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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: 1227919 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary thrombosis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? 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:
CDC Split Type: USJNJFOC20210426632

Write-up: BLOOD CLOT IN LEG; BLOOD CLOT IN LUNG; This spontaneous self-report was received from a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unspecified) dose and therapy start date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, 2 weeks after getting vaccination, the patient experienced blood clot in leg and blood clot in lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis leg and thrombosis pulmonary was not reported. The patient also reported to VAERS (no reference number provided). This report was serious (Other Medically Important Condition).; Sender''s Comments: A patient of unspecified age and sex experienced thrombosis leg and thrombosis pulmonary 2 weeks after vaccine. No concomitant medications were reported. No additional history, diagnostics, treatment, or other information was reported. There is insufficient information to make a meaningful medical assessment. Additional information has been requested.


VAERS ID: 1227921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Tennessee  
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: Deep vein thrombosis, Dyspnoea, Headache, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ESTROGEN
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427131

Write-up: DVT; HEADACHE; UNCONTROLLED SHAKING; TROUBLE BREATHING; FEVER; This spontaneous report received from a company representative concerned a 29-year-old female. The company representative heard the information on the local news. The patient''s height, and weight were not reported. The patient was taking estrogen-based birth control pills. 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 19-MAR-2021 for prophylactic vaccination. Concomitant medications included estradiol for birth control. On an unspecified date in MAR-2021, one-week post-vaccination, patient developed uncontrolled shaking, had trouble breathing and fever. She went to the emergency room for her symptoms and was sent home (no time frame was reported). One week later, she developed swollen legs and couldn''t walk, and she was diagnosed with a deep vein thrombosis (DVT). On an unspecified date she was hospitalized and admitted in the intensive care unit (ICU). Patient was out of the ICU on 11-APR-2021 (Sunday). Patient was still under treatment. It was also reported that patient had headache that persisted for 2 weeks. The report was from the local news and follow-up was not possible. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the uncontrolled shaking, trouble breathing, fever, headache and DVT was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: This is a spontaneous report of a 29-year-old female who developed a deep vein thrombosis two weeks after receipt of the Janssen COVID-19 vaccine. She also reported uncontrolled shaking, trouble breathing, and fever one week after vaccine administration, and a headache which had persisted for two weeks. No medical history was reported; she was taking estrogen-based birth control pills. Estrogen-based birth control pills place the patient at risk for thrombosis, but there are insufficient other details to make a meaningful medical assessment regarding the events in the case.


VAERS ID: 1227922 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Skeletal injury, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Gravida/Para: 1/1. The patient was 4 weeks post-partum.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427241

Write-up: BLOOD CLOT; BROKE TAIL BONE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report was received from a pharmacist via a company representative, and concerned an approximately 40 year old female. The patient''s height, weight, and medical history were not reported. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of administration not reported, batch number: unknown) dose and vaccination site were not reported, administered in 2021 for prophylactic vaccination. No concomitant medications were reported. In 2021, the patient experienced vaccine exposure during pregnancy. The date of the patient''s last menstrual period and expected delivery date were not provided. In 2021, the patient experienced broke tail bone during labor and gave birth (live birth). On an unspecified date in 2021, the patient experienced a blood clot and died. It was noted that she was at high risk for clots because she was 4 weeks post partum (gravida 1, para 1). Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. The patient died of a blood clot and broke tail bone in 2021; the outcome of vaccine exposure during pregnancy was not reported. It was unspecified if an autopsy was performed. This report was serious (Death). This case, from the same reporter is linked to 20210430297.; Sender''s Comments: V0: The case concerns a pregnant female subject around age of 40, who developed thrombosis, skeletal injury and exposure during pregnancy an unspecified time after Janssen COVID-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The subject''s past medial history, last menstrual period, estimated date of delivery and concomitant medications were not provided. Per the reporter (pharmacist) the patient was at a high risk for blood clots because she was 4 weeks post-partum. The patient broke her tail bone during the labor, gave a birth, and later died of a blood clot. No additional information was provided. It is not known whether the autopsy was performed. Given alternative explanation and risk factors of pregnancy, labor and skeletal injury (trauma) the event of thrombosis is considered inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization. Events of skeletal injury was result of an accident and therefore not considered related. Company causality for event of thrombosis is considered not related to Janssen COVID-19 vaccine (Level 4 -Insufficient information available to confirm a possible, probable or a definitive case of venous thrombosis, per the Brighton Collaboration case definition); Reported Cause(s) of Death: BLOOD CLOTS; BROKE TAIL BONE


VAERS ID: 1227923 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2021-04-01
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: Body mass index, Computerised tomogram, Electrocardiogram, Haemoglobin, Metabolic function test, Nasopharyngitis, Oxygen saturation, Platelet count, Platelet count decreased, Pulmonary embolism, Thrombosis, Troponin, Ultrasound scan, White blood cell count
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: HYDROCHLOROTHIAZIDE
Current Illness: Blood pressure high; Non-smoker
Preexisting Conditions: Comments: The patient had no personal or family history of clotting disorders, no recent trauma or travel. He has an active lifestyle (an outdoorsman who cuts his own firewood). .
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Diagnostic ultrasound; Result Unstructured Data: blood clot in right leg; Test Date: 20210413; Test Name: EKG; Result Unstructured Data: normal; Test Date: 20210414; Test Name: O2 saturation; Result Unstructured Data: 97-98 %; Test Date: 20210414; Test Name: CT scan; Result Unstructured Data: saddle pulmonary embolus with evidence of right heart strain; Test Date: 20210414; Test Name: Comprehensive metabolic panel; Result Unstructured Data: normal; Test Date: 20210414; Test Name: Troponin; Result Unstructured Data: normal; Test Date: 20210414; Test Name: White blood cell count; Result Unstructured Data: 9; Test Date: 20210414; Test Name: Hemoglobin; Result Unstructured Data: 16; Test Date: 20210414; Test Name: Platelet count; Result Unstructured Data: 120; Test Name: Body mass index; Result Unstructured Data: 32.4
CDC Split Type: USJNJFOC20210427489

Write-up: COLD SYMPTOMS; DECREASED PLATELET COUNT; SADDLE PULMONARY EMBOLUS; BLOOD CLOT IN RIGHT LEG; This spontaneous report was received from a physician, and concerned a 58 year-old male patient. Initial report was processed along with additional information received on 16-APR-2021. The patient''s height was 76 inches, weight was 266 pounds, body mass index 32.4. The patient''s concurrent conditions included hypertension, and non-smoker. The patient had no personal or family history of clotting disorders, no recent trauma or travel. He had an active lifestyle (an outdoorsman who cut his own firewood). The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of admin not reported, batch/lot number: 1808609) dose was not reported, administered on 02-APR-2021 vaccine anatomical site unknown, for prophylactic vaccination. Concomitant medications included hydrochlorothiazide for hypertension. On 03-APR-2021, the patient experienced cold symptoms. It was reported that some days later, he developed shortness of breath, dyspnea on exertion, decreased exercise tolerance and right calf swelling. On 13-APR-2021, the patient went to the doctor''s office for his symptoms. An electrocardiogram (EKG) was normal, and the ultrasound of right leg revealed a blood clot. As the patient preferred to keep costs down, he was not hospitalized and was started on anticoagulant Eliquis (apixaban). He was not hypoxic. On 14-APR-2021, he called the doctor after a syncopal episode and was advised to go to the emergency room (ER) where a computerized tomography (CT) scan showed a saddle pulmonary embolus with evidence of right heart strain. His oxygen (O2) saturation was 97-98%. No treatment was given in the ER as he already had started apixaban (2 doses received by that time). Laboratory data included a normal comprehensive metabolic profile, normal troponin, white blood cell count 9, hemoglobin 16, platelet count 120 (lower limit normal: 130). No other tests were performed, and no prior complete blood count (CBC) was available. On 16-APR-2021, the doctor called the patient for follow up, and noted that he was feeling better. Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. The outcome of the blood clot in right leg, saddle pulmonary embolus, decreased platelet count, and cold symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This 58 year-old obese (BMI 32.4) male was diagnosed with a right leg blood clot and saddle pulmonary embolus 11 and 12 days, respectively after vaccination with the Janssen Covid-19 vaccine. Medical history included hypertension controlled with hydrochlorothiazide. He is a non-smoker who leads an active lifestyle; there was no recent trauma or travel and he had no personal or family history of clotting disorders. The day after the vaccination, he experienced cold symptoms. Then, an unspecified number of days later, he developed right calf swelling, shortness of breath, dyspnea on exertion, and decreased exercise tolerance. Eleven days after vaccination, he went to see his doctor who ordered an ultrasound which revealed a blood clot in his right leg. EKG was normal and he was not hypoxic. Apixaban was started as an outpatient. The following day, the patient called the doctor after a syncopal episode and was advised to go to the emergency room; CT scan revealed a saddle pulmonary embolus with evidence of right heart strain. Oxygen saturation was 97-98%. Labs included normal comprehensive metabolic profile, troponin, white blood cell count of 9, hemoglobin 16, platelet count 120 (lower limit normal: 130). No treatment was provided in the ER as he had already started apixaban. No other tests were performed, and the patient returned home. Two days later, when his physician called him in follow up, he was reportedly feeling better. Of note, platelet count was not checked on the day of leg thrombosis diagnosis prior to apixaban initiation and no other prior values were available for comparison; thrombocytopenia is a known adverse reaction with apixaban. Based on the available information, the relationship of the blood clot in the leg and pulmonary embolus with Janssen Covid-19 vaccine is considered indeterminant.


VAERS ID: 1227928 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-03-17
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Oedema peripheral, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, 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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Smoker
Preexisting Conditions: Comments: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210429398

Write-up: POTENTIAL DEEP VEIN THROMBOSIS; SMALL BLOOD CLOT; ANKLE CALF BOTH SWOLLEN; This spontaneous self-report was received from a patient and concerned a 64 year old female. The patient''s height and weight were not reported. The patient''s concurrent conditions included no known allergies and smoker. Other relevant history included no alcohol intake, nor any drug abuse/illicit drug use. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805029, and expiry: unknown) administered on 14-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had "ankle calf both swollen" indicating potential deep vein thrombosis. She went to hospital emergency room, and "HCP confirmed small clot". The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from "ankle calf both swollen" and had not recovered from potential deep vein thrombosis and small blood clot. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This is a spontaneous report of a 64 year old female who developed a swollen calf and ankle swelling indicating a potential deep vein thrombosis 3 days after receipt of Janssen COVID 19 vaccine. Patient was seen in the emergency room by HCP, who confirmed a small clot. No other medical history was reported but patient was noted to be a smoker, reported as 2x a year. Age increases the risk of deep vein thrombosis, but the there is insufficient other details to make a meaningful medical assessment.


VAERS ID: 1227932 (history)  
Form: Version 2.0  
Age: 54.0  
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 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Deep vein thrombosis, Pain, 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? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer; Comments: The patient was not pregnant at the time of reporting. The patient had no known allergies and drug abuse/illicit drug usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430202

Write-up: BILATERAL DEEP VEIN THROMBOSIS TO LOWER EXTREMITIES; PULMONARY EMBOLISM IN BOTH LUNGS; BODY ACHE; CHILLS; This spontaneous report received from a consumer concerned a 54 year old female. The patient''s weight was 190 pounds, and height was 66 inches. The patient''s past medical history included cancer, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies and drug abuse/illicit drug usage. The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: 1805031, and expiry:not reported) dose was not reported, 1 total, administered in left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAR-2021, the patient experienced chills. On 06-MAR-2021, the patient experienced body ache. Since 09-APR-2021, patient started experiencing leg pain and was admitted to a hospital on 10-APR-2021. The patient was diagnosed with 2 deep vein thrombosis (DVTs) to the lower extremities with pulmonary embolism. The patient was on therapeutic Lovonox (enoxaparin sodium) and was prescribed Lovonox injection twice a day for 6 months. The patient had visited emergency room and hospitalized for 5 days. The patient was discharged from hospital on 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 10-MAR-2021, and was recovering from bilateral deep vein thrombosis to lower extremities, and pulmonary embolism in both lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This 54-year-old obese female with BMI of 30.7 was hospitalized due to bilateral deep vein thrombosis (DVT) to lower extremities and pulmonary embolism (PE) in both lungs 35 days after receiving JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) in left arm for prophylactic vaccination. The patient''s past medical history included cancer. The subject had chills 2 days prior to the vaccination and body ache 1 day post vaccination. The symptoms resolved 5 days post vaccination. She started experiencing bilateral leg pain 33 days post vaccination and chest pain 34 days post vaccination. The patient visited emergency room and was hospitalized. She was diagnosed with bilateral DVTs to the lower extremities and PE in both lungs. Details of the hospitalization were not reported. She was discharged after 5 days of hospitalization with prescription of enoxaparin injection twice a day for 6 months. The patient was recovering from bilateral DVT to lower extremities and PE in both lungs. Based on the available information, with risk factors of obesity and cancer, DVT and PE are assessed as indeterminate with causal association to immunization, per WHO causality classification for adverse events following immunization. Company causality is considered not related to JANSSEN COVID-19 VACCINE. Additional information has been requested for further assessment.


VAERS ID: 1227933 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Unknown  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:2021-03-22
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Burning sensation, Dyspnoea, Limb discomfort, Peripheral swelling, Scan, Thrombosis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood (Treatment included Eliquis)
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Right Arm Occluded
CDC Split Type: USJNJFOC20210430280

Write-up: THROMBOSIS ARM; SHORTNESS OF BREATHE; ARM BURNING; ARM DISCOMFORT; SWOLLEN ARM; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient''s height, and weight were not reported. The patient''s past medical history included blood clots treated with Eliquis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported,1 total administered on 08-MAR-2021, left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, two weeks after vaccination the patient experienced swollen arm and arm discomfort. On 29-MAR-2021, the patient experienced shortness of breathe and arm burning. On 30-MAR-2021, the patient experienced thrombosis arm. Laboratory data (dates unspecified) included: Scan (NR: not provided) Right Arm Occluded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and shortness of breathe, and had not recovered from thrombosis arm, arm discomfort, and arm burning. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This 59-year-old of unspecified gender, currently on Eliquis for history of blood clots noted swelling of arm with discomfort and burning (described as "like from a match") as well as shortness of breath 14 days after receiving COVID-19 VACCINE AD26.COV2.S on left arm. Scan showed right arm was occluded. Treatment for the events was not reported; the patient is recovering from swelling of arm and shortness of breath; the patient have not recovered from thrombosis of arm and arm discomfort/burning. The event is confounded by the underlying history of blood clots that is being treated medically. However, the events are assessed as indeterminate with a causal association to immunization, per the causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism. Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information has been requested for further assessment.


VAERS ID: 1227934 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-04-14
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: Deep vein thrombosis
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient medical history is unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430394

Write-up: FEMORAL DEEP VEIN THROMBOSIS; This spontaneous report received from a physician concerned a 30-40 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions were unknown. 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 25-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 14-APR-2021, approximately 20 days after the patient received vaccination, he experienced femoral deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from femoral deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: A 30-40 year-old man experienced femoral deep vein thrombosis approximately 20 days after vaccination. No past medical history or concomitant medications were reported. There were no details provided, including diagnostic workup. There is insufficient information to make a meaningful medical assessment.


VAERS ID: 1228271 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-20
Onset:2021-04-16
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity, Subclavian vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), 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: buspirone, fexofenadine, mometasone, natazia, verapamil, ondansetron, sumatriptan
Current Illness: none
Preexisting Conditions: being worked up for thoracic outlet syndrome
Allergies: no known allergies
Diagnostic Lab Data: venous duplex on 4/16/21- acute, partially occlusive left subclavian deep vein thrombosis
CDC Split Type:

Write-up: Patient has been having left arm pain. Developed acute, partially occlusive left subclavian deep vein thrombosis found on duplex on 4/16/21. She was started on lovenox and will have further work-up.


VAERS ID: 1228553 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-05
Onset:2021-04-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Fibrin D dimer increased, Mental status changes, Pain, Platelet count decreased, Portal vein thrombosis, Retching, Thrombocytopenia, Venous occlusion, Venous thrombosis limb
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CITALOPRAM, METOPROLOL TARTRATE
Current Illness:
Preexisting Conditions: HYPERTENSION
Allergies: PENICILLIN
Diagnostic Lab Data: Platelets: 4/15 12:31 92 4/16 07:00 36 4/16 15:00 32 4/17 08:52 23 4/18 07:48 19 4/19 05:20 28
CDC Split Type:

Write-up: The patient presented to the emergency department with altered mental status, dry heaving, and body aches. She was found to have a partially occluding thrombus of the right cephalic vein consistent with venous thrombosis, as well as findings of thrombosis in the anterior segment branch of the right portal vein. She had a d-dimer of 25.77 increased to 35.2, and was thrombocytopenic with a platelet count of 92, which dropped to 36 the following morning. Platelets to present were: 92-36-32-23-19-28. The patient received the Johnson & Johnson COVID-19 vaccination two weeks prior to presentation.


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