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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 17 out of 71

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VAERS ID: 1264445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
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 1808980 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dyspnoea, Gait disturbance, Insomnia, Limb discomfort, Muscle spasms, Oedema peripheral, Rash, Ultrasound scan, Weight decreased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Back injury; Chronic obstructive pulmonary disease; Dependence on oxygen therapy (On Oxygen 24/7 usually while walking and not during sitting.); Interstitial lung disease; Intervertebral disc protrusion; Sulfonamide allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Ultrasound scan; Result Unstructured Data: No venous clots and no thrombosis
CDC Split Type: USJNJFOC20210443503

Write-up: LEG CRAMPING; DIFFICULTY BREATHING; SWELLING OF LEG WITH EDEMA; HEAVY LEG; LOSS OF APPETITE; RASH ON LEFT FOREARM; LOSS OF 5 LBS; DIFFICULTY WALKING; DIFFICULTY SLEEPING WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient''s weight was 120 pounds, and height was 170.68 centimeters. The patient''s concurrent conditions included chronic obstructive pulmonary disease (copd), asthma, interstitial lung disease, herniated disc at cervical lumbar, allergy to sulfa medications, back injury, and oxygen 24/7. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of 5 lbs. On APR-2021, the subject experienced difficulty walking. On APR-2021, the subject experienced difficulty sleeping well. On 11-APR-2021, the subject experienced leg cramping. On 11-APR-2021, the subject experienced difficulty breathing. On 11-APR-2021, the subject experienced swelling of leg with edema. On 11-APR-2021, the subject experienced heavy leg. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced rash on left forearm. On 12-APR-2021, Laboratory data included: Ultrasound scan (NR: not provided) No venous clots and no thrombosis. On 20-APR-2021, treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of leg with edema, and heavy leg on 15-APR-2021, and loss of appetite, and rash on left forearm on APR-2021, was recovering from leg cramping, and difficulty breathing, and the outcome of loss of 5 lbs, difficulty walking and difficulty sleeping well was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.


VAERS ID: 1266733 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-03-11
Onset:2021-04-06
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Docusate 100mg daily Sucralfate 1mg TID Dicyclomine 10mg BID Trazodone 100mg QHS Risperidone 2mg 3 tabs daily Vistaril 50mg daily Gabapentin 400mg TID Prazosin 2mg QHS Ferrous Sulfate 325mg BID Meclizine 25mg BID prn Cholecalciferol 2000IU
Current Illness:
Preexisting Conditions: Chronic back pain Fibromyalgia GAD PTSD MDD
Allergies: Keflex, Azithromycin, PCN
Diagnostic Lab Data: 4/6/2021-venous duplex
CDC Split Type:

Write-up: Patient reported left calf pain on 4/6/2021. She underwent lower extremity duplex which was positive for left deep vein thrombosis.


VAERS ID: 1266799 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-12
Onset:2021-04-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Fibrin D dimer increased, Ultrasound scan, Venous thrombosis limb
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (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: Omeprazole
Current Illness:
Preexisting Conditions: BMI 34
Allergies: none
Diagnostic Lab Data: Ultrasound, elevater d-dimer
CDC Split Type:

Write-up: Venous thrombosis of proximal greater saphenous vein


VAERS ID: 1266872 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-06
Onset:2021-04-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time normal, Condition aggravated, Fibrin D dimer normal, Immune thrombocytopenia, Immunoglobulin therapy, Immunology test, International normalised ratio normal, Magnetic resonance imaging head normal, Platelet count decreased, Prothrombin time normal, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of recurrent ITP -1996 -2013
Allergies:
Diagnostic Lab Data: see above
CDC Split Type:

Write-up: ITP diagnosed 9 days following vaccination; platelet count 5000. Testing for VIPIT was negative: brain/head imaging negative for thrombosis, d-dimer and PT/PTT/INR within normal limits, heparin antibody ELISA negative. She was treated with IVIG and corticosteroids with a partial response (platelet count up to 43000), then placed on Promacta.


VAERS ID: 1267560 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-20
Onset:2021-04-26
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802072 / N/A UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Hemiparesis, Hypoaesthesia, Intensive care, Muscular weakness, Perfusion brain scan abnormal, Speech disorder, Subarachnoid haemorrhage, Superior sagittal sinus thrombosis, Transverse sinus thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Sexual dysfunction (broad)

Life Threatening? Yes
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: Acetaminophen 500 mg, ascorbic acid 1000 mg, tamsulosin 0.4 mg, zinc 50 mg
Current Illness:
Preexisting Conditions: Benign prostatic hyperplasia
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: This is a 59 year old male that presented to the emergency department at approximately 1447 on 04/27/2021 with sudden onset of left upper and lower extremity weakness and left-sided numbness of his face. The patient stated he may have had some weakness the previous night (04/26/2021), but mostly noticed it when he woke up around 0900 on 04/27/2021. The patient stated he may have also had some transient speech changes which he felt were improved upon emergency department presentation. The patient stated he took an 81 mg aspirin prior to hospital arrival. The patient was overall hemodynamically stable in the emergency department. Past medical history is only significant for benign prostatic hyperplasia. This patient has no history of previous CVA or TIA, no smoking history, no history of clotting disorders, no recent trauma or other injury. CT head revealed a small right frontal subarachnoid hemorrhage with no midline shift and concern for clot. CTA head and neck perfusion study was significant for ?perfusion abnormality involving the right frontal lobe in the region of known subarachnoid hemorrhage, likely related to dural venous sinus thrombosis involving the posterior aspect of the superior sagittal sinus, left greater than right transverse sinus, and left sigmoid sinus.? This patient is noted to have recently received his Johnson and Johnson vaccine on 03/20/2021. The patient was admitted to the intensive care unit. Neurology and hematology were consulted.


VAERS ID: 1268363 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-03-05
Onset:2021-04-24
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Headache, Magnetic resonance imaging, Nausea, Thrombosis, Vein disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: possible NASH, HTN, h/o prostate cancer (on Q3month Lupron), Asthma
Allergies:
Diagnostic Lab Data: MRI of abdomen with left portal vein thrombosis, benign liver cyst PF for antibodies, 7 weeks after vaccination, mildly elevated and inconclusive
CDC Split Type:

Write-up: Patient received Johnson Johnson COVID vaccination on March 5th (Its not listed as an option for me to choose - Hence Janssen). Two weeks later patient and wife described symptoms of significant abdominal pain and headache, which improved after 24 hours, since then, abdominal pain on and off with worsening, nausea vomiting and diarrhea. Presented to Hospital with sepsis, negative evaluation, possibly GI etiology, given symptoms. MRI of the abdomen shows left portal vein thrombosis/which is an unusual site. Patient has no liver cirrhosis or metastatic cancer. Is being investigated for idiopathic or acquired thrombophilia


VAERS ID: 1269146 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Ultrasound scan
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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: DVT (10 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Ultrasound scan; Result Unstructured Data: confirmed DVT (exact result not provided); Test Date: 202104; Test Name: Fibrin D dimer; Result Unstructured Data: Positive; Comments: Positive
CDC Split Type: USJNJFOC20210445329

Write-up: DVT POST COVID INJECTION; This spontaneous report received from a patient concerned a 52 year (also reported as 53 year) old male. The patient''s height, and weight were not reported. The patient''s past medical history included provoked DVT (deep vein thrombosis) 10 years ago, and concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 into left deltoid for prophylactic vaccination. The product was properly stored from receipt to administration. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Patient received J&J vaccine at place of employment. After 24 hours on an unspecified date in APR-2021, the patient developed lower leg DVT (deep vein thrombosis) post COVID injection. It was confirmed by positive d-dimer (coded as Fibrin D dimer) and US (ultrasound scan). Exact results and date of the tests were not provided. The patient was started on rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT post COVID injection was not reported (captured as unknown). This report was serious (Other Medically Important Condition).; Sender''s Comments: This 52/53-year-old hypertensive male patient of unspecified ethnicity developed lower leg deep vein thrombosis (DVT) after 24 hours of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The was prior history of "provoked" DVT 10 years ago. No concomitant merdications reported. The patient reported that D-Dimer was positive and ultrasound showed DVT. The patient was started on rivaroxaban. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.


VAERS ID: 1269148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Mexico  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Fibrin D dimer; Result Unstructured Data: a little elevated at 0.80; Test Date: 20210420; Test Name: Fibrin D dimer; Result Unstructured Data: 0.82
CDC Split Type: USJNJFOC20210446483

Write-up: ELEVATED D-DIMER; SHORTNESS OF BREATH; HEADACHE; CHEST PAINS; DECREASED APPETITE; FEVER; This spontaneous report received from a physician concerned a 25 year old female. The patient''s height, weight and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and batch number were not reported) administered on 07-APR-2021 for prophylactic vaccination. Batch number will be requested via follow up. Concomitant medications included unspecified oral contraceptives. On 08-APR-2021, the subject experienced shortness of breath, headache, chest pains, fever, and decreased appetite. Physician saw the patient on 14-APR-2021 and ordered D-dimer which came back at "0.80" and again on 20-APR-2021 which came back "0.82" (units and normal range unspecified). Physician reported that the patient''s platelet count had not been done yet, but the d-dimer was a little elevated and given her chest pains, he wanted to evaluate for a blood clot and possibly order CT (computed tomography) scan of her chest The physician did mention VAERS report filed case # 446427. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, and chest pains, and the outcome of decreased appetite, fever, and elevated d-dimer was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This case concerns a 25-year-old female who had elevated d-dimer test results 7 days after receiving the Janssen Covid-19 vaccine. Full medical history was not provided. Concomitant medications included unspecified oral contraceptives. The day after vaccination, the patient experienced shortness of breath, headache, chest pains, fever and decreased appetite. Seven days post-vaccination, she went to see her physician who ordered a d-dimer test which came back elevated at 0.80 (normal range not reported). Repeat d-dimer test 6 days later came back at 0.82. A platelet level had not been checked, nor other diagnostic tests to evaluate for possible thrombosis. As of the the time of this report, the outcome was unknown. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered unclassifiable. Further information (e.g. full medical history, social history, family history, CBC, doppler ultrasound, anti-platelet factor 4 antibodies, fibrinogen) will be requested.


VAERS ID: 1269950 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Angiogram pulmonary, Computerised tomogram abdomen, Computerised tomogram thorax, Dyspnoea, Haemoperitoneum, Mesenteric haemorrhage, Pulmonary embolism, Scan spleen, Splenic haemorrhage, Splenic rupture, Splenic thrombosis, Splenomegaly
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CENTRUM MULTIGUMMIES
Current Illness:
Preexisting Conditions: Comments: No known allergies
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Small to moderate amount of hemoperitoneum; Test Date: 20210403; Test Name: Chest CT; Result Unstructured Data: Segmental and subsegmental pulmonary emboli in both lower lobes; Test Date: 20210403; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Segmental and subsegmental pulmonary emboli; Test Date: 202104030937; Test Name: Pulmonary angiogram; Result Unstructured Data: Segmental and subsegmental pulmonary emboli; Test Date: 20210407; Test Name: Scan spleen; Result Unstructured Data: Organizing blood clot on surface
CDC Split Type: USJNJFOC20210448182

Write-up: PULMONARY EMBOLISM; HAEMOPERITONEUM; MESENTERIC HAEMORRHAGE; SPLENIC HAEMORRHAGE; SPLENIC RUPTURE; SPLENIC THROMBOSIS; SPLENOMEGALY; LEFT UPPER QUADRANT/ABDOMINAL PAIN; DYSPNOEA; This spontaneous report received from a physician concerned a 53 years old female The patient''s height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included Centrum Multi-Gummies for Women. On an unspecified date in MAR-2021 the patient began to experience slowly progressive shortness of breath; on 01-APR-2021 she had left upper quadrant pain. On 03-APR-2021 the patient presented to the emergency room. Laboratory data included: Pulmonary Angiogram/CT Chest - abnormal and computerised tomogram abdomen/pelvis at 09:37, showed segmental and subsegmental pulmonary emboli in the lower lobes of both lungs. Small volume perisplenic hemorrhage and small volume pneumoperitoneum in the pelvis or findings concerning for spontaneous splenic rupture and moderately enlarged spleen. Additional CT abdomen and pelvis with IV contrast at 23:05 showed: Small to moderate amount of hemoperitoneum, slightly increased since the earlier study. There is definitely new blood adjacent to the liver. The hemorrhage adjacent to the spleen appears similar to the earlier study. Due to the timing of the scans with relation to the contrast injection, the physician could not confirm a splenic laceration, although it was suspected to be the source of hemorrhage. Small amount of mesenteric blood was slightly increased. Continuous heparin infusion was started for bilateral pulmonary embolism. On 04-APR-2021, an inferior vena cava filter was placed and patient was vaccinated with Acthib (HIB Vaccine), Bexsero (meningococcal vaccine) and Prevnar (pneumococcal vaccine) in anticipation of splenectomy. On 07-APR-2021, a laparoscopic splenectomy was performed. The spleen was evaluated by pathology which reported that organizing blood clot on surface was consistent with rupture. No evidence of malignancy was reported. The patient was also treated with anticoagulant therapy (dates unspecified). The patient remained inpatient while recovering from surgery. On 12-APR-2021, the patient was transitioned to rivaroxaban for therapeutic anticoagulation. Patient remained hospitalized as of 12-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, haemoperitoneum, mesenteric haemorrhage, splenic haemorrhage, splenic rupture, splenic thrombosis, splenomegaly, dyspnoea, abdominal pain upper, and left upper quadrant/abdominal pain. This report was serious (Hospitalization Caused / Prolonged, Disability Or Permanent Damage).; Sender''s Comments: V0: This 53-year-old female patient of unspecified ethnicity was found to have pulmonary embolism and spontaneous splenic rupture 18 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. No concurrent illness and medical history reported. Emergency room consult for slowly progressive shortness of breath and left upper quadrant pain that starts on an unspecified date after vaccination. Pulmonary Angiogram/CT Chest showed segmental and subsegmental pulmonary emboli in the lower lobes of both lungs; small volume perisplenic hemorrhage and small volume pneumoperitoneum in the pelvis; moderately enlarged spleen with findings concerning for spontaneous splenic rupture. CT abdomen and pelvis with IV contrast showed small to moderate amount of hemoperitoneum, slightly increased since the earlier study; definite new blood adjacent to the liver. Continuous heparin infusion was started; vaccinated with Acthib (HIB Vaccine), Bexsero (meningococcal vaccine) and Prevnar (pneumococcal vaccine). Laparoscopic splenectomy was done 22 days after vaccination; pathology report is consistent with splenic rupture with no evidence of malignancy. The patient was shifted to rivaroxaban. No other details reported. The information available regarding splenic rupture precludes a complete and meaningful assessment. Based on the information that is available, the event pulmonary embolism is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism; considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, the potential vaccine contribution cannot be excluded. Additional information was requested.


VAERS ID: 1269967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood creatinine, Computerised tomogram thorax, Deep vein thrombosis, Electrocardiogram, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, International normalised ratio, N-terminal prohormone brain natriuretic peptide, Pain in extremity, Peripheral swelling, Platelet count, Prothrombin time, SARS-CoV-2 test, 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), Tendinopathies and ligament disorders (broad), COVID-19 (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Anemia; Chronic kidney disease; Hypertension; Hypoxic respiratory failure; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: DVT of legs (- not on anticoagulation since and was treated with warfarin x 3 months only)
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Diagnostic ultrasound; Result Unstructured Data: see comments; Test Date: 20210426; Test Name: Prothrombin time; Result Unstructured Data: 28.4; Test Date: 20210426; Test Name: Angiogram; Result Unstructured Data: pending; Test Date: 20210426; Test Name: Computerized tomogram thorax; Result Unstructured Data: pending; Test Date: 20210426; Test Name: ECG; Result Unstructured Data: results not provided; Test Date: 20210426; Test Name: COVID-19 virus test; Result Unstructured Data: pending; Test Date: 20210426; Test Name: Glomerular filtration rate; Result Unstructured Data: 52; Test Date: 20210426; Test Name: Fibrin D dimer; Result Unstructured Data: 3.95; Test Date: 20210426; Test Name: NT-proBNP; Result Unstructured Data: normal; Test Date: 20210426; Test Name: Hemoglobin; Result Unstructured Data: 10.4; Test Date: 20210426; Test Name: Hematocrit; Result Unstructured Data: 33.2 %; Test Date: 20210426; Test Name: Platelet count; Result Unstructured Data: 309; Test Date: 20210426; Test Name: Creatinine; Result Unstructured Data: 1.59; Test Date: 20210426; Test Name: International normalised ratio; Result Unstructured Data: 2.8
CDC Split Type: USJNJFOC20210450840

Write-up: A LEFT UPPER EXTREMITY DVT INVOLVING THE SUBCLAVIAN AND AXILLARY VEIN; LEFT UPPER ARM SWELLING; LEFT UPPER ARM PAIN; This spontaneous report received from a health care professional (nurse practitioner) and concerned a 74 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included DVT (deep vein thrombosis) of lower extremity and was not on anticoagulation since and was treated with warfarin times 3 months only. The concurrent conditions included type 2 diabetes, chronic hypoxemic respiratory failure, chronic kidney disease, anemia, and hypertension. The patient was previously treated with warfarin. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered in left deltoid on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient developed a left upper extremity DVT involving the subclavian and axillary vein, left upper arm swelling and had left upper arm pain. On 19-APR-2021, the patient called and notified the office that the left arm was sore and swollen times 4-5 days. A registered nurse did a home visit on 20-APR-2021 and recommended an ultrasound to be done. On 26-APR-2021, the ultrasound confirmed a left upper extremity DVT involving predominantly the subclavian and axillary vein. On 26-APR-2021, Laboratory data included: CT Angiogram (to rule out pulmonary embolism) pending, COVID-19 virus test (NR: not provided) pending, Computerized tomogram thorax (NR: not provided) pending, Creatinine (NR: not provided) 1.59, ECG (Electrocardiogram) results not provided, Fibrin D dimer (NR: not provided) 3.95, Glomerular filtration rate (NR: not provided) 52, Hematocrit (NR: not provided) 33.2 %, Hemoglobin (NR: not provided) 10.4, International normalised ratio (NR: not provided) 2.8, NT-proBNP (NR: not provided) normal, Platelet count (NR: not provided) 309, and Prothrombin time (NR: not provided) 28.4. The patient was treated with rivaroxaban, 15 mg, oral, twice a day. The patient was currently in the emergency room with testing pending. The patient did not have other symptoms to report or note. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left upper arm swelling, left upper arm pain, and a left upper extremity dvt involving the subclavian and axillary vein. This report was serious (Life Threatening).; Sender''s Comments: V0: This 74-year-old male patient was found to have left upper extremity deep vein thrombosis (DVT) confirmed by ultrasound 17 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient has underlying type 2 diabetes, chronic hypoxemic respiratory failure, chronic kidney disease, anemia, and hypertension; the patient had prior history of DVT of lower extremity of unspecified date and was treated with warfarin for 3 months. No concomitant medications were reported. The symptom reported left upper arm pain and swelling 5 days after vaccination; persistence prompted consult with a registered nurse the recommended ultrasound; which revealed left upper extremity DVT involving predominantly the subclavian and axillary vein. Platelet count 309, Prothrombin time 28.4, INR 2.8, NT-proBNP normal, Fibrin D-dimer 3.95, GFR 52; awaiting result of CT and CT angiogram, COVID test, and ECG. The patient was treated with rivaroxaban. No other details reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.


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