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From the 9/10/2021 release of VAERS data:

Found 7,242 cases where Vaccine is COVID19 and Manufacturer is JANSSEN and Emergency Room/Doctor Visit



Case Details

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VAERS ID: 1260272 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-01
Onset:2021-04-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril Amlodipine Lipitor Fiber supplement Fish oil Melatonin
Current Illness: None
Preexisting Conditions: High blood pressure Cough Nodule of lung
Allergies: None
Diagnostic Lab Data: Ultrasound on 4/15 Advised to go to emergency room blood clot found Treated at ER and released
CDC Split Type:

Write-up: Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot Heat applied and aspirin Still swollen


VAERS ID: 1260273 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042021A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt given vaccine. Within 10min reported feeling dizzy and that her heart was racing. Stayed in pharmacy waiting area for about an hour before ems was called at pts request. Lost to follow up.


VAERS ID: 1260327 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-10
Onset:2021-03-22
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Thyroiditis
SMQs:, Hypothyroidism (broad), Hyperthyroidism (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: not available at this time
CDC Split Type:

Write-up: acute thyroiditis


VAERS ID: 1260342 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: GABAPENTIN, METHOCARBAMOL
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: DEXAMETHASONE, ATENOLOL, SULFA ANTIBIOTICS, PENICILLIN
Diagnostic Lab Data: Ultrasound, other procedures/tests unknown to me
CDC Split Type:

Write-up: Patient came in this evening 4/26 after emergency room visit for blood clot in leg/shin. She received Janssen IMZ 4/10. Her symptoms of painful leg began several days after her IMZ and continued to worsen with her leg shin swollen, painful, bruised with a knot until she sought medical help in the ER. Ultrasound was done and ruled out deep vein thrombosis, determined to be peripheral blood clot. She was sent home on meloxicam for pain and inflammation.


VAERS ID: 1260345 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-03
Onset:2021-04-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Computerised tomogram normal, Electrocardiogram normal, X-ray normal
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Kurvelo - birth control
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray and EKG on 4/14 CT Scan w/ contrast on 4/19
CDC Split Type:

Write-up: Two events of chest pain and discomfort. One event on April 5th that lasted that full day and another event on April 13th that lasted until about April 21st. I had a CT Scan, EKG, and X-ray and nothing was identified. I began taking aspirin daily beginning on the 14th until the 21st. I am currently not experiencing any chest pain or discomfort.


VAERS ID: 1260524 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Apathy, Blood test normal, Computerised tomogram normal, Confusional state, Decreased interest, Disturbance in attention, Dizziness, Dyslexia, Fatigue, Headache, Hypersomnia, Hypoaesthesia, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Memory impairment, Nausea, Pain, Pain in extremity, Paraesthesia, Pyrexia, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Duloxetine, gabapentin, Adderall
Current Illness: N/A
Preexisting Conditions: ADHD, Depression, Anxiety
Allergies: Latex
Diagnostic Lab Data: CT Scan, IV Fluids, blood tests. Came out negative. 04/14/2021Hospital Follow-up visit, no tests 04/22/2021 Clinic
CDC Split Type:

Write-up: 04/07/2021 fatigue, low grade fever. 04/8/2021-04/14/2021 pain in injection site, fatigue, lack of interest, confusion, vision troubles, trouble understanding, nausea, dyslexia, dizziness, lightheaded, feeling of impeding doom, increased anxiety, headaches, body aches, leg pain, numbness, tingling, arm pain and numbness, face numbness. 04/14/2021 Severe headache with other symptoms described. ER visit helped severe headache. Fatigue, leg pain, confusion and oversleeping continues. Unable to wake up in the morning, consistently late to work or unable to work. Unmotivated, careless, lack of interest, unable to concentrate or function for normal daily activities. Constant Fog, repetitive headaches. Memory issues and unable to complete familiar job duties and other activities. I feel as if something broke in my brain, I just want to be me again. So far little improvement and symptoms getting worse i am afraid this will be permanent.


VAERS ID: 1260530 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Asthenia, Chest X-ray abnormal, Chest discomfort, Chest pain, Computerised tomogram thorax abnormal, Diarrhoea, Dizziness, Dyspnoea, Dyspnoea exertional, Electrocardiogram, Feeling abnormal, Flushing, Gait disturbance, Laboratory test, Lethargy, Nausea, Pulmonary function test abnormal, Pulmonary pain, Respiration abnormal, SARS-CoV-2 test negative, Scan with contrast abnormal, Throat irritation, Visual impairment
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Alegra D, Tylenol
Current Illness: none
Preexisting Conditions: Endometriosis
Allergies: allergies to pollen, mold, dander, trees, flowers, cilantro
Diagnostic Lab Data: 2 negative COVID tests, 12 lead EKG (twice), lung CT with and w/out contrast, chest x-ray, lung function testing, a large array of lab work~ to date all tests have come back negative. If you would like to view my testing and results, you can contact me.
CDC Split Type:

Write-up: The adverse reactions of light headedness, throat irritation, heaviness in my chest and difficulty inhaling began about 20 min after my injection, It lasted 5 minutes. About 30 min afterwards the 2nd wave of reaction came on, with the same symptoms but was even harder to inhale and lasted twice as long. I took a combination of benadryl, motrin and pepcid which alleviated the worst of the symptoms after about an hour. To this day, I still cannot take a deep breath in. About 72 hours after the vaccine I began to have diarrhea (and still have it 20 days later), lethargy, nausea and shortness of breath. The next day I had a little more energy, but still had continued shortness of breath. My vision had become less clear and my thought process a bit fuzzy. This is still happening today. Seven days after the vaccine, I suddenly became extremely light headed just simply walking. To the extent that I needed to sit or lay down before I began to pass out. After the light headedness came on heavily, I also noticed a very heavy weight on my upper chest and found it quite difficult to inhale. These moments would come and go throughout the day. Regardless of whether I was just sitting and relaxing or walking around. These symptoms would last anywhere from a couple minutes to a couple of hours. I found it very hard to catch my breath and could feel my heart flushing often. Additionally I would wake in the middle of the night feeling that I needed to gasp for air. I sought medical assistance from a clinic, an ER and even my allergist and I am scheduled to see my family physician later this week. I am not an anxious person, but have experienced many episodes in the last 20 days that have truly made me feel that I was going to die (no exaggeration!) due to the inability to breathe or that I may have been having a heart attack. I began to have chest pain that would travel from the center of my chest to my left shoulder. The pain also would move to my right lung area. During this I also had heaviness in my chest and felt I could not breathe in or out easily. I am still very light headed and have difficulty walking very far without taking a break because I feel I cannot catch my breath. I still have all of the same symptoms that I experienced 20 minutes after my vaccine. These symptoms have varied in intensity. I have often commented to my family that I feel the symptoms of the chest heaviness and heart flushing seem to come in waves. I am a health conscious person and have never had poor health in my life. The events in the last few weeks have definitely taught me how terrible life must be for those who chronically suffer from heart or lung issues. I am still currently battling these symptoms, however, the last few days seem the symptoms have often been less severe.


VAERS ID: 1260574 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-04-24
Onset:2021-04-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Headache, Pain in extremity
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Diabetes
Preexisting Conditions: Diabetes
Allergies: No
Diagnostic Lab Data: Cellulitis of left upper extremity
CDC Split Type:

Write-up: Headache, cellulitis pain in the arm


VAERS ID: 1260578 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-07
Onset:2021-04-20
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Blood glucose decreased, Blood urine present, Contusion, Dizziness, Feeling abnormal, Haematochezia, Headache, Heavy menstrual bleeding, Hypertension, Menstrual disorder, Platelet count normal, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Vestibular disorders (broad), Hypoglycaemia (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: Topamax 25mg x2 daily
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I have severe, random, and unprovoked bruising covering both legs. I have abdominal pain that has persistent since being vaccinated. I?m dizzy. I?m bleeding in my urine, stool, and vaginally. Period came early (unrelated to previous vaginal bleeding) and is not clotting. Just significant amounts of red blood, soaking through one ultra absorbency tampon an hour. I have a headache. Went to the ER and my platelets were (345) and my blood sugar low. My bp was 145/90 which is high for me, from the bleeding. They said I have a ?higher chance of being bitten by a shark? than having a side effect. They diagnosed me with a single contusion and sent me home. Have been feeling worse since leaving the hospital.


VAERS ID: 1260777 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Chills, Dyspnoea, Fatigue, Headache, Hot flush, Hyperhidrosis, Mononucleosis heterophile test, Nasal congestion, Pain, Pyrexia, Streptococcus test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: tri-sprintec birth control tablets & Lexapro anti anxiety medication
Current Illness: None
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: Strep and mono 04/20/2021
CDC Split Type:

Write-up: severe fatigue, headache, chills, body aches. low grade fever, hot flashes, sweating, chest pains, shortness of breath, sore throat, stomach pains, congestion


VAERS ID: 1260781 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-04-01
Onset:2021-04-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer increased, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Flomax
Current Illness:
Preexisting Conditions: Cervical stenosis Lumbar stenosis BPH
Allergies: Amoxicillin, codeine
Diagnostic Lab Data: RLE ultrasound, elevated D dimer 4/26
CDC Split Type:

Write-up: posterior tibial vein non-occlusive thrombus. RLE pain starting 4/23, diagnosed 4/26


VAERS ID: 1260946 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Computerised tomogram head abnormal, Deep vein thrombosis, Dizziness, Dyspnoea, Fibrin D dimer increased, Head injury, Myocardial strain, Peripheral swelling, Pulmonary embolism, Skin laceration, Syncope, Ultrasound Doppler abnormal, Ventricular septal defect
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sertraline, Enalapril HCT, Levothyroxine
Current Illness:
Preexisting Conditions: HTN, depression, hypothyroidism
Allergies:
Diagnostic Lab Data: See above
CDC Split Type:

Write-up: Patient had a syncopal episode while on the toilet and moving her bowels on night of 4/15. She struck head and sustained left peri-orbital laceration. Was seen at ER on 4/16. Had CT of head showing cutaneous injury only. Was discharged home. On 4/20 she first noted swelling in right calf. This worsened and was seen in Care Center on 4/23. Had high D-dimer and had ultrasound of leg at ER. This showed right leg DVT extending from the distal femoral vein through the popliteal and posterior tibial veins. She had a long wait and left. She called PCP''s on 4/24 on was prescribed Eliquis. She had trouble getting prescription filled due to cost and need for insurance pre-approval. Finally picked up and started Eliquis on the morning of 4/25. She contacted PCP''s office on morning of 4/26 with new complaint of "terrible shortness of breath and lightheadedness". Patient was seen. CTA of chest done at hospital. showed "a large bilateral acute bilateral pulmonary embolism with saddle embolus, involving the right and left main pulmonary arteries, as well as the lateral lower lobe, upper lobe, right middle lobe, and lingular segmental and subsegmental branches. There is slight bowing of the interatrial ventricular septum to the left consistent with right heart strain." Patient to be admitted for thrombectomy


VAERS ID: 1260995 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-10
Onset:2021-04-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Headache, Neuralgia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide Oxiracitam Alpha-GPC
Current Illness: None
Preexisting Conditions: High blood pressure
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Food triggered attacks with symptoms of: stomach pain, headache, nerve pain, chest pain


VAERS ID: 1261033 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-05
Onset:2021-04-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Headache, Nausea, Photophobia
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Xulane
Current Illness: Migraines
Preexisting Conditions: Acne, back pain
Allergies: None known to patient
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Morning after vaccination (on 4/6/21), pt got diffuse intermittent headache which focalized later into the right temporal area daily for 3 weeks, which she calls 8/10 in severity. These headaches have been so severe to the point that it induces nausea and creates abdominal cramping. She has not as photophobic as before during her headaches, and nothing seems to alleviate it but water and tylenol (but that has little lasting effect). Prior to these headaches her migraines came once every 2 weeks and lasted 2-3 hours at a time, with a 5/10 severity that was bitemporal with more pronounced photophobia.


VAERS ID: 1261047 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-16
Onset:2021-02-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Atrial enlargement, Atrial fibrillation, Blood creatinine increased, Brain natriuretic peptide increased, Cardiac failure congestive, Cerebellar infarction, Coordination abnormal, Dyspnoea, Echocardiogram, Fatigue, Magnetic resonance imaging head abnormal, Mitral valve incompetence, Pulmonary congestion, Tricuspid valve incompetence
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None.
Current Illness: CKD, HTN, lichen planusm Right hip osteoarthritis
Preexisting Conditions: CKD, HTN, lichen planusm Right hip osteoarthritis
Allergies: None known.
Diagnostic Lab Data: 3/4/21, and 3/18/21: BNP 700s 3/5/21: TTE EF 60%, moderate biatrial enlargement, mild-moderate mitral regurg, moderate tricuspid regurg, 3/6/21 Cr 1.48 from baseline 1.04 3/8/21: MR brain: acute right cerebellar artery infarct
CDC Split Type:

Write-up: On 2/27/21, pt had new onset chest congestion, exhaustion and shortness of breath, but no fevers (measured at home) nor orthopnea. Visited primary doctor who urged her to visit ED. On ED visit on 3/4/21, she was found to be in afib RVR (heart rate to 170s) that was refractory initially to dilt push, dilt oral, dilt gtt. On 3/7/21, stroke alert was called because of new right arm dis-coordination, and on 3/8/21, MR brain showed an acute right cerebellar artery infarct (which did not leave deficits). Prior to the vaccine, pt had absolutely no symptoms of heart failure or cardiac diagnoses. She was hospitalized from 3/4/21-3/13/21, 3/18/21-3/23/21 for afib RVR, congestive heart failure, and acute kidney injury which required dilt and diuretics. However, she was later hospitalized on 4/8/21-4/11/21 again for afib RVR, congestive heart failure and acute kidney injury. Finally after continued outpatient amiodarone, she returned to normal sinus rhythm. Patient has shared that she has never experienced such drastic health changes in her life and these frequent hospitalizations occurred after her Janssen shot.


VAERS ID: 1261153 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-05
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN GL12A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lightheadedness (From injections.); Comments: The patient had no history of any reaction to vaccines before.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210409719

Write-up: FAINTED; WEAKNESS; This spontaneous report received from a patient concerned a 30 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included lightheadedness from injections. The patient had no history of any reaction to vaccines before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: GL12A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient was fainted after receiving the vaccine and treated with emergency medical services. On the same day, the patient felt dizzy and experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and weakness on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1261166 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Abdominal distension, Amnesia, Asthenia, Atelectasis, Cardiomegaly, Confusional state, Cough, Cystitis, Dizziness, Dysstasia, Electrocardiogram, Fall, Fatigue, Feeding disorder, Feeling hot, Gait inability, Hallucination, Malaise, Memory impairment, Oedema, Oedema peripheral, Periorbital swelling, Platelet count, Platelet count decreased, Ultrasound scan
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210313; Test Name: Platelet count; Result Unstructured Data: 136 (unit not specified); Test Date: 20210313; Test Name: ECG; Result Unstructured Data: cannot rule out anterior infarct age undetermined.; Test Date: 20210314; Test Name: Platelet count; Result Unstructured Data: 130 (unit not specified); Test Date: 20210315; Test Name: Abdomen scan; Result Unstructured Data: Bibasilar atelectasis and cardiomegaly; Test Date: 20210329; Test Name: Diagnostic ultrasound; Result Unstructured Data: Normal; Test Date: 20210401; Test Name: Diagnostic ultrasound; Result Unstructured Data: Contralateral femoral vein was widely patent.; Test Date: 20210407; Test Name: ECG; Result Unstructured Data: Abnormal ECG no significant change found,; Test Date: 20210413; Test Name: Platelet count; Result Unstructured Data: 171 (unit not specified)
CDC Split Type: USJNJFOC20210423228

Write-up: LOW GRADE BLADDER INFECTION; EXTREMELY WARM SENSATION IN CHEST AND BACK; COUGH; SHORT TERM MEMORY LOSS; COULD NOT REMEMBER; NOT WELL; HALLLUCINATIONS; COULD NOT WALK; COULD NOT FEED HERSELF; CONFUSION; PLATELET COUNT DECREASED; UNABLE TO STAND; FALL; DIZZY; FELT TIRED; WEAKNESS; EYES LOOKED PUFFY; ABDOMEN WAS LARGER; BIBASILAR ATELECTASIS; CARDIOMEGALY; SWELLING IN BOTH LEGS INCLUDING ANKLE AND TOES; LEVEL 4 PITTED EDEMA; This spontaneous report received from a consumer concerned a 90 year old female. The patient''s weight and height was not reported. The patient''s past medical history included Alzheimer''s, and dementia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the patient felt tired. On 12-MAR-2021, the patient had a fall, was dizzy and unable to stand. On 13-MAR-2021, the patient was taken to the emergency room and had a low grade bladder infection and was treated with intravenous (IV) antibiotic (unspecified) from 13-MAR-2021 to 15-MAR-2021 and from 15-MAR-2021 she was switched to oral antibiotic (unspecified) until 23-MAR-2021. The patient was confused and could not walk. It was reported that, the patient was unable to feed herself. On 13-MAR-2021, the patient experienced platelet count decreased. On 13-MAR-2021, the patient''s laboratory data included: electrocardiogram (ECG) which could not rule out anterior infarct age undetermined and her platelet count was 136 (unit non specified). On 14-MAR-2021, the patient had hallucinations and her platelet count was 130 (unit non specified). On 15-MAR-2021, her laboratory data included: abdomen computerized tomography (CT) scan which showed bibasilar atelectasis and cardiomegaly, likely cyst vs hemangioma. Unchanged incompletely characterized exophytic lesion in the left kidney significant and possibly represented a hemorrhagic cyst, further evaluation with magnetic resonance imaging (MRI) would need to be performed for definitive characterization. On 17-MAR-2021, the patient''s cognition seemed well. On 19-MAR-2021, the patient started showing symptoms of blood clot. On 19-MAR-2021 to 22-MAR-2021, the patient was not well. The patient was wearing slippers because she had level 4 pitted edema and was swollen from her knees down including ankle and toes. It was reported that, her swelling was greater on the left side than the right side and she had this swelling on 23-MAR-2021. Also, the patient''s confusion returned. On 29-MAR-2021, the patient had confusion and her ultra sound of left leg was normal. On 01-APR-2021, the patient''s laboratory data included: diagnostic ultrasound revealing contralateral femoral vein was widely patent. On 03-APR-2021 and 09-APR-2021, the patient was confused and did not know where she was. On 07-APR-2021, her electrocardiogram did not mention anterior infarct and it was abnormal ECG no significant change found. On 10-APR-2021, the patient could not remember where she was. On an unspecified date, the patient had cough and extremely warm sensation in chest and back. The patient was in rehabilitation center and was set to be discharged 16-APR-2021. On 13-APR-2021, the patient''s platelet count was 171 (unit not specified). On 17-MAR-2021, In rehabilitation center the patient was no longer wearing shoes due to swelling of ankle, legs toes and feet. The patient''s eyes looked puffy and her abdomen was larger. The patient was treated with Lasix (furosemide) in the rehabilitation center. According to the patient''s physician, the patient had no sign of stroke. The patient was propped up on right side while at rehabilitation center so according to her daughter the patient was experiencing weakness. At rehabilitation center an ultrasound was ordered for left leg. The patient''s both legs were swollen and one was more swollen than the other. The patient was having an issue with memory and confusion which was unusual as the patient had previously been treated neurologist for Alzheimer''s disease and dementia and was highly intelligent. At the time of this report, the patient was being treated for low grade bladder infection. The patient''s primary care physician reports that she had no concerns about the vaccine being linked to the patient''s fall and hospitalization and reported that there were no blood clots, no stroke, no deep vein thrombosis, and no coagulation abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not well on 22-MAR-2021, was recovering from platelet count decreased, and the outcome of cough, swelling in both legs including ankle and toes, extremely warm sensation in chest and back, confusion, fall, hallucinations, low grade bladder infection, could not feed herself, could not walk, felt tired, dizzy, unable to stand, level 4 pitted edema, could not remember, eyes looked puffy, abdomen was larger, weakness, short term memory loss, bibasilar atelectasis and cardiomegaly was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: v0 This spontaneous report involves a 90-year-old white female patient with the past medical history remarkable for Alzheimer''s and dementia who felt tired 3 days after the Janssen COVID-19 Vaccine Ad26.COV2 had administered. The next day the patient had fell, was dizzy and unable to stand. The next, the patient was taken to the emergency room and was diagnosed with a low grade bladder infection. The patient was confused and could not walk and was unable to feed herself. The next day, the patient had hallucinations and her platelet count was 130 (unit non specified), normal range 179-450. While hospitalized, the patient started showing symptoms of blood clot, had pitted edema, could not remember where she was. On an unspecified date, the patient had cough and extremely warm sensation in chest and back. The patient''s eyes looked puffy and her abdomen was larger. The patient''s primary care physician reports that she had no concerns about the vaccine being linked to the patient''s fall and hospitalization and reported that there were no blood clots, no stroke, no deep vein thrombosis, and no coagulation abnormalities. Considering the patient''s age, gender ? predisposes to urinary tract infections, as well as the underlying Alzheimer''s and dementia the causality for the events assessed not related to the vaccine.


VAERS ID: 1261170 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Aphonia, Chest discomfort, Chest pain, Dyspnoea, Dyspnoea exertional, Fluid intake reduced, Headache, Insomnia, Oropharyngeal pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210424552

Write-up: COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ANXIOUS TO BE CONTACTED; HEAVINESS IN CHEST; HEADACHE; PAIN UNDERNEATH LEFT ARM; TROUBLE BREATHING,FELT LIKE GASPING FOR AIR,SHORTNESS OF BREATH/WINDED EASILY; PAIN IN RIGHT SIDE OF CHEST; TROUBLE SLEEPING; SORE THROAT; This spontaneous report received from a patient concerned a 52 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 not reported, batch number: 206a21a, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced trouble sleeping. On 08-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced trouble breathing, felt like gasping for air, shortness of breath/winded easily. On 09-APR-2021, the subject experienced pain in right side of chest. On 09-APR-2021, the subject experienced pain underneath left arm. On an unspecified date, the subject experienced could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted, heaviness in chest, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, had not recovered from pain in right side of chest, trouble breathing ,felt like gasping for air, shortness of breath/winded easily, pain underneath left arm, trouble sleeping, and headache, and the outcome of could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted and heaviness in chest was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.


VAERS ID: 1261172 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Minnesota  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood creatinine increased, COVID-19 pneumonia, Myocardial infarction, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Lack of efficacy/effect (narrow), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestive heart failure
Preexisting Conditions: Comments: takes blood pressure and cholesterol medications.
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Creatinine; Result Unstructured Data: Elevated; Test Date: 20210407; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: USJNJFOC20210424651

Write-up: HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender''s Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210424651-covid-19 vaccine ad26.cov2.s- Covid19 Pneumonia. 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). 20210424651-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS


VAERS ID: 1261175 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-03-27
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coagulation time, Coagulation time shortened, Computerised tomogram, Dizziness, Eosinophil count increased, Fatigue, Hypoaesthesia, Magnetic resonance imaging, Malaise, Mean platelet volume, Muscle twitching, Pain, Pain in extremity, Platelet count increased, Swelling face, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Blood pressure abnormal (Patient takes maintenance blood pressure medication)
Preexisting Conditions: Comments: The patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications.
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: MRI; Result Unstructured Data: unknown; Test Date: 20210329; Test Name: CT scan; Result Unstructured Data: unknown; Test Date: 20210329; Test Name: Clotting time; Result Unstructured Data: LOW; Test Date: 20210329; Test Name: Eosinophil count high; Result Unstructured Data: UNKNOWN; Test Date: 20210329; Test Name: Mean platelet volume; Result Unstructured Data: LOW; Test Date: 20210329; Test Name: Platelets increased; Result Unstructured Data: 10 times above normal
CDC Split Type: USJNJFOC20210424924

Write-up: DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time 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 assessed as non-serious


VAERS ID: 1261176 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-03-16
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial thrombosis, Fatigue, Hypoaesthesia, Lymphadenopathy, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210425183

Write-up: BLOOD CLOT FOUND IN RADIAL ARTERY OF RIGHT ARM; SWELLING OF LYMPH NODES ON BOTH SIDES OF NECK; ARM SORENESS PROGRESSED TO ACHING OF RIGHT ARM; NUMB RIGHT ARM; FATIGUE; This spontaneous report was received from a patient and concerned a 51 years 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 administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 at her right arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, after receiving vaccine, the patient felt fatigue and right arm soreness where she got the vaccine. The arm soreness progressed to aching and numbness. On 01-APR-2021, the patient noticed swelling of lymph nodes on both sides of her neck. On the same day she was sent to emergency room (ER) and was told that a blood clot was found in the radial artery of her right arm; diagnostic data not reported. She was given Plavix (clopidogrel) and sent home. On 06-APR-2021, the patient returned to ER because she was not feeling any improvement on her right arm, and it was still hurting. She was told that a surgery was planned to remove the clot but it was later cancelled. She was sent home on the same day with XARELTO (rivaroxaban). At the time of report, the patient had a pending appointment with a surgeon regarding the clot; no date was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021, was recovering from arm soreness progressed to aching of right arm, and numb right arm, and had not recovered from blood clot found in radial artery of right arm, and swelling of lymph nodes on both sides of neck. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 This report concerns a 51 years old female patient who had a blood clot in the radial artery of her right arm, 15 days after receiving Jansen COVID-19 vaccine. On the same day of vaccination, patient experienced fatigue and right arm sore where she got the vaccine. The arm soreness progressed to aching and numbness. 15 days after vaccination, the patient noticed swelling of lymph nodes on both sides of her neck and was sent to ER. She was told that a blood clot was found in the radial artery of her right arm (diagnostic data not reported) and was treated with Plavix and later with Xarelto. Based on the reported information, the causality of event blood clot in the radial artery of her right arm is considered plausible to the vaccination. Additional information has been requested.


VAERS ID: 1261204 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: No adverse event
SMQs:

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210429121

Write-up: SPENT THREE STRAIGHT DAYS IN EMERGENCY ROOM; This spontaneous report received from a consumer concerned 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced spent three straight days in emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spent three straight days in emergency room was not reported. This report was non-serious.; Sender''s Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious


VAERS ID: 1261211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN F1808980 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Ophthalmological examination, Optic neuritis
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Comments: Patient had no known drug allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Eye exam; Result Unstructured Data: diagnose with optic neuritis by eye doctor; Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: normal findings; Test Date: 20210413; Test Name: CT scan; Result Unstructured Data: normal findings
CDC Split Type: USJNJFOC20210429417

Write-up: OPTIC NEURITIS; This spontaneous report received from a patient concerned a 53 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: F1808980, and expiry: UNKNOWN) with unspecified dose on left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, patient experienced loss of vision on the right eye that had not gotten better or worse since then. Patient went to ophthalmologist on 12-APR-2021 who diagnosed patient with optic neuritis and referred to neuro-ophthalmologist. On 13-APR-2021, patient went to emergency eye and ear. Patient was having upcoming appointments with primary doctor and neuro-ophthalmologist at the time of reporting. On 12-APR-2021, Laboratory data included: Dilated pupils (NR: not provided) diagnose with optic neuritis by eye doctor. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) normal findings, and CT scan (NR: not provided) normal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from optic neuritis. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210429417-covid-19 vaccine ad26.cov2.s-Optic neuritis. 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).


VAERS ID: 1261219 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Blood test, Chest discomfort, Condition aggravated, Fatigue, Flushing, Headache, Lethargy, Myalgia, Nausea, Poor quality sleep, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; ALEVE; ALLEGRA; ADVIL [IBUPROFEN]
Current Illness: Alcohol use (rarely-occasional beer); Allergic reaction; Arthritis; Blood pressure high; Lyme disease; Non-smoker; Seasonal allergy
Preexisting Conditions: Comments: The patient was non smoker.
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210430054

Write-up: LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient''s weight was 350 pounds, and height was 75 inches. The patient''s concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender''s Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious


VAERS ID: 1261221 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Maine  
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 043A214 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Computerised tomogram, Contusion, Dizziness, Feeling abnormal, Feeling hot, Flushing, Head discomfort, Headache, Hyperaesthesia, Joint swelling, Pain in extremity, Rash pruritic, Sensory disturbance, Ultrasound scan, Urticaria, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Comments: The patient had family history of blood clots.
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: CT scan; Result Unstructured Data: Unknown; Test Date: 20210412; Test Name: Diagnostic ultrasound; Result Unstructured Data: Unknown
CDC Split Type: USJNJFOC20210430194

Write-up: SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; This spontaneous report received from a patient concerned a 56 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash. On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1261222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430228

Write-up: SHARP PAIN TO ABDOMINAL AREA ON BOTH SIDES; RIGHT LEG PAIN (THIGH); This spontaneous report received from a patient concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced sharp pain to abdominal area on both sides. On 13-APR-2021, the subject experienced right leg pain (thigh). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain to abdominal area on both sides, and right leg pain (thigh). This report was non-serious.; Sender''s Comments: V0: medical assessment comment not required as per standard procedure as the case is assessed as non serious.


VAERS ID: 1261225 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-04-11
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Hot flush, Hypertension, Pulse pressure increased
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Arthritis (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: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: The patient was not pregnant at the time of reporting. The patient had no known allergies. The patient did not have any drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Blood pressure; Result Unstructured Data: 103/101; Comments: blood pressure of 103/101 (units unknown) when the patient took vaccine; Test Name: Pulse pressure high; Result Unstructured Data: 106; Test Name: Blood pressure; Result Unstructured Data: 240/140; Comments: blood pressure of 240/ 140 (units unknown) when went to the emergency room
CDC Split Type: USJNJFOC20210430543

Write-up: HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included no-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies and the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced feeling of flush (she stated that it felt like a heat coming through), high blood pressure of 103/101 (units unknown) and pulse pressure 106 (units unknown). She also experienced the deltoid/shoulder site soreness which lasted for 1 to 2 days. On an unspecified date she went to emergency room, she had blood pressure 240/140: high (units unknown) and pulse pressure (units unknown). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deltoid/shoulder site soreness on 13-APR-2021, was recovering from feeling of flush, had not recovered from high blood pressure, and the outcome of pulse pressure of 106 was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0; 20210430543-covid-19 vaccine ad26.cov2. s-High blood pressure This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1261226 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Chills, Fatigue, Feeling abnormal, Headache, Migraine, Pain, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no previous history of migraines.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430650

Write-up: VISUAL DISTURBANCE; COMPLEX MIGRAINE; HAD DIFFICULTY FINDING WORDS; NOT FEELING NORMAL; FATIGUE; COMPLEX HEADACHES; CHILLS; BODY ACHES; This spontaneous report received from a patient concerned a 55 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient had no previous history of migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced visual disturbance. On 13-APR-2021, the subject experienced complex migraine. On 13-APR-2021, the subject experienced had difficulty finding words. On 13-APR-2021, the subject experienced not feeling normal. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced complex headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from visual disturbance, complex migraine, and had difficulty finding words, and body aches, and chills on 13-APR-2021, had not recovered from fatigue, and not feeling normal, and the outcome of complex headaches was not reported. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.


VAERS ID: 1261233 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-03-13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea, Palpitations, Presyncope, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Migraine; Non-smoker
Preexisting Conditions: Comments: The patient was not pregnant at the time of reporting. The patient had no known drug allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430883

Write-up: CHILLS; TIRED; FEVER; HEADACHE; NAUSEA; DIZZINESS; SEVERE HEART RACING; PASSING OUT; This spontaneous report received from a patient concerned a 40 year old female. The patient''s weight was 110 pounds, and height was not reported. The patient''s concurrent conditions included migraines, non 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe heart racing. On 13-MAR-2021, the subject experienced passing out. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021 06:00, the subject experienced chills. On 13-MAR-2021 06:00, the subject experienced tired. On 13-MAR-2021 06:00, the subject experienced fever. On 13-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heart racing, passing out, and nausea on 13-MAR-2021, dizziness, chills, and fever on 14-MAR-2021, tired on 15-MAR-2021, and headache on 17-MAR-2021. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.


VAERS ID: 1261238 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Bone pain, Burning sensation, Cardiac stress test, Chest pain, Computerised tomogram, Contrast media reaction, Dizziness, Dyspnoea, Echocardiogram, Electric shock, Feeling abnormal, Fibrin D dimer increased, Heart rate, Heart rate increased, Hypoaesthesia, Insomnia, Mental disorder, Nervous system disorder, Pain, Pain in extremity, Palpitations, Panic attack, Paraesthesia, Postural orthostatic tachycardia syndrome, Sensory disturbance, Suffocation feeling, Ultrasound scan, Victim of abuse
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker; Postural orthostatic tachycardia syndrome
Preexisting Conditions: Comments: The patient had Illicit drug use as a teenage. The patient was homeless from age of 14 to 22. The patient was sober as of 26-MAR-2006, past 15 years was sober.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Echocardiogram; Result Unstructured Data: not reported; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Increased; Test Date: 2021; Test Name: Fibrin D dimer abnormal; Result Unstructured Data: not reported; Test Date: 2021; Test Name: CT scan; Result Unstructured Data: not reported; Test Date: 2021; Test Name: Diagnostic ultrasound; Result Unstructured Data: not reported; Test Date: 2021; Test Name: Contrast media reaction; Result Unstructured Data: not reported; Test Date: 202104; Test Name: Stress test; Result Unstructured Data: not reported
CDC Split Type: USJNJFOC20210431221

Write-up: DIFFICULTY BREATHING; MENTAL CHANGES; RAPID HEART BEAT; FULL BODY PAIN; FEELING OF LEAD IN VEINS TOE NAILS TO HEAD; ANXIETY; BRAIN ZAPS; FEELING OF HEAT IN BRAIN; SEVERE PAIN; LEG PAIN; LEG FALLING ASLEEP; FEELING OF CHANGES IN NERVOUS SYSTEM; FEELING SPACEY; PALPITATIONS; DIFFICULTY SLEEPING; BURNING IN CHEST; LIGHTHEADED; FEELING LIKE GOING TO PASS OUT; PANIC ATTACK; EXTREME BONE PAIN; SUFFOCATING; SUFFERING AND TORTURE; FOOT FALLING ASLEEP; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; This spontaneous report received from a patient concerned a 37 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non smoker, non alcoholic user, and postural orthostatic tachycardia syndrome, and other pre-existing medical conditions included the patient had illicit drug use as a teenage. the patient was homeless from age of 14 to 22. the patient was sober as of 26-mar-2006, past 15 years was sober. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: CT scan (NR: not provided) not reported, Contrast media reaction (NR: not provided) not reported, Diagnostic ultrasound (NR: not provided) not reported, Echocardiogram (NR: not provided) not reported, Fibrin D dimer abnormal (NR: not provided) not reported, and Heart rate (NR: not provided) Increased. On MAR-2021, the subject experienced difficulty breathing. On MAR-2021, the subject experienced mental changes. On MAR-2021, the subject experienced rapid heart beat. On MAR-2021, the subject experienced full body pain. On MAR-2021, the subject experienced feeling of lead in veins toe nails to head. On MAR-2021, the subject experienced anxiety. On MAR-2021, the subject experienced brain zaps. On MAR-2021, the subject experienced feeling of heat in brain. On MAR-2021, the subject experienced severe pain. On MAR-2021, the subject experienced leg pain. On MAR-2021, the subject experienced leg falling asleep. On MAR-2021, the subject experienced feeling of changes in nervous system. On MAR-2021, the subject experienced feeling spacey. On MAR-2021, the subject experienced palpitations. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced burning in chest. On MAR-2021, the subject experienced lightheaded. On MAR-2021, the subject experienced feeling like going to pass out. On MAR-2021, the subject experienced panic attack. On MAR-2021, the subject experienced extreme bone pain. On MAR-2021, the subject experienced suffocating. On MAR-2021, the subject experienced suffering and torture. On MAR-2021, the subject experienced foot falling asleep. On MAR-2021, the subject experienced postural orthostatic tachycardia syndrome. On APR-2021, Laboratory data included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heart beat, difficulty breathing, full body pain, feeling of lead in veins toe nails to head, anxiety, brain zaps, feeling of heat in brain, severe pain, leg pain, leg falling asleep, feeling of changes in nervous system, feeling spacey, palpitations, difficulty sleeping, burning in chest, mental changes, extreme bone pain, suffocating, and suffering and torture, and the outcome of lightheaded, feeling like going to pass out, panic attack, foot falling asleep and postural orthostatic tachycardia syndrome was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.


VAERS ID: 1261245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Product storage error, Troponin increased
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Troponin increased; Result Unstructured Data: High
CDC Split Type: USJNJFOC20210431465

Write-up: HIGH TROPONINS; CHEST PAINS; PRODUCT WAS NOT PROPERLY STORED FROM RECEIPT TO ADMINISTRATION(PRODUCT STORAGE ERROR); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 13-APR-2021, the patient went to emergency room for pains in the chest on same day the patient was admitted overnight in hospital due to high level of troponins. The patient might got catheterized. It was also stated that product was not properly stored from receipt to administration (product storage error). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pains, high troponins and product was not properly stored from receipt to administration (product storage error) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20210431465-Covid-19 vaccine ad26.cov2.s-Chest pain and high troponin .This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1261255 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808480 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood test, Magnetic resonance imaging, Nausea, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Diabetes; Nonsmoker
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: COVID-19 PCR test; Result Unstructured Data: NEGATIVE; Test Date: 20210413; Test Name: MRI; Result Unstructured Data: Normal; Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210431932

Write-up: SEVERE ABDOMINAL PAIN; VOMITING; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 53-year-old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included diabetes. The patient was non-alcohol user, and non-smoker. The patient experienced drug allergy (itching and redness) when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808480, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) which was negative. On 13-APR-2021, the patient experienced severe abdominal pain, body aches and nausea and he went to Emergency room where he received IV pain medication and they performed MRI (Magnetic resonance imaging) and did blood work. Both were normal. Patient returned to the emergency room with severe pain after he took Tylenol and he vomited. He was administered with IV (intravenous) pain medication and started IV fluids. New blood work was done on 14-APR-2021 which was negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, vomiting, body aches, and nausea on 15-APR-2021 and the outcome of drug allergy was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Severe abdominal pain, Vomiting, Body aches. 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: UNDERLYING DISEASE. V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1261257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
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 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cellulitis, Headache, Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (drink beers: 3 to 4 beers, 3 to 4 times a week); Non-smoker; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Cellulitis of arm; Comments: no drug abuse or illicit drug usage
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: 100 F; Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: 103.4 F
CDC Split Type: USJNJFOC20210431961

Write-up: CELLULITIS OF ARM; SWOLLEN AND PAINFUL LYMPH NODES; SEVERE MUSCLE ACHES; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient''s weight was 160 pounds, and height was 64 inches. The patient''s past medical history included left arm cellulitis, and concurrent conditions included penicillin, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021,patient Body temperature (NR: not provided) 103.4 f and 100 f. Patient called and reported that, received Janssen covid 19 vaccine on April 1, 2021 after 2 weeks later still have a 5 cm lump on left arm ( it was hot, red and painful), swollen and painful lymph nodes, 103.4 fever for 24 hours after the vaccine.a low grade fever for 2 additional days under 100. patient also experienced severe muscle aches to lower body and a severe headache for 24 hours.Patient visited to physician on April 12, 2021 and they prescribed antibiotics. Patient was diagnosed with left arm cellulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from severe muscle aches on 03-APR-2021, and severe headache on 02-APR-2021, had not recovered from swollen and painful lymph nodes, and the outcome of cellulitis of arm was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210431961-covid-19 vaccine ad26.cov2.s-cellulitis of the arm. 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.


VAERS ID: 1261258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
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 1808982 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral vascular disorder, Vasodilatation
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431971

Write-up: VEIN BULGING; BILATERAL NUMBNESS ON LEGS; LEFT THIGH PAIN; LOST CIRCULATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost circulation. On 13-APR-2021, the subject experienced vein bulging. On 13-APR-2021, the subject experienced bilateral numbness on legs. On 13-APR-2021, the subject experienced left thigh pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thigh pain on 14-APR-2021, had not recovered from bilateral numbness on legs, and the outcome of vein bulging and lost circulation was not reported. This report was non-serious.; Sender''s Comments: V0-Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.


VAERS ID: 1261261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Illness, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210432019

Write-up: VOMITING; DIARRHEA; SICKNESS; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 64 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 not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, frequency one total, administered at right arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced vomiting, diarrhea that would not stop hence she had to go to the emergency room where she received an IV. The patient also had severe headache that lasted for several days and fever. The patient said the diarrhea stopped after getting the IV and she was pretty sick until last Saturday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea on 07-APR-2021, and severe headache, and fever on APR-2021, and the outcome of sickness was not reported. This report was serious (Other Medically Important Condition); Sender''s Comments: 20210432019-covid-19 vaccine ad26.cov2.s-vomiting, diarrhea. 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).


VAERS ID: 1261265 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Nevada  
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 1805018 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Arthralgia, Arthritis, Chest pain, Decreased appetite, Diarrhoea, Epistaxis, Haemoptysis, Hyperhidrosis, SARS-CoV-2 test negative, Weight decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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: coumadin.
Current Illness: Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test negative; Result Unstructured Data: negative
CDC Split Type: USJNJFOC20210432173

Write-up: ARTHRITIS; PAIN IN HIP; COUGHING BLOOD; BLEEDING NOSE; CHEST PAIN; DIARRHEA; LOST APPETITE; WORSENED PERSPIRATION; LOST 100LBS; This spontaneous report received from a patient concerned a 69 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included penicillin. The patient was previously treated with sulfur for drug used for unknown indication, codeine for drug used for unknown indication, and morphine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included warfarin sodium for drug used for unknown indication. On APR-2021, the subject experienced lost appetite. On APR-2021, the subject experienced worsened perspiration. On APR-2021, the subject experienced lost 100lbs. On 07-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced coughing blood. On 09-APR-2021, the subject experienced bleeding nose. On 10-APR-2021, the subject experienced pain in hip. On 11-APR-2021, the subject experienced arthritis. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative (units unspecified). Treatment medications (dates unspecified) included: ketorolac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-APR-2021, chest pain on 09-APR-2021, coughing blood, and bleeding nose on 10-APR-2021, and pain in hip on 11-APR-2021, had not recovered from lost appetite, and worsened perspiration, and the outcome of arthritis and lost 100lbs was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious


VAERS ID: 1261269 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Texas  
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 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asthenia, Blood calcium increased, Blood pressure abnormal, Blood pressure measurement, Chest X-ray, Chest discomfort, Chest pain, Chills, Dizziness, Dyspnoea, Fatigue, Gait inability, Hyperventilation, Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscle contracture, Myalgia, Pain in extremity, Paraesthesia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (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: The patient had no known drug allergy. The patient had no known medical history. The patient was not pregnant at the time of report.
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Chest X-ray; Result Unstructured Data: CLEAR; Comments: Clot test negative.; Test Date: 20210414; Test Name: Blood pressure; Result Unstructured Data: BP was off; Test Date: 20210416; Test Name: Calcium increased; Result Unstructured Data: Very High; Test Date: 20210418; Test Name: MRI; Result Unstructured Data: No clots in her chest or legs
CDC Split Type: USJNJFOC20210432572

Write-up: FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient''s weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.


VAERS ID: 1261270 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction
SMQs:

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210432587

Write-up: ADVERSE REACTION; This spontaneous report received from a patient via a company representative concerned 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: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction 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 assessed as non-serious


VAERS ID: 1261272 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Chest pain, Cough, Dyspnoea, Fatigue, Headache, Heart rate increased, Rash, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPRIN
Current Illness: Abstains from alcohol; Allergic rash (unknown cause.); Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Low platelets (due to genetic.); Comments: The patient had no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210432655

Write-up: SHORTNESS OF BREATH; CHEST PINCHING; FAST HEART BEAT; RASHES HAD REDNESS; RASHES AS ITCHY; RASHES ON CHEST AND BACK AS PAINFUL; EASILY GOT TIRED; FELT HEART WAS CONGESTED; COUGH; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 48 year old male. The patient''s weight was 150 pounds, and height was 170 centimeters. The patient''s past medical history included low platelet, and bypass surgery, and concurrent conditions included rashes allergy, non drinker, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for low platelet. On 31-MAR-2021, the subject experienced little bit of headache. On APR-2021, the subject experienced felt heart was congested. On APR-2021, the subject experienced cough. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced chest pinching. On 12-APR-2021, the subject experienced fast heart beat. On 12-APR-2021, the subject experienced rashes had redness. On 12-APR-2021, the subject experienced rashes as itchy. On 12-APR-2021, the subject experienced rashes on chest and back as painful. On 12-APR-2021, the subject experienced easily got tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of headache on 01-APR-2021, had not recovered from shortness of breath, chest pinching, fast heart beat, rashes on chest and back as painful, easily got tired, rashes as itchy, and rashes had redness, and the outcome of felt heart was congested and cough was not reported. This report was non-serious.; Sender''s Comments: V0- Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1261285 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: Fruit allergy (severely allergic to Bananas)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210436119

Write-up: ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s concurrent conditions included banana allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the patient felt a little lightheaded 15 minutes after vaccination. The patient was then left for 25 minutes to 30 minutes. It was reported that the patient''s body got hot all over, ears started itching, face started tingling and was feeling tight. The patient''s chest and neck also started feeling tight. The patient visited emergency room for treatment of the events. It was reported that the patient was having an anaphylactic reaction and was given Benadryl and prednisone. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and prednisone non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210436119-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1261296 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Dyspnoea, Headache, Nonspecific reaction, Scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Scan; Result Unstructured Data: unknown; Comments: unknown; Test Date: 20210415; Test Name: Blood test; Result Unstructured Data: unknown; Comments: unknown
CDC Split Type: USJNJFOC20210437768

Write-up: TROUBLE BREATHING; PINCHING IN THE CHEST; TROUBLE GETTING OUT OF BED; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pinching in the chest. On APR-2021, the subject experienced trouble getting out of bed. On APR-2021, the subject experienced severe headache. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, pinching in the chest, trouble breathing, and trouble getting out of bed. This report was non-serious.


VAERS ID: 1261302 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Missouri  
Vaccinated:0000-00-00
Onset:2021-04-15
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210438066

Write-up: BILATERAL PULMONARY EMBOLISMS; This spontaneous report received from a pharmacist concerned an 84 year old male. 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: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 10-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. 10-MAR-2021 After administration of vaccine on 15-APR-2021, patient had bilateral pulmonary embolisms and was hospitalized in local hospital then triaged to heart institute, Reporter also report patient will get discharged soon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolisms was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: This 84 year-old male patient was hospitalized for bilateral pulmonary embolisms 36 days after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, social history, family history, diagnostic test results, corrective treatment, and outcome were not reported. Based on the limited information, the event is considered unclassifiable. Additional information is being sought.


VAERS ID: 1261307 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Pennsylvania  
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 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Epiploic appendagitis
SMQs:

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: Antiinflammatory therapy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210438612

Write-up: EPIPLOIC APPENDAGITIS; This spontaneous report received from a consumer concerned a 20 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included anti-inflammatory therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced epiploic appendagitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from epiploic appendagitis. This report was non-serious.; Sender''s Comments: : V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1261315 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Headache, Injection site pain, Limb discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: patient does not have diabetes, circulation problems, and is not overweight. She is not taking birth control pills.
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Body temperature; Result Unstructured Data: 100.1 (unit unspecified); Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: UNKNOWN
CDC Split Type: USJNJFOC20210439354

Write-up: LEGS FELT "HEAVY" BILATERALLY, LEFT MORE THAN RIGHT; PAIN IN THE ARM; FEVERISH; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient does not have diabetes, circulation problems, and is not overweight. she is not taking birth control pills. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain in the arm. On 12-APR-2021, the subject experienced feverish. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced legs felt "heavy" bilaterally, left more than right. Laboratory data included: Body temperature (NR: not provided) 100.1 (unit unspecified). Treatment medications included: paracetamol. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 16-APR-2021, had not recovered from legs felt "heavy" bilaterally, left more than right, and the outcome of pain in the arm and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.


VAERS ID: 1261320 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Headache, Impaired work ability, Injection site pain, Limb discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medications prior to the Janssen Covid-19 vaccine. The patient had no diabetes, no circulation problems, and was not overweight. The patient was not taking birth control pills.
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Body temperature; Result Unstructured Data: 100.1; Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: Not reported
CDC Split Type: USJNJFOC20210439458

Write-up: HEAVINESS IN LEGS; MISSED WORK DUE TO THE FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1261325 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A01A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeding disorder, Insomnia, Tinnitus
SMQs:, Hearing impairment (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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210440448

Write-up: TINNITUS; UNABLE TO EAT; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 64 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 not reported, batch number: 042A01A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced unable to eat. On 08-APR-2021, the subject experienced unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, unable to eat, and unable to sleep. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non serious.


VAERS ID: 1261326 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2021-03-19
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood test, Bursal fluid accumulation, Computerised tomogram, Headache, Pain in extremity, Paraesthesia, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (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:
Current Illness:
Preexisting Conditions: Comments: The patient had no known allergies. The patient was not pregnant at the time of reporting.
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Blood test; Result Unstructured Data: No blood clot; Test Date: 20210411; Test Name: Diagnostic ultrasound; Result Unstructured Data: No blood clot but fluid below the spine; Test Date: 20210411; Test Name: CAT scan; Result Unstructured Data: No blood clot but fluid below the spine
CDC Split Type: USJNJFOC20210440542

Write-up: FLUID IN THE HIP AREA BELOW THE SPINE; PAIN IN BOTH LEGS; EXTREME LOWER BACK PAIN; TINGLING IN FEET; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced extreme lower back pain. On 25-MAR-2021, the subject experienced tingling in feet. On 25-MAR-2021, the subject experienced pain in both legs. On 11-APR-2021, the subject experienced fluid in the hip area below the spine. Laboratory data included: Blood test (NR: not provided) No blood clot, CAT scan (NR: not provided) No blood clot but fluid below the spine, and Diagnostic ultrasound (NR: not provided) No blood clot but fluid below the spine. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, was recovering from extreme lower back pain, pain in both legs, and tingling in feet, and the outcome of fluid in the hip area below the spine was not reported. This report was non-serious.


VAERS ID: 1261328 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Magnetic resonance imaging, Surgery
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: not provided
CDC Split Type: USJNJFOC20210440597

Write-up: URGENTLY OPERATED; HEADACHE; This spontaneous report (social media) received from a patient via a company representative concerned a 36 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) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache for days. It was reported that the patient underwent Magnetic resonance imaging (MRI) and was urgently operated and was saved. The patient was hospitalized (date unspecified). Laboratory data (dates unspecified) included: MRI (NR: not provided) unknown (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and urgently operated was not reported. This report was serious (Hospitalization Caused/Prolonged).; Sender''s Comments: V0: 20210440597-covid-19 vaccine ad26.cov2.s-urgently operated. 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).


VAERS ID: 1261329 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hemiparesis, Loss of consciousness, Thrombosis, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness: Food allergy
Preexisting Conditions: Comments: The patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition
Allergies:
Diagnostic Lab Data: Test Name: X-ray; Result Unstructured Data: heart, head and lungs
CDC Split Type: USJNJFOC20210440625

Write-up: THROMBOSIS; Dizziness; Pass Out; Weakness in the all side of the body; This spontaneous report received from a patient. The patient''s height, and weight were not reported. The patient''s concurrent conditions included sea food allergy, and other pre-existing medical conditions included the patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition. 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 02-APR-2021 11:25 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included metformin for drug used for unknown indication. On an unspecified date, the subject experienced thrombosis, dizziness, pass out, and weakness in the all side of the body, and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: X-ray (NR: not provided) heart, head and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombosis, dizziness, pass out, and weakness in the all side of the body. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: This is a report of a patient, who was noted to have thrombosis on unspecified time after receiving the covid-19 vaccine ad26.cov.2. Patient''s height and weight were not reported. Patient medical history was not reported. Concomitant medications included metformin for unknown indication. Patient is allergic to seafoods. On an unspecified date, the subject experienced dizziness and passed out. She also had weakness on the left side of the body. Patient was noted to have thrombosis. Patient was hospitalized, where laboratory and diagnostic tests were done. Results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.


VAERS ID: 1261334 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: South Carolina  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Malaise
SMQs:

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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441085

Write-up: ALL THE SIDE EFFECTS; STILL DON''T FEEL WELL; This spontaneous report received from a patient concerned 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: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced all the side effects. On APR-2021, the subject experienced still don''t feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still don''t feel well, and the outcome of all the side effects was not reported. This report was non-serious.; Sender''s Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious


VAERS ID: 1261335 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Facial pain, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441476

Write-up: PAIN IN LEFT SIDE OF FACE; BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 25 year old male. The patient''s weight, height, and medical history were not reported. 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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced pain in left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and nausea on 14-APR-2021, and had not recovered from pain in left side of face. This report was non-serious.; Sender''s Comments: V0:As per standard protocol ,no MAC comment is required for non-serious case


VAERS ID: 1261340 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-15
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Chest pain, Dyspnoea, Heart rate increased, Hypertension, Laboratory test, Myalgia, Sensory loss, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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: Abstains from alcohol; Allergic reaction to antibiotics; Autoimmune disorder; Blood pressure high; Latex allergy; Non-smoker; Thyroiditis
Preexisting Conditions: Comments: The patient did not have any drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Lab test; Result Unstructured Data: UNKNOWN
CDC Split Type: USJNJFOC20210441976

Write-up: EXTREMELY HIGH BLOOD PRESSURE; INCREASED HEART RATE; SHORTNESS OF BREATH; INCREASED GAS AND INTESTINAL PROBLEM; CHEST PAIN; SHAKINESS; CAN''T DISTINGUISH HOT FROM COLD; UNCONTROLLED MUSCLE PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included auto-immune disease, thyroiditis, high blood pressure, non alcohol, non smoker, latex allergy, sulfa allergy, and erythromycin allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced extremely high blood pressure. On 15-APR-2021, the subject experienced increased heart rate. On 15-APR-2021, the subject experienced shortness of breath. On 15-APR-2021, the subject experienced increased gas and intestinal problem. On 15-APR-2021, the subject experienced chest pain. On 15-APR-2021, the subject experienced shakiness. On 15-APR-2021, the subject experienced can''t distinguish hot from cold. On 15-APR-2021, the subject experienced uncontrolled muscle pain. Laboratory data included: Lab test (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely high blood pressure, increased heart rate, chest pain, and increased gas and intestinal problem, had not recovered from shakiness, and can''t distinguish hot from cold, and the outcome of uncontrolled muscle pain and shortness of breath 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 assessed as non-serious.


VAERS ID: 1261341 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-07
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dizziness, Feeling of body temperature change, Full blood count, Headache, Injection site bruising, Insomnia, Muscle spasms, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: CBC; Result Unstructured Data: Normal; Test Date: 20210421; Test Name: CT scan; Result Unstructured Data: CLEAR
CDC Split Type: USJNJFOC20210442470

Write-up: SLIGHT CALF CRAMPING; SEVERE HEADACHE; BRUISE AT THE INJECTION SITE; FEELING HOT AND COLD; BODY HURT/BODY ACHEY; ARM SORENESS AT INJECTION SITE; NAUSEA; DIZZINESS; COULDN''T SLEEP; This spontaneous report received from a patient concerned a 25 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 not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced couldn''t sleep. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced body hurt/body achey. On 08-APR-2021, the subject experienced arm soreness at injection site. On 09-APR-2021, the subject experienced feeling hot and cold. On 10-APR-2021, the subject experienced bruise at the injection site. On 11-APR-2021, the subject experienced severe headache. On 20-APR-2021, the subject experienced slight calf cramping. On 21-APR-2021, Laboratory data included: CBC (NR: not provided) Normal, and CT scan (NR: not provided) CLEAR. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn''t sleep, and arm soreness at injection site on 10-APR-2021, and body hurt/body achey on 09-APR-2021, was recovering from nausea, dizziness, feeling hot and cold, and bruise at the injection site, and had not recovered from severe headache, and slight calf cramping. This report was non-serious.


VAERS ID: 1261344 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: West Virginia  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chills, Dyspnoea, Fatigue, Headache, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Blood test; Result Unstructured Data: normal
CDC Split Type: USJNJFOC20210442887

Write-up: SHORTNESS OF BREATH/FELT LIKE I COULDN''T BREATHE; ACHEY; CHILLS; EXTREMELY FATIGUED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced achey. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extremely fatigued. On APR-2021, the subject experienced headache. Laboratory data included: Blood test (NR: not provided) normal. On 17-APR-2021, the subject experienced shortness of breath/felt like i couldn''t breathe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achey, headache, chills, extremely fatigued and shortness of breath/felt like i couldn''t breathe was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1261346 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-03-28
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210443184

Write-up: SHINGLES ON WRIST; This spontaneous report received from a patient via a company representative concerned a 40 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 not reported, batch number: Unknown) dose was not reported, administered on 18-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 28-MAR-2021, the subject experienced shingles on wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles on wrist. This report was non-serious.; Sender''s Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.


VAERS ID: 1261353 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: California  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Chills, Computerised tomogram, Discomfort, Dizziness, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (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: Alcohol use (One glass every 4-5-6 months, special occasions only .); Non-smoker; Penicillin allergy
Preexisting Conditions: Comments: The patient had no Known medical history. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of reporting.
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Diagnostic ultrasound; Result Unstructured Data: NEGATIVE; Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: NOT REPORTED; Test Date: 20210415; Test Name: CT scan; Result Unstructured Data: NEGATIVE
CDC Split Type: USJNJFOC20210443650

Write-up: TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST VACCINE PULLING, ON LEFT AND RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.


VAERS ID: 1261381 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:2021-04-15
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210444704

Write-up: BLOOD WITH NUMBER 2''S; COMPLICATIONS OF CHEST PAIN; This spontaneous report received from a consumer concerned a 56 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 not reported, batch number: unknown, expiry: unknown) start therapy date were not reported, 1 total administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that, on 15-APR-2021 (last thursday) the patient had complications of chest pain. On 17-APR-2021 (saturday), she went to emergency room. The team of doctors stated that nothing was wrong with her. The reporter was unable to provide specific information regarding the lot number, date of vaccine received or the location but informed that he can obtain the information and provide it. The reporter was contacted again on 22-APR-2021, where details (age, date of birth) of the patient was provided but was unable to recall the specific date of vaccination. Providing further information it was reported that on 22-APR-2021, the patient had blood with number 2''s, but did not had chest pain anymore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from complications of chest pain on 22-APR-2021, and had not recovered from blood with number 2''s. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210444704-COVID-19 VACCINE AD26.COV2.S-Blood in stool. 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).


VAERS ID: 1261388 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Kentucky  
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 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Confusional state, Disorientation, Feeling hot, Headache, Hypoaesthesia, Palpitations, Pyrexia, Swelling, Tinnitus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataracts (the consumer states that after having received the Janssen Covid-19 vaccine, her eyesight is better and she said she can now see the mountains.)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Fever; Result Unstructured Data: 101.1
CDC Split Type: USJNJFOC20210445248

Write-up: NECK NUMBNESS; NECK SWELLING; POPPING NOISES IN HEAD; FEELING HOT; HEART RACING; CHILLS; HEADACHE; FEVER OF 101.1; DISORIENTED; CONFUSED; This spontaneous report received from a patient concerned a 56 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included cataracts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced disoriented. On APR-2021, the subject experienced confused. On APR-2021, the subject experienced fever of 101.1. Laboratory data included: Fever (NR: not provided) 101.1. On 07-APR-2021, the subject experienced neck numbness. On 07-APR-2021, the subject experienced neck swelling. On 07-APR-2021, the subject experienced popping noises in head. On 07-APR-2021, the subject experienced feeling hot. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck numbness, neck swelling, heart racing, and chills on 09-APR-2021, and popping noises in head, and feeling hot on APR-2021, and the outcome of headache, fever of 101.1, confused and disoriented was not reported. This report was non-serious.


VAERS ID: 1261442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210448391

Write-up: TOE TURNED BLUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-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 APR-2021, the subject experienced toe turned blue. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from toe turned blue on APR-2021. This report was non-serious.


VAERS ID: 1261444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-03-13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site bruising, Lymphadenopathy, Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm cerebral
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210448451

Write-up: SWOLLEN LYMPH NODES; DISCOLORATION ON THE INJECTION SITE (BIG BRUISE); PAIN; VOMITING; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a parent concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced swollen lymph nodes. On 13-MAR-2021, the subject experienced discoloration on the injection site (big bruise). On 13-MAR-2021, the subject experienced pain. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pain, vomiting, swollen lymph nodes, discoloration on the injection site (big bruise), nausea, and fatigue. This report was non-serious.


VAERS ID: 1261450 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2021-04-06
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: Blood test, Dyspnoea, Electrocardiogram, Fatigue, Injection site pain, Mobility decreased, Pain
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE
Current Illness:
Preexisting Conditions: Comments: The patient allergic to triple antibiotic ointment.
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: Blood test; Result Unstructured Data: within normal limits; Test Date: 20210417; Test Name: EKG; Result Unstructured Data: within normal limits
CDC Split Type: USJNJFOC20210448539

Write-up: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.


VAERS ID: 1261867 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-03-30
Onset:2021-04-15
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Death, Hypercoagulation, Mechanical ventilation, Myocardial infarction, Resuscitation, Thrombosis, Transcutaneous pacing
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Plavix Aspirin Fluoxetine Furesemide Atoravastatin Potassium Carvedilol Wellbutrin Spironolactone Norco
Current Illness:
Preexisting Conditions: Congestive Heart Failure
Allergies:
Diagnostic Lab Data: Epinephrine, electrical external pacemaker Breathing machine aka ventalator,
CDC Split Type:

Write-up: Blood clots, heart attack, died, cpr 5 times survived Blood is very thick blood thinners unable to thin


VAERS ID: 1262094 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Maryland  
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 041A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac flutter, Chest X-ray, Chest pain, Chills, Dizziness, Fatigue, Head discomfort, Injection site pain, Migraine, Muscle spasms, Myalgia, Nausea, Pain in extremity, Poor peripheral circulation, Pyrexia, Tinnitus, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; FIORICET; RIBOFLAVIN; TURMERIC [CURCUMA LONGA RHIZOME]; OMEGA 3 6 9 [FISH OIL]; ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]; OXYBUTYNIN; SAVELLA; ZOFRAN [ONDANSETRON]; LOPERAMIDE HCL; HYOSCYAMINE; REMICAIDE; GUAIFENESIN; ZYRTEC [CETIRI
Current Illness: Allergy to animal; Anemia, unspecified; Blood pressure high; Cockroach allergy; Crohn''s ileitis; Cystitis interstitial; Drug allergy (The patient has allergy to Latanoprost eye drops-it feels like alcohol poisoning, Macrobid & Bactrium-Rash, prednsisone at high levels, long term ? steroid myopathy cats, dogs, dust, roaches. Adverse: Penicillin & Elmiron-stomach issues, Statins, Crestor, welchol, Bentyl & Librax-dizziness & fatigue, Mercaptopur (6MP)- nausea, kidney/liver issues, Lyrica- tremors/twitching (stop 11/29/2012) Topimax - numb face and tongue & shock sensations throughout nervous system, Nuvigil ? loose stools, tiredness, nausea, rash. Cymbalta: brain shocks when lowered dose. Budesonide (some steroid myopathy issues after a month of use. Also: weakness, headache, tiredness, dizziness, unusual tiredness, vision problems, mental/mood changes - agitation), muscle weakness/pain), Humira: fibo flare: arm pain and fatigue. Started 10/11/2013 40MG (4 pens), next dose 2 pens 10/25 then one pen every other week. Stopped 11/18/2013. Depakote IV- made migraine worse. Neurontin- may have increased migraine pain Mirena: horrible cramping/blinding pain.); Dust allergy; Fibromyalgia; Gastric polyps; Gastritis; Gastrooesophageal reflux disease; Hemorrhoids; Legs restless; Migraine; Sleep apnea; Spinal stenosis; Triglycerides high
Preexisting Conditions: Medical History/Concurrent Conditions: Automobile accident; Cervical radiculopathy; Degeneration of lumbar or lumbosacral intervertebral disc; Intervertebral disc bulging; Intramedullary rod insertion; Radiculopathy; Smoker (The patient quit Smoking in 2005, smoked 11 years.); Tonsillectomy; Vertebral fracture; Comments: the patient received Vaccines: Engerix-B, Havrix, Hep A & Hep B.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: 99 F; Test Name: Chest X-ray; Result Unstructured Data: unknown; Test Name: Troponin; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210424591

Write-up: TOE CRAMP; FINGER CIRCULATION ISSUE; DIZZINESS; TINNITUS; HEAD VIBRATING; TEETH VIBRATING/CHATTERING; LEG PAIN; FATIGUE; MUSCLE ACHE; SORENESS AT INJECTION SITE; FEVER, HOT FLUSHES THROUGHOUT CHEST; NAUSEA; CARDIAC FLUTTER; CHEST PAIN; MIGRAINE; This spontaneous report received from a patient concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included tonsillectomy, car accident, broken 2nd vertebrae, right femur-metal rod, smoker, radiculopathy 5/6, radiculopathy L5, bulging disc L4/L5, and mild degenerative disc disease L5/S1 and concurrent conditions included allergy to latanoprost eye drops, macrobid, bactrium, prednsisone, penicillin, elmiron, crestor, welchol, bentyl, librax, mercaptopur (6mp), lyrica, topimax, nuvigil, cymbalta, budesonide, humira, depakote IV, neurontin and mirena and very sensitive to medication, high blood pressure when in pain, migraines (neck pain, hormones, weather), fibromyalgia, interstitial cystitis, crohns- ileitis, gastritis, acid reflux, spinal stenosis, haemorrhoids, gastric polyp, high triglyceride''s, low red blood cell count anemia (d and iron-sometimes), possible mild obstructive sleep apnea, restless leg, cats and dogs allergy, cockroach allergy and dust allergy, and the patient received vaccines: engerix-b, havrix, hep a & hep b. The patient was previously treated with botulinum toxin type for migraine, ethinylestradiol/norgestimate for birth control. The patients diet for IC included no maltodextrin, no sorbitol/sucralose/Splenda/equal, low sodium. The patient''s family history included sleep apnea in brother from 1982-2016, muscular dystrophy in maternal grandmother who was deceased at 70 and the mathernal grandmother also had cataracts, stroke, and diabetes and she took Diethylstilbestrol (DES), the patients mother had interstitial cystitis since 1955, hepatitis C, high cholesterol, sleep apnea, restless leg, died of lung cancer, the patients aunt had fibromyalgia, cataracts, and migraines, her cousin had severe Crohn''s, patients paternal grandmother had leukemia and died at 45 years due to suicide, paternal grandfather had breast cancer and died at age of 50 years due to heart disease (heart attack), and her cousin mothers side had history of Crohn''s and diverticulitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A) dose was not reported, administered on 03-APR-2021 at 01:15 in right arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride and guaifenesin for allergies; lisinopril for blood pressure due to back pain; hyoscyamine, infliximab, loperamide hydrochloride and ondansetron for crohns; oxybutynin, amitriptyline and milnacipran hydrochloride for interstitial cystitis and fibromyalgia; omeprazole and sucralfate for gastritis; butalbital/caffeine/paracetamol, curcuma longa rhizome, fish oil and riboflavin for migraine, ascorbic acid, calcium, folic acid, magnesium, and zinc for vitamins supplements. On 03-APR-2021, within 10 mins of vaccination at 01:30 the patient experienced toe cramp. On an unspecified date in APR-2021, the patient experienced finger circulation issue, dizziness, tinnitus, head vibrating, teeth vibrating/chattering, fatigue, muscle ache, soreness at injection site, fever, hot flushes throughout chest, nausea, cardiac flutter, chest pain, migraine, and leg pain and visited emergency room on 10-ARP-2021. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F, Chest X-ray (NR: not provided) unknown, and Troponin (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the toe cramp, fatigue, finger circulation issue, fever, hot flushes throughout chest, soreness at injection site, muscle ache, tinnitus, teeth vibrating/chattering, migraine, cardiac flutter, leg pain, chest pain, head vibrating, nausea and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cardiac flutter. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1262095 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Tennessee  
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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to antibiotics; Congestive heart failure; Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210426651

Write-up: INCREASED CHEST PAIN; This spontaneous report received from a patient concerned a 69 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included congestive heart disease, penicillin allergy, and sulfas allergy. The patient experienced drug allergy when treated with oxycodone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced increased chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased chest pain. This report was non-serious.; Sender''s Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases


VAERS ID: 1262174 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Fibrin D dimer, Foaming at mouth, Ventilation/perfusion scan
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Generalised convulsive seizures following immunisation (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Obesity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Fibrin D dimer; Result Unstructured Data: Elevated; Test Date: 20210414; Test Name: VQ scan; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210431418

Write-up: DEATH; FROTHING AT MOUTH; COVID-19; This spontaneous report received from a consumer concerned a 63 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included obese and diabetes. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in Mar-2021, (7-10 days after vaccination), the patient developed COVID 19. The patient self quarantined for 14 days. On 14-APR-2021, the patient went to emergency room with the complaint of shortness of breath. Her D-Dimer was very elevated, but had a ventilation/perfusion scan (VQ) scan which came back negative. They treated her with heparin. On 15-APR-2021, early morning at 06:00, the patient coded (cardiopulmonary arrest) and frothing at the mouth. The team gave her epinephrine, but did not get a return to circulation. It did not revive her. The patient coded for 30-40 minutes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of covid-19 and frothing at mouth was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0-covid-19 vaccine ad26.cov2.s-Death and Covid 19. 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).; Reported Cause(s) of Death: PATIENT CODED


VAERS ID: 1262189 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-03-23
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Dizziness, Loss of consciousness, Muscle spasms, Nausea, Night sweats, Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431527

Write-up: PASSED OUT; TIGHTNESS IN CHEST; SWELLING IN RIGHT LEG AND RIGHT CALF; DIZZINESS; NAUSEA; STOMACH PAIN; LEG CRAMPS; FOOT PINS AND NEEDLES; LEG PAIN; CHILLS; FEVER; NIGHT SWEATS; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, one total, administered to the left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced night sweats, chills, fever and leg pain. On 30-MAR-2021, the patient experienced leg cramps, stomach pain and foot pins and needles. On 08-APR-2021, the patient experienced swelling in right leg and right calf, tightness in chest, dizziness, nausea and patient passed out The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 08-APR-2021, and night sweats, chills, and fever on 26-MAR-2021, and had not recovered from leg pain, stomach pain, foot pins and needles, swelling in right leg and right calf, tightness in chest, dizziness, nausea, and leg cramps. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- covid-19 vaccine ad26.cov2.s -Passed out. 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).


VAERS ID: 1262195 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-03
Onset:2021-04-23
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN JOHNSON / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Crohn?s
Allergies: None
Diagnostic Lab Data: April 25, 2021 ultrasound
CDC Split Type:

Write-up: Deep vein thrombosis


VAERS ID: 1262196 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-14
Onset:2021-03-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Dizziness, Headache, Hypoaesthesia, Immediate post-injection reaction, Migraine, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Topamax Gabapentin Meloxicam Amitriptyline Latanoprost Eyedrops Broadline Eyedrops
Current Illness:
Preexisting Conditions: Migraines-controlled Gastroparesis Connective tissue disorder Low Tension Glaucoma
Allergies: Levaquin Sulfa CT Contrast Histamines Eggs, Walnuts, Pineapple, Cannabis strain(closes my throat)
Diagnostic Lab Data: CT Scan-by Hospital Blood Work
CDC Split Type: vsafe

Write-up: I had a rash from the shot and an immediate headache in my temple right above my eye. I started to get Migraines which became very painful four days after the vaccine. I had to go to the ER because the pain was so bad one day that I almost passed out. It is a much different pain than my normal Migraines my left arm and leg were numb. I have been getting Migraines daily for five weeks now. I have been trying to control my diet and switched medication in an effort to control the Migraines. The medication helps a little if I take it early. I also still get a little of the numbness in the left side of my body. All services provided by insurance company.


VAERS ID: 1262198 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-16
Onset:2021-04-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Chills, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: headache, chest pain, fever/chills


VAERS ID: 1262263 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Wisconsin  
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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Feeling abnormal, Sinusitis
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular 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:
Current Illness: Anxiety; Blood pressure high; Drug intolerance (The patient had Tylenol allergy. It was an intolerance rather than an allergy. When she took Tylenol she shakes.); Seasonal allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210432044

Write-up: SINUS INFECTION; CHILLS; FOGGY FEELING IN HEAD/ DID NOT FEEL LIKE HERSELF; DIZZINESS; This spontaneous report received from a patient concerned a 60 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure, anxiety, seasonal allergies, and drug intolerance. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced foggy feeling in head/ did not feel like herself. On APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sinus infection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, had not recovered from foggy feeling in head/ did not feel like herself, and dizziness, and the outcome of sinus infection was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious


VAERS ID: 1262382 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-06
Onset:2021-04-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft, Prevacid
Current Illness:
Preexisting Conditions:
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested for Covid 8 days after vaccination


VAERS ID: 1262401 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-10
Onset:2021-04-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deep vein thrombosis, Injection site mass, Injection site pain, Movement disorder, Pain, Thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: atenolol-chlorthalidone 100-25 alprazolam 1-3 mg for sleep only Januvia 50 mg
Current Illness:
Preexisting Conditions: Diabetes 2
Allergies: sulfa drugs metformin certain high blood pressure medicine, in medical charts, name unknown at the time
Diagnostic Lab Data: Vascular ultra sound down on left arm, covid vaccine arm.
CDC Split Type:

Write-up: Throbbing pain at injection site and entire arm. Unable to move up without assistance. Pain grew more and more intense. Went to urgent care on unspecified date. NP examined me and discovered a lump in my arm. Both the lump and the vaccination site hurt when she pressed on them. She prescribed presdone and gave me a work order for a vascular ultrasound to be performed on my left arm. I went on unspecified date for the scan. It was discovered that a DVT blood clot had formed in my brachial vein in the left arm. I was then prescribed eliquis, 20 mg a day for 7 days and told not to take the predesone. NP called my pcp, his office immediately called me and asked me to come in as they are concerned about the high dosage of the eliquis.


VAERS ID: 1262430 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye swelling, Eyelid function disorder, Fatigue, Hypersomnia, Migraine, Periorbital swelling, Somnolence
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: oxycodone flexeril estrolven
Current Illness: no
Preexisting Conditions: Chronic back issues Degenerative disc disease
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day vaccine was administered to patient the only effective on that date was Tired and drowsiness were experienced. in the late afternoon this condition was only intensified . The next business day was difficult due to a Migraine that was in full force on that Friday. Patient was unable to perform any actions including Work from home. Patient slept for the next 20 hours. Other than sleep no other actions were committed. On that date 3/19/2021 it was noticed that her eyes were sensitive to Light and were also very puffy.. On the Sunday there was little and or no change still sensitive to light and the puffiness was still felt but the eyes were so swollen that it was almost impossible to open them. The Urgent care patient went to on the Sunday was the initial with Healthcare facility


VAERS ID: 1262471 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: My Adverse event is strong head ache, A weird Rash in my Body. Its been like that for 1 week and doesn''t want to go. I''m not allergic to nothing. I put the Vaccine the 03/30/21 and the rash star the 04/19/21. I went to emergency and the prescribe, Medrol 4mg and Benadryl 25mg. I try Benadryl for days but didn''t do nothing, and I''m going to make a appt with my Doctor as soon as possible.


VAERS ID: 1262490 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-18
Onset:2021-03-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Cardiomegaly, Chest pain, Hiatus hernia, Hypokalaemia, Oesophageal stenosis, Pericardial effusion, Pericarditis, Pleural effusion, Pneumonia
SMQs:, Cardiac failure (broad), Systemic lupus erythematosus (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Taking Ventolin HFA 108 (90 Base) MCG/ACT Aerosol Solution 1 puff as needed Inhalation every 4 hrs, Taking Imipramine HCl 50 MG Tablet 1 tablet Orally Once a day, Taking Triamcinolone Acetonide 0.1 % Cream apply small amount with q tip to e
Current Illness: Patient is a stable type 2 diabetic other than that no illnesses prior.
Preexisting Conditions: Patient had no other long standing chronic health condition.
Allergies: Allergies: Codeine Phosphate, Losartan Potassium, ACE Inhibitor, Milk, Caffeine.
Diagnostic Lab Data: testing and bloodwork was performed in hospital.
CDC Split Type:

Write-up: 03/28/2021 to 03/30/2021- Admitted Ip via E/R , Dx: Pneumonia, Cardiomegaly, Small pericardial effusion, Esophageal stenosis (s/p dilation), Small hiatal hernia. F/U with PCP for Hopital F/u on 04/01/2021. Visit ER on 04/03/2021- 04/05/21 04/14/21-ReAdmitted IP via E/R. -Dx: Dx: Chest pain, Pericarditis w/ mod-large Pericardial effusion (s/p pericardiocentesis), Hypokalemia, Pleural Effusion (s/p thoracentesis)


VAERS ID: 1262491 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-19
Onset:2021-03-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Guillain-Barre syndrome, Pain, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), 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? No
Previous Vaccinations:
Other Medications: multivitamin
Current Illness: none
Preexisting Conditions: none
Allergies: sulfa, walnuts, apples
Diagnostic Lab Data: Complete blood panel, chest x-ray, EKG
CDC Split Type:

Write-up: Onset of symptoms: piercing sensation in legs, feet, ankles, knees and leg . Pain and pins and needles. Worsened at night. Tingling in fingers. 1:) Urgent care 2.) ER Dept 3.) Primary Care Dr. suspected Guillian Barre


VAERS ID: 1262541 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes zoster, Oral viral infection
SMQs:, Oropharyngeal infections (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I went to the emergency room and followed up with doctor
CDC Split Type:

Write-up: I was diagnosed with oral shingles on april 17th, symptoms started on April 13th


VAERS ID: 1262582 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-03-23
Onset:2021-04-05
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Full blood count, Headache, Metabolic function test, Urine analysis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Well Buterin
Current Illness: None
Preexisting Conditions: Asthma, anxety
Allergies: None
Diagnostic Lab Data: CB Scan, CBC, Urinalysis, BMP
CDC Split Type:

Write-up: Headaches


VAERS ID: 1262588 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-10
Onset:2021-04-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion, Dyspnoea, Fibrin D dimer increased, Headache, Injection site bruising
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Patient went to the emergency department on 4/26/21 and she said tests/scans were done. They found that her D-dimer was elevated which doctors think is what is causing the bruising. They did not find any blood clots in her system. She said she will follow up with her primary care physician.
CDC Split Type:

Write-up: Patient states that bruising started about 3 days after her shot. The bruising started at the injection site, then it spread to her left leg and thigh. She woke up two days ago with bruises on her shin. Her on/off headaches began when bruising started. They intensified when her shortness of breath began three days ago.


VAERS ID: 1262665 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-05
Onset:2021-04-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Headache, Limb discomfort, Pain, Pain in extremity, Pelvic pain, Ultrasound scan
SMQs:, Tendinopathies and ligament disorders (broad), Sexual dysfunction (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: Daily multivitamin
Current Illness: Between 7 hours and 14 hours after having vaccine on 4/5/21, I had severe chills, severe headache, internal sharp pain in my pelvis (right and left side).
Preexisting Conditions: None
Allergies: Levofloxacin (Levaquin)
Diagnostic Lab Data: Wed 4/14/21 - Sought medical attention at ED. Was evaluated for blood clots, none found on this day. CT scan, ultrasound of both legs, blood tests. Returned home with directions to take Extra Strength Tylenol for headache.
CDC Split Type:

Write-up: Mon 4/12/21 - Headaches started and have continued daily. Tue 4/13/21 - Soreness in right calf muscle, continued for 4 days. Headache continued. Wed 4/14/21 - Sharp pain in pelvis (right and left side) same location I experienced pain the day of receiving vaccine. Occasionally felt this pain 2 or 3 times / day for 2 days. Sought medical attention at ED on the advice of our Nurse Call Center. Was evaluated for blood clots, none found on this day. CT scan, ultrasound of both legs, blood tests. Returned home with directions to take Extra Strength Tylenol for headache. Thu 4/15/21 - Shooting pain in random parts of my body, mostly legs and arms. Experienced throughout this day only. As of 4/27/21, 22 days after being vaccinated, I am still experiencing headaches. More noticeable when I am exerting myself - walking outside for 1-2 minutes triggers the headache. Headaches are usually located in the lower back of my head. Before being vaccinated, I would experience less than 1 headache per month, and they go away within the day.


VAERS ID: 1262676 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN LOT 206A21A EXP / 1 LA / SYR
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER E / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test abnormal, Procalcitonin increased, Pruritus, Rash, Skin irritation, Skin test negative, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lamictal, Junel
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood tests done. Allergy panel negative for allergic reaction. White blood cell and procalcitonin count high.
CDC Split Type:

Write-up: On 4/18 woke up with a rash on arms, legs, butt, and back. Went to Urgent care and was given a steroid and benadryll. That evening the rash intensified and went to the emergency room. Was admitted so they could monitor the rash. Was discharged on 4/20 with instruction to start a steroid pack and continue with benadryl cream, benadryl, claratin and pepcid. Rash is still continuning to appear as of 4/27/21. Very itchy and irritating. TRYING TO ENTER HOSPITALIZATION DATES IN PART 21 BUT IT WILL NOT ALLOW ME TO TYPE ANYTHING. , 2 DAYS STAY,


VAERS ID: 1262703 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-03-13
Onset:2021-03-29
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cerebrovascular accident, Hospitalisation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: lexapro hctz thyroid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hospital stay 03/30/2021
CDC Split Type:

Write-up: Stroke


VAERS ID: 1262795 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-04-06
Onset:2021-04-22
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, COVID-19, Computerised tomogram thorax, Cough, Dyspnoea, Pulmonary embolism, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: insulin-dependent type 2 diabetic, hypertensive, high cholesterol
Allergies: NSAIDs
Diagnostic Lab Data: COVID-19 BioFire CTA Chest
CDC Split Type:

Write-up: Patient developed cough, fever, shortness of breath on 4/22/21. Tested positive for COVID-19 and was found to have a pulmonary emoblus in the ER on 4/27/21. She is currently admitted at Hospital, under my care. I''m also her primary care physician.


VAERS ID: 1262842 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Unknown  
Location: Connecticut  
Vaccinated:2021-03-15
Onset:2021-03-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Retinal detachment, Retinopexy, Surgery, Visual impairment, Vitreous floaters
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Two days after being vaccinated I developed floaters in my right eye. This continued for 2-3 days and then my eye sustained a detached retina. I require a emergency surgery to save my vison. A week later I had to have a second surgery to complete the repairs of the detached retina. 6 weeks later vison is not restored to where I was prior to the detachment.


VAERS ID: 1262914 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Blood test abnormal, Cardio-respiratory arrest, Death, Decreased appetite, Discoloured vomit, Endotracheal intubation, Eye movement disorder, Hallucination, Headache, Nausea, Pain in extremity, Screaming, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ocular motility disorders (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin 81 mg qd, Lisinopril 5mg qd, gabapentin 800mg qd, vasa statin 20mg qd, furosemide 40mg qd, magnesium oxide 400mgqd, carvedilol 25mg qd, metformin 1000mg qd
Current Illness:
Preexisting Conditions: Diabetes, Pacemaker, Heart Condition
Allergies: nka
Diagnostic Lab Data: Blood Test
CDC Split Type:

Write-up: pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated.


VAERS ID: 1263011 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Pyrexia, Thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: tylenol, ibu
Current Illness: none
Preexisting Conditions: none
Allergies: PCN, IV Contrast, Macrobid
Diagnostic Lab Data: none. Pt is saying you can see the blood clot
CDC Split Type:

Write-up: Fever over 105, chills, cough, soar throat. aches and pain for 2 days. Led patient to go to the ER on monday 4/12. MD found blood clot at that point. No treatment was given patient was told to follow up with her PCP. Did not go to PCP as yet.


VAERS ID: 1263053 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I reported my reaction but wanted to report that I am still having symptoms. I continue with intermittent nausea and headaches, poor appetite, body aches and joint pain.


VAERS ID: 1263056 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Electromyogram normal, Fatigue, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging normal, Muscular weakness, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: time unknown-pnemonia-brand unknown-arm infection
Other Medications: methrotresate, ibuprophen, folic acid, restasis, ometrosol, methosinodate
Current Illness: no
Preexisting Conditions: RA, Crest Syndrome
Allergies: gluten, cipro, amoxicillin, Z-Pack, floxin
Diagnostic Lab Data: EMG-normal MRI-normal
CDC Split Type: vsafe

Write-up: I had an EMG performed last week which was normal and a F/U with the neurologist because I am still experiencing the numbness to the right side of my body and when performing activities it gets worse. I have developed a limp and I dont have the strenght in my hands and feet that I once had. When I push myself to perform activities the numbness , fatigueness, and pain is just so intense that its nearly impossible. If I continue to try to push myself to perform activities its as if my body begins to shut down and does nothing. Its as if im ok until I begin to perform any body activities.


VAERS ID: 1263096 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Confusional state, Decreased appetite
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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:
Current Illness:
Preexisting Conditions: prior gastric cancer and colon cancer, HTN, DM, dementia
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: decreased appetite and confusion for 2 weeks since getting vaccine


VAERS ID: 1263112 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20121A / N/A RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity
SMQs:, 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: unknown
Current Illness: none
Preexisting Conditions: lyme disease, headache, arthralgia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccine. She states symptoms started 24 hours after vaccine and has not resolved. Patient advised to proceed to the nearest ER for evaluation for potential side effect due to J&J vaccine. Patient states understanding.


VAERS ID: 1263158 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-27
Onset:2021-04-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Face injury, Fall, Nausea, Skin laceration, Syncope, Traumatic haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? No
Previous Vaccinations:
Other Medications: NO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: THE PATIENT RECEIVED JANSSEN COVID 19 VACCINE IN THE LEFT ARM. I RECOMMENDED TO SIT FOR 15 MINUTES TO OBSERVE THE PATIENT. PATIENT REQUESTED TO USE THE BATHROOM IN THE PHARMACY RIGHT AFTER VACCINE. PATIENT CAME BACK FROM THE BATHROOM SAYING THAT HE FAINTED AND FELL IN THE BATHROOM AND SLASH OPEN THE LEFT SIDE OF HIS CHEEK WAS BLEEDING A LOT AND HE FELT DIZZY AND NAUSEA. HE FAINTED THE SECOND TIME ON THE FLOOR. 911 WAS CALLED PROMPTLY. POLICE AND AMBULANCE CAME TO GO TO THE HOSPITAL.


VAERS ID: 1263160 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20121A / N/A RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity
SMQs:, 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: Cromolyn Sodium, Levocetirizine, Lisinopril -HCTZ, Montelukast, Omeprazole,
Current Illness:
Preexisting Conditions: Cannabis use, chronic Fatigue, cocaine use, GERD, Hypertension, Tobacco Use, Cardiac Murmur
Allergies: Aspirin
Diagnostic Lab Data:
CDC Split Type:

Write-up: From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccine. She states symptoms started 24 hours after vaccine and has not resolved. Patient advised to proceed to the nearest ER for evaluation for potential side effect due to J&J vaccine. Patient states understanding.


VAERS ID: 1263183 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-06
Onset:2021-04-03
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abdominal pain lower, Ultrasound pelvis
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Falmina birth control
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pelvic Ultrasound Pathology
CDC Split Type: vsafe

Write-up: Four weeks after the vaccine I started to have lower abdominal pain for a 24-hour period. I am on Birth Control, Falmina and it was before the Placebo Pills Started. I passed a large clot of blood the next day and went to Urgent Care. It was sent for Pathology and it was deemed a Deciduous casting. I had a Pelvic Ultrasound the following week and it was normal. The clinic I went to for follow up was.


VAERS ID: 1263262 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-06
Onset:2021-04-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Dyspnoea, Pain in extremity, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: Acarbose 50 mg PO TID Alprazolam 0.25 mg PO QD PRN anxiety Lamotrigine 100 mg PO HS Lisinopril 20 mg PO QD Simvastatin 20 mg PO HS Vilazodone 40 mg PO QD
Current Illness:
Preexisting Conditions: Anxiety Depression HTN HLD Sleep Apnea Morbid Obesity
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received J&J vaccine at 4/6/21. She began complaining of calf pain 1 week later. She was diagnosed with DVT and started on Eliquis 10 mg PO BID x 7 days on 4/15/21, followed by 5 mg PO BID on 4/22/21. She continued to complain of shortness of breath. CT chest was done to rule out PE. She was diagnosed with PE and sent to the emergency room for a continuous heparin drip (despite adequate anticoagulation with Eliquis) She is saturating at 97% on room air. Her BP is stable. She is afebrile Of note, she is morbidly obese Her height is 64 in (5'' 4") Her weight is 106 kg (233 lbs) Her BMI is 39.99 kg/m2 She is not on any hormone replacement therapy, contraceptives, etc. Her last known use of oral contraceptives was 10 years ago. She is not an active smoker


VAERS ID: 1263264 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-06
Onset:2021-04-22
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Bell's palsy, Hemiplegia, Hypoaesthesia, Neck pain, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Arthritis (broad), Sexual dysfunction (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: April 22nd, woke with neck pain. Persisted for 2 days and developed tingling of one side (left) of the tongue. Continued pain and numbness until unspecified time when left sided paralysis began. Went to ER and was diagnosed with Bell?s Palsy. Taking a steroid and Valtrex as prescribed by hcp.


VAERS ID: 1263321 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-02
Onset:2021-04-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Eye pain, Facial paralysis, Facial paresis, Fatigue, Myalgia, Ocular discomfort, Oropharyngeal pain, Pain of skin, Photophobia, Plasmapheresis, Sciatica, Sensitive skin
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune 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? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Coconut flesh/milk BHA BHT TBHA food preservatives
Diagnostic Lab Data: I am still in the hospital. If this is important I can provide my medical records.
CDC Split Type:

Write-up: On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Clothing was uncomfortable when it moved across my skin. Those symptoms lasted about a week. Then as they started to lessen I had some back pain (Sciatic) and a sore throat. Also the muscles behind my eyes were slightly painful and bright lights were uncomfortable. Then about 4/21 most of the symptoms reduced and I was feeling close to normal. Then on 4/22 I was brushing my teeth and noticed that I couldn?t spit water like normal. I called my GP doc and she recommended I head to the ER. After thinking about it I also remember on 4/21 while drinking something I had some water squirt out of my lips. At the time I thought I was just being clumsy but in hindsight the muscle weakness in my face started on 4/20. I checked into the ER on 4/22. When I checked into the hospital my facial weakness was very difficult to notice. By the evening of 4/22 it was noticeable if I tried to ?show my teeth? or make a big smile. By the morning of 4/23 it was very noticeable. The morning of 4/24 I couldn?t move my lips, nose or eyebrows. My tongue, jaw and throat were not impacted at all. I was started on plasmapheresis on 4/24. I had another treatment on 4/25. I noticed facial weakness was very slightly recovering the evening of 4/25. By 4/27 my facial weakness is still healing with noticeable improvement day to day.


VAERS ID: 1263365 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-03
Onset:2021-04-16
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Pain in extremity, Platelet count normal, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (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: Combination oral contraceptive
Current Illness: None
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 30yo female has been on combination oral contraceptive for 15 years, no PMH, no person/family hx of VTE. 2 weeks prior received Johnson & Johnson COVID vaccine, 2 days later develops bilateral calf pain which progressed until 3 days prior to Emergency Dept arrival when PCP ordered ultrasound, showed non-occlusive DVT in the left common femoral vein and no right leg DVT. Non-smoker. D-dimer 0.32 ug/mIFEU, platelets normal at 269k. Treated by starting apixaban and stopping combination oral contraceptive, discharged home from Emergency Dept with follow-up.


VAERS ID: 1263423 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous thrombosis, Magnetic resonance imaging head abnormal, Thrombotic cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: gabapentin, omeprazole
Current Illness: none
Preexisting Conditions:
Allergies: ibuprofen (gastritis)
Diagnostic Lab Data: MRI brain 4/23/21
CDC Split Type:

Write-up: New small left frontal venous infarct with evidence for cortical vein thrombus


VAERS ID: 1263463 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fall, Hypoaesthesia, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Sexual dysfunction (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: None known
Current Illness: none reported
Preexisting Conditions: none reported
Allergies: none known
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: 1432hr Pt fell to the ground c/o shortness of breath & dizziness. Dose of J+J vaccine given about 15 minutes prior. B/P 70/50 HR 84 SPO2 100% on R.A., Lungs clear bilateral. Pt complained of tingling in both hands & feet. Pt refused epi but agreed to Benadryl 50MG po Liquid. Benadryl Administered at 1435hrs no improvement, pt feeling more short of breath & Numbness in Lt arm, 1 dose of epi administered at 1440. Pt had no improvement, pt complained of numbness now in right arm. At 1445 a 2nd epi pen was administered. 1447 pt stated he was feeling better. VS taken BP 100/60 R.24 HR 80 SPO2 97% RA. Lungs Clear bilateral. EMS arrived @1448. Pt stable and was transported to the hospital.


VAERS ID: 1263467 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-03-13
Onset:2021-03-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Bursitis, Chest X-ray abnormal, Chills, Computerised tomogram thorax abnormal, Deep vein thrombosis, Immediate post-injection reaction, Influenza, Joint swelling, Magnetic resonance imaging abnormal, Pain in extremity, Pulmonary embolism, Pyrexia, Ultrasound Doppler abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen, allopurinol, amlodipine, apixaban, clonidine
Current Illness: Regular Health Issues
Preexisting Conditions: Chronic Gout, Type 2 diabetes ,Hyperlipdemia, Essential Hypertension, Tobacco dependence, Right inguinal hernia, gerd
Allergies: Gemfibrozil, Statins, Lisinopril
Diagnostic Lab Data: Xrays, MRI, CT Scans, Ultrasound, Blood Test
CDC Split Type:

Write-up: Immediately after shot had fever and chills with flu symptoms for about 4-5 days after vaccination. On 3/22 went to urgent care for left elbow swelling which had never occured before in this joint visit deteremined was olecranon bursitis. The very next day began complaining about leg pain around 3/23 and by 3/26/2021 pain was unbearable in the leg and went to ER where patient was then admitted for DVT and pulmonary embolisms.


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