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

Found 595 cases where Vaccine targets COVID-19 (COVID19) and Manufacturer is JANSSEN and Write-up contains 'thrombosis'



Case Details

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VAERS ID: 1223432 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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? 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: CVA and cerebral venous sinus thrombosis


VAERS ID: 1225905 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-07
Onset:2021-04-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Pain in extremity, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN 10MG, WOMEN''S MULTIVITAMIN
Current Illness:
Preexisting Conditions:
Allergies: SULFA MEDICATIONS,
Diagnostic Lab Data: 04/16/2021: D-DIMER & ULTRASOUND
CDC Split Type:

Write-up: ADVERSE EVENT: DEEP VEIN THROMBOSIS SYMPTOMS: RIGHT INNER THIGH PAIN TIME: 9 DAYS POST VACCINATION


VAERS ID: 1226180 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 UN / SYR

Administered by: Public       Purchased by: ?
Symptoms: Angiogram, Aphasia, Cerebral haemorrhage, Computerised tomogram abnormal, Computerised tomogram head, Computerised tomogram neck, Electroencephalogram, Epilepsy, Fibrin D dimer increased, Full blood count abnormal, Headache, Hemiparesis, Magnetic resonance imaging head abnormal, Muscular weakness, Periorbital pain, Platelet count decreased, Superior sagittal sinus thrombosis, Thrombocytopenia, Venogram
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), 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)

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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No home prescription medications. No hormone supplementations. Patient taking as needed Advil for headaches which started approximately 7 days following vaccination.
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: See above. All relevant tests from 4/18/2021: CT brain, CTA brain/neck, CTV brain, MRI brain wwo contrast, routine EEG, D-dimer, CBC
CDC Split Type:

Write-up: 52-year-old previously healthy female who received first dose of Janssen COVID-19 vaccine on 4/7/2021. She started having periorbital right headaches starting on or about 4/14/2021. Headaches were alleviated with OTC Advil. On the morning of 4/18/2021, she awoke with RIGHT arm weakness which, over the course of several hours, progressed to include right-sided leg weakness and aphasia. Initial CT head showing multifocal hemorrhage within the LEFT frontal lobe. Course complicated by epileptic seizure. MRI brain with and without contrast and CT venogram brain notable for superior sagittal sinus thrombosis involving the mid and anterior segments of the superior sagittal sinus. Patient found to have new thrombocytopenia on admission with platelet level 78k; previously had normal platelets 6/4/2019. D-dimer elevated $g 4.00 mcg/ml FEU. Started on Argatroban gtt, nicardipine, and IVIG.


VAERS ID: 1227129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? 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: Suspected COVID-19
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210424659

Write-up: BLOOD CLOT; RIGHT LEG PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s concurrent conditions included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 at 02:19 for prophylactic vaccination. No concomitant medications were reported. The patient reported that she had a blood clot/pain in right leg 2-3 days after she received the vaccine. She reported that she used compression socks for a week. The patient also reported that she experienced headaches (date unspecified), which still come and go every other day. The patient stated that she had the same blood clot pain in the same leg as when she had COVID-19 infection in MAR-2020. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of blood clot and right leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: A patient of unspecified age and sex reported a "blood clot/pain" in right leg 2-3 days after vaccine. The patient had a history of "blood clot pain" in the same leg when she had COVID infection one year ago. History of thrombosis would provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment. The patient was contacted and could not be immediately reached. Additional information has been requested for further assessment.


VAERS ID: 1227131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arachnoid cyst, Blood pressure measurement, Heart rate, Magnetic resonance imaging, Magnetic resonance imaging head, Platelet count, Platelet factor 4, Venogram
SMQs:

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MARIJUANA; TYLENOL; ALEVE
Current Illness: Ex-smoker; Insomnia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Platelet count; Result Unstructured Data: over 200000, normal; Test Date: 20210415; Test Name: Platelet count; Result Unstructured Data: 268; Test Date: 20210415; Test Name: Platelet count; Result Unstructured Data: 227; Test Date: 20210415; Test Name: MRI brain; Result Unstructured Data: Cerebral venous sinus thrombosis observed; Test Date: 20210415; Test Name: CT venograph; Result Unstructured Data: no thrombosis, rather there was arachnoid granulation; Test Name: MRI; Result Unstructured Data: see comments; Comments: nonvisualized of A1 segment of right ACA, more distal segment supplied by Left ACA, this is a normal anatomic variant. Also non visualization of R vertebral artery which is felt to be a normal anatomic variant as well.; Test Name: Heart rate; Result Unstructured Data: 88; Test Name: Venogram; Result Unstructured Data: see comments; Comments: An absence of flow in right traverse sinus highly suggestive of thrombosis sluggish flow in sigmoid sinus and superior IJ; Test Name: Platelet factor 4; Result Unstructured Data: testing planned; Test Name: Blood pressure; Result Unstructured Data: 120/86
CDC Split Type: USJNJFOC20210428480

Write-up: ARACHNOID GRANULATION; This spontaneous report was originally received from the patient''s husband and concerned a 45-year-old female patient. Initial information was received and processed with additional information received in discussion with treating physician on 15-APR-2021. The patient''s weight 69 kg and height 178 cm. Patient''s medical history included smoking for 10 years and quit 10 years ago. Subject''s concurrent conditions included insomnia. The patient was reported to be in good health, Body Mass Index (BMI) reported as 21.7. The patient had no family history of blood clots. On 08-APR-2021, the patient received vaccination with Janssen COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported; batch number not reported and requested), dose unspecified, for COVID-19 vaccination. Batch number was not reported, will be requested. Non-company suspect drug included unspecified contraceptive pill (unknown, oral) for unspecified indication. Concomitant medications included cannabis sativa for insomnia. On an unspecified date ''just following'' vaccination, the patient had influenza-like symptoms . On 10-APR-2021, patient started experiencing headaches. On 14-APR-2021 (6th day post-vaccination), the patient presented to Emergency Room (ER) with four days of worsening headache and diagnosed with suspected right transverse sinus thrombosis (later ruled out.) The patient was transferred to a second hospital''s intensive care unit (ICU) on an unspecified date. On 15-APR-2021 (7th day post-vaccination), a magnetic resonance imaging (MRI) scan of the brain showed suspected cerebral venous sinus thrombosis (CVST). No other symptoms or neurologic deficits reported, and her platelet count was reported as normal at 268,000 on admission (units and normal range not reported). The admitting physician initiated argatroban whilst closely following the patient''s platelet count. Testing for a panel for heparin-induced thrombocytopenia including anti-platelet factor 4 (anti-PF4) antibodies and other unspecified workup were also planned. On an unspecified date, MRV of brain showed an absence of flow in right transverse sinus highly suggestive of thrombosis, sluggish flow in sigmoid sinus and superior IJ. MRA showed non-visualized of A1 segment of right ACA, more distal segment supplied by Left ACA, this is a normal anatomic variant. Also non visualization of R vertebral artery which is felt to be a normal anatomic variant as well. This read was reviewed on 15-APR with neuro-interventionalist physician and 3 radiologist who were all in agreement that this was instead a normal variant (arachnoid granulation.) Report was addended to clarify that there was never any thrombosis. Patient''s blood pressure was 120/86 and heart rate 88. Patient was fully anticoagulated with argatroban. No heparin was received. Heparin induced thrombocytopenia (HIT) panel was sent and lab was requested to urgently process. Platelet count remained normal from 268 to 227 on 15-APR-2021. On 15-APR-2021, a CT venogram was performed which again confirmed no thrombosis; rather there was arachnoid granulation (normal variant). All imaging was confirmed with neuro-interventionalist physician and 3 radiologist who were all in agreement. Treatment with agratroban was discontinued on 15-APR-2021. As of 15-APR-2021, patient was clinically improving. Headache was resolved and neurologically intact. Patient was eating and was planned to discharge home later in the day. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. Action taken with contraceptive pill was unknown. The event arachnoid granulation was recovering This report was serious (hospitalization/prolonged hospitalization).; Sender''s Comments: V0: A 45-year-old female experienced headache 2 days after vaccine and was hospitalized for suspected transverse venous sinus thrombosis (which was ruled out) 6 days after vaccine. There was no secondary hemorrhage, and after the imaging was reviewed with a neuroradiologist, it was determined that there was no thrombosis at all, but rather an arachnoid granulation (normal anatomic variant.) This was confirmed on follow up CT venogram the following day. Relevant concomitant medications included oral contraceptives. Platelet count was normal (268,000) on admission. No heparin was received, but a panel for heparin-induced thrombocytopenia, including ELISA for anti-PF4 antibodies is pending. The patient was initially anticoagulated on argatroban and symptoms improved one day after admission; the headache is resolved, she is neurologically in tact, and discharge is planned to home. Although the use of oral contraceptives is a risk factor for thrombosis, there was no thrombosis in this case.


VAERS ID: 1227376 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-03-15
Onset:2021-03-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Acute respiratory failure, Anaemia, Blood test, Catheter directed thrombolysis, Chest X-ray abnormal, Deep vein thrombosis, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal, Headache, Hyponatraemia, Intensive care, Metabolic acidosis, Myocardial strain, Nausea, Pulmonary embolism, Pulmonary function test abnormal, Ultrasound Doppler abnormal, Urine analysis, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: April 4th-7th: Chest x-ray, EKG, CT, Echocardiogram, Ultrasound on legs, blood tests, urine test March 30: EKG, Chest x-ray, blood tests, urine test March 31: Pulmonary function test
CDC Split Type:

Write-up: Shortness of breath, nausea, headache, incident of blurred vision in one eye. Had visit with PCP on March 26th with follow-up testing on March 30th and 31st. Condition worsened and went to emergency room on April 4th and was admitted to ICU. EKOS procedure performed on April 5th. Discharge diagnosis on April 7th: 1) Acute bilateral PE (Pulmonary Embolisms/Blood Clots) with significant right heart strain status EKOS cath directed thrombolytics on April 5th. 2) Extensive bilateral deep vein thrombosis. 3) Significant right heart strain confirmed on the echo 4) Mild anemia 5) Metabolic acidosis with mild hyponatremia 6) Hypercoagulable workup, most results pending at discharge 7) Acute hypoxic respiratory failure


VAERS ID: 1227819 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood pressure measurement, Body mass index, Fatigue, Fibrin D dimer, Heart rate, International normalised ratio, Oxygen saturation, Prothrombin time, Swelling, Thrombosis, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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: BACLOFEN; LEXAPRO; ACTONEL
Current Illness: Edema of lower extremities (pre-existing for years); Non-smoker; Progressive multiple sclerosis
Preexisting Conditions: Comments: The patient had no known drug allergies. The patient was not a pregnant at the time of reporting. The patient had no family history of thrombosis, no prior DVT.
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: Fibrin D dimer; Result Unstructured Data: Blood clot identified on left thigh; Test Date: 20210406; Test Name: Heart rate; Result Unstructured Data: 88 beats min; Test Date: 20210406; Test Name: APTT; Result Unstructured Data: 34.8 sec; Test Date: 20210406; Test Name: Ultrasound scan; Result Unstructured Data: Blood clot identified on left thigh; Test Date: 20210406; Test Name: Blood pressure; Result Unstructured Data: 124/70 mmHg; Test Date: 20210406; Test Name: Oxygen saturation; Result Unstructured Data: 99 %; Test Date: 20210406; Test Name: Prothrombin time; Result Unstructured Data: 13.4 sec; Test Date: 20210406; Test Name: INR; Result Unstructured Data: 1.2; Test Name: Body mass index; Result Unstructured Data: 19.5 kg/m2; Test Name: Body mass index; Result Unstructured Data: 19.5 kg/m2
CDC Split Type: USJNJFOC20210423970

Write-up: BLOOD CLOT IN LEFT THIGH; SWELLING; FATIGUE; This spontaneous report received from a consumer concerned a 55 year old female. Initial information received on 13-APR-2021, processed along with information received via telephone communication on 15-APR-2021 The patient''s weight was 100 pounds, and height was 152.4 centimeters. The patient''s concurrent conditions included progressive multiple sclerosis, swelling of the left leg and foot, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not a pregnant at the time of reporting. The patient had no family history of thrombosis, no prior deep vein thrombosis (DVT). 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, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included baclofen, escitalopram oxalate, and risedronate sodium (received 2 doses and stopped after the event). The patient''s husband reported that in MAR-2021, the patient had symptoms of fatigue. On 23-MAR-2021, the patient had swelling and fatigue. Her fatigue was resolved on 24-MAR-2021 and swelling was resolving. On 05-APR-2021, the patient developed left thigh swelling. On 06-APR-2021, the patient''s swelling was not going down and she visited her primary care physician. The physician could not determine the cause of swelling (left thigh very noticeable clot swollen around where clot was located) and the physician suspected clot and performed an AD dimer (fibrin degradation) test to look for potential blood clotting. The patient also had a venous duplex ultrasound that showed left leg clot. At 19:00 on the same day, the patient''s physician advised to visit emergency room and determined there was a clot on left thigh and she was prescribed Eliquis Starter Pack (apixaban) for 3 months treatment and recommended another scan in several months. On 06-APR-2021, the patient''s vitals were reported as blood pressure 124/70 mmHg, heart rate 88 bpm and oxygen saturation of 99%. Laboratory data included prothrombin time (PT) 13.4 sec , International normalized ratio (INR) 1.2 and activated partial thromboplastin time (APTT) 34.8 sec. (Normal range not reported for all) d-dimer and platelet count results were not available and Covid-19 test was not performed. Body max index was 19.5 kg/m2. On an unspecified date the patient was feeling better but had not recovered from the event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 24-MAR-2021, had not recovered from blood clot in left thigh, and recovering from swelling. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This case concerns a 55-year- old female subject, immobile due to progressive multiple sclerosis who developed a left thigh swelling 12 days after Janssen COVID-19 vaccine was administered intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection. The patient''s concurrent conditions included body max index of 19.5 kg/m2, progressive multiple sclerosis and swelling of the left leg and foot. She is a non-smoker, no known drug allergies, no family history of thrombosis, or prior deep vein thrombosis (DVT). Symptoms started with swelling of the left thigh and fatigue. The fatigue resolved the next day. The patient''s swelling in the left thigh was not going down and she visited her primary care physician who checked her D-dimer dimer (level not known to patient) and scheduled a venous duplex ultrasound that showed a clot in the left thigh. Her vital signs were blood pressure of 124/70 mmHg, heart rate 88 bpm and oxygen saturation of 99%. and she was prescribed Eliquis Starter Pack (apixaban) for 3 months treatment and recommended another scan in several months. Laboratory data included PT 13.4 sec, INR 1.2 and APTT 34.8 sec. D-dimer and platelet count results were not available and Covid-19 test was not performed. The patient is feeling better but had not recovered from blood clot in the left thigh, and is recovering from the swelling. Given underlying progressive multiple sclerosis with immobility and preexisting swelling of the left leg and foot on the same lower extremity, the clotting of the left thigh is considered not related to Janssen COVID-19 vaccine. Additional information has been requested.


VAERS ID: 1227915 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram pulmonary, Body temperature, Cardiovascular examination, Chills, Computerised tomogram thorax, Cough, Oxygen saturation, Pain, Platelet count, Pulmonary embolism, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Factor V Leiden mutation (Diagnosed after right leg DVT)
Preexisting Conditions: Medical History/Concurrent Conditions: Meniscus operation (on right knee;); Superficial thrombophlebitis; Thrombosis of leg deep venous (after arthroscopic meniscus surgery on R knee followed by a long car ride); Comments: No oral contraceptive pills, No history of clots in immediate family; A family member on mom''s side has had clots
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Body temperature; Result Unstructured Data: 102 F; Test Date: 20210404; Test Name: Oxygen saturation; Result Unstructured Data: 93-94 on RA at rest %; Test Date: 20210404; Test Name: Platelet count; Result Unstructured Data: 154; Test Date: 20210404; Test Name: Pulmonary angiogram; Result Unstructured Data: Pulmonary Emoblism; Test Date: 20210404; Test Name: Platelet count; Result Unstructured Data: 181; Test Date: 20210404; Test Name: Chest CT; Result Unstructured Data: w/ contrast: Massive pulmonary embolism; Test Date: 20210404; Test Name: Cardiovascular examination; Result Unstructured Data: "stress on heart" came back high; Test Date: 20210405; Test Name: Platelet count; Result Unstructured Data: 160
CDC Split Type: USJNJFOC20210424714

Write-up: PULMONARY EMBOLISM; FEVER; SLIGHT COUGH; FEELING ACHY; CHILLS; This spontaneous report received from a patient concerned a 57 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included right leg deep vein thrombosis (2011), arthroscopic meniscus surgery (2011), and superficial thrombophlebitis on left leg from mid-calf up to mid-thigh (AUG-2020), and concurrent conditions included factor V Leiden mutation. (2011). The patient was not on oral contraceptive pills. No immediate family had history of clots. A family member on mom''s side has had clots. She had right leg deep vein thrombosis in 2011 after arthroscopic meniscus surgery on right knee, followed by long car ride. She was diagnosed with Factor V Leiden mutation in 2011 at the time of that clot. She was on warfarin for about 4 months then taken off. She did well for almost a decade. In last AUG-2020 had a superficial thrombophlebitis in left leg from mid-calf up to mid-thigh. She was Xarelto (rivaroxaban), monitored with ultrasound, taken off on 15/17-JAN-2021. The patient was previously treated with warfarin for right leg deep vein thrombosis, and rivaroxaban for superficial thrombophlebitis on left leg from mid-calf up to mid-thigh. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980), administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient felt good with slight cough on the day. She experienced achy by 7 PM, went to bed, then started getting the chills. At 2 AM on 31-MAR-2021 she had fever of 102 F. The laboratory appointment on Thursday, 01-APR-2021 unrelated laboratory was ordered. On 01-APR-2021, she was walking from parking lot to a building and was very short of breath. On 03-APR-2021, she was going up one flight of stairs, and felt severely short of breath and had dry cough. On 4-APR-2021, she experienced pain between shoulder blades in back. Oxygen saturation at home was 93-94% on RA while resting. On 4-APR-2021, she went to emergency room at a computerized tomogram (CT) of chest with contrast around at 6:30 PM showed massive pulmonary embolism. The right chamber the heart was enlarged due to the blockage from the embolism. Blood levels for "stress on heart" came back high. The patient went to cath lab for pulmonary angiogram on 4-APR-2021 and had EKOS catheter direct thrombolysis. She was started on heparin and transitioned to Xarelto (rivaroxaban) on 5-APR-2021. She was on blood thinners and the left lung was cleaned up and removed. The clot was still on the right lung, unable may or may not be cleared. The patient was discharged on 06-APR-2021. The patient was hospitalized for 2 days. On 04-APR-2021, Platelet count was 181 (normal range 140-440), on 5-APR-2021, Platelet count was 160 (normal range 140-440), on 6-APR-2021 Platelet count was 154 (normal range 140-440). At the time of this massive PE event, the patient was not on any anticoagulation and since the event, had been restarted on Xarelto, and she was told she needs to continue for life. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of feeling achy, chills, fever and slight cough was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: A 57-year-old woman with a history of Factor V Leiden deficiency (off anticoagulation for several months) and previous DVT 10 years ago was hospitalized for pulmonary embolism four days after vaccine. The same day after vaccine, the patient reported chills and a 102 F fever. Two days after vaccine she experienced shortness of the breath and four days after vaccine, the shortness of breath became worsened with pain in the back between the shoulder blades. The patient went to the hospital and was diagnosed with massive pulmonary embolism with enlargement of the right side of the heart. She underwent direct catheter thrombolysis in the cath lab and was started on Xarelto. The patient was hospitalized for 2 days and is doing well. Although there is a close temporal relationship, the history of Factor V Leiden with previous DVT provides plausible alternate explanation for the event.


VAERS ID: 1227916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-03-01
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: 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? No
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: USJNJFOC20210425372

Write-up: BLOOD CLOTS IN BRAIN; This spontaneous report was received concerning a female patient 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 administration not reported), administered on an unspecified date in MAR-2021. The batch number was not reported. No medical history or concomitant medications were reported. On an unspecified date in MAR-2021, the patient was ill for a few weeks with a headache and was subsequently hospitalized with blood clots in her brain. The outcome of blood clots in brain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: 20210425372 V0: This is a spontaneous report of a female of unspecified age who experienced a headache and reportedly blood clots in her brain (cerebral thrombosis), a few weeks after receipt of the Janssen COVID-19 vaccine. No medical history, concomitant medications or additional details were reported. No laboratory results were provided. Additional information has been requested. The blood clot could represent cerebral venous sinus thrombosis (to be clarified). The case will be assessed further when additional information is received.


VAERS ID: 1227918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:2021-03-13
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, COVID-19, Deep vein thrombosis, Haematocrit, Haemoglobin, Platelet count, Red blood cell count, Ultrasound scan, White blood cell count
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Body mass index (26.6 kg/m2); Clotting disorder (unspecified, family medical history on mother''s side, mother does not have clotting disorder); Non-smoker
Preexisting Conditions: Comments: Past medical history was insignificant with no prior history of blood clots. Patient reportedly active and does not use birth control.
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: COVID-19; Result Unstructured Data: negative; Comments: 3 months ago; Test Date: 202103; Test Name: Red blood cell count; Result Unstructured Data: 5.19; Test Date: 202103; Test Name: Platelet count; Result Unstructured Data: 316,000; Test Date: 202103; Test Name: White blood cell count; Result Unstructured Data: 9.1; Test Date: 202103; Test Name: Aspartate aminotransferase; Result Unstructured Data: 15; Test Date: 202103; Test Name: Hemoglobin; Result Unstructured Data: 14.6; Test Date: 202103; Test Name: Hematocrit; Result Unstructured Data: 41.9; Test Date: 202103; Test Name: Alanine aminotransferase; Result Unstructured Data: 15; Test Date: 20210320; Test Name: Diagnostic ultrasound; Result Unstructured Data: blood clot confirmed
CDC Split Type: USJNJFOC20210426156

Write-up: DEEP VEIN THROMBOSIS OF LEFT PERONEAL VEIN; This spontaneous self-report was received from a patient, female 24 years of age. Initial information received from the patient on 13-APR-2021 was processed with additional information received from on 14-APR-2021 and from the patient via telephone follow up on 16-APR-2021. The patient''s weight was 180 pounds, height 69 inches and BMI 26.6 kg/m2. Past medical history was insignificant with no prior history of blood clots, does not smoke, and does not use birth control. The patient was reportedly active and working as a teacher. Family medical history included clotting disorder (unspecified) on mother''s side; mother does not have clotting disorder. In DEC-2020, COVID-19 test was negative. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805018, expiry: unknown) administered on 13-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were taken. On 13-MAR-2021, the patient experienced deep vein thrombosis of left peroneal vein (also reported as 2 blood clots). The pain started the day after vaccination on 14-MAR-2021, and she thought it was muscle soreness. On 20-MAR-2021, her physician sent an order for ultrasound, and on 21-MAR-2021, the blood clot was confirmed (also reported as 2 blood clots), report not provided. Laboratory tests included Platelet count (NR: not provided) 316,000 (units not provided), White blood cell count (NR: not provided) 9.1 (units not provided), Red blood cell count (NR: not provided) 5.19 (units not provided), Hemoglobin (NR: not provided) 14.6 (units not provided), Hematocrit (NR: not provided) 41.9 (units not provided), Alanine aminotransferase (NR: not provided) 15 (units not provided) and Aspartate aminotransferase (NR: not provided) 15 (units not provided). Antiplatelet PF4 antibodies was not performed. The patient was prescribed XARELTO (rivaroxaban) for 6 months. At the time of the report, the patient was still in pain described as throbbing with some improvement with treatment and no redness. The patient agreed to send medical records. The patient considered the blood clots to be caused by the vaccine. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from deep vein thrombosis of left peroneal vein. The suspected product quality complaint number 90000176260 was evaluated and voided; based on the PQC evaluation/investigation performed, it was confirmed that no product quality complaint was identified within the report. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: The case concerns a 24-year-old overweight female patient (BMI 26.6 kg/m2) who developed deep vein thrombosis of left peroneal vein 7 days after Janssen COVID-19 vaccine was administered intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection. The subject does not report any significant medical history or prior history of blood clots. She is a teacher, does not smoke and is active. Her family history is significant for clotting disorder in maternal family, but her mother does not have it. She does not take any medication or birth control. Last COVID-19 test 3 months prior was negative. The pain in the left leg started on the day of vaccination and was thought to be a muscle soreness. A week later her medical doctor ordered a diagnostic ultrasound, and the blood clot was confirmed (report not provided). Platelet count was 316, 000, WBC 9.1, RBC 5.19, HGB 14.6, HCT 41.9, ALT 15, AST 15 (D-dimer, platelet PF4 antibodies not available). The patient was prescribed rivaroxaban for deep vein thrombosis for 6 months. Leg redness had resolved, she is still in pain, but has some improvement with the prescribed treatment. Given short temporal relationship (with first symptoms on the day of vaccination), subject''s risk factors of being overweight and a family history of blood clotting disorder, the event of deep vein thrombosis of left peroneal vein is considered to have an indeterminate causal association to immunization, per the WHO causality classification for adverse events following immunization (Level 3 of diagnostic certainty, per the Brighton Collaboration case definition). The company causality is considered not related to Janssen COVID-19 vaccine.


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