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From the 9/17/2021 release of VAERS data:

Found 2,302 cases where Vaccine is COVID19 and Manufacturer is JANSSEN and Symptom is Cerebral venous sinus thrombosis or Cerebral venous thrombosis or Coagulopathy or Deep vein thrombosis or Disseminated intravascular coagulation or Embolism or Idiopathic thrombocytopenic purpura or Immune thrombocytopenia or Immune thrombocytopenic purpura or Ischaemic stroke or Myocardial infarction or Petechiae or Pulmonary embolism or Purpura or Thrombocytopenia or Thrombosis or Vasculitis



Case Details

This is page 6 out of 231

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VAERS ID: 1157533 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dizziness, Fall, Injury, Oxygen consumption decreased, Renal disorder, SARS-CoV-2 test positive, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? 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: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Oxygen consumption decreased; Result Unstructured Data: 87; Test Date: 20210322; Test Name: COVID-19 virus test positive; Result Unstructured Data: Positive; Test Date: 20210325; Test Name: Body temperature; Result Unstructured Data: Over 103
CDC Split Type: USJNJFOC20210355610

Write-up: DIZZINESS; FELL; HURT HIMSELF; SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the patient became ill with COVID like symptoms, and got tested for COVID on 22-Mar-2021 and received results that he was COVID positive on 25-Mar-2021 and was running high temperatures (fevers over 103), On 27-MAR-2021, the patient became dizzy, fell and hurt himself, was rushed to the hospital and was admitted same day. He did some damage to his kidneys in the process. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Over 103. Laboratory data included: Oxygen consumption decreased (NR: not provided) 87. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 positive, dizziness, fell, injury to kidney, hurt himself and blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition) This report was associated with product quality complaint : 90000174591.; Sender''s Comments: V0: 20210355610- Covid-19 Vaccine Ad26.Cov2.S-Confirmed Covid-19 Positive. 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. 20210355610- Covid-19 Vaccine Ad26.Cov2.S - Dizziness, Fell, Hurt himself, Some damage to his kidneys in the process (blood clot). This events are considered Unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1160343 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chills, Exposure during pregnancy, Induced labour, Platelet count decreased, Pyrexia, SARS-CoV-2 test negative, Tachycardia, Thrombocytopenia, White blood cell count increased
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal Vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: COVID negative WBC 11 Plts 98,000 and repeated at 92,000. She had no prior dx of gestational thrombocytopenia although this is the most likely cause.
CDC Split Type:

Write-up: Patient is a 28 y.o. year old G1P0 at 38w6d who presented for fevers, chills and decreased fetal movement. She received her first COVID vaccine 8 hours prior. No cough. She felt well before the shot. No bleeding or leaking fluid. Her COVID test was negative. She was tachycardic to the 140''s and the baby was tachycardiac to the 180''s starting at presentation. She was treated with oral tylenol and IV fluids. After about 90 minutes of monitoring a prolonged fetal heart rate deceleration was noted to the 60''s for 6 minutes. This recovered with repositioning. After another hour a reactive tracing was noted with a normal heartrate for baby. In induction of labor was started.


VAERS ID: 1164783 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-11
Onset:2021-03-29
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: insulin, estradiol, ibuprofen
Current Illness:
Preexisting Conditions: diabetes, morbid obesity
Allergies: metformin, Trulicity
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pulmonary embolism and bilateral DVTs, received vaccine on 3/11/21, was admitted to the hospital on 3/29/21


VAERS ID: 1165571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210331460

Write-up: PULMONARY EMBOLISM AFTER VACCINATION; This spontaneous report received from a pharmacist 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) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On evening 15-MAR-2021, the patient experienced pulmonary embolism after vaccination, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism after vaccination was not reported. Vaccination anatomical approach site is unknown. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210331460-pulmonary embolism. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1168274 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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? 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: Aspirin 81mg QD, Atorvastatin 80mg QD, Carvedilol 12.5mg BID, Clopidogrel 75mg QD. Fluoxetine 40mg QD , Furosemide 20mg QD, Gabapentin 300mt TID, Isosorbide Mononitrate ER 60mg QD, LIdoderm 5% patch on 12 hours off 12 hours Lisinopril 40m
Current Illness: M54.5 Low back pain (Primary / Admission) R27.0 Ataxia, unspecified I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris I69.30 Unspecified sequelae of cerebral infarction G30.9 Alzheimer''s disease, unspecified E04.9 Nontoxic goiter, unspecified E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified F03.90 Unspecified dementia without behavioral disturbance M19.90 Unspecified osteoarthritis, unspecified site M51.36 Other intervertebral disc degeneration, lumbar region N28.1 Cyst of kidney, acquired N40.0 Benign prostatic hyperplasia without lower urinary tract symptoms R51.9 Headache, unspecified Z20.822 Contact with and (suspected) exposure to COVID-19 Z95.5 Presence of coronary angioplasty implant and graft W19.XXXD Unspecified fall, subsequent encounter
Preexisting Conditions: M54.5 Low back pain (Primary / Admission) R27.0 Ataxia, unspecified I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris I69.30 Unspecified sequelae of cerebral infarction G30.9 Alzheimer''s disease, unspecified E04.9 Nontoxic goiter, unspecified E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified F03.90 Unspecified dementia without behavioral disturbance M19.90 Unspecified osteoarthritis, unspecified site M51.36 Other intervertebral disc degeneration, lumbar region N28.1 Cyst of kidney, acquired N40.0 Benign prostatic hyperplasia without lower urinary tract symptoms R51.9 Headache, unspecified Z20.822 Contact with and (suspected) exposure to COVID-19 Z95.5 Presence of coronary angioplasty implant and graft W19.XXXD Unspecified fall, subsequent encounter
Allergies: None
Diagnostic Lab Data: hospital has that information
CDC Split Type:

Write-up: About 24 hours after the vaccine administration, he became unresponsive at the nursing home. He was sent to the hospital where he is now on a heparin drip due to bilateral Pulmonary Embolisms and multiple DVTs.


VAERS ID: 1169918 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-23
Onset:2021-03-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / IM

Administered by: Public       Purchased by: ?
Symptoms: Chest pain, Deep vein thrombosis, Dyspnoea, Pain in extremity, Pulmonary embolism, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: aspirin 81 mg daily calcium 500 mg daily
Current Illness: None
Preexisting Conditions: History of DVT and PE in 2015 after riding in a car for a long period of time on vacation. Hypertension. Hyperlipidemia. Obesity.
Allergies: No known allergies
Diagnostic Lab Data: She was admitted to Hospital and diagnosed with a DVT and PE.
CDC Split Type:

Write-up: She developed symptoms of right lower leg pain 4 days after receiving the vaccine. It then progressed to right chest pain, tachycardia, and shortness of breath. She was diagnosed with a DVT and PE.


VAERS ID: 1172452 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Burning sensation, Chills, Hyperhidrosis, Myalgia, Nausea, Pain in extremity, Pruritus, Purpura, Skin lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Naproxen 500mg tablet BID
Current Illness: No other ilnesses at the time of vaccination or within 1 month of vaccination
Preexisting Conditions: Patient has had various lesion on body for past several months (at least 2-3 months)
Allergies: No known allergies
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having right arm pain, diaphoresis, chills, nausea, and muscle aches/pain in upper leg/lower back at 5:30am the following morning. Patient took 2 tablets of 500mg naproxen in the morning and in the afternoon. Symptoms did not resolve and patient had to leave work early. Upon getting home patient took 2 tablets of 650mg tylenol and symptoms resolved within 48 hours. On 4/3/21 patient reported mild to severe pain in heel of left foot. The following day the patient went to WellNow urgent care to get his heel examined. During examination provider noticed patient''s lesions and patient stated more lesions have appeared since getting the vaccine. 1 on his stomach, 1 on the dorsum of his left foot, 1 on his back, 1 on his left elbow, in between his toes of his left foot, and in between the fingers of his right hand. Patient stated that these lesions cause a burning sensation and can become itchy. Patient was sent to Hopsital ED as provider at urgent care was concerned patient may have purpura. Patient was seen and discharged on 4/4/21 from the ED. The heel pain was determined to be plantar fascitis which was treated with at home exercises with a heel cup. The patient was given clotrimazole for his lesions. The patient had a follow-up visit with his primary care provider at hospital on 4/6/21 in which he explained the clotrimazole only made his lesions worse. Patient was referred to follow up with dermatology on 4/8/21. Primary care provider believes progression of the lesions since getting the vaccine leads to concern of an underlying autoimmune exacerbated by vaccine.


VAERS ID: 1172945 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-18
Onset:2021-03-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Cerebral venous sinus thrombosis, Chills, Headache, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Intensive care, Nausea, Pain, Platelet count decreased, Portal vein thrombosis, Pulmonary embolism, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine 50mcg PO daily Bupropion 300mg PO daily
Current Illness:
Preexisting Conditions: hypothyroidism and depression
Allergies:
Diagnostic Lab Data: Platelets 124 on admission heparin-PF4 Antibody 3.018 (positive) because of the heparin-PF4 Antibody 3.018 (positive) and concern for syndrome of thrombosis after covid vaccination she was started on IVIG and switched to Argatroban.
CDC Split Type:

Write-up: Admitted 4/3 with a cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. Pt received covid vaccine 3/18. Symptoms began 3/26 which started with chills and body aches. Then on 3/27- developed a severe headache in the back of her head with associated nausea. On 3/28 she had the most severe headache on the right side of her head. She was vomiting from 3/28-3/30. On 3/30 she went to the ER for evaluation of her severe headache. She was given a "migraine cocktail", no imaging was completed and she was sent home. Appetite improved on 3/31 and she had a small headache relieved with Excedrin. Then on 4/1-4/2 she had severe bloating , abdominal pain and fever of 100.4. She had been visiting her mom for the holidays and came to the ER. Imaging revealed cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. She was started on a heparin drip and brought to ICU for monitoring.. She is not on any oral contraceptives and does not have any family history of clotting disorders.


VAERS ID: 1173076 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-03-22
Onset:2021-03-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Coagulopathy, Surgery
SMQs:, Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nutritional supplements prescribed by her nephrologist
Current Illness:
Preexisting Conditions: Chronic renal failure
Allergies: Axcin
Diagnostic Lab Data: Surgery to clear clots
CDC Split Type: vsafe

Write-up: On 03-23-21, I woke up I felt a pulse and y dialysis access and there was no pulse which indicates that the graft has become clotted. I went to the dialyses center contacted dr. and he said I needed to go to another town, to get surgery to clear the clot with another Dr. I flew there had surgery to clear the surgery, surgery was success. I went to dialysis that night, when I checked the graft again it was clotted. I then had to go make arrangements again to fly to another town to get surgery again with Dr. to clear the clots. Surgery was successful and subsequently and I have had a good pulse on my dialysis access.


VAERS ID: 1176466 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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? 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: Familial risk factor
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210332653

Write-up: PE; DVT; This spontaneous report received from a physician via a company representative concerned a 53 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included family history of DVT, and family history of PE. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in 2021, the patient experienced PE (pulmonary embolism) and DVT (deep vein thrombosis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the PE and DVT was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210332653-Covid-19 Vaccine AD26.COV2.S-PE and DVT. 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: MEDICAL HISTORY


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