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

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



Case Details

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VAERS ID: 1146214 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-17
Onset:2021-03-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin negative, Muscle spasms, Thrombosis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: HCG levels test at 488 on March 29th 2021 should have been over 3000 for week 7 gestation.
CDC Split Type:

Write-up: Was 5 weeks pregnant at time of vaccine with strong HCG levels, approximately 2 weeks after vaccination patient suffered a miscarriage. Vaginal bleeding, cramping and passed large clots including a sac like tissue.


VAERS ID: 1147888 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-07
Onset:2021-03-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Decreased appetite, Dialysis, Dysstasia, Hepatic failure, Mechanical ventilation, Multiple organ dysfunction syndrome, Myocardial infarction, Parosmia, SARS-CoV-2 test positive, Sepsis, Staphylococcal infection, Staphylococcus test positive
SMQs:, Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Taste and smell disorders (narrow), Myocardial infarction (narrow), 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, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin for controlled type 2 diabetes and blood pressure medicine.
Current Illness:
Preexisting Conditions: Type 2 diabetes
Allergies: None.
Diagnostic Lab Data: Sepsis 03/27/2021. Fully vented. Full dialysis. Liver failure. Heart Attack, positive for COVID-19 and Staph.
CDC Split Type:

Write-up: No appetite for days. The smell of food made patient sick. On week two after vaccine, oxygen stayed at 84%, patient couldn?t stand as he had no energy. Patient began to eat after lots of convincing and seemed to be doing at least 20% by week 3, but oxygen was still in mid 80%. On day 20 after vaccine patient had to be rushed to the ER due to sepsis. All vital organs began to fail and on transport patient suffered a mild heart attack. Patient was a healthy 78 year old male that lived alone and drove and had no major health issues before the date of the vaccine.


VAERS ID: 1147890 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-03-09
Onset:2021-03-22
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Acquired dysfibrinogenaemia, Coagulopathy, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient currently hospitalized with profound bleeding and clotting, suspect dysfibrinogenemia, otherwise healthy without history of dysfibrinogenmeia


VAERS ID: 1151246 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-03-09
Onset:2021-03-22
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Full blood count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: esomeprazole 40 mg daily; citalopram 40 mg daily, famotidine 40 mg daily, simvastatin 20 mg daily, alprazolam 0.5 mg prn
Current Illness: None
Preexisting Conditions: Hyperlipidemia, Depression with anxiety, GERD, h/o breast cancer (no active disease), osteoarthritis
Allergies: NKDA
Diagnostic Lab Data: CBC done on 22 March 2021
CDC Split Type:

Write-up: Asymptomatic thrombocyctopenia, platelet count of 41 (with plt clumping on micro) on routine screening 2 weeks after vaccination. Pateint had a normal platelet counter for years up until this draw. Again, no abnormal bruising or bleeding.


VAERS ID: 1153088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210331140

Write-up: MAJOR HEART ATTACK; This spontaneous report received from a consumer concerned a 50 year old female. 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, she had major heart attack and died. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The reporter and company provided causality between Covid-19 vaccine ad26.cov2.s and major heart attack as possible. This report was serious (Death).; Sender''s Comments: - covid-19 vaccine ad26.cov2.s -Heart attack. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MAJOR HEART ATTACK


VAERS ID: 1153098 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maine  
Vaccinated:0000-00-00
Onset:2021-03-10
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Electrocardiogram, Myocardial infarction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Electrocardiogram; Result Unstructured Data: Not reported; Test Date: 20210310; Test Name: Blood test; Result Unstructured Data: Not reported.; Test Date: 20210310; Test Name: Blood pressure; Result Unstructured Data: Not reported; Test Date: 20210310; Test Name: Computerized tomography; Result Unstructured Data: Not reported
CDC Split Type: USJNJFOC20210333833

Write-up: HEART ATTACK; HIGH FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included heart disorder ("born-in" heart issues). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021 at 19:30, the patient unexpectedly broke out into a very cold sweat, high fever, extreme stomach nausea, and his heart raced to levels he had never felt. The patient could not walk and could barely respond verbally to his fiance for help. The patient was admitted to the hospital. The patient was taken on a wheel chair and was attended to immediately because of the severity of his condition. The emergency room doctors and nurses thought the patient was having a heart attack, as did he. The patient informed emergency room doctors and nurses that he had been given covid-19 vaccine ad26.cov2.s earlier in the day. After several hours of testing including electrocardiogram, computerized tomography scans, intravenous and constant blood pressure monitoring, it was determined that the patient should be transported to a hospital that was better equipped to service his apparent condition. The hospital staff was concerned about a possible heart attack and not knowing the patient''s history or having the equipment and staff to service this, they decided the patient needed to be taken to a hospital that specializes in heart events. Having had cardiology care in the past for "born-in" heart issues, the patient wanted to be transported to Medical Center where all of his doctors were residences. According to the patient, they had a fabulous team of world renowned cardiology experts from Cardiology. The hospital staff at the Hospital offered to send the patient to Hospital. Both hospitals were about equal distance from the Hospital. The patient obviously wanted to go to where his doctors were and who know him personally for almost his whole life. According to the patient, the staff at the Hospital were fantastic, and as they stated to him verbally, probably saved his life. An Ambulance ride followed at about 3:00 AM on 11-MAR-2021 arrived at approximately 04:30 at medical center. The patient''s cardiologist''s covering doctors met him on the cardiology floor to immediately begin monitoring and performing every test at their disposal. The patient also informed the cardiology team that he had received the covid-19 vaccine ad26.cov2.s vaccine on 10-MAR-2021 (Wednesday) afternoon. According to the patient, their eyes lit up immediately believing that the vaccine might had caused this. After almost 2 days and countless tests, blood screens, monitoring and consultation, the patient was released late afternoon on 12-MAR-2021 from hospital after being stabilized to a normal level. According to the patient''s doctors, the only cause of these events could have been the covid-19 vaccine ad26.cov2.s vaccine. According to the patient, the severity of this events were only curtailed by the excellent care he received from both of his hospital visits and the almost 2 day stays. The patient''s doctors had instructed him to stay close to home and continue to monitor his condition in the upcoming weeks because no one knows if these events could happen again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, and heart attack on 12-MAR-2021. This report was serious (Hospitalized and Other Medically Important Condition).; Sender''s Comments: V0: 20210333833- Covid-19 vaccine ad26.cov2.S- Heart Attack. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY. 20210333833-covid-19 vaccine ad26.cov2.s- high fever. This event is labeled and is therefore considered potentially related.


VAERS ID: 1154739 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-03-08
Onset:2021-03-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: borderline hypothyroidism
Allergies: prevacid latex synthroid
Diagnostic Lab Data: Extensive Hospital admission 3/10-3/15
CDC Split Type:

Write-up: Ischemic stroke right cerebellar, left thalamic


VAERS ID: 1156253 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Blood test, Computerised tomogram abnormal, Diarrhoea, Headache, Pulmonary embolism
SMQs:, Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Doesn''t have them on hand
Current Illness:
Preexisting Conditions:
Allergies: Bactrim Levofloxacin
Diagnostic Lab Data: CT scan Blood work
CDC Split Type: vsafe

Write-up: I didn''t have pain in the arm, after an hour I had a slight headache. The headache lasted about a day. After the 3-4 day I had serve diarrhea and stopped taking my supplements. It stopped for a couple days then came back for a day. I had no headache or pain, just 3 bad episodes of diarrhea. On March 24th I went into the Hospital with severe pain in my lower left back side. I thought I was passing a kidney side, with the pain I was having. When I got there they did a CT scan and blood work and it wasn''t kidney stone but I had a blood clot on the lower left side of lung and the right side as well. They immediate put me on blood thinners. I was there for a day and a night. They released and put me on medication. I''ve had minor pain but nothing like the pain I had before. I have since followed up with a Pomologist and PCP. Pulmonologist said I had blood clots but couldn''t give me a cause. My PCP said she thought I had or have Covid. I asked to have my blood drawn and she said it was too late for that because I had taken the vaccine already.


VAERS ID: 1157490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-03-24
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Troponin T
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NITROGLYCERIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Coronary artery disease; Coronary bypass; Single bypass; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: Troponin T; Result Unstructured Data: 5.9 to 12.2; Comments: The patient''s Troponin levels went from 5.9 to 12.2 while admitted to emergency department.
CDC Split Type: USJNJFOC20210340970

Write-up: CARDIAC SYMPTOMS, CHEST PAINS, FEELS NOT GOOD, HR IS FAST; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, one total, administered on 17-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included glyceryl trinitrate. On 18-MAR-2021, the patient experienced chest pain and called emergency services. On 24-MAR-2021, the patient reported to have heart attack, confirmed and experienced the following symptoms including cardiac symptoms, chest pains, feels not good, heart rate is fast, and was hospitalized. The patient stated that the ambulance came on 24-MAR-2021 and was admitted to hospital on 24-MAR-2021 and was discharged on 26-MAR-2021. The patient was hospitalized for 3 days. The patient reported that she have cardiac concerns prior to injection with the Janssen covid-19 vaccine and reported to have past medical history as 2007- by pass, 2008- single by pass, 2015 double by pass. The patient stated that she is going to have a stents by consulting Dr. The patient also reported that she is now on 8 more medications. (medications not reported). Laboratory data included: Troponin T (NR: not provided) 5.9 to 12.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cardiac symptoms, chest pains, feels not good, hr is fast. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 28-MAR-2021. The following information was updated and incorporated into the case. The patient''s past medical history included bypass (2007), single bypass (2008), and double bypass (2015). The patient reported additional events as heart attack, heart rate is fast, and feels not good. The seriousness criteria of ''chest pain'' was updated to serious. The patient had visit to emergency room. The patient was hospitalized on 24-MAR-2021 and discharged on 26-MAR-2021. The number of days hospitalized is 3 days.; Sender''s Comments: V1 Additional information received in this version is regarding medical history (bypass (2007), single bypass (2008), and double bypass (2015)), events (heart attack, heart rate is fast and feeling not good), seriousness criteria and hospitalization details. 20210340970- Covid-19 vaccine ad26.cov2.s -Heart attack. Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE


VAERS ID: 1157508 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Deep vein thrombosis, Hypochromasia, Injection site pain, Lacrimation increased, Rhinorrhoea, Ultrasound scan, Urinary tract infection, Urine analysis, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Lacrimal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Baker''s cyst; Reflex sympathetic dystrophy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: Diagnostic ultrasound; Result Unstructured Data: confirmed DVT right lower leg; Test Date: 20210323; Test Name: Urinalysis; Result Unstructured Data: Unknown; Test Date: 20210323; Test Name: White blood cell count high; Result Unstructured Data: 10.35 increased, not reported
CDC Split Type: USJNJFOC20210348648

Write-up: HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included baker''s cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


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