embolism. CT scan of thorax and abdomen showed: bilateral pulmonary emboli, thrombosis of vena portae (extra- and intrahepatic); thrombus in mesenteric veins, left renal vein and multiple collateral veins; spleen and bilateral renal infarcts. CT scan of the brain showed possible thrombus on the torcula. Laboratory results: HIT test negative, ELISA anti-PF4/ VITT negative, and platelet count of 59,000 (units unspecified). Patient died the following day. Height was 166 cms and weight was 100 kg (BMI: 36.6 - obese). Past medical history included: thrombocytopenia (2013), splenorenal shunt and embolization (2020); and previous hospitalization for decompensated cirrhosis (February/early March 2021). Current conditions also included: esophageal varices, mild splenomegaly, and diabetes. No exposure to any heparin. Last ultrasound in March 2021 showed no "portatrombosis". Platelet count on April 2021 was 64000 (units not specified). Patients with cirrhosis have slow blood flow which leads to thrombosis and there is platelet sequestration in the spleen that leads to thrombocytopenia. Obesity, cirrhosis and its complications could represent plausible occurrence, especially in view of the pre-existing risk factors, rendering the events inconsistent with the vaccination. Moreover, HIT and VITT tests were negative.; Reported Cause(s) of Death: HYPOVOLEMIC SHOCK; HEPATIC FAILURE; DEATH; RENAL INFARCTION; CEREBRAL HEMATOMA; PORTAL VEIN THROMBOSIS; VENOUS OBSTRUCTION; PULMONARY EMBOLISM; SPLENIC VEIN THROMBOSIS; CEREBRAL HEMORRHAGE; SPLENIC INFARCTION; MULTI ORGAN FAILURE; MESENTERIC VEIN TH


VAERS ID: 1419267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Coma, Deep vein thrombosis, Ischaemia, Platelet count, Platelet count abnormal, Venous thrombosis
SMQs:, Haematopoietic thrombocytopenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Platelet count; Result Unstructured Data: altered values
CDC Split Type: ITJNJFOC20210631847

Write-up: ISCHEMIA; DEEP VEIN THROMBOSIS; PERIPHERAL VENOUS THROMBOSIS; ALTERED PLATELET VALUES; COMA; CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report received from a company representative via social media concerned a 54 year old male. Initial information was processed with additional information received on 16-JUN-2021 via a company representative from a news report. 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, frequency 1 total, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable perform follow-up to request the batch number. No concomitant medications were reported. On 09-JUN-2021, 14 days after receiving the vaccine; the patient first started experiencing symptoms (unspecified) and was diagnosed with deep vein thrombosis (also reported as peripheral venous thrombosis) altered platelet values at a hospital. He was treated with heparin without any hospitalization and was sent home. However the patient''s symptoms worsened despite treatment prescribed and he went to a different emergency room/hospital. He was hospitalized on the night between 11-JUN-2021 and 12-JUN-2021 in serious condition. He was admitted to the resuscitation/intensive care area with deep vein thrombosis and ischemia. The hospital suspected adverse ischemic event occurring in the period following the vaccination. On an unspecified date the patient also experienced cerebral venous sinus thrombosis (CVST) and cerebral thrombosis (subsumed to CVST). It was reported the patient went into a coma for the thrombosis and died on 15-JUN-2021. His death was due to cerebral thrombosis, peripheral venous thrombosis and altered platelet values. It was unknown if an autopsy was performed. It was stated no correlation had been confirmed by the physicians following the patient receiving the vaccine and complications; they have also not ruled out possible previous illnesses. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome was fatal for the following events: CVST, peripheral venous thrombosis and altered platelet values. The events coma, deep vein thrombosis and ischemia were not recovered. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender''s Comments: V0: This spontaneous report received from a patient via social media concerned a 54-year-old man (ethnicity unknown) who experienced Cerebral venous sinus thrombosis (CVST), Deep vein thrombosis (DVT)/peripheral venous thrombosis (PVT), ischemia, and altered platelet values 14 days after vaccine and died on day 20. No past medical history or concomitant medications were reported. On day 14 after receiving vaccine, the patient was diagnosed with deep vein thrombosis (DVT). He was treated with heparin at the hospital on day 14 but not admitted. The patient''s condition worsened between days 16 and 17. On day 17, the patient was hospitalized for DVT and ischemia. The hospital suspected adverse ischemic event occurring in the period following the vaccination. On an unspecified date the patient experienced altered platelet values without a specific reported numerical value. The patient went into a coma and died on day 20 due to thrombosis and altered platelet values. It was unknown if an autopsy was performed. No further details on clinical course, laboratory values, or treatment were reported. It was stated no correlation had been confirmed by the physicians following the patient receiving the vaccine and complications; they have also not ruled out possible previous illnesses. The use of heparin may have increased the risk for the events to occur, and the platelet value is not reported. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.; Reported Cause(s) of Death: PERIPHERAL VENOUS THROMBOSIS; ALTERED PLATELET VALUES; CEREBRAL VENOUS SINUS THROMBOSIS


VAERS ID: 1427638 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery thrombosis, Headache, Myocardial infarction
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: 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: Arteriosclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210638122

Write-up: DEATH TEMPORALLY RELATED TO COVID-19 VACCINATION (1 DAY INTERVAL BETWEEN VACCINATION AND DEATH) CAUSE OF DEATH: RUPTURED MYOCARDIAL INFARCTION IN CORONARY THROMBOSIS; DEATH TEMPORALLY RELATED TO COVID-19 VACCINATION (1 DAY INTERVAL BETWEEN VACCINATION AND DEATH) CAUSE OF DEATH: RUPTURED MYOCARDIAL INFARCTION IN CORONARY THROMBOSIS; HEADACHES; This spontaneous report received from a consumer via a Regulatory Authority, DE-PEI-CADR2021099560] concerned a 64-year-old male patient of unspecified race and ethnic origin. The patient''s weight was 98 kilograms, and height was 176 centimeters. The patient''s concurrent condition included arteriosclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry: 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 22-MAY-2021, the patient experienced headaches. On 23-MAY-2021, the patient died from ruptured myocardial infarction and coronary thrombosis which was determined by an autopsy (date unspecified). It was reported that the patient''s death was temporally related to covid-19 vaccination (1 day interval between vaccination and death). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. An autopsy was performed on an unspecified date. The patient died of death temporally related to covid-19 vaccination (1 day interval between vaccination and death) cause of death: ruptured myocardial infarction in coronary thrombosis, and headaches on 23-MAY-2021. This report was serious (Death).; Sender''s Comments: V0;20210638122- covid-19 vaccine ad26.cov2.s-death temporally related to covid-19 vaccination (1 day interval between vaccination and death) cause of death: ruptured myocardial infarction in coronary thrombosis, headaches . 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: CORONARY THROMBOSIS; INFARCT MYOCARDIAL; HEADACHE; Autopsy-determined Cause(s) of Death: CORONARY THROMBOSIS; INFARCT MYOCARDIAL; HEADACHE


VAERS ID: 1430808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-08
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   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:
Current Illness: Arterial hypertension; Hypothyreosis; Nicotine abuse
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210650031

Write-up: PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS LEG; This spontaneous report received from a physician via a Regulatory Authority concerned a 57 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included nicotine abuse, arterial hypertension, and hypothyreosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: X0985 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The drug start period was 10 days. No concomitant medications were reported. On 08-JUN-2021, the patient experienced deep vein thrombosis leg. On 13-JUN-2021, the patient experienced pulmonary embolism. On same day patient died from lung embolism. 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 deep vein thrombosis leg and pulmonary embolism on 13-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210650031-Covid-19 vaccine ad26.cov2.s-Pulmonary embolism, Deep vein thrombosis leg. 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: LUNG EMBOLISM


VAERS ID: 1434115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-18
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 2021-06-18
   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: DEJNJFOC20210660106

Write-up: THROMBOSIS OF VENOUS SINUSES; This spontaneous report received from a physician via a Regulatory Authority DE-PEI-202100110773 concerned a 44 year old female. 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: XB985) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the patient experienced thrombosis of venous sinuses and died. It was unknown if an autopsy was performed. Outcome of the event was fatal. 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 physician via Regulatory Authority DE-PEI-202100110773 concerns a 44 year old female who had thrombosis of venous sinuses and died 11 days after receiving the Janssen Covid-19 vaccine. Patient''s height and weight were not reported. Patient''s concurrent conditions and concomitant medications were not reported. Information regarding past smoking history, illicit drug use and alcohol abuse were not provided. Information is limited in this case. The relationship of the thrombosis of the venous sinuses to vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.; Reported Cause(s) of Death: THROMBOSIS OF VENOUS SINUSES


VAERS ID: 1442987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram head, Fibrin D dimer, Immune thrombocytopenia, International normalised ratio, Mechanical ventilation, PCO2, Platelet count, Prothrombin time, Thrombin time, Thromboelastogram, Thrombosis, Venogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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), Acute central respiratory depression (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No history of any pre-existing arterial and/or venous thrombotic disease/complications or hormonal therapy prior to the ictus. No medical history of any known pre-existing diseases and /or regular medication intake.
Allergies:
Diagnostic Lab Data: Test Name: Platelet count; Result Unstructured Data: 48 g/L; Test Name: Prothrombin time; Result Unstructured Data: 8.6 S; Test Name: International normalized ratio; Result Unstructured Data: 1.0; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 19.9 S; Test Name: Thrombin clotting time; Result Unstructured Data: 18.8 S, lower than 25; Test Name: Fibrinogen; Result Unstructured Data: 294 mg/dL; Test Name: Venogram; Result Unstructured Data: large-scale sinus thrombosis and ICH; Test Name: Thromboelastography; Result Unstructured Data: roTEG K: 10 min (NR: 3-10); Test Name: Thromboelastography; Result Unstructured Data: roTEG ME: 52 (NR 80-150); Test Name: Fibrin D dimer; Result Unstructured Data: $g35 mg/L; Test Name: Assisted ventilation; Result Unstructured Data: preoperative ventilator settings: APRV 20/10, 2.5 s/2.5 s, fiO2 30%; Test Name: PCO2; Result Unstructured Data: 32.2 mmHg; Comments: Preoperative; Test Name: Head CT; Result Unstructured Data: large-scale sinus thrombosis and ICH; Test Name: Thromboelastography; Result Unstructured Data: roTEG R: 12 min (NR 8-16)
CDC Split Type: DEJNJFOC20210700505

Write-up: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; CEREBRAL SINUS VENOUS THROMBOSIS; INTRA-CEREBRAL HAEMORRHAGE; This spontaneous report was received after SARS-CoV-2-Vaccination in Vaccine Induced Thrombotic Thrombocytopenia. This report concerned a 44 year old female. The authors shed light on the detrimental course that patients may take after admission for intracranial bleeding in the context of vaccine-induced immune thrombotic thrombocytopenia. Further, they proposed specific actions to be taken and to be avoided by physicians of various specialties in the joint treatment of these complex patients. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no history of any pre-existing arterial and/or venous thrombotic disease/complications or hormonal therapy prior to the ictus, and no medical history of any known pre-existing diseases and /or regular medication intake. 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 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 patient presented to the Emergency Department with progressive headache on 12 day after vaccine administration. The patient suffered rapid neurological deterioration within a few hours. Head computed tomography imaging including venograms revealed large-scale sinus thrombosis and ICH (intracerebral hemorrhage) resulting in a mass effect with clinical signs of herniation warranting emergent surgical intervention. Laboratory data (dates unspecified) included: Activated partial thromboplastin time, Assisted ventilation (NR: not provided) preoperative ventilator settings: APRV 20/10, 2.5 s/2.5 s, fiO2 30%, Fibrin D dimer (NR: 0 - 0.5) $g35 mg/L, Fibrinogen (NR: 180 - 355) 294 mg/dL, International normalized ratio (NR: not provided) 1.0, PCO2 (NR: 35 - 46) 32.2 mmHg, Platelet count (NR: 150 - 370) 48 g/L, Prothrombin time (NR: 7.6 - 9.8) 8.6 S, Thrombin clotting time (NR: not provided) 18.8 S, and Thromboelastography (NR: not provided) roTEG K: 10 min (NR: 3-10), roTEG ME: 52 (NR 80-150), roTEG R: 12 min (NR 8-16). Given that immune-mediated thrombocytopenia was suspected, therapy with intravenous immunoglobulin (IVIg at 1 g/kg) and corticosteroids was immediately initiated after consultation with the Hematology department as management was extrapolated from the treatment of immune HIT (Heparin-induced thrombocytopenia). Given radiographic/clinical signs of impending herniation and the urgent need for decompressive surgery, platelets were given perioperatively despite the suspicion of anti-PF4 antibodies. Intraoperatively, severe bleeding and venous stasis posed a challenge to the surgeon requiring immaculate hemostasis despite a cautious intraoperative strategy with an effort to avoid injury to the brain. The use of artificial hemostyptics and further transfusions controlled intraoperative bleeding, thereby allowing for sufficient surgical decompression of the affected hemisphere via DC (decompressive craniectomy). The patient was transferred to the Neuro-intensive care unit for further therapy postoperatively. Argatroban was employed for anticoagulation. Ultimately, the patient succumbed to her extensive cranial injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced immune thrombotic thrombocytopenia (coded as thrombosis and thrombocytopenia), cerebral sinus and vein thrombosis and intra cerebral haemorrhage on an unspecified date. This report was serious (Death and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report from literature concerns a 44 year-old female who was hospitalized for vaccine-induced immune thrombotic thrombocytopenia 12 days after receiving the Janssen Covid-19 vaccine and subsequently died. She had no pre-existing medical conditions including no arterial and/or venous thrombotic disease/complications or hormonal therapy and was not taking regular medications. The patient presented to the Emergency Department with progressive headache after suffering rapid neurological deterioration within a few hours. CT Head including venograms revealed large-scale sinus thrombosis and intracerebral hemorrhage resulting in a mass effect with clinical signs of herniation warranting emergent surgical intervention. Laboratory data included: Fibrin D dimer (NR: 0 - 0.5) $g35 mg/L, Fibrinogen (NR: 180 - 355) 294 mg/dL, Platelet count (NR: 150 - 370) 48 g/L. Corrective treatment included IVIg at 1 g/kg & corticosteroids. Platelets were given perioperatively despite the suspicion of anti-PF4 antibodies. The use of artificial hemostyptics & further transfusions controlled intraoperative bleeding, thereby allowing for sufficient surgical decompression of the affected hemisphere via decompressive craniectomy. Argatroban was employed for anticoagulation. The patient died from her extensive cranial injuries. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; CEREBRAL SINUS AND VEIN THROMBOSIS; INTRA-CEREBRAL HAEMORRHAGE; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA


VAERS ID: 1488068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet antibody, Cerebral artery thrombosis, Fibrin D dimer, Immunology test, Platelet count, Portosplenomesenteric venous thrombosis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 5
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: 20210706; Test Name: Platelet count; Result Unstructured Data: 14.000; Test Date: 20210706; Test Name: Fibrin D dimer; Result Unstructured Data: 128000; Test Date: 20210707; Test Name: ELISA; Result Unstructured Data: Positive
CDC Split Type: ESJNJFOC20210736305

Write-up: THROMBOCYTOPENIA; PORTOMESENTERIC VEIN THROMBOSIS; CEREBRAL ARTERIAL THROMBOSIS; ANTI-PLATELET ANTIBODY; This spontaneous report was received from a physician via a regulatory authority, case reference number ES-AEMPS-936765, and concerned a 36 year-old male patient. The patient''s weight was 92 kilograms and his height was 180 centimeters. 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 21C17-04, expiry date not reported), dose not reported, administered once in total on 25-JUN-2021 for COVID-19 (prophylactic) vaccination. No concomitant medications were reported. On 01-JUL-2021, on day 6 after receiving the vaccine, the patient experienced thrombocytopenia, portomesenteric vein thrombosis, cerebral arterial thrombosis and anti-platelet antibody, and was hospitalized on an unspecified date. On 06-JUL-2021, the patient''s platelet count was "14.000" and fibrin D-dimer was 128000 (units and normal ranges [NRs] not reported). On 06-JUL-2021, it was reported that the patient died from middle cerebral artery infarct and multi-organ failure. It was reported as unknown if an autopsy was performed. On 07-JUL-2021, the ELISA (enzyme-linked immunosorbent assay) test result came back as positive. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the thrombocytopenia, portomesenteric vein thrombosis, cerebral arterial thrombosis and anti-platelet antibody was reported as fatal. This report was serious (death, life-threatening and caused/prolonged hospitalization).; Sender''s Comments: V0: This spontaneous report was received from a physician via a regulatory authority (ID: ES-AEMPS-936765) concerned a 36-year-old male patient who experienced thrombocytopenia, portomesenteric vein thrombosis, cerebral arterial thrombosis, and anti platelet antibody 6 days after vaccine. No past medical history or concomitant medications were reported. On day 11, the patient''s platelet count was 14,000 and D-dimer was 128,000 (units and normal ranges not reported). On day 11, it was reported that the patient died from middle cerebral artery infarct and multi-organ failure. It was unknown if an autopsy was performed. On day 12, the ELISA test result came back as positive. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from a regulatory authority), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: MIDDLE CEREBRAL ARTERY INFARCT; MULTI-ORGAN FAILURE


VAERS ID: 1501462 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-26
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: BRJNJFOC20210742007

Write-up: THROMBOSIS; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis 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 20210723538.; Sender''s Comments: V0: 20210742007-JANSSEN 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: THROMBOSIS


VAERS ID: 1540245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Pulmonary embolism, Thrombocytopenia, Thrombosis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   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:
CDC Split Type: DEJNJFOC20210807037

Write-up: LUNG EMBOLISM; THROMBOSIS; THROMBOCYTOPENIA; MYOCARDITIS; VENTRICULAR FIBRILLATION; This spontaneous report received from a physician via the regulatory authority, case reference number DE-PEI-202100149468, and concerned a 27 year-old male patient of unspecified 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 XD974 expiry date not reported), dose not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced ventricular fibrillation. On unspecified dates, the patient developed lung embolism, thrombosis, thrombocytopenia, and myocarditis. The patient was hospitalized on an unspecified date. On 17-JUL-2021, the patient died from an unknown cause of death. An autopsy was performed on an unspecified date, the results of which were not reported. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome was reported as fatal for lung embolism, thrombosis, thrombocytopenia, myocarditis and ventricular fibrillation. This report was serious (death, life-threatening and caused/prolonged hospitalization).; Sender''s Comments: V0: This spontaneous report received from a Regulatory Authority (DE-PEI-202100149468) concerns a 27-year-old male patient of unspecified ethnicity who was found to have ventricular fibrillation, lung embolism, thrombosis, thrombocytopenia, and myocarditis 7 days after receiving the Janssen Covid-19 vaccine. The patient died from an unspecified cause on an unspecified date. No other pertinent information reported. Information regarding other potential etiologies was insufficient and precludes a complete and meaningful assessment. The relationship of capillary leak syndrome to vaccination is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1547292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Embolic stroke, Embolism venous, Guillain-Barre syndrome, Pulmonary embolism
SMQs:, Peripheral neuropathy (narrow), 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), Thrombophlebitis (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210809369

Write-up: DEEP VEIN THROMBOSIS; PULMONARY THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM; EMBOLIC STROKE; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a physician via the Regulatory Authority, case reference number PT-INFARMED-J202107-4266, and concerned a 58 year old female. Initial information was processed with additional information received on 06-AUG-2021. The patient''s weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number: XD955) .5 ml, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain-Barre Syndrome. On 21-JUL-2021, the patient experienced embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism. On 23-JUL-2021 the patient died due to an unspecified cause. It was unknown if an autopsy was performed. The outcome for the events deep vein thrombosis, pulmonary thromboembolism, venous thromboembolism and embolic stroke were fatal. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Reporter''s Comments: Sender''s Comments: This spontaneous report, received from a physician via the Regulatory Authority, (case reference number PT-INFARMED-J202107-4266), concerning a 58-year-old female of unknown ethnicity who experienced Guillain-Barre Syndrome on an unspecified date. She was also reported to have experienced time an, embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism 67 days post vaccination. She and died 2 days later. It was unknown if an autopsy was performed. No other pertinent information is reported. Information is limited in this case, and the occurrence of the events could represent background incidence of such events in the general population. Therefore, the relationship of GBS, embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism to vaccination is considered unclassifiable due to insufficient information.


VAERS ID: 1577084 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-17
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: PHJNJFOC20210824738

Write-up: cough, loss of appetite, blood clot; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097326] concerned a 69 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, intramuscular, batch number: 212C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021 at 05:00, the patient experienced cough, loss of appetite, blood clot. On an unspecified date, the patient died from cough, loss of appetite, 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: 20210824738-Covid-19 vaccine ad26.cov2.- Cough, loss of appetite, 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: COUGH, LOSS OF APPETITE, BLOOD CLOT


VAERS ID: 1588707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 2021-08-04
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Type II diabetes mellitus; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210835510

Write-up: THROMBOSIS OF VENOUS SINUSES; This spontaneous report was received from a health care professional via the Regulatory Authority, case reference number DE-PEI-202100165005, and concerned a 52 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included arterial hypertension and type 2 diabetes mellitus. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration, batch number and expiry date not reported), dose and vaccination date 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 04-AUG-2021, the patient experienced thrombosis of venous sinuses and died the same day. The cause of death was reported as unknown. It was unknown if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.CoV2.S was reported as not applicable. This report was serious (death).; Sender''s Comments: V0:This spontaneous report was received from a health care professional, case reference number DE-PEI-202100165005, and concerns a 52 year-old male patient with unknown past medical history and concomitant medications experienced thrombosis of venous sinuses and died the same day at unspecified time post vaccination. The patient''s concurrent conditions included arterial hypertension and type 2 diabetes mellitus. No other pertinent details reported. Information is limited in this case, and the occurrence of thrombosis of venous sinuses could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1632115 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-08-25
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, Anti-platelet antibody, Blood fibrinogen, Body temperature, C-reactive protein, Cerebral haemorrhage, Cerebral venous thrombosis, Deep vein thrombosis, Disseminated intravascular coagulation, Electrocardiogram, Fibrin D dimer increased, Headache, Heparin-induced thrombocytopenia test, Heparin-induced thrombocytopenia test positive, Immunology test, Influenza like illness, International normalised ratio, Laboratory test, Magnetic resonance imaging head, Muscle spasms, Myalgia, Platelet count, Pregnancy test, Prothrombin time, Prothrombin time shortened, SARS-CoV-2 test, Superior sagittal sinus thrombosis, Thrombocytopenia, Ultrasound Doppler
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (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), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
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: Medical History/Concurrent Conditions: Contraception; Comments: She was not on hormonal contraception
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: 296 x1000/microL; Test Date: 20210514; Test Name: EKG; Result Unstructured Data: confirmed thrombosis; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: $g200: normal; Test Date: 20210514; Test Name: C-reactive protein; Result Unstructured Data: 19 mg/dL; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: 37.32 C; Test Date: 20210514; Test Name: APTT; Result Unstructured Data: 30 S; Test Date: 20210514; Test Name: Laboratory test; Result Unstructured Data: 119 AUC (postmortem); Test Date: 20210514; Test Name: Prothrombin time; Result Unstructured Data: 99 %; Test Date: 20210514; Test Name: INR; Result Unstructured Data: 1; Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: normal; Test Date: 20210517; Test Name: Fibrinogen; Result Unstructured Data: 0.8 g/L; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: < 25 g/L, Thrombocytopenia; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: 25 g/L; Test Date: 20210517; Test Name: Pregnancy test; Result Unstructured Data: Negative; Test Date: 20210517; Test Name: C-reactive protein; Result Unstructured Data: 19 mg/dL; Test Date: 20210517; Test Name: Venous Doppler; Result Unstructured Data: See relevant lab tests; Test Date: 20210517; Test Name: COVID-19 PCR test; Result Unstructured Data: Negative; Test Date: 20210519; Test Name: Head MRI; Result Unstructured Data: See relevant lab tests; Test Date: 20210519; Test Name: Prothrombin time; Result Unstructured Data: 48 %; 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: Fibrin D dimer abnormal; Result Unstructured Data: over 35000; Test Date: 20210519; Test Name: Fibrinogen; Result Unstructured Data: 91; Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 348 AUC (postmortem); Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 27 AUC (postmortem); Test Date: 20210520; Test Name: Anti-platelet antibodies; Result Unstructured Data: positive; Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 91 AUC (postmortem); Test Name: ELISA; Result Unstructured Data: PF4 assay negative; Test Name: Heparin-induced platelet antibody; Result Unstructured Data: positive
CDC Split Type: SIJNJFOC20210550911

Write-up: CEREBRAL VENOUS THROMBOSIS; SAGITTAL SINUS THROMBOSIS; INTRACEREBRAL BLEED; DISSEMINATED INTRAVASCULAR COAGULATION; HEPARIN-INDUCED THROMBOCYTOPENIA TEST POSITIVE; Fibrin D dimer increased; Prothrombin time decreased; THROMBOCYTOPENIA; DEEP VEIN THROMBOSIS; MUSCLE CRAMPS; INFLUENZA LIKE ILLNESS; MYALGIA; administration site pain; HEADACHE; 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 social media article reported that an adult female aged 41 died due to rare thrombosis; previous reports also mentioned a female under 40. 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 and headache, both for 2 days. On 08-MAY-2021, the patient experienced malaise, tiredness (both recovering), and increased body temperature 39 Celsius. On 10-MAY-2021, (3 days post vaccine) the patient had flu-like symptoms including chills for 1 day, sore throat with linings and was diagnosed angina tonsillitis, difficulty swallowing, myalgia and arthralgia for 36 hours (all recovering), malaise, headache, tiredness, body temperature 39 degrees Celsius. On 14-MAY-2021, the patient experienced muscle cramps and thrombosis leg (fatal) as confirmed by electrocardiogram (ECG). The patient also had consultation for influenza like illness. She had normal thrombocytes 296 x1000/microL (Normal range (NR) not provided). On 14-MAY-2021, laboratory data included: APTT (NR: not provided) 30 S, Body temperature (NR: not provided) 37.32 C, C-reactive protein (NR: not provided) 19 mg/dL, EKG (NR: not provided) confirmed thrombosis, INR (NR: not provided) 1, Laboratory test (NR: not provided) 119 AUC (postmortem) and Prothrombin time (NR: not provided) 99 %. On 17-MAY-2021, following swelling of the leg, a deep vein thrombosis in the calf was detected. Treatment started with low molecular weight heparin, Innohep (tinzaparine) 10.000 once a day for 2 injections total despite thrombocytopenia 25 g/L. On 17-MAY-2021, laboratory data included: Body temperature (NR: not provided) normal, C-reactive protein (NR: not provided) 19 mg/dL, COVID-19 PCR test (NR: not provided) Negative, Fibrinogen (NR: not provided) 0.8 g/L, Pregnancy test (NR: not provided) Negative, and Venous Doppler showed acute deep popliteal venous thrombosis of all veins of the right leg; the femoral vein was transient. 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. On 19-MAY-2021, a head magnetic resonance (MRI) showed supratentorially in both (brain) hemispheres numerous areas of bleeding, more on left; areas of hemorrhage are mainly extra axial along the cerebral falx, by dissection of the corpus callosum, and by effusion into the left (lateral) ventricle. Dilated venous thrombosis of the upper sagittal sinus on convexity was seen. Diffusion imaging showed changes with features of venous ischemia in almost the entire left hemisphere that spread to the paramedian areas and to the cerebral cortex of the right frontal and parietal lobes. A large mass effect was seen with transtentorial descending hernia, compression of the third ventricle of the diencephalon and midbrain (mesencephalon) and with significant obliteration (squeezing) of the fourth ventricle and cerebrospinal fluid spaces in the posterior (cranial) cavity. The neuroradiologist concluded that there was dilated sagittal sinus thrombosis at the vertex level, areas of intra- and extra-axial hemorrhage with intraventricular hemorrhage in the left lateral ventricle, and ischemia with venous features throughout the left hemisphere and part in the right hemisphere in the paramedian; and parietal lobe. Transtentorial displacement with mesencephalon / brainstem compression was also seen. 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. On 20-MAY-2021, the subject died from thrombosis, hemorrhage intracerebral, and thrombocytopenia after her hospitalization. Autopsy was performed and it proved venous thrombosis and intracranial hemorrhage, but written autopsy report could not be gained persuant to legislation. On 20-MAY-2021, Laboratory data included: Anti-platelet antibodies (NR: not provided) positive, and Laboratory test (NR: not provided) 27 AUC (postmortem), 348 AUC (postmortem), 91 AUC (postmortem). 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 died of disseminated intravascular coagulation, thrombocytopenia, cerebral hemorrhage, fibrin d dimer increased, prothrombin time decreased, sagittal sinus thrombosis, deep vein thrombosis and cerebral venous thrombosis on 20-MAY-2021, was recovering from administration site pain, and myalgia, and the outcome of influenza like illness, headache, muscle cramps, and heparin-induced thrombocytopenia test positive was not reported. Sender''s Comment: External expert advices :Expert 1 : The PF4 assay. was negative by ELISA but positive by functional test. If we receive written confirmation of the positivity of the functional PF4 testing, there is in my view a clear causal link. We should also know whether this lady was on oral contraception with EE. Expert 2: The clinical presentation, the delay in vaccination, the age of the patient, the absence of other known favourable factors, the platelet count at the diagnosis of DVT at D10, the evolution towards a CVST with a low platelet count at D12 are strongly in favour of a TTS secondary to the vaccination. However, we do not have any information concerning the possible previous exposure to heparin treatment (necessary for classification according to the Brighton collaboration). We do not have either an echodoppler protocol concerning the diagnosis of lower limb DVT whereas this clinical presentation seems rare in the previously described cases (other cases of VIPIT with lower limb DVT). So highly suspicious case but incomplete information to give you a definitive analysis. Expert 3: At the time of writing this assessment, I have not yet received the results of the requested PF4 functional test (positive according to verbal information from Prof. x, no written protocol yet).Nevertheless, the diagnosis of a "thrombosis with thrombocytopenia syndrome" (TTS) seems to me to be highly probable (level 1). It is not mentioned in the case description if an echo-Doppler and/or a brain scan were performed to prove the thrombosis. I am not sure if the deep venous thrombosis of the lower limb was objectified (venous Doppler on 5/17) but the description of the cerebral findings requires imaging and it seems logical to me to think that the cerebral venous thrombosis and cerebral hemorrhage were objectified, along with the thrombocytopenia, which is sufficient to make the diagnosis. Additional elements in favor of this diagnosis are the timing after vaccination (D10), the flu-like symptoms (showing a strong immune response), the cerebral venous thrombosis immediately complicated by hemorrhage, the decreased PTT, the very high D-dimer values and unfortunately the fatal course of the disease. In my opinion, there is no other etiology than the vaccine to plausibly explain the occurrence of these medical events. I identify as "probable" the link with the vaccine but it could be "certain" in case of definitive confirmation of the presence of anti-PF4 antibodies. Expert 4 :The course, clinic, and biochemical tests do indeed fit a VITT. I would consider the correlation probable/likely (code 2).Strictly speaking, initially a HIT could not be excluded, but there were already low platelets at first presentation and no obvious heparin exposure beforehand, as far as known. The subsequent course would also be a short time frame for HIT. The positive anti-PF4-ELISA very strongly suggest a VITT, with strong reactivity in the absence of heparin (argues against HIT) and no additional increase with increasing concentrations of heparin. Thus, this fits the diagnosis of VITT according to the typical described biochemical and clinical course. This report was serious (Death, and Hospitalization Caused / Prolonged). This case is linked to duplicate cases 20210550864, 20210550753. Additional information was received on 17-AUG-2021 via Regulatory Authority. The following information was updated and incorporated into the case narrative: date of death was updated from 21-MAY-2021 to 20-MAY-2021, serious criteria of life threatening removed, events added (heparin-induced thrombocytopenia test positive and cerebral venous thrombosis), onset dates updated for events (thrombocytopenia and influenza like illness), and event terms updated (deep vein thrombosis and intracerebral bleed). Upon review, the following information was amended: Social Media added as source in structured field.; Sender''s Comments: Follow-up updated date of death and event details. This spontaneous report received from health professionals via regulatory authority & from an online article concerned a 37-year-old woman who died after experiencing thrombocytopenia on day 10 & cerebral venous sinus thrombosis (CVST) on day 12 after receiving Janssen Covid-19 vaccine. Medical history was not reported. Concomitant medications included paracetamol and the patient was not using hormonal contraception. Day 3, she had flu-like symptoms (chills, sore throat, malaise, myalgia, headache, & fever). Day 7, platelet count was 296,000. Day 10, a deep vein thrombosis was detected in right leg via venous doppler; Covid-19 PCR was negative. Treatment was initiated with low molecular weight heparin despite new thrombocytopenia (25,000). Day 12, the patient presented to the emergency department for disturbance of consciousness & hemiplegia during the night. She had disseminated intravascular coagulation (DIC). MRI showed cerebral hemorrhage with a CVST of sagittal sinus and transtentorial displacement with mesencephalon/brainstem compression. Lab data included: high D-dimer $g 35000, low fibrinogen 91, platelet count 50,000. Patient was intubated & placed on mechanical ventilation. Treatment medications included mannitol and polyvalent immunoglobulins for 2 days & dexamethasone for 4 days; tinzaparine was discontinued & switched to danaparoid. Patient died on day 12 from thrombosis, hemorrhage intracerebral, & thrombocytopenia. Autopsy confirmed venous thrombosis & intracranial hemorrhage. Anti-platelet antibody test & heparin-induced thrombopenia test were positive. Although the use of heparin may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (per definition from Brighton Collaboration), 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.; Reported Cause(s) of Death: THROMBOSIS; INTRACEREBRAL BLEED; THROMBOCYTOPENIA; Autopsy-determined Cause(s) of Death: THROMBOSIS; INTRACEREBRAL BLEED


VAERS ID: 1667212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 26
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: Disseminated sclerosis (chronic-progredient); Osteoporosis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZJNJFOC20210857355

Write-up: Embolism lung; Thrombosis; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, CZ-CZSUKL-21009803) on 27-AUG-2021 concerned a 70 year old female of unspecified race and ethnic origin. The patient''s weight was 45 kilograms and height was 154 centimeters. The patient''s concurrent conditions included that she had disseminated sclerosis and osteoporosis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986, expiry: unknown) 0.5 ml, 1 total administered on 10-JUN-2021 for covid-19 immunization. No concomitant medications were reported. On JUN-2021, the patient experienced embolism lung and thrombosis. On an unspecified date she was hospitalized. The number of days hospitalized was not reported. On 27-JUN-2021, the patient died from embolism lung. An autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of thrombosis on 27-JUN-2021. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Reported Cause(s) of Death: EMBOLISM LUNG


VAERS ID: 1671720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210904490

Write-up: BRAIN CLOT; This spontaneous report received from a patient via a company representative concerned a 19 year old male 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) dose, frequency was 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 died from the brain clot after getting vaccinated with Janssen Covid-19 Vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210904490- covid-19 vaccine ad26.cov2.s -Brain 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 CLOT


VAERS ID: 1679472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-11
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Coma, Confusional state, Headache, Immune thrombocytopenia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (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), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 6
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: Electronic cigarette user
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210902066

Write-up: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; HEADACHE; CONFUSION; SINUS VEIN THROMBOSIS; COMA; FEVER; VOMITING; This spontaneous report was received from a consumer following publication of a newspaper article and concerned a 34 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included being an electronic cigarette user, but was otherwise healthy. The patient''s wife and mother had experienced no vaccine-related reactions. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number unknown) dose and vaccination date not reported, for prophylactic vaccination. The batch number was not reported and the company is unable to perform follow-up. No concomitant medications were reported. On an unspecified date following vaccination, the patient experienced a headache, vomited and developed a fever. A doctor prescribed unspecified antibiotics for a suspected infected mosquito bite, which was ineffective. A day prior to a planned vacation, the patient''s wife telephoned for an ambulance as his headache was bad and he was walking around confused. The patient was hospitalised on an unspecified date and was in a coma in the intensive care unit of the hospital from 11-JUN-2021 (reported as 2 weeks post-vaccination) with sinus vein thrombosis. The patient underwent several unspecified operations in the hospital, together with unspecified medications. The doctor''s report from the hospital reported that the findings were typical of a SARS-CoV2 vaccine-induced immune thrombotic thrombocytopenia. On 17-JUN-2021, the patient died from the vaccine-induced immune thrombotic thrombocytopenia and sinus vein thrombosis. An autopsy was ordered by the public prosecutor and was performed on an unspecified date, with the report confirming the family and doctor''s suspicions and ended ''this is a serious (fatal) vaccination reaction''. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcomes of the fever, headache, vomiting and confusion were not reported. This report was serious (death, caused/prolonged hospitalization and other medically important condition). This case, from the same reporter, is linked to case 20210902067.; Sender''s Comments: V0: This spontaneous report received from a consumer following publication of a newspaper article concerns a 34-year-old male patient who was hospitalized 2 weeks after vaccination and subsequently died from vaccine-induced immune thrombocytopenic thrombocytopenia and sinus vein thrombosis. Patient''s height, weight and concomitant medications were not reported. The patient''s concurrent conditions included being an electronic cigarette user but was otherwise healthy. The patient''s wife and mother had experienced no vaccine-related reactions. Unspecified time after vaccination patient experienced headache, vomiting and fever. He was prescribed unspecified antibiotics for a suspected infected mosquito bite, which was ineffective. A day prior to a planned vacation, the patient''s wife telephoned for an ambulance as his headache was bad and he was walking around confused. The patient died after 6 days being hospitalized in the intensive care unit in coma with sinus vein thrombosis. He has undergone several unspecified operations in the hospital, he has been treated with unspecified medications and the doctor''s report from the hospital stated that the findings were typical of a SARS-CoV2 vaccine-induced immune thrombotic thrombocytopenia. Autopsy report confirmed the family and doctor''s suspicions and ended ''this is a serious (fatal) vaccination reaction''. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; SINUS VEIN THROMBOSIS


VAERS ID: 1685823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Atelectasis, Blood fibrinogen, Brain contusion, Brain death, Brain oedema, Cardiac arrest, Central nervous system necrosis, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Congestive hepatopathy, Deep vein thrombosis, Fibrin D dimer, Haematoma, Haemorrhage subcutaneous, Haemorrhagic ovarian cyst, Haemothorax, Heparin-induced thrombocytopenia test positive, Immune thrombocytopenia, Laryngeal haematoma, Magnetic resonance imaging, Platelet count, Pleural effusion, Pulmonary embolism, Pupils unequal, Right ventricular dilatation, Subarachnoid haemorrhage, Vena cava thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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), Pulmonary hypertension (narrow), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 13
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: Adiposity; Cardiovascular disease, unspecified; Chronic renal insufficiency (with suspected vascular neuropathy); Hirsutism (Hirsutism in the chin area. Tumorous pituitary enlargement (18:12:6 mm) - suspected pituitary adenoma.); Hypertension arterial (arterial hypertension); Left ventricular hypertrophy (left ventricular hypertrophy); Leukoencephalopathy (Leukoencephalopathy DD vasculitis. Cadasil genetic test negative.); Mitral valve prolapse (mitral valve prolapse, tricuspid insufficiency); Pituitary tumour (Tumorous pituitary enlargement (18:12:6 mm) - suspected putuitary adenoma.); Renal vascular disorder NOS (with suspected vascular neuropathy); Splenomegaly (Splenomegaly (14 cm MR 14.2.18)); Struma nodosa (Small-nodule goiter, both sides); Tricuspid valve incompetence (tricuspid insufficiency); Uterine myomatosis (Uterus myomatosus); Vasculitis (Leukoencephalopathy DD vasculitis. Cadasil genetic test negative.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20180214; Test Name: MRI; Result Unstructured Data: Splenomegaly (14 cm); Test Date: 20210811; Test Name: Fibrinogen; Result Unstructured Data: 118 mg/dL; Test Date: 20210811; Test Name: Platelet count; Result Unstructured Data: 29000 G/l; Test Date: 20210811; Test Name: Antibody test; Result Unstructured Data: 2.46; Test Date: 20210811; Test Name: Fibrin D dimer; Result Unstructured Data: less than 20
CDC Split Type: ATJNJFOC20210845391

Write-up: HEPARIN-PLATELET FACTOR 4 ANTIBODY COMPLEX TEST POSITIVE; CARDIAC ARREST; IMMUNE THROMBOCYTOPENIA; BRAIN DEATH; INTRACEREBRAL HEMORRHAGE (ICH); HAEMATOMA; INFERIOR VENACAVAL THROMBOSIS; BRAIN CONTUSION; RECURRENT PULMONARY EMBOLISM; EFFUSION PLEURAL; HEPATIC CONGESTION; BLEEDING SPOT SUBCUTANEOUS; DEEP VEIN THROMBOSIS LEG; RIGHT VENTRICULAR DILATATION; HAEMORRHAGE INTO OVARIAN CYST; PARTIAL ATELECTASIS; CEREBRAL VENOUS SINUS THROMBOSIS; PLEURAL HAEMORRHAGE; BRAIN EDEMA; CENTRAL NERVOUS SYSTEM NECROSIS; LARYNGEAL HAEMATOMA; HAEMORRHAGE SUBARACHNOID; RIGHT PUPIL CONSIDERABLY WIDER THAN LEFT ONE; This spontaneous report received from a physician by a Regulatory Authority (AT-EMA-DD-20210831-banala_s-154341) on 03-SEP-2021 and concerned a 35 year old female of unknown race and ethinicity. Initial information was processed with additional information received on 06-Sep-2021. The patient''s weight was 90 kilograms, and height was 160 centimeters. The patient''s concurrent conditions included: mitral valve prolapse, chronic renal insufficiency, vasculitis, splenomegaly, left ventricular hypertrophy, renal vascular disorder nos, hypertension arterial, leukoencephalopathy, tricuspid valve incompetence, pituitary tumour, hirsutism, adiposity, uterine myomatosis, struma nodosa, and cardiovascular disease, unspecified. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 0.5 ml, 1 dosage forms, 1 total administered on 31-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-FEB-2018, Laboratory data included: MRI (NR: not provided) Splenomegaly (14 cm). On AUG-2021, the patient experienced haematoma, inferior venacaval thrombosis, brain contusion, recurrent pulmonary embolism, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, right ventricular dilatation, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, brain edema, central nervous system necrosis, laryngeal haematoma, haemorrhage subarachnoid, immune thrombocytopenia. On 11-AUG-2021, the patient experienced brain death, intracerebral hemorrhage (ich), right pupil considerably wider than left one. The patient was hospitalized (date unspecified). Laboratory data included: Antibody test (NR: not provided) 2.46, Fibrin D dimer (NR: not provided) less than 20, Fibrinogen (NR: not provided) 118 mg/dL, and Platelet count (NR: not provided) 29000 G/l. On 14-AUG-2021, the patient experienced cardiac arrest. On an unspecified date, the patient experienced heparin-platelet factor 4 antibody complex test positive, and was hospitalized. On 14-AUG-2021, the patient died from intracerebral haemorrhage, and cardiac arrest. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of immune thrombocytopenia, brain death, intracerebral hemorrhage (ICH), brain contusion, recurrent pulmonary embolism, right ventricular dilatation, brain edema and central nervous system necrosis on 14-AUG-2021, had not recovered from right pupil considerably wider than left one, haematoma, inferior venacaval thrombosis, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, laryngeal haematoma, and haemorrhage subarachnoid, and the outcome of heparin-platelet factor 4 antibody complex test positive was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition) Additional information was received from Physician on 03-Sep-2021. The following information was updated and incorporated into the case narrative: New reporter added (consumer), New patient medical history was added under disease which are pituitary tumour, hirsutism, adiposity, uterine myomatosis, struma nodosa, and cardiovascular disease, unspecified, in Event tab new events were added which are haematoma, inferior venacaval thrombosis, brain contusion, recurrent pulmonary embolism, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, right ventricular dilatation, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, brain edema, central nervous system necrosis, laryngeal haematoma, haemorrhage subarachnoid, right pupil considerably wider than left one, heparin-platelet factor 4 antibody complex test positive and cardiac arrest.; Reported Cause(s) of Death: INTRACEREBRAL HAEMORRHAGE; CARDIAC ARREST


VAERS ID: 1687789 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug addict
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210913720

Write-up: LEG THROMBOSIS; CARDIAC ARREST; This spontaneous report received from a patient via a company representative via social media concerned a 30 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: drug addict. It was unspecified whether autopsy was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) frequency one 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. The young man wanted to find a job, so he had to be vaccinated. He was reluctant to get the vaccine, as he was afraid of the side effects. The patient said to a friend that this situation obliged him to get vaccinated. In the video, it was reported that the young men died of cardiac arrest, provoked by the thrombosis. The patient wrote on social media that his leg became hard, like a stone. The patient also wrote that all his veins are almost blocked and only a small quantity of blood flows in his veins. The patient wrote that he was 30 years old but he is going to die in a few days because some angiologists hesitate to open me. Under the information of the reportage, some comments of the people mention that the young man had already problems and he should not have been vaccinated. One of them says that he knew the young man and that he was a drug addict. On an unspecified date, the patient experienced leg thrombosis after 20 days of vaccination and cardiac arrest, and a 30 year old, who was hospitalized (date unspecified) that happened some days after his vaccination. The patient reported that his leg became hard, like a stone and all his veins are almost blocked and only a small quantity of blood flows in his veins. On 02-SEP-2021, the patient died from cardiac arrest, and leg thrombosis. 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: V0:20210913720-COVID-19 VACCINE AD26.COV2.S-Leg thrombosis,Cardiac arrest. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: Cardiac arrest; LEG THROMBOSIS


VAERS ID: 1687790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-02
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 2021-09-02
   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:
CDC Split Type: GRJNJFOC20210914006

Write-up: THROMBOSIS IN LEG; DEATH; This spontaneous report received from a patient via a company representative concerned a 4 decade (30 or 31) old male of unspecified 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, batch number and expiry were not reported) dose, start therapy date were not reported, frequency time 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 (a few days after the coronavirus vaccination), it was reported that the patient''s leg was rocky as all his veins were blocked (reported as thrombosis in the leg) and was hospitalized . He was alive because enough blood was flowing into his heart was reported. On 02-SEP-2021 (Thursday), the patient died from an unknown cause of death. 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 on 02-SEP-2021, and the outcome of thrombosis in leg was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210914006-Covid-19 vaccine ad26.cov2.s-Death, Thrombosis in leg. 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


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https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&PERPAGE=200&SYMPTOMS[]=Aortic+thrombosis+%2810002910%29&SYMPTOMS[]=Arterial+thrombosis+%2810003178%29&SYMPTOMS[]=Arterial+thrombosis+limb+%2810003180%29&SYMPTOMS[]=Atrial+thrombosis+%2810048632%29&SYMPTOMS[]=Axillary+vein+thrombosis+%2810003880%29&SYMPTOMS[]=Basilar+artery+thrombosis+%2810063093%29&SYMPTOMS[]=Brachiocephalic+vein+thrombosis+%2810063363%29&SYMPTOMS[]=Carotid+artery+thrombosis+%2810007688%29&SYMPTOMS[]=Cavernous+sinus+thrombosis+%2810007830%29&SYMPTOMS[]=Cerebral+artery+thrombosis+%2810008092%29&SYMPTOMS[]=Cerebral+thrombosis+%2810008132%29&SYMPTOMS[]=Cerebral+venous+sinus+thrombosis+%2810083037%29&SYMPTOMS[]=Cerebral+venous+thrombosis+%2810008138%29&SYMPTOMS[]=Coronary+artery+thrombosis+%2810011091%29&SYMPTOMS[]=Deep+vein+thrombosis+%2810051055%29&SYMPTOMS[]=Hepatic+vein+thrombosis+%2810019713%29&SYMPTOMS[]=Iliac+artery+thrombosis+%2810021340%29&SYMPTOMS[]=Injection+site+thrombosis+%2810022104%29&SYMPTOMS[]=Intracranial+venous+sinus+thrombosis+%2810061251%29&SYMPTOMS[]=Jugular+vein+thrombosis+%2810023237%29&SYMPTOMS[]=Mesenteric+vein+thrombosis+%2810027402%29&SYMPTOMS[]=Ophthalmic+artery+thrombosis+%2810081144%29&SYMPTOMS[]=Ophthalmic+vein+thrombosis+%2810074349%29&SYMPTOMS[]=Pelvic+venous+thrombosis+%2810034272%29&SYMPTOMS[]=Peripheral+artery+thrombosis+%2810072564%29&SYMPTOMS[]=Portal+vein+thrombosis+%2810036206%29&SYMPTOMS[]=Postpartum+venous+thrombosis+%2810036300%29&SYMPTOMS[]=Pulmonary+artery+thrombosis+%2810037340%29&SYMPTOMS[]=Pulmonary+thrombosis+%2810037437%29&SYMPTOMS[]=Retinal+artery+thrombosis+%2810038831%29&SYMPTOMS[]=Retinal+vascular+thrombosis+%2810062108%29&SYMPTOMS[]=Retinal+vein+thrombosis+%2810038908%29&SYMPTOMS[]=Spinal+artery+thrombosis+%2810071316%29&SYMPTOMS[]=Splenic+vein+thrombosis+%2810041659%29&SYMPTOMS[]=Subclavian+vein+thrombosis+%2810049446%29&SYMPTOMS[]=Superior+sagittal+sinus+thrombosis+%2810042567%29&SYMPTOMS[]=Thrombosis+%2810043607%29&SYMPTOMS[]=Thrombosis+in+device+%2810062546%29&SYMPTOMS[]=Transverse+sinus+thrombosis+%2810044457%29&SYMPTOMS[]=Truncus+coeliacus+thrombosis+%2810062363%29&SYMPTOMS[]=Umbilical+cord+thrombosis+%2810071652%29&SYMPTOMS[]=Vena+cava+thrombosis+%2810047195%29&SYMPTOMS[]=Venous+thrombosis+%2810047249%29&SYMPTOMS[]=Venous+thrombosis+limb+%2810061408%29&VAX=COVID19&VAXMAN=JANSSEN&DIED=Yes


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