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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: 1248237 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-05
Onset:2021-04-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Cough, Dyspnoea, Gait disturbance, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: NONE
Preexisting Conditions: CHILDHOOD ASTHMA - resolved in high school TREE NUT ALLERGY
Allergies: TREE NUTS
Diagnostic Lab Data:
CDC Split Type:

Write-up: Got vaccine at 7:30 PM. On 4/6/2021 woke up at 2:20 AM with RIGORS. No fever. Difficulty walking. Wheezing and trouble breathing. In ER initial pulsox was 88% but reduced to 42% and difficult to obtain BP. Given oxygen, epinephrine, magnesium, steroids and albuterol. Discharged but continues with coughing and wheezing.


VAERS ID: 1248268 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Blood lactic acid, Dehydration, Differential white blood cell count, Dizziness, Fatigue, Full blood count, Metabolic function test, Pain, Pyrexia, SARS-CoV-2 test, Troponin I
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), 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: Bupropion 300mg once a day
Current Illness: 24 flu 2 weeks prior. Tested at time, NOT COVID
Preexisting Conditions: None
Allergies: none
Diagnostic Lab Data: April 13, 2021 Rushed to Hospital CBC with Automated Diff, Troponin I, Lactic Acid W/Reflex, Metabolic Panel, Comprehensive, POC Covid-19 test Ketorolac (Toradol) given at 6:34 PM, Sodium Chloride
CDC Split Type:

Write-up: Bodily aches and pains, Fatigue, Lightheadedness, Fever, Acute and extreme weakness (Rushed to Hospital) Dehydration


VAERS ID: 1248277 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Full blood count normal, Pain, 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: Oral contraceptive - Cryselle
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CBC test on the 16th and 23rd, both came back normal but pain continues (day 15)
CDC Split Type:

Write-up: Since day 5 post-vaccine, I have been having short, stabbing pains in various areas of the body, but primarily legs. These pains last anywhere from just a second to maybe a full minute before going away and coming back - sometimes within a couple minutes, sometimes longer like 30 minutes.


VAERS ID: 1248311 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: School       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Dyspnoea, Groin pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Osteonecrosis (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: none
Current Illness: none
Preexisting Conditions: allergic rhinitis, asthma
Allergies: morphine
Diagnostic Lab Data: records not available to review
CDC Split Type:

Write-up: constant back pain that started on April 11 presented to ER on April 19 for back pain and abdominal pain, afraid that she has a clot a few days ago, started having shortness of breath and left leg pain that radiates to the left groin


VAERS ID: 1248330 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-03-09
Onset:2021-04-19
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 5 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Muscle spasms, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), 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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: n/a
Preexisting Conditions: chronic
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient has leg cramps starting on Monday, April 19th. She went to the hospital at later date. Doctor diagnosed her with leg clot.


VAERS ID: 1248402 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Dizziness, Headache, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (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: Allegra Flonase
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood work CT scan
CDC Split Type:

Write-up: I?m currently 13 days post vaccine. I?m experiencing constant dizziness and headaches My right arm was numb for approx 12 days afterwards.


VAERS ID: 1248564 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-04-11
Onset:2021-04-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram cerebral normal, Atelectasis, Blood calcitonin normal, Blood culture negative, Chest X-ray abnormal, Computerised tomogram abdomen, Computerised tomogram thorax abnormal, Echocardiogram abnormal, Electronic cigarette user, Headache, Hunt and Hess scale, Hydrocephalus, Hypoxia, Legionella test, Lung opacity, Oxygen saturation decreased, Oxygen therapy, Pleural effusion, Pulmonary arterial pressure abnormal, Pulmonary congestion, Pulmonary hypertension, Respiratory distress, SARS-CoV-2 test negative, Subarachnoid haemorrhage, Urine analysis normal, Ventricular drainage, Viral test, Viral test negative, Vomiting, Wheezing
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: 4/21 Chest X-Ray - mild pulmonary congestion 4/22 CT chest/abd/pelvis - no pulmonary embolism, bilateral opacities/ground glass, bilateral pleural effusions, bil atelectasis 4/22 ECHO - Ejection Fraction 60-65%, normal biventricular function, mild pulmonary hypertension, PASP 36 4/22 Chest X-ray - diffuse, bilateral pulmonary congestion 4/23 Chest X-ray - improving pulmonary congestion COVID negative x 3 (4/17, 4/22, 4/23) VIRAL PCR negative 4/22 Blood Culture - no growth to date 4/22 Ua - neg 4/22 S. pneumoniae urine - negative 4/22 urine legionella - negative 4/22 procalcitonin < 0.1 (negative)
CDC Split Type:

Write-up: Patient was doing paperwork when he experienced the worst headache of his life on 4/17 with associated emesis. Patient found to have a Hunt Hess 3 Fisher Grade 3 Subarachnoid Hemorrhage with hydrocephalus s/p EVD, s/p cerebral angiogram on 4/18 negative for aneurysm/AVM. On the evening of 4/20, patient became acutely hypoxic with wheezing for which he required oxygen via 10L oxymask. During 4/21, his oxygen requirements continued to increase with increased work of breathing requiring high flow nasal cannula (HFNC) at 50L/60% + pulmonary congestion on imaging and he was treated with diuresis. On 4/22, oxygen needs increased requiring 70L/100% with worsening imaging. He was then started on steroids, antibiotics were broadened, epoprostenal started in addition to diuresis. On 4/23, patient reports improved breathing and is on non-rebreather. Antibiotics, steroids, and epoprostenal were discontinued as patient showed improvement of oxygenation without clear signs of infection. Of note, patient reports vaping in the past 2-3 months. Patient has also been intermittently febrile. Wife was concerned that these symptoms were possibly related to him getting the J&J vaccine on 4/11. Patient is currently still in hospital on day 6 of admission at this time.


VAERS ID: 1248591 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-03-09
Onset:2021-03-30
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Heart rate decreased, Loss of consciousness, Pain in extremity, Ultrasound scan normal, Urine analysis
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levoxythyrone, Zidas zyprexa, vitamins B, D, C, zinc, magnesium, baby aspirin, cranberry pill, colace
Current Illness: None
Preexisting Conditions: Thyroid
Allergies: Penicillin, sulfa drugs
Diagnostic Lab Data: On 3/24/21, had ultrasound of right leg, nothing observed. On 3/30/21, numerous blood work, ekg, urine test. On 3/31/21 had CAT scan of abdomen and pelvis with contrast. Positive urine test.
CDC Split Type:

Write-up: On 3/24/21, pain in right leg. On 3/30/21, pulse dropped to 37 and she passed out and was unable to recover, so called 911


VAERS ID: 1248777 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Immediate post-injection reaction, Oropharyngeal pain, Swelling face, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt presented to UC for facial swelling and throat closing sensation. Pt received Johnson and Johnson covid vaccine 4/9 and reports facial swelling, throat closing sensation, and throat pain immediately following vaccination; states she was transported to ER following that vaccine and treated with prednisone. Patient states she was doing well, but began to experience for facial swelling and throat closing sensation again today. Patient treated with 0.3mg epinephrine and 50mg Benadryl IM. Transported to hospital via EMS.


VAERS ID: 1248833 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-25
Onset:2021-04-22
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Lung opacity, Mental status changes, Pyrexia, SARS-CoV-2 test positive
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: insulin, lasix, ceftazidime, amlodipine, metoprolol, losartan, keppra, nystatin, lactulose, oxybutynin, calcium acetate, calcitriol, atorvastatin, sinemet, aspirin, senna, tylenol
Current Illness: delirium, UTI
Preexisting Conditions: HTN, DM2, parkinsons disease, urinary retention s/p suprapubic catheter, seizure, ESRD on PD, sacral decubitus ulcer, dyslipidemia,
Allergies: none
Diagnostic Lab Data: CXR with opacities, COVID PCR+ (NP swab) on 4/22.
CDC Split Type:

Write-up: Admitted to hospital 4/22 with altered mental status and fever. Found to be COVID+ by PCR.


VAERS ID: 1248836 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Facial discomfort, Headache, Hypoaesthesia, Oropharyngeal discomfort, Pain in extremity, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (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: B complex Ayurveda herbal remedies
Current Illness:
Preexisting Conditions:
Allergies: Aspirin
Diagnostic Lab Data: None so far the doctor suggested an allergy test but ignored the leg complain
CDC Split Type:

Write-up: I had severe headaches and very sharp sight on the first day. The next day I experienced a strange leg numbness in the middle of the night. A week later as I was traveling I had a very bad allergic reaction that required me to call 911, as the throat swallowed. I am still experiencing leg pain when I walk. Sometimes the face feels tight also and I?m not sure this is something from the vaccine.


VAERS ID: 1248862 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-03-15
Onset:2021-03-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Autopsy, Cardiac arrest, Chest X-ray abnormal, Cough, Death, Dyspnoea, Endotracheal intubation, Feeling hot, Impaired work ability, Insomnia, Myocardial infarction, Peripheral swelling, Poor peripheral circulation, Pulmonary oedema, Pulse absent, SARS-CoV-2 test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 6
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: Metformin Atorvastatin Lisinipril HCL Lantus
Current Illness: none
Preexisting Conditions: Diabetes
Allergies: none
Diagnostic Lab Data: Covid tests neg on 3/15, 3/17 (fast and PCR), and post mortem on 3/22. Chest xray on 3/22 showed fluid thus difficulty breathing Dr said heart attack 3-5 days prior and cardiac arrest 1 hr before pronounced dead.
CDC Split Type:

Write-up: Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.


VAERS ID: 1248922 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-03-06
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210313384

Write-up: CHILLS; FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. 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: 1249023 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802072 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Dehydration, Dysphagia, Headache, Heart rate increased, Lymphadenopathy, Nausea, Peripheral coldness, Pyrexia, SARS-CoV-2 test, Swelling, Thirst, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), COVID-19 (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: SYMBICORT; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THI; HORMONES
Current Illness: Alcohol use (For a month); Allergy to animal (Dog); Allergy to molds; Asthma; COPD; Drug allergy; Dust allergy; Fibromyalgia; Joint pain; Joint swelling; Non-smoker; Osteoarthritis; Ragweed allergy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: The patient had no illness at time of vaccination. The patient had no past history of similar events. The patient had no pre-existing acute illness in 30 days prior to vaccination. The patient had no hospitalization in last 30 days prior to vaccination. The patient had no family history of any disease or allergy.
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20210317; Test Name: Body temperature; Result Unstructured Data: 99.4 deg
CDC Split Type: USJNJFOC20210340741

Write-up: SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient''s weight was 190 pounds, and height was 155.44 centimeters. The patient''s past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender''s Comments: This case was non serious


VAERS ID: 1249090 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Blood pressure increased, Blood pressure measurement, Dizziness, Influenza like illness, Muscle spasms, Nausea, Neuralgia, Pruritus, Sinus congestion, Spinal pain, Swelling face, Tremor, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (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: no known drug allergies
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 160/90 mmHg; Test Date: 20210408; Test Name: Blood pressure; Result Unstructured Data: 240/130 mmHg; Test Date: 20210409; Test Name: Blood pressure; Result Unstructured Data: 153/87 mmHg
CDC Split Type: USJNJFOC20210417592

Write-up: SINUS CLOGGED/ SINUS HEADACHE; SHOOTING NERVE PAIN IN BACK; FACE SWOLLEN; SHAKES; ITCHY; SHARP NERVE PAIN IN SPINE; INCREASED BLOOD PRESSURE; FEELING LIKE FLU; ARTHRITIC PAIN; LEG CRAMPS; NAUSEA; DIZZINESS; ANXIETY; BLURRING OF EYES; This spontaneous report received from a patient concerned a 49-year-old female. The patient''s weight was 185 pounds, and height was not reported. The patient''s pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, Laboratory data included: Blood pressure (NR: not provided) 160/90 mmHg. On 08-APR-2021, within 5 minutes after vaccination the patient experienced dizziness, chills with shakes, nausea, anxiety and 20 minutes later she was evaluated by an emergency medical services onsite. On 08-Apr-2021, Blood pressure (BP) reading was 240/130 mmHg. She was kept under evaluation at the vaccination site until BP was 160/90. She experienced pain (body aches, shooting nerve pain in back with itching, arthritic pain from neck to spine and in hands) which began around midnight on 09-Apr-2021 and in morning she experienced full blown flu (ringing of ears, face swollen, sinus clogged, headache, body ache, chill). On 09-Apr-2021, Blood pressure (BP) reading was 153/87 mmHg The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, blurring of eyes, and nausea on 08-APR-2021, had not recovered from increased blood pressure, itchy, arthritic pain, sharp nerve pain in spine, leg cramps, feeling like flu, and anxiety, and the outcome of sinus clogged/ sinus headache, shooting nerve pain in back, face swollen and shakes was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210417592-Covid-19 vaccine ad26.cov2.s-Increased 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: 1249109 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-04-03
Onset:2021-04-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate increased, Laboratory test, Magnetic resonance imaging, Pulmonary embolism, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None at time
Current Illness: None
Preexisting Conditions: None
Allergies: Arithmerisn
Diagnostic Lab Data: Echocardiogram, ekg, chest X-ray, full body ultrasound, mri, ct scan. Blood work. More unknown tests
CDC Split Type:

Write-up: Pulmonary embolism. Chest pain, shortness of breath, rapid heart rate.


VAERS ID: 1249112 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-03-08
Onset:2021-03-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Blood test, Chills, Computerised tomogram, Headache, Hepatic function abnormal, Impaired work ability, Inflammatory marker increased, Liver function test decreased, Magnetic resonance imaging abnormal, Myalgia, Nausea, Pyrexia, Renal impairment, Spinal cord abscess, Spinal laminectomy, Streptococcal bacteraemia, Walking aid user, White blood cell count increased, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (broad), 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? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Citalopram, Losartan, Rosuvastatin
Current Illness: mild low back pain, scheduled for tooth extractions.
Preexisting Conditions: High Blood Pressure, elevated cholesterol, anxiety
Allergies:
Diagnostic Lab Data: x ray, CT scans, MRI''s , multiple over the 21 plus days (in hospital at present) , Daily blood tests. High inflammatory levels, decreased Liver and kidney function. High white cell count.
CDC Split Type:

Write-up: By 10:00 pm that evening I got Chills, fever, muscle aches, headache, nausea and low back pain. Stayed home from work for 1 or 2 days. Felt better in all ways except my low back got very, very painful. I asked my wife to buy me a walker to take to work because I had difficulty walking the distance from the parking lot to inside my office. Also used the walker at work. My boss said to go home, it looks like you''re in pain. Saw Dr. on Monday March 15 because the low back was getting worse. He prescribed muscle relaxors and anti-inflammatory medicine. Called the next day asked for something stronger for pain because worse. Nurse responded to continue on existing meds. Went to Chiropractor on both March 16 and 18 without back pain relief. On March 19 went to urgent care, got X-ray and pain meds. MRI done 2 days later on March 21st which revealed a spinal abcess. Admitted to Hospital, surgery done to remove spinal abcess on March 22. Bacteremia, laminectomies in L3,4,5 S1 to relive spinal cord pressure. Puss had the filled spinal epidural cavity, cultured out as Strep bacteria. Remained hospitalized until April 2nd. Sent home for 1 night then returned to hospital via ambulence the next day April 3rd with 103 degree fever. Discharged April 8th. Readmitted to hospital for 3rd time on April 17 where I remain today with Kidney and liver function problems likely reactions to meds. Continue to have excruciating low back back which is why continues to be hospitalized at the time of this report.


VAERS ID: 1249132 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 10805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Fatigue, Insomnia, Psychotic disorder, Urine analysis
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cognitive disorder (The patient had a cognitive disability (low IQ) but she was not on medication for anything.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210405; Test Name: Urine analysis; Result Unstructured Data: Negative; Test Date: 20210405; Test Name: CT scan; Result Unstructured Data: Didn''t show anything; Test Date: 20210405; Test Name: Blood test; Result Unstructured Data: Didn''t show anything
CDC Split Type: USJNJFOC20210420207

Write-up: PSYCHOTIC EPISODES; MINIMAL SLEEP FOR AT LEAST 50 HOURS; TIREDNESS; This spontaneous report received from a consumer concerned a 29-year-old white female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cognitive disability, but she was not on medication for anything. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10805031 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 in left arm around 4:40 pm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient exhibited bizarre behaviors that raised eyebrows but not red flags, as her father thought she was goofing around, she was talking loudly and laughing to herself with nobody around. She seemed very tired, taking a long time in the bathroom (about an hour/an hour and a half). On 03-APR-2021, she was saying things that did not make sense and people could not make sense of what she was talking about. On 04-APR-2021, she started experiencing really bizarre behavior. She was hearing voices, talking to herself and seeing people that were not there, insisting that people were coming over to the house and she had to go there. By the evening, she experienced hallucinations and delusions. She was taken to emergency hospital. She had been awake for about 12 hours, possibly longer. She was tested for a urinary tract infection, but the result was negative. In the emergency room, she had a blood test and computed tomography (CT) scan that did not show anything. In the night on same day, her condition was bad. She was trying to get out of the house. On 05-APR-2021, at 6am, she went back to the hospital room and was admitted to the psych ward for psychotic behaviors. She had been there for 7 days. She had been on unspecified medications, which was helping the symptoms. She was examined by a doctor and admitted to the psychiatric ward. In the evening on same day, her behavior became more severe, showed signs of aggression, flipping furniture, throwing things, saying a light on the wall was watching her. On 06-APR-2021, the psychiatrist stated that she was experiencing psychotic episodes and she was put on antipsychotic medication and examined her. She did not sleep for almost 3 days, started 04-APR-2021 morning at 7:00 am until 06-APR-2021 night (about 50 hours with minimal sleep). Then she was sedated, and she finally slept. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minimal sleep for at least 50 hours on 06-APR-2021, was recovering from psychotic episodes, and the outcome of tiredness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210420207- Covid-19 vaccine ad26.cov2.s-psychotic episodes. 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: 1249143 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Headache, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Severe headache that lasted 12 days. Tachycardia that lasted 8 days. Resting heart rate would jump from 70 to 115 while sitting and would feel pounding heart and that I couldn?t catch my breath.


VAERS ID: 1249144 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-03-06
Onset:2021-03-26
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 UN / UN

Administered by: Public       Purchased by: ?
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Asthenia, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood creatinine normal, Contusion, Differential white blood cell count normal, Fatigue, Fibrin D dimer normal, Haematochezia, Haematocrit normal, Haemoglobin normal, Headache, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae, Platelet count decreased, Red blood cell count normal, Thrombocytopenic purpura, White blood cell count
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Invokana 300mg PO daily Lisinopril-HCTZ 10/12.5 mg PO daily Allopurinol 100mg PO daily Venlafazine 75mg PO BID Omeprazole 40mg PO daily Goodies powder 4 times PO daily Atorvastatin 40mg PO daily Metformin 1000mg PO daily
Current Illness:
Preexisting Conditions: Type 2 Diabetes Mellitus, obesity, gout, HLD, HTN, MMD, OSA, galactose-alpha-1,3-galactose (Alpha gal) allergy, Chronic back pain, Headache, erectile disfunction.
Allergies: Codeine, Hydromorphone, galactose-alpha-1,3-galactose (Alpha gal)
Diagnostic Lab Data: 4/8/2021 Platelets: 4 x 10^9/L, Repeat value 5 x 10^9/L Hgb 15.1, Hct 46, RBC 5, WBC 6.9, SCr 1.1 . AST 21, ALT 28, Bilirubin 0.5, Alk Phos 85 4/9/2021 Platelets: 15 x 10^9/L 4/10/2021 Platelets: 81 x 10^9/L 4/13/2021 Platelets 277 x 10^9/L, Repeated Platelets: 257, D-Dimer <0.27
CDC Split Type:

Write-up: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone. Platelets increased to 15 x 10^9/L. 4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L. Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up. Patient advised to stop Goodies Powder for Headache. 4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27. Patient was discharged home from the emergency department.


VAERS ID: 1249155 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Appendicitis, Blood test, Computerised tomogram
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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data: Ct scar, blood work
CDC Split Type:

Write-up: Acute appendicitis


VAERS ID: 1249165 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Headache, Hypersensitivity, Myalgia, Pain, Paraesthesia, Pyrexia, Somnolence, Tachycardia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210421297

Write-up: HIGH HEART BEAT / TACHYCARDIA; ALLERGIC REACTION (SWOLLEN FACE UNDER EYES, ITCHINESS IN MOUTH, ITCHINESS IN PALMS / FEET); SHAKINESS; TINGLING; FEVER; HEADACHE; WEAKNESS; MUSCLE PAIN IN BACK AND LEGS; DROWSINESS / SLEEPINESS; BACK PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 30 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced drowsiness / sleepiness. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced muscle pain in back and legs. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced high heart beat / tachycardia. On 02-APR-2021, the subject experienced allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet). On 02-APR-2021, the subject experienced shakiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart beat / tachycardia, and muscle pain in back and legs on 02-APR-2021, drowsiness / sleepiness, and weakness on 16-MAR-2021, tingling on 28-MAR-2021, fever on 18-MAR-2021, and headache on 19-MAR-2021, had not recovered from shakiness, and allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet), and the outcome of back pain and body aches 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: 1249166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Lymphadenopathy, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), 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:
Current Illness: Non-Hodgkin''s lymphoma (In remission at the time of report.)
Preexisting Conditions: Medical History/Concurrent Conditions: Neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210421314

Write-up: HEAT BLISTERS; SWOLLEN GLANDS; LEFT SIDE OF FACE ENLARGED/SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included neck tumor, and concurrent conditions included non-hodgkins lymphoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: hydrocortisone. On 08-APR-2021, the subject experienced swollen glands. On 08-APR-2021, the subject experienced left side of face enlarged/swollen. On 10-APR-2021, the subject experienced heat blisters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen glands, and left side of face enlarged/swollen, and had not recovered from heat blisters. 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: 1249175 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose normal, Blood pressure measurement, Blood test, Blood triglycerides, Cardiac function test, Chest pain, Electrocardiogram, Oxygen saturation
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood pressure; Result Unstructured Data: okay; Test Date: 20210409; Test Name: EKG; Result Unstructured Data: okay; Comments: okay; Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: okay; Comments: okay; Test Date: 20210409; Test Name: Triglycerides; Result Unstructured Data: okay; Test Date: 20210409; Test Name: Cardiac function test; Result Unstructured Data: okay; Test Date: 20210409; Test Name: Blood glucose normal; Result Unstructured Data: okay; Comments: Okay; Test Date: 20210409; Test Name: Oxygen saturation; Result Unstructured Data: okay
CDC Split Type: USJNJFOC20210422153

Write-up: SHOOTING PAIN IN THE HEART; This spontaneous report received from a consumer concerned a 24 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On APR-2021, treatment medications included: acetylsalicylic acid. On 06-APR-2021, the subject experienced shooting pain in the heart. On 09-APR-2021, Laboratory data included: Blood glucose normal (NR: not provided) okay, Blood pressure (NR: not provided) okay, Blood test (NR: not provided) okay, Cardiac function test (NR: not provided) okay, EKG (NR: not provided) okay, Oxygen saturation (NR: not provided) okay, and Triglycerides (NR: not provided) okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shooting pain in the heart. 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: 1249191 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Dysmenorrhoea, Dyspnoea, Fatigue, Feeling abnormal, Headache, Heavy menstrual bleeding, Lymphadenitis, Pain, Vaccination site inflammation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: Seasonal allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis (used an inhaler years ago.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210423006

Write-up: INFLAMED LYMPH NODES; VACCINE SITE INFLAMMATION; MENSTRUAL CRAMPS; ASTHMA SYMPTOMS; EXCESSIVE PERIOD BLEEDING AND LONG PERIODS; SHORTNESS OF BREATH; FELT LOOPY; BODY ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included bronchitis, and concurrent conditions included seasonal allergy. The patient experienced drug allergy when treated with cetirizine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: salbutamol. On 08-APR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced felt loopy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excessive period bleeding and long periods. On 09-APR-2021, the subject experienced menstrual cramps. On 09-APR-2021, the subject experienced asthma symptoms. On 10-APR-2021, the subject experienced inflamed lymph nodes. On 10-APR-2021, the subject experienced vaccine site inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt loopy on 08-APR-2021, was recovering from body aches, and had not recovered from fatigue, headache, shortness of breath, excessive period bleeding and long periods, asthma symptoms, vaccine site inflammation, inflamed lymph nodes, and menstrual cramps. 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: 1249198 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic seizure, Injection site mass, Injection site warmth, Pain, Tenderness
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Generalised convulsive seizures following immunisation (narrow), 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: Seizure (Patient have not had seizure for 2 years after she started taking her medication)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210424069

Write-up: 2X GRAND MAL SEIZURE; TENDER; SORE; LUMP AT INJECTION SITE; INJECTION SITE FELT HOT; This spontaneous report received from a patient concerned a white, not hispanic or latino female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included seizure which was under control with medications. 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,1 total administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced tender, sore, lump at injection site, injection site felt hot to touch. On 11-APR-2021, the patient had two grand mal seizure and and had to visit an emergency room/hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump at injection site, and injection site felt hot on 11-APR-2021, was recovering from tender, and sore, and the outcome of 2x grand mal seizure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210424069- covid-19 vaccine ad26.cov2.s -2x grand mal seizure. 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: 1249200 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-03-29
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Atrial fibrillation, Atrial flutter, Bradycardia, Dyspnoea, Echocardiogram, Malaise, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Echocardiogram; Result Unstructured Data: Normal rhythm
CDC Split Type: USJNJFOC20210424129

Write-up: BRADYCARDIA; RAPID ATRIAL FLUTTER; RAPID ATRIAL FIBRILLATION; TACHYCARDIA; SHORTNESS OF BREATH; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 66 year old white and Hispanic or Latino 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: 1805031, and expiry: UNKNOWN) dose was not reported, once total, administered on 10-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 10-MAR-2021, patient had echocardiogram and the rhythm was normal. On 29-MAR-2021, the patient experienced rapid atrial flutter which became rapid atrial fibrillation and had tachycardia and shortness of breath. On same day patient was hospitalized for monitoring and On 30-MAR-2021, the patient developed bradycardia. It was stated that patient was bouncing between tachycardia and bradycardia which he never experienced before. Also patient stated that if symptoms doesn''t resolve he had to have cardioversion procedure. On 31-Mar-2021, patient got discharged from hospital. It was reported that patient''s medical doctor was aware about the adverse events and cardiologist does not know about the administration of vaccine. It was also reported that clinician who administered the vaccine to patient advised to take Motrin. Treatment medications (dates unspecified) included: Motrin(ibuprofen) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid atrial flutter, rapid atrial fibrillation, shortness of breath, tachycardia, and bradycardia, and the outcome of did not feel well was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210424129-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, Bradycardia and Atrial flutter. These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1249201 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-04-04
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1888979 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Chills, Headache, Malaise, Pain, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Guillain-Barre 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210424184

Write-up: SEVERE BACK PAIN; PAIN ALL OVER; MALAISE; WEAK; CHILLS; HEADACHE; WEIGHT LOST; This spontaneous report received from a parent concerned a 21 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: 1888979 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced weight lost. On 04-APR-2021, the subject experienced pain all over. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced weak. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced severe back pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from severe back pain on APR-2021, was recovering from headache, and weight lost, and had not recovered from chills, malaise, pain all over, and weak. This report was non-serious. This parent/child case is linked.; Sender''s Comments: V0-Medical assessment comment is not required as per standard operating procedures.


VAERS ID: 1249220 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Dizziness, Laboratory test, Nausea, Swelling, Thrombosis, Ultrasound scan, Wisdom teeth removal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Lab test; Result Unstructured Data: elevated clot levels; Test Date: 20210410; Test Name: Diagnostic ultrasound; Result Unstructured Data: Unknown
CDC Split Type: USJNJFOC20210425728

Write-up: ELEVATED CLOT LEVELS; DIZINESS/LIGHTHEADED; NAUSEA; BRUISE ON LEG; SWELLING; WISDOM TOOTH PULLED; This spontaneous report was received from a consumer and concerned a female of unspecified age and sex, White, Hispanic or Latino. 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 and expiration date: Unknown) dose was not reported,1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient''s father reported that on 06-Apr-2021, in urgent care patient''s wisdom tooth was pulled. On 08-APR-2021, the subject experienced diziness/lightheaded, nausea, bruise on leg, swelling 4x4 inches on lower right calf. The next day, the patient''s bruise/swelling move to inside of right knee, she had new bruise on leg and went to urgent care; the doctor told her she hit it. On 09-APR-2021, the bruise moved to inside of knee, and the patient was taken to emergency room (ER) where "clot test" showed elevated clot levels and rivaroxaban (Xarelto) was prescribed for treatment. On 10-APR-2021 (Saturday morning), ultrasound was done; result not reported. At the time of report there was decreased in swelling. The patient''s father stated that, the event''s might be related to wisdom tooth pulled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated clot levels, diziness/lightheaded, nausea, bruise on leg, and swelling. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced elevated clot levels 29 days after receiving the Janssen COVID-19 vaccine and 3 days after the patient''s wisdom tooth was pulled out. The patient had her wisdom tooth pulled out 26th day post vaccination. 2 days later (28 days after the vaccination), the patient experienced dizziness and nausea and was noted to have bruise and swelling (around 4x4 inches) on the right lower leg. The next day, bruise/swelling was noted to reach the area of the right knee, probably the medial side, which prompted consult at the ER. The "clot test" done as was noted to be elevated (no actual results provided). An ultrasound was also done but the result was not reported. Long periods of immobility (sitting in the dental chair) and the temporal plausibility from the dental procedure to the event of elevated clot levels confounds the temporal plausibility of the elevation of clot level and the vaccine; hence this is assessed as indeterminate per WHO classification of adverse event following immunization. Additional information requested.


VAERS ID: 1249235 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Cognitive disorder, Computerised tomogram, Diplopia, Disturbance in attention, Headache, Infarction, Magnetic resonance imaging
SMQs:, Myocardial infarction (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Ocular motility 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: Test Date: 202103; Test Name: MRI; Result Unstructured Data: Possible infarction; Test Date: 20210316; Test Name: CAT scan; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20210427306

Write-up: DOUBLE VISION; SHORT TERM MEMORY LOSS; LACK OF ATTENTION; COGNITIVE DEFICIENCIES; HEADACHE; POSSIBLE INFARCTION DUE TO RECENT EVENT; This spontaneous report received from a health care professional concerned a 67 year old white and not Hispanic or Latino 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) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced headache and dizziness. On 15-MAR-2021, patient had experienced double vision, trouble reading, lack of attention, short term memory loss and cognitive deficiency. One or two days later, (possibly on 16-MAR-2021), the patient visited emergency room and his computerized axial tomography (CAT) scan was normal. In MAR-2021 (a week after), the patient''s symptoms got worsened and he consulted primary care physician. The patient underwent magnetic resonance imaging (MRI) scan which showed possible infarction due to recent event. It was reported that, the patient was yet to visit cardiologist and neurologist for follow up on the MRI scan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, had not recovered from double vision, short term memory loss, lack of attention, and cognitive deficiencies, and the outcome of possible infarction due to recent event was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210427306-covid-19 vaccine ad26.cov2.s-possible infarction due to recent event. 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: 1249249 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-03-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Diverticulitis, Headache
SMQs:, Gastrointestinal nonspecific inflammation (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 had no known allergies and did not have any drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: CAT scan; Result Unstructured Data: Unknown
CDC Split Type: USJNJFOC20210428413

Write-up: DIVERTICULITIS; HEADACHE; This spontaneous report received from a patient concerned a 53 year old African American and not Hispanic or Latino female. The patient''s height, and weight were not reported. The patient was non alcohol user, non-smoker, and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at unspecified time to left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of this report. On 08-MAR-2021, the patient experienced headache. On 04-APR-2021 patient experienced unbearable abdominal cramps and went to emergency room on 08-APR-2021 where lab test of CAT scan was done and the patient diagnosed with diverticulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and had not recovered from diverticulitis. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210428413-covid-19 vaccine ad26.cov2.s-Diverticulitis. 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: 1249254 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-28
Onset:2021-04-13
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Headache, Injection site pain, Pain, X-ray
SMQs:, Extravasation events (injections, infusions and implants) (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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: ECG; Result Unstructured Data: UNKNOWN; Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: unknown; Test Date: 20210413; Test Name: X-ray; Result Unstructured Data: UNKNOWN
CDC Split Type: USJNJFOC20210428904

Write-up: BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. 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: 1249257 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies, not on any chronic medications and is not allergic to any medications.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210429140

Write-up: TIGHTNESS OF THROAT; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 37 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no known allergies, not on any chronic medications and is not allergic to any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-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 allergic reaction. On APR-2021, the subject experienced tightness of throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and tightness of throat 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: 1249263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Body temperature; Result Unstructured Data: 103 F; Test Date: 20210413; Test Name: Body temperature; Result Unstructured Data: 102 F
CDC Split Type: USJNJFOC20210429270

Write-up: SHORTNESS OF BREATH; FEVER; 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 on 12-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 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-APR-2021, the subject experienced shortness of breath. 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 fever, headache, and shortness of breath. 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: 1249268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-03-19
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Blood pressure measurement, Blood test, Chest pain, Dyspnoea exertional, Electrocardiogram, Fatigue, Feeling abnormal, Full blood count, Hypertension, Hypoaesthesia, Imaging procedure, Insomnia, Troponin, X-ray
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (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: Abstains from alcohol; Diabetes; Smoker
Preexisting Conditions: Comments: Patient had No known allergies. Patient had no drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: ECG; Result Unstructured Data: unknown; Test Date: 202104; Test Name: X-ray NOS; Result Unstructured Data: unknown; Comments: two views; Test Date: 202104; Test Name: CBC; Result Unstructured Data: negative; Test Date: 202104; Test Name: Blood test; Result Unstructured Data: negative; Test Date: 202104; Test Name: Imaging procedure; Result Unstructured Data: negative; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: up; Test Date: 202104; Test Name: Troponin; Result Unstructured Data: negative
CDC Split Type: USJNJFOC20210429778

Write-up: SHORTNESS OF BREATH WHILE WALKING; FEELING LIKE HE WAS GOING TO DIE; HIGH BLOOD PRESSURE; SEVERE CHEST PAIN/ON AND OFF CHEST PAIN; SEVERE BACK PAIN; DIFFICULTY SLEEPING; TIREDNESS; NUMBNESS IN LEFT ARM; WEAKNESS; CRAZY JOINT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 41 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included diabetes, no alcohol use, and smoker (smokes cigarettes twice a day), and other pre-existing medical conditions included patient had no known allergies. patient had 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: 1805031, 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 crazy joint pain in left arm. On 21-MAR-2021, the subject experienced weakness. On 23-MAR-2021, the subject experienced numbness in left arm. On 28-MAR-2021, the subject experienced tiredness. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) up, Blood test (NR: not provided) negative, CBC (NR: not provided) negative, ECG (NR: not provided) unknown, Imaging procedure (NR: not provided) negative, Troponin (NR: not provided) negative, and X-ray NOS (NR: not provided) unknown. On 04-APR-2021, the subject experienced shortness of breath while walking. On 04-APR-2021, the subject experienced feeling like he was going to die. On 04-APR-2021, the subject experienced high blood pressure. On 04-APR-2021, the subject experienced severe chest pain/on and off chest pain. On 04-APR-2021, the subject experienced severe back pain. On 04-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left arm on 26-MAR-2021, and difficulty sleeping on 06-APR-2021, was recovering from shortness of breath while walking, and severe back pain, had not recovered from weakness, tiredness, severe chest pain/on and off chest pain, and crazy joint pain in left arm, and the outcome of high blood pressure and feeling like he was going to die 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: 1249270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Fibrin D dimer, Fibrin D dimer increased, Ultrasound scan
SMQs:, Haemorrhage laboratory terms (broad), 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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Diagnostic ultrasound; Result Unstructured Data: Unknown; Test Date: 202104; Test Name: Fibrin D dimer; Result Unstructured Data: POSITIVE
CDC Split Type: USJNJFOC20210430212

Write-up: D DIMER POSITIVE; DIZZY; FEELS TERRIBLE; This spontaneous report received from a company representative via media post and concerned an adult female (age approximately 30). 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in APR-2021, the patient reported dizzy and felt terrible. On an unspecified date, the patient went to urgent care and tested positive for D-Dimer (PT of Fibrin D dimer increased). The patient went to emergency room for full body ultrasound to look for clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, feels terrible and d dimer positive was not reported. This report was non-serious.


VAERS ID: 1249271 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-03-14
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Computerised tomogram, Electrocardiogram, Headache, Heart rate, Heart rate increased, Pain, Pulmonary thrombosis, Pyrexia, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LYRICA
Current Illness: Back disorder; Fibromyalgia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: Body temperature; Result Unstructured Data: 100 F, 100 F; Comments: 100 F; Test Date: 20210413; Test Name: X-ray; Result Unstructured Data: unknown; Comments: unknown; Test Date: 20210413; Test Name: CT scan; Result Unstructured Data: unknown; Comments: unknown; Test Date: 20210413; Test Name: Electrocardiogram; Result Unstructured Data: unknown; Comments: unknown; Test Date: 20210413; Test Name: Heart rate; Result Unstructured Data: 144, 144; Comments: 144; Test Date: 20210413; Test Name: Electrocardiogram; Result Unstructured Data: Unknown; Comments: unknown
CDC Split Type: USJNJFOC20210430369

Write-up: FAST HEART RATE; BLOOD CLOT IN BOTH LUNGS; ACHY; LOW ENERGY; VERY WEAK; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included pregabalin(Lyrica) for fibromyalgia and bad back. The patient reported pregabalin makes her gait off. On 13-MAR-2021, the patient felt okay. On 14-MAR-2021, the patient experienced achy, low energy, very weak, headache, fever of 100 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, she had wellness visit. The patient had a fast heart rate. Laboratory data included: Heart rate (NR: not provided) 144 (units unspecified). So immediately her electrocardiogram was taken and she was hospitalized for 2 days in emergency room by ambulance and started running tests. The patient had a computer tomography with dye contrast and it showed blood clots in both lungs. She had many tests, echocardiogram and X-rays. Treatment medications (dates unspecified) included: continuous oxygen via nasal prong (3.2 litre down to 2 litre), warfarin sodium(Coumadin), blood, whole, and rivaroxaban(Xarelto). The patient stated once she had rivaroxaban she felt "free". Currently also had 2 intravenous and taking blood regular. She was also on physical therapy. The therapist came in and made her walk across her room twice according to therapist she did not need oxygen. The patient currently had 2 IV''s and taking blood regular. The patient will be discharged with or without the oxygen. The patient has machine on her chest with all kinds of wires. She don''t know about her oxygen saturation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, low energy, very weak, headache, and fever on 15-MAR-2021, had not recovered from fast heart rate, and the outcome of blood clot in both lungs was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender''s Comments: V0: This is a 72 year old female, unspecified ethnicity, who experienced tachycardia and was noted to have blood clots in both lungs 32 days (around 1 month) after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Patient had Fibromyalgia and is maintained on Pregabalin (Lyrica). Patient''s height and weight were not reported as well as history of smoking, allergies or drug abuse. One day after receiving the vaccine, the patient experienced fever, headache, weakness and pain, which resolved. During a wellness visit after a month from the vaccine, tachycardia was noted and an EKG was done. Patient was immediately brought to the ER, where the CT Scan (with contrast) showed blood clots in both lungs (detailed result not reported). Other tests done were also not reported. Patient was subsequently admitted in the hospital and was discharged after 2 days. The information provided is insufficient to show that the vaccine is causing the event; hence, this is assessed as indeterminate per WHO causality classification of adverse event following immunization. Additional information requested.


VAERS ID: 1249273 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430918

Write-up: BILATERAL BLOOD CLOTS IN LEFT AND RIGHT LOWER LUNGS; This spontaneous report received from a patient via a company representative concerned a 46 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: unknown, expiry: unknown) dose was not reported, 1 total administered on 05-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 08-APR-2021, the patient experienced mild chest pain and dyspnea. On 14-APR-2021, the patient visited to emergency room and diagnosed with bilateral blood clots in left and right lower lungs. The patient had no prior medical history of blood clot and pulmonary issues. On 14-MAR-2021, treatment medications included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral blood clots in left and right lower lungs was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This is a 46 male patient, unspecified ethnicity who was noted, at the emergency room (ER), to have bilateral blood clots in left and right lower lungs 9 days after receiving the covid-19 vaccine ad26.cov2.s. Weight and height were not reported. Medical history, smoking history and concomitant medications were not reported. Six (6) days prior to the visit to the emergency room, the patient experienced mild chest pains and dyspnea. Patient was sent home from the ER with Rivaroxaban. Based on the available information and considering the temporal causality, this is assessed as indeterminate per WHO causality classification of adverse reaction following immunization.


VAERS ID: 1249274 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Dizziness, Dyspnoea, Headache, Hyperhidrosis, Injection site pain, Pain in extremity, Pulmonary thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NIFEDIPINE; LABETALOL
Current Illness: Fruit allergy; Hypertension (Labetalol, Nifedipine); Latex allergy; Non-smoker
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: positive for blood clot; Test Date: 20210413; Test Name: CAT scan; Result Unstructured Data: blood clot in left lung
CDC Split Type: USJNJFOC20210430952

Write-up: BLOOD CLOT IN LEFT LUNG; SHORTNESS OF BREATH; DIARRHEA; LEG PAIN; INJECTION SITE PAIN; HEADACHE; SWEATING; DIZZINESS/FEELING FAINT; This spontaneous self-report was received from a patient and concerned a 29 year Black Mexican, White (Hispanic or Latino) old female. The patient''s height and weight were not reported. The patient''s concurrent conditions included hypertension, latex allergy, allergic to banana, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total dose on left arm administered on 08-APR-2021 (Thursday) for prophylactic vaccination. Concomitant medications included labetalol and nifedipine for hypertension. On 08-APR-2021, when patient received a vaccination it hurt at the time of injection. Later, she developed a headache. At night, she woke up with sweating. She went down to the kitchen and felt shortness of breath and felt faint. On 09-Apr-2021 (Friday), after she woke up, she developed diarrhea all day. On 10-APR-2021 (Saturday), her symptoms were continuing included diarrhea, sweating, dizziness, legs hurting, headache, and feeling shortness of breath. On 11-APR-2021 (Sunday), she felt better, however headache was ongoing. At night, she started feeling bad again. On 12-APR-2021, she woke up with diarrhea and sweating, no symptoms have resolved. On 13-APR-2021, her legs continued to be in pain. At night, she went to emergency room (ER) and have blood work done, showing it was positive for a blood clot. Her computerized axial tomography (CAT) was performed and blood clot in left lung was found. Her doctor said that all other blood work came back normal, and he did not see anything else wrong with her, and that the blood clot was related to the vaccine. He wanted to put her on a blood thinner and prescribed Eliquis (apixaban). Doctor mentioned that if she felt shortness of breath or started feeling dizzy, she must go to the hospital. It was reported that she was hospitalized for 1 day, and both admission and discharge dates were reported 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left lung, injection site pain, headache, sweating, shortness of breath, dizziness/feeling faint, leg pain, and diarrhea. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: This is a 29 year old male patient, who experienced leg pain and noted to have blood clot in the left lung 1 day and 5 days, respectively, after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Height and weight not reported. Patient has hypertension and is taking Labetalol and Nifedipine. Patient has history of allergy to latex and banana. Patient is not a smoker. Few hours after receiving the vaccine, patient developed headache, sweating, dizziness and shortness of breath. The following day, patient had diarrhea and experienced leg pain, laterality not reported. The symptoms were persistent and, 5 days after the vaccine, patient sought consult at the Emergency Room (ER) where the CAT scan showed blood clot in left lung. Patient was prescribed with Apaxiban. The information provided precludes a meaningful medical assessment. Additional information requested.


VAERS ID: 1249275 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Liver injury
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (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: Social alcohol drinker (not excessive alcoholic.)
Preexisting Conditions: Comments: Patient had no history of drugs/prescription drugs. Patient had not consumed unhealthy and fatty foods.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430986

Write-up: LIVER DAMAGE; PAIN IN LOWER RIGHT ABDOMINAL AREA; This spontaneous report received from a patient concerned a 3 decade (in twenties)old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included social alcohol drinker, and other pre-existing medical conditions included patient had no history of drugs/prescription drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, 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. After vaccine, on an unspecified date, the patient was rushed to the emergency room. The doctors could not diagnose the pain in lower right abdominal area but found that the liver had been severely damaged (coded as liver damage) in a short period of time. Patient stated that his medical group would like him to undergo further testing and had scheduled him for the same since their concerns were whether the patient''s liver would fail or cause immune system disorders in the future. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from liver damage, and the outcome of pain in lower right abdominal area was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210430986 - covid-19 vaccine ad26.cov2.s - liver damage. 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: 1249285 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Blood test, Chills, Feeling hot, Heart rate, Heart rate increased, Hyperhidrosis, Hypertension, Insomnia, Muscle strain, Pain in extremity, Peripheral swelling, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), 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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Blood test; Result Unstructured Data: did not find anything; Test Date: 202104; Test Name: Diagnostic ultrasound; Result Unstructured Data: did not find anything; Test Date: 20210411; Test Name: Blood pressure; Result Unstructured Data: High; Test Date: 20210411; Test Name: Heart rate; Result Unstructured Data: Increased
CDC Split Type: USJNJFOC20210431740

Write-up: WARM RUSH FEELING IN HEAD; SWEATING; BLOOD PRESSURE HIGH; HEART RATE INCREASED; CANNOT SLEEP; TENDERNESS TO ARM ELBOW TO WRIST; CHILLS; SWOLLEN ARM ELBOW TO WRIST; ANXIOUS; MUSCLE STRAIN; This spontaneous report received from a patient concerned a 31 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle strain. Laboratory data included: Blood test (NR: not provided) did not find anything, and Diagnostic ultrasound (NR: not provided) did not find anything. On 11-APR-2021, the subject experienced swollen arm elbow to wrist. On 11-APR-2021, the subject experienced anxious. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced blood pressure high. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced cannot sleep. On 11-APR-2021, the subject experienced tenderness to arm elbow to wrist. On 11-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) Increased. On 13-APR-2021, the subject experienced warm rush feeling in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm elbow to wrist, tenderness to arm elbow to wrist, anxious, chills, sweating, blood pressure high, heart rate increased, cannot sleep, warm rush feeling in head, and muscle strain. This report was non-serious.; Sender''s Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.


VAERS ID: 1249297 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Emergency care, Flushing, Injection site pain, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness: Non-smoker
Preexisting Conditions: Comments: Allergic to other antibiotic((can''t remember)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: COVID-19 virus test; Result Unstructured Data: negative
CDC Split Type: USJNJFOC20210431831

Write-up: HUSBAND BEING IN EMERGENCY RIGHT NOW. 8 DAYS AFTER HAVING A COVID 19 SHOT; FLUSHING; WEAK; FEVER; INJECTION SITE PAIN; FEELING SICK; This spontaneous report received from a consumer via a company representative concerned a 65 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 allergic to other antibiotic((can''t remember). The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 06-APR-2021, the subject experienced feeling sick. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced weak. On 07-APR-2021, the subject experienced flushing. On 07-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced husband being in emergency right now. 8 days after having a covid 19 shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, weak, flushing, and fever, and the outcome of injection site pain and husband being in emergency right now. 8 days after having a covid 19 shot 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: 1249321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Feeling cold, Headache, Respiratory tract congestion, Thrombophlebitis superficial, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Accidents and injuries (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: Medical History/Concurrent Conditions: Tuberculosis; Comments: The patient does not have hypertension, diabetes, or any known medical history
Allergies:
Diagnostic Lab Data: Test Name: Diagnostic ultrasound; Result Unstructured Data: superficial leg thrombosis
CDC Split Type: USJNJFOC20210431951

Write-up: SUPERFICIAL LEG THROMBOSIS; CHEST CONGESTION; TERRIBLE HEADACHE; LEGS WERE FROZEN; BRUISES ON HER LEGS; This spontaneous self-report was received from a patient and concerns a 68 year old female of unspecified race and ethnicity. Initial information received from the patient on 13-APR-2021 was processed with additional information received from the patient on 14-APR-2021 and telephone follow up with the patient on 20-APR-2021. The patient''s weight and height were not reported. The patient had tuberculosis and had completed TB medication course. The patient does not have hypertension or diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, date, vaccination site, and batch number were not reported) for prophylactic vaccination. The batch number will be requested in follow up. The patient was not taking any concomitant medications. On the third day after vaccination, the patient experienced terrible headache. Two days later, both her legs were frozen, and she had bruises on her legs. She went to a physician who advised her to go to the Emergency Room (ER), where they did an ultrasound on her legs. The physician told her that she had superficial leg thrombosis and asked her to take aspirin. No labs or any other diagnostic tests were performed. On the fifth day post-vaccination, the patient had chest congestion for 1 day. At the time of report, the patient was feeling better, and her bruises were disappearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest congestion and terrible headache, and was recovering from superficial leg thrombosis, legs were frozen, and bruises on her legs. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This 68-year-old female patient of unspecified ethnicity was found to have superficial blood clots in both legs 5 days after receiving COVID-19 VACCINE AD26.COV2.S intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection. The patient reported "terrible" headache 3 days after vaccination, "chest congestion" and that both her legs were "frozen" and with bruises 5 days after vaccination. Ultrasound on both legs showed superficial leg thrombosis during emergency room consultation and was advised to take asprin as treatment. The event is recovering. Based on the information that is available, the event is assessed as plausible per the causality classification for adverse events. Considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information has been requested for further assessment.


VAERS ID: 1249325 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-11
Onset:2021-04-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, Electrocardiogram normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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: Morning of: citalopram, zertec, gianvi, probiotic Evening: cannabis, 3-4 hits
Current Illness:
Preexisting Conditions: Delayed gastric emptying, asthma
Allergies: Penicillin, dairy
Diagnostic Lab Data: ECG and blood work, all normal.
CDC Split Type:

Write-up: Fainted for 30 seconds after standing up and walking. Ambulance came to the house and recommended a trip to the ER where I received an IV.


VAERS ID: 1249385 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-03-21
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Headache, Influenza like illness, Lethargy, Muscle spasms, Pain, Pain in extremity, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Abstains from alcohol; Non-smoker; Vitamin supplementation
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: CT scan; Result Unstructured Data: small clots in lower lobe of both lungs
CDC Split Type: USJNJFOC20210435658

Write-up: HAD BODY ACHE; HAD HEADACHE; PULMONARY EMBOLISM IN BOTH LUNGS; SHORTNESS OF BREATH; CHARLIE HORSE IN LEGS IN MIDDLE OF NIGHT; LOWER EXTREMETIES HURTING AND SWELLING; HAD FLU-LIKE SYMTPOMS; TIRED/LETHARGIC; This spontaneous report received from a patient concerned a 49 year old female. The patient''s height, and weight were not reported. The patient was a non alcohol user and non smoker, and he took vitamins.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date progressively 4 days after receiving vaccine the patient had headache and had body ache. On 21-MAR-2021, the patient had flu-like symptoms and felt tired/lethargic. On 24-MAR-2021, the patient had lower extremeties hurting and swelling. On 26-MAR-2021, the patient felt charlie horse in legs in middle of night. On 01-APR-2021, the patient had shortness of breath and he could not catch her breath. At that point patient went to emergency room. In emergency room the patient underwent CT scan and revealed with small clots in lower lobe of both lungs. The patient was treated with 40 mg Eliquis for treatment. The emergency room doctor advised consumer to saw pulmonary specialist and follow up with him primarily. On 15-APR-2021, the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had flu-like symtpoms, and had not recovered from pulmonary embolism in both lungs, lower extremeties hurting and swelling, shortness of breath, tired/lethargic, charlie horse in legs in middle of night, headache, and body ache. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This is a 49 year old female patient, African American, who experienced pain on lower extremities and was noted to have small clots in the lower lobes 5 days and 13 days, respectively, after receiving the the COVID-19 vaccine ad26.cov2.s. Patient''s height and weight were not reported. Patient is a non smoker and non alcoholic beverage drinker. Past medical history not reported and patient denied taking medications, except vitamins. Four (4) days after receiving the vaccine, patient experienced flu like symptoms. lethargy, headache and body ache which were noted to resolve. Five (5) days after receiving the vaccine, patient developed pain on the lower extremities and patient noted to fell charley horse (muscle spasm and pain). Thirteen (13) days after receiving the vaccine, patient experienced shortness of breath, which prompted consult at the emergency room. CT Scan done revealed small clots in the lower lobe of both lungs. Patient was noted to have pulmonary embolism. The temporal relationship may be consistent but there is insufficient evidence for the vaccine to cause the events; hence this is assessed as indeterminate per causality classification of adverse events following immunization. Additional information requested.


VAERS ID: 1249408 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-11
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Nausea, Polymerase chain reaction, Suspected COVID-19, Taste disorder
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: PCR; Result Unstructured Data: Negative (unit unspecified)
CDC Split Type: USJNJFOC20210438020

Write-up: COVID SYMPTOMS; CHILLS; NAUSEA; TASTE SENSATION; LIGHTHEADEDNESS; This spontaneous report received from a patient 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: PCR (NR: not provided) Negative (unit unspecified). On 11-APR-2021, the subject experienced taste sensation. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced covid symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from taste sensation, and chills, was recovering from lightheadedness, and covid symptoms, and had not recovered from nausea. This report was non-serious.


VAERS ID: 1249411 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Hypersomnia, Investigation, Palpitations, Pyrexia, X-ray
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (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: Aneurysm (has a family history 9MOTHER,FATHER ,BROTHER)); Hyperthyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Radiation thyroiditis
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: NOTHING WAS FOUND; Test Name: X-ray; Result Unstructured Data: NOTHING WAS FOUND
CDC Split Type: USJNJFOC20210438126

Write-up: SLEEPING ALOT; RACING HEART; ABDOMINAL PAIN; STILL NOT GETTING HER ENERGY BACK/FEELING BETTER; DIARRHEA; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included thyroid irradiated, and concurrent conditions included aneurysm, and hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleeping alot, racing heart, abdominal pain, still not getting her energy back/feeling better, diarrhea, fatigue, and fever. Laboratory data (dates unspecified) included: Investigation (NR: not provided) NOTHING WAS FOUND, and X-ray (NR: not provided) NOTHING WAS FOUND. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleeping alot, and still not getting her energy back/feeling better, and the outcome of fever, diarrhea, abdominal pain, racing heart and fatigue was not reported. This report was non-serious.


VAERS ID: 1249414 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-03-17
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Headache, Limb discomfort, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and 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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Diabetes
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210438380

Write-up: CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.


VAERS ID: 1249416 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-03-23
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dysgeusia, Dyspnoea, Fatigue, Insomnia, Pain, Paraesthesia, Peripheral swelling, SARS-CoV-2 test positive, Skin discolouration, Tinnitus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Patient had covid-19 positive.); Comments: The patient previously tested positive for COVID-19 "over Christmas" and had since recovered
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: COVID-19 virus test positive; Result Unstructured Data: Positive
CDC Split Type: USJNJFOC20210438653

Write-up: RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHORTNESS OF BREATH; FATIGUE; BODY ACHE; METALLIC TASTE IN MOUTH; FINGERS TURNED COLD AND TINGLY; This spontaneous report received from a patient concerned a 52 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included covid-19, "over Christmas" and had since recovered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 23-MAR-2021, the subject experienced metallic taste in mouth. On 23-MAR-2021, the subject experienced fingers turned cold and tingly. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced insomnia. On 25-MAR-2021, the subject experienced ringing in the ears. On 25-MAR-2021, the subject experienced chest pain. On 25-MAR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced right middle finger turned purple. On 08-APR-2021, the subject experienced fingers swelling. Treatment medications (dates unspecified) included: doxycycline, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right middle finger turned purple, chest pain, metallic taste in mouth, and fingers swelling, had not recovered from insomnia, ringing in the ears, and shortness of breath, and the outcome of fingers turned cold and tingly, body ache and fatigue was not reported. This report was non-serious.


VAERS ID: 1249449 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Breast discomfort, Dyspnoea, Electrocardiogram, Hypotension, Injection site mass, Injection site pain, Oxygen saturation, Peripheral swelling, Rash, Urine abnormality, X-ray
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Proteinuria (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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: Test Date: 20210410; Test Name: Oxygen saturation; Result Unstructured Data: 90s down to 83; Test Date: 20210410; Test Name: Blood pressure; Result Unstructured Data: LOW; Test Date: 20210413; Test Name: X-ray; Result Unstructured Data: No issue in lungs; Test Date: 20210413; Test Name: Electrocardiogram; Result Unstructured Data: No issue in Heart
CDC Split Type: USJNJFOC20210440435

Write-up: BREATHING PROBLEMS; THICK HEAVY/SWOLLEN LEGS; LOW BLOOD PRESSURE; PRESSURE IN BREAST AREA; LUMP AT INJECTION SITE; HOT URINE; HUGE RASH ON ARM, SHOULDER AND BACK; INJECTION SITE PAIN/ PAIN DURING INJECTION; This spontaneous report received from a patient concerned a 55 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pressure in breast area. On 30-MAR-2021, the subject experienced lump at injection site. On 30-MAR-2021, the subject experienced hot urine. On 30-MAR-2021, the subject experienced huge rash on arm, shoulder and back. On 30-MAR-2021, the subject experienced injection site pain/ pain during injection. On 10-APR-2021, the subject experienced breathing problems. On 10-APR-2021, the subject experienced thick heavy/swollen legs. On 10-APR-2021, the subject experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) LOW, and Oxygen saturation (NR: not provided) 90s down to 83. On 13-APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) No issue in Heart, and X-ray (NR: not provided) No issue in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing problems, thick heavy/swollen legs, and injection site pain/ pain during injection on 18-APR-2021, low blood pressure on 10-APR-2021, pressure in breast area on 30-MAR-2021, lump at injection site on 17-APR-2021, hot urine on 01-APR-2021, and huge rash on arm, shoulder and back on 19-APR-2021. This report was non-serious.


VAERS ID: 1249454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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 allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210440594

Write-up: PARESTHESIA; WEAKNESS IN LEGS; This spontaneous report received from a consumer concerned a 38 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced weakness in legs. On 18-APR-2021, the subject experienced paresthesia. Treatment medications included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paresthesia, and weakness in legs. This report was non-serious.


VAERS ID: 1249473 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (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: Abstains from alcohol; Graves'' disease; Non-smoker
Preexisting Conditions: Comments: Patient had no known allergies. No drug abuse/ illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441520

Write-up: SORE; RASH ALL OVER THE BODY; SHIVERING; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included graves disease, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. 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 14-APR-2021, the subject experienced sore. On 14-APR-2021, the subject experienced rash all over the body. On 14-APR-2021, the subject experienced shivering. On 14-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, rash all over the body, shivering, fever, and tiredness on 14-APR-2021. This report was non-serious.


VAERS ID: 1249488 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad), Hypokalaemia (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism; Iodine allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441834

Write-up: BRADYCARDIA; HYPOTENSION; This spontaneous report received from a health care professional concerned a 56 year old female. This report was received from news/social media. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypothyroidism, and iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported. On 08-APR-2021, at 12:46, the patient experienced lightheadedness, hypotension, bradycardia and nausea and the patient was evaluated by emergency medical services (EMS), the patient was sent to hospital for further observation. The patient was hospitalized for 1 day and discharged in good health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bradycardia, and hypotension on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210415566.; Sender''s Comments: 20210441834-covid-19 vaccine ad26.cov2.s-Bradycardia, Hypotension. 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: 1249489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Depression
Preexisting Conditions: Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441898

Write-up: SYNCOPE; This spontaneous report received from a other health professional (Nurse) via social media/news concerned a 37 year old white, not Hispanic female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included depression, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, administered, 1 total, on 08-APR-2021 for prophylactic vaccination. The vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported. On 08-APR-2021, at 12:57, the patient experienced syncope, hypotension and bradycardia. The patient was evaluated by emergency medical services (EMS) and sent to hospital for further observation. The patient was discharged in good health. The patient recovered from syncope on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210415566.; Sender''s Comments: V0: 20210441898-COVID-19 VACCINE AD26.COV2.S - Syncope. 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: 1249491 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441919

Write-up: ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 48 year old white Hispanic female. This report was received from news/social media. 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: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. Vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced allergic reaction (rash), after vaccination and was hospitalized (date unspecified). Treatment medications given on an unspecified date in /APR/2021 included: epinephrine, methylprednisolone sodium succinate, diphenhydramine hydrochloride and fluid. The patient was hospitalized overnight and was discharged with good health. The duration of hospitalization was 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to. Sender''s Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- ALLERGIC REACTION. This event is labeled and is therefore considered potentially related.


VAERS ID: 1249497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Painful respiration
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: USJNJFOC20210442476

Write-up: SHARP PAIN UPON DEEP INHALATION; This spontaneous report received from a health care professional concerned a 6 decade 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced sharp pain upon deep inhalation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain upon deep inhalation. This report was non-serious.


VAERS ID: 1249503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Rhode Island  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Dry eye, Feeling abnormal, Feeling cold, Head discomfort, Headache, Hypertension, Limb discomfort, Paraesthesia, Peripheral coldness, Poor quality sleep, Stress
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Corneal disorders (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), 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: LISINOPRIL; FLOMAX [MORNIFLUMATE]; PREVACID; PEPCID [FAMOTIDINE]; VITAMIN D [ERGOCALCIFEROL]
Current Illness: Abstains from alcohol; Benign prostatic hyperplasia; Blood pressure high (Normal BP ranges: 132-134 mmHg/82-84 mmHg, when high BP is 140/90 or 130/89, comes down on its own.); Cramp abdominal; Diarrhea; GERD; Headache; Itchy throat; Nausea; Non-smoker; Rash; Seasonal allergy; Skin inflammation; Spinning sensation
Preexisting Conditions: Comments: The patient was exposed to a person with covid-19 before 5 days of vaccination, and had no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: CT scan; Result Unstructured Data: negative/nothing; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 200/90 mmHg; Test Date: 20210417; Test Name: CT scan; Result Unstructured Data: negative; Test Date: 20210420; Test Name: Blood test; Result Unstructured Data: normal
CDC Split Type: USJNJFOC20210442527

Write-up: BIG TOES COLD; STRESSED OUT; FELT LIKE HEAD 2 TO 3 TIMES NORMAL SIZE; HIGH BLOOD PRESSURE; TINGLING IN BOTH BIG TOES, FINGERS, LEFT AND RIGHT HAND AND THIGHS; TINGLING IN LEFT ARM; LEFT ARM FELT HEAVY; COLD WET SENSATION IN EXTREMITIES; DRY LEFT EYE; POUNDING HEADACHE; WOKE HIM UP; FOGGINESS; MILD HEADACHE/JABS IN THE BACK OF HIS HEAD; This spontaneous report received from a patient concerned a 58 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure, benign prostatic hyperplasia, gerd, headache, seasonal allergy, diarrhea from peanuts, cramping from peanuts, shellfish when younger itchy rash, skin inflammation, itchy throat, valium-nausea, spinning, non alcohol user, non smoker, and exposure to person with covid infection, and other pre-existing medical conditions included the patient was exposed to a person with covid-19 before 5 days of vaccination, and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included morniflumate for benign prostatic hyperplasia, lisinopril for blood pressure, ergocalciferol for gerd, famotidine for gerd, and lansoprazole for gerd. On 31-MAR-2021, the subject experienced fogginess. On 31-MAR-2021, the subject experienced mild headache/jabs in the back of his head. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg, 200/90 mmHg, 180/100 mmHg. On 01-APR-2021, Laboratory data included: CT scan (NR: not provided) negative/nothing. On 01-APR-2021 03:00, the subject experienced woke him up. On 01-APR-2021 03:00, the subject experienced pounding headache. On 05-APR-2021, the subject experienced dry left eye. On 17-APR-2021, Laboratory data included: CT scan (NR: not provided) negative. On 18-APR-2021, the subject experienced cold wet sensation in extremities. On 19-APR-2021, the subject experienced tingling in left arm. On 19-APR-2021, the subject experienced left arm felt heavy. On 20-APR-2021, the subject experienced tingling in both big toes, fingers, left and right hand and thighs. Laboratory data included: Blood test (NR: not provided) normal. On an unspecified date, the subject experienced stressed out, felt like head 2 to 3 times normal size, high blood pressure, and big toes cold. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in both big toes, fingers, left and right hand and thighs, and big toes cold, was recovering from fogginess, and high blood pressure, had not recovered from mild headache/jabs in the back of his head, and cold wet sensation in extremities, and the outcome of woke him up, stressed out, felt like head 2 to 3 times normal size, tingling in left arm, left arm felt heavy, pounding headache and dry left eye was not reported. This report was non-serious.


VAERS ID: 1249524 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Lethargy, Nightmare, Pain, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: USJNJFOC20210443272

Write-up: SEVERE BODY ACHES; NIGHTMARES; LETHARGY; ARM SWELLING; HEADACHE; FEVER; SEVERE FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 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: Unk) dose, start therapy date were not reported 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 subject experienced severe body aches, nightmares, lethargy, arm swelling, headache, fever, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, severe body aches, nightmares, lethargy, severe fatigue and arm swelling was not reported. This report was non-serious.


VAERS ID: 1249529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Sinusitis
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: Test Date: 20210419; Test Name: Blood test; Result Unstructured Data: results came out clear; Test Date: 20210419; Test Name: CAT scan; Result Unstructured Data: results came out clear
CDC Split Type: USJNJFOC20210443448

Write-up: SINUS INFECTION A WEEK AFTER SHOT; 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, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 19-APR-2021, the patient experienced sinus infection a week after shot. Laboratory data included: Blood test (NR: not provided) results came out clear, and CAT scan (NR: not provided) results came out clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus infection a week after shot was not reported. This report was non-serious.


VAERS ID: 1249535 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bone pain, Bronchitis, Chest X-ray, Influenza like illness, Nasal oedema, SARS-CoV-2 test
SMQs:, Angioedema (broad), Guillain-Barre syndrome (broad), Osteonecrosis (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: LUPRON DEPOT
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Chest X-ray; Result Unstructured Data: bronchitis; Test Date: 20210415; Test Name: COVID-19 virus test; Result Unstructured Data: negative
CDC Split Type: USJNJFOC20210443557

Write-up: BRONCHITIS; WEAKNESS THROUGHOUT ENTIRE BODY; RIGHT NOSE SWELLED; BONES BEGAN TO ACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 38 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included leuprorelin acetate. On 10-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced bones began to ache. On 13-APR-2021, the subject experienced right nose swelled. On 14-APR-2021, the subject experienced bronchitis. On 14-APR-2021, the subject experienced weakness throughout entire body. On 15-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative, and Chest X-ray (NR: not provided) bronchitis. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bronchitis, and the outcome of bones began to ache, right nose swelled, weakness throughout entire body and flu like symptoms was not reported. This report was non-serious.


VAERS ID: 1249537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Exposure to SARS-CoV-2, Hypokinesia, Insomnia, Muscle strain, Rib fracture
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210443601

Write-up: FELT LIKE CRACKED RIB; ABDOMINAL MUSCLE PULL; COULD NOT SLEEP ON AFFECTED SIDE; COULD NOT MOVE; EXPOSED TO COVID-19 INFECTED PERSON; 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, 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 felt like cracked rib. On APR-2021, the subject experienced abdominal muscle pull. On APR-2021, the subject experienced could not sleep on affected side. On APR-2021, the subject experienced could not move. On APR-2021, the subject experienced exposed to covid-19 infected person. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not sleep on affected side, abdominal muscle pull, could not move, felt like cracked rib and exposed to covid-19 infected person was not reported. This report was non-serious.


VAERS ID: 1249792 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebrovascular accident, Disorientation, Electrocardiogram abnormal, Feeling abnormal, Illiteracy, Impaired driving ability, Magnetic resonance imaging abnormal, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lipitor, Calciuma, Vitamin C, Vitamin D
Current Illness: None, But did have Covid in 1/2021
Preexisting Conditions: Knee replacement 12/20
Allergies: None
Diagnostic Lab Data: MRI revealed stroke. EKG revealed AFib.
CDC Split Type:

Write-up: Patient complained of not being able to read 1 week after vaccine. 1 week and one day, became very disoriented. Taken to ER on 1 week and 2 days after the shot and diagnosed with a stroke in the left occipital lobe of brain. Also diagnosed with atrial fibrillation same day. (for first time.). Patient had no history of blood clotting disorders nor heart problems. This stroke rendered patient with restricted vision. She is now unable to drive, and still quite foggy, though she is likely to recover almost fully.


VAERS ID: 1249867 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Magnetic resonance imaging, Nausea, Neuralgia, Pain in extremity, Paraesthesia, Scan
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin, Lutera
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI and MRV on 4/20/21
CDC Split Type:

Write-up: Severe Headache, left leg tingling, nausea, nerve pain in left leg and arm. All started on 4/13 in the PM and are currently ongoing.


VAERS ID: 1250119 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / -

Administered by: Public       Purchased by: ?
Symptoms: Blood test abnormal, Bone pain, Chills, Dehydration, Headache, Influenza like illness, Loss of personal independence in daily activities, Neck pain, Pain, Pain of skin, Pyrexia, Sleep disorder, Tongue discolouration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: crestor
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: blood clot in leg test was negative , blood work was good except for alt number was alittle higher than normal , dr said perhaps cause of dehydration . item 21 could be permanent disbility or damage dont know yet
CDC Split Type:

Write-up: on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches . Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration , continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with headache everyday and at night headaches are bad . i drink plenty of fluids all day , should not be feeling dehydrated . its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake


VAERS ID: 1250590 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Blood test normal, Computerised tomogram normal, Dizziness, Head discomfort, Headache, Lymph node pain, Lymphadenopathy
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxicillin, penicillin, kiwi
Diagnostic Lab Data: Blood work was done to check for clot markers, and a normal blood work up...it all checked out okay. Cat scan done on head to check for blood clots because I felt dizzy with a headache and a fullness in head w migrating pain. Also clear.
CDC Split Type:

Write-up: Swollen lymph node in left breast. Painful, very swollen for 4 to 5 days, then slowly resolved over the next couple days. No doctor seen for this. About one week after vaccination, i started to get headaches and feel dizzy on and off. I did go to the hospital for this because I have never had anything like that happen before.


VAERS ID: 1250599 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / -

Administered by: School       Purchased by: ?
Symptoms: Dizziness, Influenza like illness, Pain, Pain in extremity, Sleep disorder
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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: none
Current Illness: none
Preexisting Conditions: childhood asthma
Allergies: Tree nuts, shell fish
Diagnostic Lab Data:
CDC Split Type:

Write-up: on 4/9 He said he had flu like symptoms, and dizziness and pain to the point that he could not sleep(he said all of his teammates got sick) on 4/11 He had some much pain in left arm he could not play tennis. He had not been able to play tennis since its been two weeks on 4/17 He went to Urgent Care and they prescribed pain and anitinflammatories He still cannot play tennis


VAERS ID: 1250734 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-03-08
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Chills, Diarrhoea, Migraine, Pain, Pyrexia, Rash erythematous, Restless legs syndrome
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210320338

Write-up: RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone 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: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills 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: 1250758 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-03-06
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue, Heart rate increased, Hypertension, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (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:
Current Illness: Blood pressure high; Heart rate increased
Preexisting Conditions: Comments: The patient was not pregnant at the time of reporting. The patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: EKG; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20210321465

Write-up: HIGH BLOOD PRESSURE; INCREASED HEART RATE; HEART PALPITATIONS; SHORTNESS OF BREATH; CHEST TIGHTNESS; TIRED; 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 high blood pressures, and increased heart rate, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced heart palpitations. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced chest tightness. On 10-MAR-2021, the subject experienced high blood pressure. On 10-MAR-2021, the subject experienced increased heart rate. Laboratory data included: EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, heart palpitations, shortness of breath, chest tightness, high blood pressure, and increased heart rate. 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: 1250807 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-08
Onset:2021-04-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Aspartate aminotransferase normal, Computerised tomogram head, Computerised tomogram normal, Dehydration, Differential white blood cell count, Dizziness, Electrocardiogram normal, Erythrocyte osmotic fragility test, Feeling cold, Full blood count, Headache, Lipase normal, Metabolic function test, Nausea, SARS-CoV-2 test negative, Urine analysis normal, Venogram normal, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Dehydration (narrow), COVID-19 (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: Fosomax
Current Illness: None
Preexisting Conditions: Bladder cancer survivor; osteoporosis
Allergies: Sulpha
Diagnostic Lab Data: 4/22/21: CBC and differential - normal Covid 19 raid - normal Comp metabolic panel - normal Got - normal Hemolysis index- normal Lipase - normal UA reflex to micro - normal CT head w/o contrast - normal CT venogram head - normal ECG 12 lead - normal
CDC Split Type:

Write-up: Extreme vomiting leading to dehydration requiring 3 L of IV saline; headache; nausea; chills; woozy feeling; all beginning 11 days after shot, leading to ER visit 14 days after shot. Still ill 15 days after shot but now have meds for symptoms.


VAERS ID: 1250843 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-07
Onset:2021-04-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / SYR

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vyvanse wellbutrin Lorazepam
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart attack due to tear in major artery in heart


VAERS ID: 1250896 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest X-ray normal, Chest discomfort, Computerised tomogram head, Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Headache, Lip swelling, Nausea, Peripheral swelling, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Flu
Other Medications: Atorvastatin, Exetimibe, Omeprazole, Flonase
Current Illness:
Preexisting Conditions: Gastritis, glaucoma, arthritis.
Allergies: Penicillin
Diagnostic Lab Data: Went to ER on 04/15 where they did US Doppler Venous Lower Extremity ; results negative. Also did EKG which was "normal". Headache continued so went back to ER on 04/17 where they did a EKG (normal), Chest X-ray (normal) and a CT Head without contrast (determined no clots). Was given Toradol and Reglan. Those drugs calmed my headache and I started to feel better. Slight headache ret 04/24.
CDC Split Type:

Write-up: Started 1 week after injection. Swelling in lower legs, felt like balloons. Feeling of swelling in lips. Headache started in left temple area of head; after a couple of days went across forehead and on back of head with intensity increasing but not extreme pain. Slight nausea; no vomiting. Some abdominal pain that would come and go. Periods of shortness of breath; tightness feeling in upper chest. Loss of energy and some light headed feeling.


VAERS ID: 1250927 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / N/A LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Ear discomfort, Electrocardiogram, Feeling hot, Gait disturbance, Head discomfort, Hemiparesis, Hypoaesthesia, Magnetic resonance imaging, Neurological symptom, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), 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), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), 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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: mild allergies to chicken eggs and bakers yeast
Diagnostic Lab Data: CT scan; MRI; EKG; bloodwork; cognitive testing for suspected stroke
CDC Split Type:

Write-up: 1 hour after the vaccine I was walking with my sister and began experiencing neurological adverse effects--I was dragging my right lag and slurring my speech. 3 hours after the vaccine my right arm and right leg began tingling, went numb, and became weak. These symptoms persisted and my doctor advised me to go to the ER for brain imaging 24 hours after the vaccine. On day 3 after the vaccine, my symptoms had diminished but not subsided and I began to have new symptoms: extreme heat and pressure starting at my right ear and spreading through my face and head. The heat has subsided but not the pressure, as I am writing this it is day 13. Tests came back normal, but weakness and pressure neurological symptoms persist.


VAERS ID: 1250956 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-06
Onset:2021-04-23
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Discomfort, Pain, 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Awaiting ultrasound
CDC Split Type:

Write-up: Left leg began hurting and throbbing, both legs began hurting, feeling pressure in legs


VAERS ID: 1251038 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-04
Onset:2021-04-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Flank pain, Full blood count, Haemoglobin decreased, Headache, Human chorionic gonadotropin negative, Metabolic function test, Pain in extremity, Platelet count normal, Ultrasound Doppler abnormal, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills
Current Illness: none
Preexisting Conditions: none
Allergies: amoxicillin, azithromycin, sulfa
Diagnostic Lab Data: 4-19-2021 + D-dimer 0.8 4-19-2021 CBC with Hgb 9.9/platelets 322/WBC 7.2 4-19-2021 normal CMP 4-19-2021 negative HcG 4-19-2021 Doppler U/S Occlusive DVT in left gastrocnemius veins in the proximal to mid calf
CDC Split Type:

Write-up: Initial severe headache after vaccine- this resolved in 24-48 hours. Had some LEFT flank pain for a few days. This resolved on its own. Then awoke on 4-17-2021 with LEFT calf pain that was constant and persistent. Called triage on Monday 4-19-2021 for guidance- came to Urgent Care. D dimer done and was positive. Was then sent to ER for imaging with + Doppler U/S LLE DVT- started on Eliquis.


VAERS ID: 1251057 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-04-07
Onset:2021-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Contusion, Fatigue, Pain, Pain in extremity, Pyrexia, Ultrasound scan normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), 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: none
Preexisting Conditions: scoliosis
Allergies: bactrim, biaxin, omnicef
Diagnostic Lab Data: Emergency room ultrasound on April 23, 2021 of both legs came back with no sign of clots.
CDC Split Type:

Write-up: The day of vaccination I got chills, body aches, and fever along with tiredness and bruises. The next 2 days also had tiredness. Every day since I got the shot I''ve had bruises and leg pains. I continue to have the bruises and leg pains.


VAERS ID: 1251068 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-02
Onset:2021-04-22
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Limb discomfort, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: PT STATED HE WENT TO THE CLINIC AND THEN THE ER WITH A BUMP ON THE BACK OF HIS LEG. PT WAS TOLD IT WAS A BLOOD CLOT.


VAERS ID: 1251070 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Headache, Hypertension, Hypoaesthesia, Hypokalaemia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Tendinopathies and ligament disorders (broad), Hypokalaemia (narrow), 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: Hydrochlorothiazide, aspirin, ibuprofen
Current Illness: None
Preexisting Conditions: HBP
Allergies: Penicillin
Diagnostic Lab Data: Hypo kale Mia
CDC Split Type:

Write-up: Head aches, numbness in legs, pressure elevated and left arm soreness.


VAERS ID: 1251098 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-03-14
Onset:2021-03-21
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK AR / SC

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (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: Alcoholism
Preexisting Conditions: Cirrhosis
Allergies:
Diagnostic Lab Data: Received Decatron Steroid injection in the ER which was ineffective. Continued pain.
CDC Split Type:

Write-up: Severe wrist and hand pain and numbness


VAERS ID: 1251144 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Headache, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Ambien, Depo-Provera, Zoloft
Current Illness:
Preexisting Conditions: Lupus (remission)
Allergies: Lomatrigine
Diagnostic Lab Data: April 16, 2021: Blood tests, EKG and chest x-ray completed.
CDC Split Type:

Write-up: Severe headaches, stomach and leg pain, shortness of breath. Discussed symptoms with primary doctor on April 16, 2021, he advised to go to the ER. Headaches, leg pain (severe) and shortness of breath have not subsided as of day 14 following vaccine.


VAERS ID: 1251202 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-03-19
Onset:2021-03-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Erythema, Hysterectomy, Pain in extremity, Peripheral swelling, Pulmonary embolism, Thrombosis, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Events: Vaccine was given on 3/19/21; Hysterectomy on 3/25/21; blood clots diagnosed on 3/30/21 Left forearm was swollen, with a light reddish tint to it, and tender. After getting an ultra sound on my forearm a DVT was found and I was sent to the emergency room. I then had a CT scan done of my chest and it was discovered I had several pulmonary emboli. I was admitted to the hospital and put on a heparin drip. I am currently taking Eliquis and will be following up with a pulmonologist and a hematologist in a week or two.


VAERS ID: 1251253 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-05
Onset:2021-04-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angioedema, Blood test, Diarrhoea, Dizziness, Fatigue, Immediate post-injection reaction, Lip swelling, Muscle spasms, Nausea, Pain, Peripheral swelling, Swelling face, Swollen tongue, Ultrasound abdomen, Ultrasound scan
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: IBS
Allergies: Lactose intolerant
Diagnostic Lab Data: Blookwork 5/13 (Primary care) and 5/16 (ER) and ultra sounds of abdomen and right leg.
CDC Split Type:

Write-up: Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic reaction including violent diarrhea with severe cramping and pain, and swollen lips, tongue, face, hands and feet. Acute swelling and diarrhea lasted 12 hours. Ongoing angioedema lasted 4 days and moved from mouth to face and hands and feet. No previous food allergies or allergic reactions.


VAERS ID: 1251294 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-10
Onset:2021-04-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN FB201A21A / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Full blood count normal, Headache, Migraine, Pain, Pain in extremity, Platelet count normal, SARS-CoV-2 test negative
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (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: Multi-vitamin, Vitamin C and Vitamin D, no other meds
Current Illness: No
Preexisting Conditions: No
Allergies: Gluten and dairy sensitivity - no allergies
Diagnostic Lab Data: On Tuesday 4/20 I had a CBC test to check for low platelets and it came back normal.
CDC Split Type:

Write-up: On 4/10 I got the J&J shot at Medical Center at 8am. 12 hours later at 8pm I experienced the normal side effects - body aches, tired, arm pain. I slept it off and the next day felt better - took a nap, but no problems. 8 days later on Sunday (4/18) I started to get a headache, on the top of my head (where a hat would go) and the back of my head. It was on / off, but it''s out of character as I don''t normally get headaches. On Monday, it continued on/off so I wrote my doctor...on Tuesday it continued more "on" then off - she recommended I go get bloodwork for low platelets and I did (at medical center). They came back normal. On Wednesday (4/21), the headache became a migrane and was screaming at me - all day with no relief. I''ve never had a migrane in my life and needed to be in low light - screen time became hard to deal with. I did get a Covid Test to rule out that and it came back negative Thursday morning. Thursday morning - same....screaming headache. Friday, less screaming but still not great - I met with my doctor on telehealth and she recommended I go to the ER to get evaluated. I went to another hospital on Friday afternoon to get evaluated. Since my bloodwork from Tuesday was all clear - they believe the migrane was inflammation from my immune response to the vaccine - especially because i never had a migrane before. They gave me anti-inflammatory meds via IV to mellow out the pain. They said if the pain came back or if I had other symptoms in the coming week to check back and likely need imaging. Today is Saturday (4/24) - the anti-inflammatory meds have helped but not 100%. I do still have some throb on/off and had a few dizzy feelings earlier.


VAERS ID: 1251326 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-04-09
Onset:2021-04-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Laboratory test normal, Testicular pain, Urinary incontinence
SMQs:, Sexual dysfunction (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: One a day Men''s Multivitamins, Vitamin D 2000 IU.
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Al lab results within normal ranges
CDC Split Type:

Write-up: Right Testicular Pain / difficulty urinating


VAERS ID: 1251424 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-04-10
Onset:2021-04-22
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bell's palsy, Dyskinesia, Speech disorder
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Dyskinesia (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hearing impairment (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: metoprolol er 100mg, losartan 100mg, cymbalta 60mg
Current Illness: none
Preexisting Conditions: high blood pressure
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bell''s Palsy on right side of face developed 4/22/21. Pt thought he was having a stroke and went to the ER. Doctor gave him B12 to inject 2 doses. Worsening 4/24/21 and having a lot of trouble speaking and eating/drinking.


VAERS ID: 1251493 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-03-11
Onset:2021-04-11
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Ischaemic stroke, Loss of consciousness, Magnetic resonance imaging head abnormal, Visual field defect, Visual impairment
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), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Biotin, Calcium supplement, Celebrex, Fish oil supplement, OXcarbazepine, Vitamin C & D3 supplements
Current Illness: None
Preexisting Conditions: Post neuropathic Shingles
Allergies: None
Diagnostic Lab Data: CT Scan & MRI indicated partial blockage leading to unconsciousness and stroke
CDC Split Type:

Write-up: Ischemic Stroke requiring hospitalization. Significant reduction in field of vision. Loss of nearly all Left Side peripheral vision


VAERS ID: 1251577 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-02
Onset:2021-04-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood test, Joint swelling
SMQs:, Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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:
Allergies: Sulfa drugs
Diagnostic Lab Data: Blood tests taken on April 12th
CDC Split Type:

Write-up: Swelling of joints, especially knees and wrists but every joint in my body is sore. Started in my knees on April 9 then progressively got worse over the weekend. Saw doctor on Monday and they prescribed meloxicam. Went to er on Wednesday because condition wasn''t getting better and was in a lot of pain and they prescribed a steroid for 6 days. After 6 days and not feeling any better I contacted both the doctor and the er and never got a response. Very concerned at their lack of concern. Im not a doctor but I''m pretty sure you don''t just wake up with severe arthritis after never showing any symptoms? Really just need someone to assist me because I''m not getting better and its becoming extremely debilitating


VAERS ID: 1251601 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Blood pressure increased, Decreased appetite, Diplopia, Disorientation, Dizziness, Feeling abnormal, Metabolic function test, Muscle tightness, Pain in extremity, Pelvic pain, Peripheral swelling, Thirst, Urine analysis abnormal
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Arthritis (broad), 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: None
Current Illness: fibrosis caused by exposure to injected gadolinium-based contrast dye
Preexisting Conditions: gadolinium deposition disease, tachycardia
Allergies: yes, antibiotics, penicillins, MRI contrast dyes
Diagnostic Lab Data: Saw Dr at urgent Care where a Comprehensive metabolic was done. I hope to attach the results. On April 18th When I was with Dr. I had dizziness and disorientation and again on the April 20th along with a spike in blood pressure.
CDC Split Type:

Write-up: got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.


VAERS ID: 1251605 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-03-19
Onset:2021-04-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Bell's palsy, Computerised tomogram, Electrocardiogram
SMQs:, Hearing impairment (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: OTC Generic Allergy
Current Illness: None
Preexisting Conditions: None
Allergies: Buckwheat
Diagnostic Lab Data: CAT Scan , EKG. To rule out stroke.
CDC Split Type:

Write-up: Developed Bell?s Palsy on right side of my face. Gained most movement back in 1 1/2 weeks.


VAERS ID: 1251620 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-05
Onset:2021-04-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Blood test, Groin pain, Pain in extremity, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Osteonecrosis (broad), Arthritis (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: Tylenol
Current Illness: Stage 3 kidney disease
Preexisting Conditions: Kidney disease
Allergies: none
Diagnostic Lab Data: Ultra Sound in ER Blood Work
CDC Split Type:

Write-up: Severe pain in left thigh groin & knee area. Went to ER, confirmed blood clot. Sent home w/blood thinners - Xarelto


VAERS ID: 1251733 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-27
Onset:2021-03-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Cerebral artery occlusion, Movement disorder, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 8 days after receiving vaccine, recipient suffered a mini stroke. He was hospitalized for several days. He was told he had a clogged artery with 60% blockage. They gave him blood thinner. He recovered and was released from hospital. He moves much slower now and receives physical therapy.


VAERS ID: 1251762 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-16
Onset:2021-04-12
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cognitive disorder, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Magnetic resonance imaging normal, Nausea, SARS-CoV-2 test negative, Speech disorder, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (narrow), COVID-19 (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: Levothyroxine 5 mcg 2x week Levothyroxine 75 mcg 5x week Liothyronine 5 mcg 1x daily Clindamycin Phosphate & Benzyne Peroxide Gel 1.2%/5% 1x daily morning Tretinoin Cream USP 0.1% 1x daily evening Claritin Ready Tabs 1x daily as needed Niac
Current Illness: none
Preexisting Conditions: Hypothyroid
Allergies: Indocin, Acacia pollen. Occasional itchiness with avocado, pork, shrimp, and lobster.
Diagnostic Lab Data: April 14 - COVID19 negative, requested MRI of brain. EKG normal. April 16 - COVID19 negative, requested MRI of brain. EKG normal. Stroke negative, CT scan, MRI of brain all normal.
CDC Split Type:

Write-up: Date of injection: swelling, redness, soreness and itchy around injection site that continued for a week. April 12 Unexplained symptoms. Woke with throbbing head, light headed, off balance, impaired cognitive functions, impaired speech and random mild nausea that continued through mid-day April 13. Throbbing head and dizziness all dissipated when sitting or lying down. Visited Doctor on April 14 and ruled out stroke, heart attack and tested negative for COVID19. Symptoms lessened but did not disappear and visited hospital where they again ruled out stroke, heart attack and tested negative for COVID19. Performed Catscan and MRI of the brain that all showed normal. Performed inner ear testing that was normal, although they said I appeared to be experiencing some vertigo. April 23 still experiencing mild speech impairment and tire after talking for more than 10 minutes. Cognitive abilities inhibited by ongoing focus issues and search for right words. Balance issues easily impacted vigorous head movement.


VAERS ID: 1251844 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-10
Onset:2021-04-21
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Cerebrovascular accident, Chest X-ray, Computerised tomogram head abnormal, Echocardiogram, Electrocardiogram, Glycosylated haemoglobin, Laboratory test, Lipids, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck, Saline infusion sonogram
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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASA 81 mg, Brilinta 90 mg, Altace 5 mg, crestor 40 mg, lopressor tartrate 25 mg , vit C, calcium, saw palmetto, flomax, b6-mag
Current Illness: Non-ST elevation MI February 19, 2021
Preexisting Conditions: Underlying coronary artery disease, hypertension, hyperlipidemia, BPH, history of prostate cancer
Allergies: Penicillin - hives and Lovenox - rash
Diagnostic Lab Data: Hospital admission, head CT, EKG, chest x-ray, lab work, A1c, lipid profile, MRI/MRA brain/head/neck, transthoracic echocardiogram with bubble study
CDC Split Type:

Write-up: acute CVA


VAERS ID: 1251851 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / N/A AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Activated partial thromboplastin time shortened, Angiogram cerebral abnormal, Blood fibrinogen decreased, Cerebral venous sinus thrombosis, Fibrin D dimer increased, Haemoglobin normal, Headache, Immune thrombocytopenia, International normalised ratio increased, Magnetic resonance imaging head abnormal, Platelet count decreased, Scan with contrast abnormal, Thrombocytopenia, Vaccination complication, Venogram, White blood cell count normal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Benign fatty liver
Allergies: NKDA
Diagnostic Lab Data: 4/23/2021: MAGNETIC RESONANCE IMAGING - MR BRAIN W WO CONT 04/23 1700 *** Report Impression - Status: SIGNED Entered: 04/23/2021 1905 IMPRESSION: 1. The superior sagittal sinus does not completely homogeneously enhance. Uncertain if this is related to flow phenomenon or this represents nonocclusive thrombosis. CT venogram can be considered. 2. The remainder of the brain is within normal limits. MAGNETIC RESONANCE IMAGING - MR ANGIO HEAD WO CONT 04/23 1800 *** Report Impression - Status: SIGNED Entered: 04/23/2021 1905 IMPRESSION: 1. The superior sagittal sinus does not completely homogeneously enhance. Uncertain if this is related to flow phenomenon or this represents nonocclusive thrombosis. CT venogram can be considered. 2. The remainder of the brain is within normal limits. COMPUTERIZED TOMOGRAPHY - CT VENOGRAM BRAIN 04/23 1954 *** Report Impression - Status: SIGNED Entered: 04/23/2021 2029 CBC: WBC 5.7, Hgb 13.9, platelets 22,000 INR 12, aPTT 26, D-dimer $g12.80, fibrinogen 104 mg/dL.
CDC Split Type:

Write-up: Progressive headache, leading to ER admission, diagnosis of Left sigmoid sinus thrombosis accompanied by severe thrombocytopenia. Diagnosis confirmed as vaccine-induced immune thrombocytopenia and thrombosis (VITT)/vaccine-associated thrombosis and thrombocytopenia (VATT).


VAERS ID: 1251905 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Burning sensation, Computerised tomogram, Head discomfort, Magnetic resonance imaging, Myalgia, Pain of skin, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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: Multivitamin
Current Illness: None
Preexisting Conditions: High cholesterol, tinnitis
Allergies: None know
Diagnostic Lab Data: Hospital ER for exam and CT, MRI and Bloodwork negative on April 20, 2021.
CDC Split Type:

Write-up: Burning and tingling pain on left side of head and face getting progressively worse. Hurts worse to move facial muscles or touch skin at area. No lesions.


VAERS ID: 1251931 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

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

Write-up: Right peroneal vein DVT


VAERS ID: 1252121 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-21
Onset:2021-03-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Adverse event, Electrocardiogram, Exposure during pregnancy, Heart rate increased, Pregnancy
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Dehydration (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: POLYCYCSTIC OVARIAN SYNDROME, DEPRESSION
Allergies:
Diagnostic Lab Data: EKG (March 21, 2021)
CDC Split Type:

Write-up: I had a fast heart rate (approx 120 beats per minute while resting). I called my consulting nurse who advised me to go into Urgent Care. I went to Urgent Care. They gave me an EKG, which showed my increased heart rate, but nothing abnormal. I was given Tylenol to see if that decreased my heart rate, but it didn''t. I was told to drink lots of water to see if dehydration might be why my heart rate was increased. The Urgent Care doctor consulted with an OB Doctor and concluded that my increased heart rate was due to my body''s response to the vaccine in connection with the pregnancy. At the time of the adverse event, I was 23 weeks pregnant. My estimated date of delivery is July 13, 2021. This current pregnancy is my 3rd. My second pregnancy ended in a miscarriage. During my first pregnancy, I developed Gestational Diabetes and Preeclampsia. I needed insulin to manage the Gestational Diabetes and I was induced at 37 weeks pregnant because of the Preeclampsia. My daughter had to be in the NICU after birth for 5 days due to low oxygen, low blood sugar, low muscle tone, dusky color, and no cry.


VAERS ID: 1252137 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cerebrovascular accident, Death
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? Yes
   Date died: 2021-04-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Heart Stints
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Stoke 6 days after vaccine. Death 5 days after stroke.


VAERS ID: 1252213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: West Virginia  
Vaccinated:0000-00-00
Onset:2021-03-10
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Product administered at inappropriate site
SMQs:, Drug abuse and dependence (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Fatty liver; Heart disease, unspecified; Implantable defibrillator user; Lupus erythematosus; Pre-diabetic
Preexisting Conditions: Comments: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210324292

Write-up: VACCINE NOT ADMINISTERED IN DELTOID; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included heart disease, defibrillator, lupus, fatty liver, prediabetic, and high blood pressure, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 08:30, the subject experienced vaccine not administered in deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine not administered in deltoid was not reported. This report was non-serious. Version created to amend previously reported information on 11/MAR/2021. Upon review, the following information was amended: Company causality updated for event.


VAERS ID: 1252397 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-27
Onset:2021-03-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Haematology test normal, Nausea, Platelet count normal, Retching, Seizure, Ultrasound abdomen normal
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), 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: Loratadine (10 mg QD); fluoxetine (20 mg QD);
Current Illness: None
Preexisting Conditions: Obesity
Allergies: meperidine
Diagnostic Lab Data: Ultrasound at the ED showed normal gallbladder and right kidney, including normal hepatopetal flow in the main portal vein. o No brain imaging was done.
CDC Split Type:

Write-up: On 27 MAR 2021, 9:25 am, I received Janssen vaccine Lot # 1805020 in the left deltoid. o Later that same afternoon I had upper quadrant abdominal pain, which was partially relieved by resting on the floor on my hands and knees. The pain subsided after a few hours, and I assumed that it was gallbladder related because of a single ?gallbladder attack'' I had over 10 years ago. o Three days later (30 MAR 2021), while on a Zoom call with a friend, I began to experience more severe upper quadrant abdominal pain and nausea, saying several times over the hour that I thought I might have to vomit. On my return from the bathroom, she tells me that I put my arm up over


VAERS ID: 1252404 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-13
Onset:2021-03-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / SYR

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

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: Glimepiride, Metformin, Valsartan, Atorvastatin
Current Illness: None
Preexisting Conditions: Diabetes, high blood pressure, cholesterol
Allergies: None
Diagnostic Lab Data: Labs: CBC w/auto Diff, CMP, Lipase, UA complete, UA micro Radiology: CT abdomen and pelvis w/o contrast: kidney stone
CDC Split Type:

Write-up: Kidney stone


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