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From the 10/15/2021 release of VAERS data:

Found 710 cases where Vaccine targets COVID-19 (COVID19) and Manufacturer is JANSSEN and Write-up contains 'thrombosis'



Case Details

This is page 16 out of 71

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VAERS ID: 1261010 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-03-04
Onset:2021-03-09
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN J&J 1802068 / N/A RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Blood test, Deep vein thrombosis, Peripheral swelling, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Terazosin HCL 10mg; Montelukast NA; Loratadine 10mg; Simvastatin 80mg; Fish Oil 1200mg; Calcium 600mg; CoQ10 100mg; B Complex; Turmeric Curcumin 500mg; Saw Palmetto 320mg
Current Illness: None
Preexisting Conditions: High Blood Pressure
Allergies: Pork, Pollen
Diagnostic Lab Data: Saunagram and blood testing
CDC Split Type:

Write-up: Deep Vein Thrombosis right leg. Five days after being vaccinated I began to notice swelling in my right leg from my knee through my ankle-foot area. There was an associated increase in pain in the knee. I tried to shake it off hoping that the swelling and pain would go away, but I finally relented to the concerns of my family and sought care on the 6th of April at the emergency room because my doctor refused an in-person appointment. The emergency room physician prescribed Eliquis which I have been taking. The swelling seems to have leveled off, but my right leg still appears to be twice the size of my left leg


VAERS ID: 1261166 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Abdominal distension, Amnesia, Asthenia, Atelectasis, Cardiomegaly, Confusional state, Cough, Cystitis, Dizziness, Dysstasia, Electrocardiogram, Fall, Fatigue, Feeding disorder, Feeling hot, Gait inability, Hallucination, Malaise, Memory impairment, Oedema, Oedema peripheral, Periorbital swelling, Platelet count, Platelet count decreased, Ultrasound scan
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210313; Test Name: Platelet count; Result Unstructured Data: 136 (unit not specified); Test Date: 20210313; Test Name: ECG; Result Unstructured Data: cannot rule out anterior infarct age undetermined.; Test Date: 20210314; Test Name: Platelet count; Result Unstructured Data: 130 (unit not specified); Test Date: 20210315; Test Name: Abdomen scan; Result Unstructured Data: Bibasilar atelectasis and cardiomegaly; Test Date: 20210329; Test Name: Diagnostic ultrasound; Result Unstructured Data: Normal; Test Date: 20210401; Test Name: Diagnostic ultrasound; Result Unstructured Data: Contralateral femoral vein was widely patent.; Test Date: 20210407; Test Name: ECG; Result Unstructured Data: Abnormal ECG no significant change found,; Test Date: 20210413; Test Name: Platelet count; Result Unstructured Data: 171 (unit not specified)
CDC Split Type: USJNJFOC20210423228

Write-up: LOW GRADE BLADDER INFECTION; EXTREMELY WARM SENSATION IN CHEST AND BACK; COUGH; SHORT TERM MEMORY LOSS; COULD NOT REMEMBER; NOT WELL; HALLLUCINATIONS; COULD NOT WALK; COULD NOT FEED HERSELF; CONFUSION; PLATELET COUNT DECREASED; UNABLE TO STAND; FALL; DIZZY; FELT TIRED; WEAKNESS; EYES LOOKED PUFFY; ABDOMEN WAS LARGER; BIBASILAR ATELECTASIS; CARDIOMEGALY; SWELLING IN BOTH LEGS INCLUDING ANKLE AND TOES; LEVEL 4 PITTED EDEMA; This spontaneous report received from a consumer concerned a 90 year old female. The patient''s weight and height was not reported. The patient''s past medical history included Alzheimer''s, and dementia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the patient felt tired. On 12-MAR-2021, the patient had a fall, was dizzy and unable to stand. On 13-MAR-2021, the patient was taken to the emergency room and had a low grade bladder infection and was treated with intravenous (IV) antibiotic (unspecified) from 13-MAR-2021 to 15-MAR-2021 and from 15-MAR-2021 she was switched to oral antibiotic (unspecified) until 23-MAR-2021. The patient was confused and could not walk. It was reported that, the patient was unable to feed herself. On 13-MAR-2021, the patient experienced platelet count decreased. On 13-MAR-2021, the patient''s laboratory data included: electrocardiogram (ECG) which could not rule out anterior infarct age undetermined and her platelet count was 136 (unit non specified). On 14-MAR-2021, the patient had hallucinations and her platelet count was 130 (unit non specified). On 15-MAR-2021, her laboratory data included: abdomen computerized tomography (CT) scan which showed bibasilar atelectasis and cardiomegaly, likely cyst vs hemangioma. Unchanged incompletely characterized exophytic lesion in the left kidney significant and possibly represented a hemorrhagic cyst, further evaluation with magnetic resonance imaging (MRI) would need to be performed for definitive characterization. On 17-MAR-2021, the patient''s cognition seemed well. On 19-MAR-2021, the patient started showing symptoms of blood clot. On 19-MAR-2021 to 22-MAR-2021, the patient was not well. The patient was wearing slippers because she had level 4 pitted edema and was swollen from her knees down including ankle and toes. It was reported that, her swelling was greater on the left side than the right side and she had this swelling on 23-MAR-2021. Also, the patient''s confusion returned. On 29-MAR-2021, the patient had confusion and her ultra sound of left leg was normal. On 01-APR-2021, the patient''s laboratory data included: diagnostic ultrasound revealing contralateral femoral vein was widely patent. On 03-APR-2021 and 09-APR-2021, the patient was confused and did not know where she was. On 07-APR-2021, her electrocardiogram did not mention anterior infarct and it was abnormal ECG no significant change found. On 10-APR-2021, the patient could not remember where she was. On an unspecified date, the patient had cough and extremely warm sensation in chest and back. The patient was in rehabilitation center and was set to be discharged 16-APR-2021. On 13-APR-2021, the patient''s platelet count was 171 (unit not specified). On 17-MAR-2021, In rehabilitation center the patient was no longer wearing shoes due to swelling of ankle, legs toes and feet. The patient''s eyes looked puffy and her abdomen was larger. The patient was treated with Lasix (furosemide) in the rehabilitation center. According to the patient''s physician, the patient had no sign of stroke. The patient was propped up on right side while at rehabilitation center so according to her daughter the patient was experiencing weakness. At rehabilitation center an ultrasound was ordered for left leg. The patient''s both legs were swollen and one was more swollen than the other. The patient was having an issue with memory and confusion which was unusual as the patient had previously been treated neurologist for Alzheimer''s disease and dementia and was highly intelligent. At the time of this report, the patient was being treated for low grade bladder infection. The patient''s primary care physician reports that she had no concerns about the vaccine being linked to the patient''s fall and hospitalization and reported that there were no blood clots, no stroke, no deep vein thrombosis, and no coagulation abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not well on 22-MAR-2021, was recovering from platelet count decreased, and the outcome of cough, swelling in both legs including ankle and toes, extremely warm sensation in chest and back, confusion, fall, hallucinations, low grade bladder infection, could not feed herself, could not walk, felt tired, dizzy, unable to stand, level 4 pitted edema, could not remember, eyes looked puffy, abdomen was larger, weakness, short term memory loss, bibasilar atelectasis and cardiomegaly was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: v0 This spontaneous report involves a 90-year-old white female patient with the past medical history remarkable for Alzheimer''s and dementia who felt tired 3 days after the Janssen COVID-19 Vaccine Ad26.COV2 had administered. The next day the patient had fell, was dizzy and unable to stand. The next, the patient was taken to the emergency room and was diagnosed with a low grade bladder infection. The patient was confused and could not walk and was unable to feed herself. The next day, the patient had hallucinations and her platelet count was 130 (unit non specified), normal range 179-450. While hospitalized, the patient started showing symptoms of blood clot, had pitted edema, could not remember where she was. On an unspecified date, the patient had cough and extremely warm sensation in chest and back. The patient''s eyes looked puffy and her abdomen was larger. The patient''s primary care physician reports that she had no concerns about the vaccine being linked to the patient''s fall and hospitalization and reported that there were no blood clots, no stroke, no deep vein thrombosis, and no coagulation abnormalities. Considering the patient''s age, gender ? predisposes to urinary tract infections, as well as the underlying Alzheimer''s and dementia the causality for the events assessed not related to the vaccine.


VAERS ID: 1261192 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Gait inability, Musculoskeletal stiffness, Pain, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cigarette smoker (Occasional pot - rarely.)
Preexisting Conditions: Comments: The patient had no history of bloody nose.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427998

Write-up: BLOOD CLOT FROM NOSE; TEMPORARILY UNABLE TO WALK, RICKETY KNEES; BURNING LEG PAIN; JOINT PAIN/ SHOULDER PAIN; SHOULDER FEEL TIGHT; This spontaneous report received from a patient concerned a 30 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cigarette smoker (occasional pot; rarely). The patient''s grandfather died from blot clot under knee (thrombosis). The patient had no history of bloody nose. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 (two days after vaccination) the patient experienced really bad burning leg pain for few days and his joints in shoulder and knees were affected two days after vaccination and he could not walk (temporarily unable to walk). The patient also experienced rickety knees. On the same day, the patient blew out a huge blood clot from his nose. On 2021, the patient''s shoulder felt tight. At the time of this report, the patient''s knees and shoulders were still feeling tight like there was hardly any cartilage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot from nose, and temporarily unable to walk, rickety knees, was recovering from joint pain/ shoulder pain, and the outcome of burning leg pain and shoulder feel tight was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-Covid-19 vaccine ad26.cov2.s-blood clot from nose. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY


VAERS ID: 1261329 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hemiparesis, Loss of consciousness, Thrombosis, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness: Food allergy
Preexisting Conditions: Comments: The patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition
Allergies:
Diagnostic Lab Data: Test Name: X-ray; Result Unstructured Data: heart, head and lungs
CDC Split Type: USJNJFOC20210440625

Write-up: THROMBOSIS; Dizziness; Pass Out; Weakness in the all side of the body; This spontaneous report received from a patient. The patient''s height, and weight were not reported. The patient''s concurrent conditions included sea food allergy, and other pre-existing medical conditions included the patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition. 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 02-APR-2021 11:25 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included metformin for drug used for unknown indication. On an unspecified date, the subject experienced thrombosis, dizziness, pass out, and weakness in the all side of the body, and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: X-ray (NR: not provided) heart, head and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombosis, dizziness, pass out, and weakness in the all side of the body. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: This is a report of a patient, who was noted to have thrombosis on unspecified time after receiving the covid-19 vaccine ad26.cov.2. Patient''s height and weight were not reported. Patient medical history was not reported. Concomitant medications included metformin for unknown indication. Patient is allergic to seafoods. On an unspecified date, the subject experienced dizziness and passed out. She also had weakness on the left side of the body. Patient was noted to have thrombosis. Patient was hospitalized, where laboratory and diagnostic tests were done. Results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.


VAERS ID: 1262195 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-03
Onset:2021-04-23
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN JOHNSON / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Crohn?s
Allergies: None
Diagnostic Lab Data: April 25, 2021 ultrasound
CDC Split Type:

Write-up: Deep vein thrombosis


VAERS ID: 1262742 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-05
Onset:2021-04-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Contraception, Injection site erythema, Injection site swelling, Thrombophlebitis superficial, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: Tobacco use, diabetes, Crohn''s disease
Allergies: Beta-lactam antibiotics, mercaptopurine analogues
Diagnostic Lab Data: Ultrasound of right arm on 4/22 shows a superficial clot in the right cephalic vein. No deep vein involvement.
CDC Split Type:

Write-up: Patient received vaccine on 4/5/21. She presented to her PCP on 4/22 with swelling and redness in the inside upper area of her right arm. Determined to be a superficial thrombosis. Patient has not history of VTE, but does smoke. Uses a Mirena IUD for contraception as well. Platelet count remained normal during this time, and was never affected.


VAERS ID: 1263150 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-09
Onset:2021-04-23
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary normal, Anticoagulant therapy, Arteriogram carotid normal, Computerised tomogram neck, Computerised tomogram thorax, Deep vein thrombosis, Magnetic resonance imaging head normal, Scan with contrast normal, Ultrasound Doppler, Ultrasound scan abnormal, Vascular access site thrombosis
SMQs:, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Apixaban, Citalopram, Lisinopril, Lorazepam, Melatonin, KCL, Prednisone, Senna-c Completed Chemotherapy with Taxol 2 days prior.
Current Illness: Breast cancer Hypertension Rheumatoid arthritis Vascular port related clot Depression
Preexisting Conditions: Breast cancer Hypertension Rheumatoid arthritis ADHD Depression
Allergies: No Known Allergies
Diagnostic Lab Data: Ultrasound duplex revealed multifocal deep venous thrombosis of left upper extremity CTA chest: No acute pulmonary embolism; there is no infiltrate, effusion or pneumothorax CTA head neck with without contrast: No evidence of cerebral venous sinus thrombosis MRI Brain w/w/o contrast:No hemorrhage, demyelination or acute stroke detected in the brain. No abnormal enhancement detected in the brain after contrast injection Platelet count on CBC:16000(4/25/2021), 18000(4/26/2021), 27000(4/27/2021)
CDC Split Type:

Write-up: Deep venous thrombosis at the site of vascular access line-Initially started on heparin, now switched to Rivaroxaban Thrombocytopenia-Supportive treatment and monitoring


VAERS ID: 1263266 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-11
Onset:2021-04-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Deep vein thrombosis, Fibrin D dimer increased, Pulmonary embolism, Ultrasound Doppler abnormal
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril, Rosuvastatin
Current Illness: None
Preexisting Conditions: Hypertension, Hyperlipidemia
Allergies: Codeine
Diagnostic Lab Data: 04/26/2021: D-Dimer = 4080, CTA Chest = small distal peripheral pulmonary emboli, Doppler RLE = extensive deep vein thrombosis involving the superficial femoral and popliteal veins
CDC Split Type:

Write-up: Pulmonary embolism, Deep vein thrombosis - treating with Eliquis


VAERS ID: 1263940 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-04-08
Onset:2021-04-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Anticoagulant therapy, Blood electrolytes normal, Blood fibrinogen normal, Deep vein thrombosis, Electrocardiogram normal, Fibrin D dimer increased, Full blood count, Haematocrit normal, Haemoglobin normal, Headache, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Immunology test, Peripheral swelling, Platelet count decreased, Pulmonary embolism, Vaccination complication, White blood cell count increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: None reported
Preexisting Conditions: None reported
Allergies: None reported
Diagnostic Lab Data: On admission to current facility: HIT antibody: negative Fibrinogen: 200 mg/dL D-dimer: 28,980 FEU CBC: WBC 12.3 10*9/L, hemoglobin: 14.7 g/dL, hematocrit 41.1%, platelets 54 10*9/L Electrolytes within normal ranges Vaccine-induced (VITT) HIT ELISA (detects presence of IgG antibodies to heparin-platelet factor 4 (PF4) complexes: 3.016 OD ECG: normal sinus rhythm
CDC Split Type:

Write-up: Janssen COVID-19 Vaccine EUA: two weeks after vaccination patient reported to an urgent care with right leg swelling and headache. Two days later patient presented an emergency department, diagnosed with left lower extremity deep vein thrombosis (DVT) and bilateral pulmonary emboli (PE). Transferred to current hosptial for management including anticoagulation with a direct thrombin inhibitor, intravenous immune globulin (IVIG), and additional laboratory testing.


VAERS ID: 1264393 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Dizziness, Fatigue, Haemarthrosis, Headache, Pain in extremity, Somnolence, Therapeutic response unexpected
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Varicose vein
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210436178

Write-up: BURNING; SLEEPY; THROMBOSIS AND BURNING WENT AWAY; SORE ARM; FELT TIRED; WARM BANDANA LIKE HEADACHE; DIZZINESS; BLEEDING BY ANKLE; This spontaneous report received from a patient concerned a 62 year old white and not Hispanic or Latino male. The patient''s height, and weight were not reported. The patient''s past medical history included thrombosis, burning on inner thighs and concurrent conditions included thick varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced bleeding by ankle. On 05-APR-2021, the patient experienced dizziness, sore arm, felt tired and warm bandana like headache. On 05-APR-2021, after getting a shot the patient noticed thrombosis and burning went away. On 06-APR-2021, the patient experienced sleepy. On 16-APR-2021, the patient experienced burning The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on APR-2021, dizziness, sleepy, felt tired, and warm bandana like headache on 06-APR-2021, and sore arm on 07-APR-2021, and the outcome of bleeding by ankle and thrombosis and burning went away was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0; 20210436178-covid-19 vaccine ad26.cov2. s-Bleeding by ankle. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE


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