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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: 1152074 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-15
Onset:2021-03-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Current Outpatient Medications: ? amLODIPine (NORVASC) 5 MG tablet, Take 1 tablet (5 mg) by mouth daily, Disp: 90 tablet, Rfl: 3 ? aspirin 81 MG tablet, Take 81 mg by mouth daily, Disp: , Rfl: ? Blood Glucose Monitoring Suppl (EASY TOU
Current Illness:
Preexisting Conditions:
Allergies: pcn
Diagnostic Lab Data:
CDC Split Type:

Write-up: 91 y.o. female who presents with difficulty breathing onset 1 week ago. States symptoms have worsened the last couple of days and has developed intermittent chest pain, at times on the right lower chest and today on the left upper chest. Patient does have a history of stage III kidney disease, hypertension and was told many years ago that she had congestive heart failure. 3/31/21 admitted observation dx chest pain , sob


VAERS ID: 1152243 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Rash, Throat irritation
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexium, Plaquenil, Depo-Provera, Zyrtec
Current Illness: Chronic idiopathic urticaria, Lumbar radiculopathy
Preexisting Conditions: Chronic idiopathic urticaria, Lumbar radiculopathy
Allergies: Cobalt, methylmethacrylate, nickel, Nyquil, pineapple, propylene Glycol, Shellfish, Strawberry, tree nuts
Diagnostic Lab Data: 50mg Benadryl capsule PO
CDC Split Type:

Write-up: itching throat, dizziness, rash to neck within 25 minutes of admin


VAERS ID: 1152392 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / N/A RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: UNKNOWN
Diagnostic Lab Data: NO
CDC Split Type:

Write-up: DIAPHORETIC, PULSE 40, VAGAL DOWN EPISODE


VAERS ID: 1152456 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Enuresis, Eye movement disorder, Musculoskeletal stiffness, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: A few minutes after the vaccine was administered, the patient appeared to have a seizure for a few seconds. Her eyes rolled back, stiff arm, and she urinated herself. Her mom was holding her hand and after a few seconds, she was able to talk and said that she thought that she fell asleep for a few seconds. We called an ambulance and they are taking her to the hospital for a CT scan.


VAERS ID: 1152459 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-03-06
Onset:2021-03-22
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Chills, Condition aggravated, Cough, Dyspnoea, Dyspnoea exertional, Fatigue, Hypoxia, Pneumonia pseudomonal, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Proair HFA, Spiriva Respimat, Aspirin, Symbicort, Singulair, Protonix, Claritin, Prilosec
Current Illness: Admitted (12/16/2020 to 12/17/2020 for Sepsis 2/2 Pneumonia, then again (12/31/2020 to 1/2/2021) for severe persistent asthma/eosinophilia.
Preexisting Conditions: Coronary Artery Disease, Diabetes mellitus, Hypertension, Gout, Asthma, Atrial Flutter (s/p ablation), Chronic Kidney Disease (Stage III).
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID-19 (+) on 3/22/2021 Presented with hypoxemia, cough, dyspnea on exertion. Per ED report, patient had received the Johnson and Johnson COVID-19 vaccine on 3/6/2021 and started becoming symptomatic on 3/19/2021 with dyspnea, fevers, chills, fatigue and cough. He had reported resolution of his fever/chills, however his dyspnea and cough had progressively worsened. He then presented to the ED (3/25/2021 and discharged on 3/29/2021). In addition to his COVID-PNA, he also had a superimposed Pseudomonas PNA and was discharged on Levaquin and oral steroids (Dexamethasone) for a total of 10-day therapy.


VAERS ID: 1152520 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-03-24
Onset:2021-03-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Eye pain, Fatigue, Influenza virus test negative, Myalgia, Ocular discomfort, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative, Tonsillar inflammation
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? 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: 03/31/2021 - SARS-COV-2 + INFLUENZA A+B PCR - negative 03/31/2021 - STREP A SCREEN DIRECT W RFLX STREP A CULTURE - Screen negative, awaiting culture results
CDC Split Type:

Write-up: 03/24/2021 - Mild sore throat in the evening. 03/25/2021 - Moderate sore throat, moderate fatigue and muscular pain. 03/26/2021 - Mild sore throat and mild fatigue. 03/27/2021 - Moderate sore throat, moderate fatigue and muscular pain. Low grade fever of 99.1F. 03/28/2021 - Moderate sore throat, mild ear pain, eye pain/pressure. Fever spiked to 102.4F during the night. 03/29/2021 - Severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, fever of 101.9F. Consulted a doctor on MD Live who felt it might still be a reaction to the vaccine and prescribed Ibuprofen 600mg to manage symptoms. 03/30/2021 - Extremely severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, low grade fever of 99.5F. 03/31/2021 - Symptoms same as 03/30/2021. Consulted a doctor at the local Urgent care clinic. Prescribed amoxicillin-clavulanate and predniSONE.


VAERS ID: 1152715 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Anal incontinence, Hypopnoea, Loss of consciousness, Pulse abnormal
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), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), 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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Patient sitting in chair passed out sternal run performed lowered to floor sternal rub performed again responsive breathing shallow lost bowels pulse weak ammonia salts used and EMS called


VAERS ID: 1152729 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: NO KNOWN
Diagnostic Lab Data:
CDC Split Type:

Write-up: INCREASED HEART RATE AND BLOOD PRESSURE, NEEDING HOSPITALIZATION


VAERS ID: 1152804 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Body temperature decreased, Chest X-ray, Diarrhoea, Dizziness, Dry mouth, Electrocardiogram, Full blood count, Hypoaesthesia, Hypotension, Metabolic function test, Oxygen saturation, Paraesthesia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin D, Viviscal vitamin supplement
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data: EKG, chest x-ray, complete blood count (CBC), basic and comprehensive metabolic profile, cardiac enzymes, pulse oximeter, heart monitor. All results returned normal
CDC Split Type:

Write-up: 25 minutes post injection hypotension, tachycardia (116), lowered body temp.(96.8), dizziness, dry mouth, numbness and tingling in hands. Arrived at Hospital ER 2 hours post injection. Symptoms subsided about 2.5 hours post injection. Similar but milder symptoms on the morning of 03/31 with diarrhea.


VAERS ID: 1153087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Cough, Heart rate, Heart rate increased, Influenza like illness, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METHOTREXATE
Current Illness: Abstains from alcohol; Alcohol allergy; Food allergy; Immunocompromised; Nonsmoker; Vasculitis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: 90/60 mmHg; Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: 157/90 mmHg; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: 99 F; Test Date: 20210311; Test Name: Heart rate; Result Unstructured Data: above 100 BPM; Test Date: 20210311; Test Name: Fever; Result Unstructured Data: 102 F
CDC Split Type: USJNJFOC20210329139

Write-up: INCREASED HEART RATE; FLU-LIKE SYMPTOMS; BLOOD PRESSURE INCREASED; COUGH; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 51 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included vasculitis, alcohol allergy, cinnamon allergy, immunocompromised, no smoking, and no alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:10 at left arm for prophylactic vaccination. Concomitant medications included methotrexate for vasculitis. On unspecified date in MAR-2021, the patient''s regularly blood pressure was 90/60 mmHg, but at hospital blood pressure increased to 157/90 mmHg. The patient had experienced bad reaction. The patient had nap after work on 11-Mar-2021. The patient had first noticed chills, fever, fast heart rate. On 11-MAR-2021 17:30, the patient pulse was over 100. The patient heart rate was 100 for 5 hrs. On 11-MAR-2021, the patient experienced flu-like symptoms. On 11-MAR-2021 10:00 pm, the patient''s temperature was 102 F. The entire was hurting for patient. The patient was treated with fluids and antibiotics to treat fever and monitored heart rate in hospital. The blood pressure was returned to normal and temperature to 99 F at discharge. The patient felt flu like symptoms, body aches and chest tightness even on 14-Mar-2021. The patient had cough at the time of reporting. Treatment medications (dates unspecified) included: azithromycin non-company, and ceftriaxone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate on 12-MAR-2021 and blood pressure increased on MAR-2021, and had not recovered from chest tightness, flu-like symptom and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Increased Heart Rate. This event is labeled and is therefore considered potentially related. 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Flu Like Symptoms. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY. 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Blood Pressure Increased. 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: 1153089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pharyngeal swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Adhesive tape allergy
Preexisting Conditions: Comments: The patient had no history of illness at the time of vaccination. Patient had no history of allergy to vaccines, drug or food and no family history of any disease. Patient had past age of conception and was not pregnant at the time of reporting.
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: COVID-19 virus test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210331224

Write-up: SHORTNESS OF BREATH; THROAT SWELLING; This spontaneous report received from a patient concerned a 62 year old female. The patient''s weight was 185 pounds, and height was 67 inches. The patient''s concurrent conditions included skin irritation to tape. The patient had no history of illness at the time of vaccination. The patient had no history of allergy to vaccines, drug or food and no family history of any disease. Patient had passed age of conception and was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced shortness of breath, and was hospitalized. On MAR-2021, the patient experienced throat swelling and was given Epipen (epinephrine). The patient was treated every 4 hours. The patient had Covid-19 test while in the hospital 2 weeks ago and test was negative. The patient did not suspect any causes including co-administered vaccines/risk factors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was not related. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 23-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (Date of birth-13-FEB-1959, height-5''7", Weight-185 lbs), reporter details (address, state code, zip code), reporter causality (not related), patient history and disease tab, lab data (Covid-19 test).; Sender''s Comments: v1: The following information received updates Patient demographic details reporter details, reporter causality (not related), patient history and disease tab, lab data (Covid-19 test). This updated information does not alter prior causality assessment. 20210331224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Shortness of breath, Throat swelling. 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: 1153091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-03-12
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Diplopia, Eye disorder, Headache, Heart rate, Heart rate increased, Hypertension, Nausea, Somnolence, Vertigo, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Ocular motility 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: 202103; Test Name: Blood pressure; Result Unstructured Data: High Blood pressure; Test Date: 20210312; Test Name: Heart rate; Result Unstructured Data: elevated Heart rate
CDC Split Type: USJNJFOC20210332091

Write-up: ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; CHEST TIGHTNESS; COATING OVER EYES; VERTIGO; BLURRY VISION; SEEING DOUBLE; HEADACHE; NAUSEA; SLEEPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High Blood pressure. On 12-MAR-2021, the patient experienced elevated blood pressure. On the same day, the patient experienced coating over her eyes, vertigo, elevated blood pressure and heart rate 5 minutes within receiving the vaccine, headache, nausea, and sleepy. The patient felt heart racing fast. Ambulance was called and on the same day, the patient was hospitalized for 8-9 hours until blood pressure stabilized. Laboratory data included: Heart rate (NR: not provided) elevated Heart rate. It was not known if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and seeing double on MAR-2021, was recovering from coating over eyes, chest tightness, and elevated heart rate, and had not recovered from elevated blood pressure, vertigo, headache, nausea, and sleepy. The reporter and company causality considered between covid-19 vaccine ad26.cov2.s and blurry vision, seeing double, coating over eyes, chest tightness, elevated heart rate, blood pressure, vertigo, headache, nausea, and sleepy as possible. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210332091-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. 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: 1153092 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Kansas  
Vaccinated:0000-00-00
Onset:2021-03-16
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Seizure
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Dehydration; Feeling anxious; Non-smoker; Penicillin allergy
Preexisting Conditions: Comments: The patient did not had history of drug abuse or illicit drug use. The patient was not pregnant at the time of reporting.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210332197

Write-up: SEIZURE; DEHYDRATION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included dehydrated, anxious, non alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not had history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient had an seizures with in 1 minute after vaccine administration which was lasted for 10 second. The patient did not had history of seizure. The patient was taken to hospital via ambulance and they found that she was dehydrated and was given fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 16-MAR-2021, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210332197 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizure, Dehydration. 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: 1153096 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-03-08
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210333680

Write-up: DRY HEAT; NAUSEA; SORE ARM AT UPPER ARM AT SITE OF ADMINISTRATION; This spontaneous report received from a patient concerned a non patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination on Left Deltoid .No concomitant medications were reported. On 08-MAR-2021, the patient experienced sore arm at upper arm at site of administration. On 10-MAR-2021 02:00, the patient experienced dry heat, and nausea. Patient visited emergency room for severe nausea and dry heat which went on for 8-10 hours and ended up going to ER. In the ER patient received anti nausea medication and IV fluids. Patient stated that they had no fever. Patient went to hospital around noon time and it was resolved soon after receiving fluids and medication in hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry heat, and nausea on 10-MAR-2021, and sore arm at upper arm at site of administration on MAR-2021. The reporter causality with covid-19 vaccine ad26.cov2.s was related. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210333680 - COVID-19 VACCINE Ad26.COV2.S - Dry Heat . This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is un-labelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0: 20210333680 - COVID-19 VACCINE Ad26.COV2.S -Nausea . This event is labelled and is therefore considered potentially related.


VAERS ID: 1153102 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-03-04
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Cigarette smoker (one pack per day); Sulfonamide allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210340063

Write-up: STROKE; This spontaneous report received from a patient concerned an 84 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021,13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0:20210340063-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY


VAERS ID: 1153327 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Laboratory test, 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:
Current Illness: no significant past medical history
Preexisting Conditions: no significant past medical history
Allergies: no known allergies
Diagnostic Lab Data: No significant lab results
CDC Split Type:

Write-up: Patient received dose of J&J COVID-19 vaccine at local vaccine clinic. Reportedly, a couple minutes later, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. Patient was then transported to ED next door by ED staff where patient was monitored and ultimately discharged home.


VAERS ID: 1154390 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-07
Onset:2021-03-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Painful respiration, Pneumonia, SARS-CoV-2 test negative, X-ray
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Depakote XR Folic Acid Neurontin Singulair Protonic Vitamin D Reequip Compazine Nortek Magnesium Infusions every two weeks Butox''for Migraines (quarterly) Nerve Blocks(weekly)
Current Illness:
Preexisting Conditions: Possible spinal fluid leak New Daily Persistant Headaches
Allergies: Reglan Zofran Flexural Aflexa Dhe-45
Diagnostic Lab Data: Chest X-Ray EKG Covid-19 test-negative.
CDC Split Type: vsafe

Write-up: I had extreme chest pain on the 24th of March. It really hurt to breathe and it felt like I had pressure on my chest. I went to the Emergency room and they did a chest x-ray and a Covid-19 both of which were negative. I went home and I returned to the ER because the chest pain became worse. The chest X-Ray the second day showed I had pneumonia. I was told that it could have been from the Covid-19 in December or if was community acquired. I was prescribed with antibiotics and discharged. I still feel some chest pain after about a week and I have already finished the full course of antibiotics. I''ve seen my Primary Care physician, my cardiologist and my Pulmonologist.


VAERS ID: 1154639 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-27
Onset:2021-03-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Penicillin
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Patient began having seizures about four hours post vaccine while at a friends house and passed away


VAERS ID: 1154740 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-01
Onset:2021-03-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Eye pain, Eye swelling, Fatigue, Impaired work ability, Laboratory test, Lip swelling, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (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:
Other Medications: Multivitamin, metformin
Current Illness:
Preexisting Conditions: Diagnosed with Diabetes March 2021
Allergies: NA
Diagnostic Lab Data: Blood work has been done March 29th.
CDC Split Type:

Write-up: Within 9 hours I had fever, chills, fatigue. When I woke up the next morning both of my eyes were swollen. I took ceterizine and Benadryl with no relief. I missed the following Monday of work due to my eyes still be swollen. My lips started swelling by Wednesday. Only one side of my upper lip would swell at a time or one side of my lower lip. By they following Saturday my lips were still swelling at any given time. Monday March 29 my bottom lip started swelling at 1:45 pm and by 2:30 pm both eyes were swollen. I had tremendous pain behind my left eye which caused me to go to the Emergency room. I was given IV meds and had prescriptions ons waiting for me at the pharmacy the next day. My eyes were still swollen the following Tuesday the 30th. I am on a steroid and to antihistamines to help prevent this from happening again along with Benadryl, ibuprofen for pain.


VAERS ID: 1154759 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-03-30
Onset:2021-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline 75 mg QD (recently increased 1 wk ago from 50 mg), Trazodone 50 mg @ HS for sleep, Albuterol inhaler PRN asthma (rare use), Milli BCP (just started this one month ago), Vitamine D supplement, Zyrtec 10 mg @ HS, Ibuprofen 200 mg 2
Current Illness: anxiety/depression
Preexisting Conditions: asthma
Allergies: No known allergies
Diagnostic Lab Data: None at the time of her clinic visit.
CDC Split Type:

Write-up: The patient reported that beginning around 6 pm on the day of the vaccination (3/30/21) she began to feel achey, with body aches and headache that was a 4 on a 1-10 scale with chills, fever, and a temperature of 99.1. She stated that at 8 pm her symptoms worsened and she took Ibuprofen 600 mg without effect. She was able to sleep, however. This morning (3/31/21) @ approximately 8:30 AM she was standing in the bathroom and became lightheaded and thought she was going to pass out, sat down for a few minutes, felt better, began to walk into her bedroom holding onto the walls and then collapsed against the wall and "passed out". She recoved later on her own and sought help. She denied any head injury or tenderness of the scalp. Upon arrival at the clinic her vital signs: BP 80/46, P 88, R 16, O2sat 98%, T97.5 (she had just come in from outside where it was cold). Her vitals signs after 10 min: BP 80/50, P 104, R 16, O2sat 98%, T 99.1 She remained lightheaded for the remainder of her visit. She was instructed she would need to be evaluated in the local ED where she was then sent.


VAERS ID: 1153878 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-06
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphthous ulcer, Blood test, Dizziness, Eye inflammation, Fall, Fatigue, Headache, Loss of consciousness, Nausea, Palpitations, Urticaria, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy; Seasonal allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20210323730

Write-up: LOSS OF CONSCIOUSNESS, FAINTED; HEART WAS RACING; DIZZY; VOMITING; CANKER SORE UNDER TONGUE; HEADACHE; NAUSEA; FATIGUE; INFLAMMATION ON LEFT EYE; FALL ON BED; SMALL HIVES UNDER EYE; This spontaneous report received from a patient concerned a 63 year old female. The patient''s weight, height, and medical history were not reported. The patient''s concurrent conditions included seasonal allergies, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, after vaccination, she felt fine all day and night. The next morning she woke up and felt sick. She had nausea, headache, hive under eye. She laid back down and tried to sleep. A few hours later, she woke up to use the bathroom. She was very nauseous and dizzy. She lost consciousness and fell trying to get to the bathroom. She fell on her bed and was uninjured. The paramedics took her to the hospital. She was given medication for nausea, headache, and IV fluids. She gave blood for lab tests and they came back normal. No COVID test was administered. When she felt better, she was released. A few days later, she discovered her tongue was sore and red. She called her primary care physician (PCP). PCP said the red and sore tongue was probably related to allergies. Two weeks later, her tongue was not sore, but still red. They advised her to get a second opinion with another HCP. She was going to visit her allergy specialist.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, fatigue, inflammation on left eye, and small hives under eye on MAR-2021, and vomiting on 07-MAR-2021, and had not recovered from canker sore under tongue, and the outcome of fall on bed was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from the patient on 23-Mar-2021. The following information was updated and incorporated into case narrative: Patient''s medical history added as seasonal allergies and codeine allergy, Vaccination site as left arm added; Additional events as small hives under eye, fall on bed; lab test of blood work added; Event outcome of loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, and fatigue was updated to recovered/resolved.; Sender''s Comments: v1: Follow up information received updates patient''s medical history (seasonal allergies and codeine allergy), Vaccination site as left arm; Additional events (small hives under eye and fall on bed), laboratory test (Blood Work); Event outcome (loss of consciousness, fainted, heart was racing, dizzy, headache, nausea and fatigue was updated to recovered/resolved). This updated information does not alter prior causality assessment of reported events 20210323730-COVID-19 VACCINE AD26.COV2.S-headache, nausea and fatigue. These events are labeled and are therefore considered potentially related. 20210323730-COVID-19 VACCINE AD26.COV2.S-loss of consciousness, fainted, heart racing, dizzy, vomiting, canker sore under tongue. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are no information on any other factors potentially associated with the events.


VAERS ID: 1153883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Confusional state, Heart rate increased, Hypersensitivity, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to bee sting; Penicillin allergy; Reaction to monosodium glutamate; Reaction to preservatives
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Blood pressure; Result Unstructured Data: increased; Test Date: 20210315; Test Name: Heart rate; Result Unstructured Data: increased
CDC Split Type: USJNJFOC20210328872

Write-up: FAINT; SHAKING; CONFUSION; INCREASED HEART RATE; INCREASED BLOOD PRESSURE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a not Hispanic or Latino white female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included Penicillin allergy, bee stings allergy, preservatives allergy, and MSG allergy. The patient received Covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, after 10 minutes of vaccine administration, the patient experienced faint, shaking, confusion, increased heart rate, increased blood pressure and allergic reaction. The patient was sent to emergency room. The patient received dose of EpiPen for the treatment of allergic reaction and symptoms subsided and resolved as of now per caller. It was reported that HCP was notified. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction on 15-MAR-2021. The reporter considered the causality between Janssen Covid-19 Vaccine and faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction was possible. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:21210328872-covid-19 vaccine ad26.cov2.s-Allergic reaction. This event is labeled and is therefore considered potentially related. V0:21210328872-covid-19 vaccine ad26.cov2.s-Faint,shaking, confusion, increased heart rate, increase blood pressure. This event is considered unassessable. The events 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 events.


VAERS ID: 1153886 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Abdominal tenderness, Aphasia, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Dysphagia, Headache, Nausea, Pharyngeal inflammation, Pyrexia, Stomatitis, Tachycardia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: IBUPROFEN
Current Illness: Glucose-6-phosphate dehydrogenase deficiency
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: F, $g102 F; Test Name: Blood pressure; Result Unstructured Data: Increased; Test Name: Tachycardia; Result Unstructured Data: $g115
CDC Split Type: USJNJFOC20210330272

Write-up: INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen. On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature $g102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) $g115. Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. 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). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1153895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: USJNJFOC20210334839

Write-up: CONFIRMED COVID-19 INFECTION; DECREASED OXYGENATION; This spontaneous report received from a consumer 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 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the patient experienced confirmed Covid-19 infection. On MAR-2021, the patient experienced decreased oxygenation. On 11-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient started exhibiting Covid-19 symptoms decreased appetite, shivers, sweats and muscle aches. On Thursday 3/11/2021 father in law was taken to emergency room and was admitted, tested positive to Covid-19 on /March/2021. Since then father in law was discharged, but had to be readmitted some time later due to decreased oxygenation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and decreased oxygenation was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with a product quality complaint number: 90000173361 This case is a duplicate of 20210335533.; Sender''s Comments: V0: 20210334839-Covid-19 vaccine ad26.cov2.s-Covid-19 infection. This event is considered not related. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. 20210334839-Covid-19 vaccine ad26.cov2.s-decreased oxygenation. 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: 1153896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-03-13
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Feeling abnormal, Feeling jittery, Heart rate, Muscle spasms, Oxygen saturation, Pain in extremity, Pyrexia, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: Pulse rate; Result Unstructured Data: 120 bpm; Test Date: 20210316; Test Name: Oxygen saturation; Result Unstructured Data: 100% on room air; Test Date: 20210316; Test Name: Respiratory rate; Result Unstructured Data: 20 (units unspecified)
CDC Split Type: USJNJFOC20210335101

Write-up: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine Ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported. On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. 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: 1153901 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Utah  
Vaccinated:0000-00-00
Onset:2021-03-09
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling abnormal, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: LETAIRIS; ADEMPAS; UPTRAVI
Current Illness: Primary pulmonary hypertension (Diagnosis code for primary pulmonary hypertension is ICD 9; ICD 10)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: Blood pressure; Result Unstructured Data: Low blood pressure
CDC Split Type: USJNJFOC20210342442

Write-up: FAINTED; LOW BLOOD PRESSURE; FEELING FUNNY; This spontaneous report received from a patient concerned a 51 year old female. The patient''s weight was 72.7 kilograms, and height was not reported. The patient''s concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. The patient received selexipag (form of admin and route of admin were not reported, batch number: 031491701) 800 ug, every 2 days, frequency, and therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included ambrisentan, and riociguat. On 09-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) Low blood pressure. On 09-MAR-2021 13:00, the patient experienced low blood pressure, felt funny and she fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the low blood pressure, fainted and feeling funny was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210342442-Covid-19 vaccine ad26.cov2.s-Fainted, Low blood pressure. These events are considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS V0 20210342442-Selexipag-Fainted. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY AND UNDERLYING DISEASE V0 20210342442-Selexipag-Low blood pressure. This event is labeled and is therefore considered potentially related


VAERS ID: 1154226 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-03-27
Onset:2021-03-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Nothing that I know of
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: Two hours after the COVID-19 Jansen shot I started to see a rash of my neck ,chest, back and know going down to my stomach and legs.


VAERS ID: 1154997 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN RS-AD26 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dizziness, Electrocardiogram, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad), 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: Triphasic Estra Metoprolol Succinate 25 mg
Current Illness: Unknown
Preexisting Conditions: No
Allergies: Penicillin
Diagnostic Lab Data: ECG and CT angio Chest
CDC Split Type:

Write-up: Patient came to the ED with dizziness and tachycardia and was treated with adenosine 6 mg IVP and metoprolol 5 mg IVP x 3 doses and was sent home.


VAERS ID: 1155112 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-10
Onset:2021-03-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802072 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness, Hypotension, Loss of consciousness, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: First report failed to submit. Pt experienced a syncope event within 1-2 minutes after receiving. It took ~30 seconds for her to regain consciousness. Afterwards, she experienced significant dizziness/nausea and could not pick up her head without these symptoms instensifying. After ~30 minutes, a full bottle of water, and at least 3 BP checks (all of which read <95/60), there was no improvement in s/sx and BP was still low. Recommended pt to go to ER. Improved by next day after fluids/zofran.


VAERS ID: 1155118 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Heart rate increased, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Omega 3 COQ10 Vitamin D Quercetin
Current Illness: No
Preexisting Conditions: Asthma
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Elevated heart rate (120-135 resting) typically 65 Chills at night Headache Ache joints


VAERS ID: 1155483 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Coordination abnormal, Dizziness, Dyspnoea, Electrocardiogram, Feeling hot, Heart rate increased, Nausea, Pyrexia, Throat tightness, Urine analysis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (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: Concerta, estarylla, omeprazole, iron, D3, allerclear
Current Illness: N/A
Preexisting Conditions: ADD, hormone imbalance
Allergies: Sulfa medications
Diagnostic Lab Data: On 3/31/21 I got sent to the hospital where they did a urine sample, blood test and I was hooked up to an EKG. The results said everything was fine.
CDC Split Type:

Write-up: I got hot and my throat started to close up before I got dizzy and nauseous. Then my heartbeat spiked and I got really loopy and uncoordinated while having trouble breathing. That night I got the chills and a fever of 102.


VAERS ID: 1155690 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-03-20
Onset:2021-03-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Condition aggravated, Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: CROHN''S FLARE UP


VAERS ID: 1155788 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / -

Administered by: School       Purchased by: ?
Symptoms: Dyspnoea, Nausea, Pruritus, Rash erythematous, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Allergies: Penicillin, coconut
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Developed red rash along left side of face and neck followed by mild pruritis. Then, developed tachycardia with normal blood pressure and mild shortness of breath. Then, nausea and vomiting. Treated with epinephrine .3mg and .5mg five minutes later due to lack of improvement in symptoms. Transported to hospital ER. patient reportedly felt much better by arrival at ER.


VAERS ID: 1155970 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Nausea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (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: Not Sure
Current Illness: Not sure
Preexisting Conditions: Not Sure
Allergies: None
Diagnostic Lab Data: None hat I know of
CDC Split Type:

Write-up: Sweating, thought she was going to vomit, close to fainting, was talking the whole time 15 minutes later she felt tightness in her throat Called 911 and paramedics came and took her to hospital


VAERS ID: 1156134 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pro air, Eloquis, Abilify, Symbicort, Bupirone, cholestyramine,, Dexilant, Diazepam, Lomotil, Fluoxetine, Flonase, metolazone, multivitamin, oxcarbazepine, oxycodone, Spiriva, Tamsulosin, spironolactone, Compazine, prazosin, gabapentin, hyd
Current Illness: Unknown
Preexisting Conditions: Chronic Obstructive lunge disease, hypertriglyceridemia
Allergies: aspirin, acetaminophen, divalproex, hydrochlorothiazide, lorazepam, topiramate, trazodone, varenicline tartrate
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt reported tingling, swelling in lips and tingling in arm 32min post vaccine. Administered epi 0.3mg and 50mg IM Benadryl and called 911. Pt transported to local ER awake, alert and breathing on his own. Called ER 5 hours later. Pt continued to be observed. No more epi had been administered.


VAERS ID: 1156361 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-21
Onset:2021-03-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Appendicectomy, Appendicitis
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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Appendicitis requiring appendectomy 3/23/21


VAERS ID: 1156405 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Chills, Dizziness, Electrocardiogram, Fatigue, Nausea, Pneumonia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: only a scar on my arm from a polio/measles vaccine at age 4-5
Other Medications: armour thyroid, progesterone, magnesium, Vit D, Multi-vitamin, Quercetin,
Current Illness: Hashimoto''s
Preexisting Conditions: Hashimotos
Allergies: metals, pollen, dust, mold, gluten, dairy
Diagnostic Lab Data: Chest xray, blood work, EKG,
CDC Split Type:

Write-up: I first had symptoms of nausea, chills, fatigue and wooziness for 7 days after the vaccine, then developed pneumonia a week after taking this vaccine. I had chest pain and pressure and ended up in the urgent care. After 3 weeks and zpak I am feeling better but not back to normal.


VAERS ID: 1156798 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-06
Onset:2021-03-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Ear pain, Glossodynia, Hyperhidrosis, Influenza like illness, Nausea, Pain, Pyrexia, Rhinalgia, SARS-CoV-2 test negative, Sensitive skin, Streptococcus test negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, multi-vitamin, Novalog (insulin)
Current Illness:
Preexisting Conditions: Diabetes, Inflammatory disease, RA, ankolophspondylitis
Allergies: NKDA
Diagnostic Lab Data: Covid test, negative, strep test, negative
CDC Split Type: vsafe

Write-up: Initially three days after flu like symptoms, body aches, sweat, chills cough, fever, nausea. On 03-23-2021, when I woke up the entire left side of my face and head was extremely sensitive. My hair was sensitive, left side, and I also had a fever. My left ear hurt, left side of my tongue, nasal cavity hurt. Strep test was performed was negative, Covid test was negative performed at an urgent care. My symptoms have gotten better but my symptoms to my head are still present nut not as severe.


VAERS ID: 1156865 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Methadone Advil
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: No fever and vitals were ok. The hospital would have any other test results.I know they took urine and blood.
CDC Split Type:

Write-up: Severe Spasms in all muscles from feet all the way up through back, lasting for up to 10 seconds and occuring every 10 to 15 minutes. I felt as if my entire body was frozen during the spasms. Had a very hard time breathing. Called 911, no fever, taken to emergency room. Was given an injection of ativan and it relieved the spasms. I slept the rest of that night and woke up very sore in all muscles for 5 days after.


VAERS ID: 1156899 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Fall, Immediate post-injection reaction, Pain in extremity
SMQs:, Accidents and injuries (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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: Vitamin B-12 injections, migraine injections
Current Illness: None
Preexisting Conditions: Anemia, migraine
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient did not report any history of syncope with injections; stated she takes B-12 injection and injections for her migraine with no issues. She received the J&J vaccine at 3:41pm. Reported immediate arm soreness. While in the 15-min observation area at 3:45pm, patient fell out of chair onto the floor 2/2 LOC. I attended immediately to the patient (EMS was called at 3:47 due to LOC) When I arrived, patient was laying on her stomach and was awaking up. We turned her onto back and placed her feet in the air. Patient was immediately able to tell me her name and date of birth. She was given cold towels and she was cooled down. Initial vitals taken at 3:47p were 146/98, HR 66. EMS arrived at 4:02 and took vitals (BP=146/94, SPO2=99%). EMS stood the patient up and patient refused to go with EMS. Patient instructed to wait an additional 15 mins after EMS left. Patients left in care of boyfriend


VAERS ID: 1157004 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid normal, COVID-19, Chest X-ray, Chills, Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count normal, Headache, Heart rate increased, Laboratory test normal, Metabolic function test normal, Pain, Palpitations, Pyrexia, Urine analysis
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (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? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Mild allergy to amoxicillin
Diagnostic Lab Data: In the ER, they did an EKG, chest x-ray, COVID-19 test, urinalysis, CBC W auto differential, comprehensive metabolic panel, blood cultures, and lactic acid blood reflex. All tests came back normal/negative.
CDC Split Type:

Write-up: I experienced chills, fever, headache, body aches, feeling very tired, racing heartbeat, and difficulty breathing. I called the on-call nurse line and was advised to go to the emergency room due to my fast heartbeat.


VAERS ID: 1157006 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Private       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? No
Previous Vaccinations:
Other Medications:
Current Illness: asthma
Preexisting Conditions: asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: syncope


VAERS ID: 1157060 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dysphagia, Oropharyngeal discomfort
SMQs:, Anticholinergic syndrome (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 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: Stage 4 metastatic cancer
Preexisting Conditions: Stage 4 metastatic cancer, origin prostate
Allergies: Penicillian, Cipro
Diagnostic Lab Data: Unknown at this time
CDC Split Type:

Write-up: Pt received Janssen vaccine, pt waited 30 minutes post vaccine administration due to his allergies. Pt reported throat pressure and difficulty swallowing approx 30 minutes post vaccine. Pt alert and no difficulty with speaking. EMS activated and patient transported to ER for evaluation


VAERS ID: 1157485 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Body temperature, Echocardiogram, Pyrexia, Troponin
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Troponin; Result Unstructured Data: level of 65; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: 101.7 tympanic; Test Date: 202103; Test Name: Echocardiogram; Result Unstructured Data: ejection fraction of 30% baseline was 50 to 55%
CDC Split Type: USJNJFOC20210331243

Write-up: ACUTE PULMONARY EDEMA; FEVER; This spontaneous report received from a physician concerned a patient of unspecified age and unspecified sex. The patient''s weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported by HCP that the patient was admitted to hospital on MAR-2021, the patient experienced acute pulmonary edema with symptoms (shortness of breath(SOB), questionable bloody sputum) and was intubated in emergency room (ER) where he developed troponin level of 65, ejection fraction of 30% baseline was 50 to 55%, and fever. Laboratory data included: Body temperature 101.7 tympanic, Echocardiogram ejection fraction of 30% baseline was 50 to 55%, and Troponin level of 65. The treatment of intubation was administered for acute pulmonary edema. The days of hospitalization was not known. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the acute pulmonary edema and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: 20210331243-COVID-19 VACCINE AD26.COV2.S-Acute Pulmonary edema . 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(s). 20210331243-COVID-19 VACCINE AD26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.


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

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

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

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


VAERS ID: 1157492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-08
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Gait inability, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (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: MS
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210342113

Write-up: MUSCLE WEAKNESS; TIREDNESS; UNABLE TO WALK; 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 pre-existing medical conditions included MS. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, vaccinated at right arm, once total, administered on 08-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, 09:00 AM the patient received Janssen Covid-19 vaccine and at 16:00 PM, the patient started feeling really, tired and at 21:00 PM feeling not well with muscle weakness. On 09-MAR-2021, at midnight, patient had called to go to the emergency room and patient was unable to get up at all and was hospitalized on 09-Mar-2021 for 3.5 days and on 12-MAR-2021, the patient was discharged from the hospital. The patient had physical therapy coming to house. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from tiredness, muscle weakness, and unable to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210342113-COVID-19 VACCINE AD26.COV2.S-Tiredness and muscular weakness. These events are labeled and are therefore considered potentially related. 20210342113-COVID-19 VACCINE AD26.COV2.S-unable to walk. 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: 1157495 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Flushing, Generalised tonic-clonic seizure, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (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: USJNJFOC20210342978

Write-up: GRAND MAL; SEIZURES; FAINT; CHEST PAIN; FLUSHED; This spontaneous report received from a health care professional concerned 49 patients of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2019, post-vaccination many patients needed to be seen by EMS for various medical incidents such as faint, flushed, chest pain. Later it was 49 people needing EMS attention and several seizures and 1 grand mal experienced took place after covid-19 vaccine ad26.cov2.s vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, faint, flushed, chest pain and grand mal was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210342978-Covid-19 vaccine ad26.cov2.s-Grand mal, seizure and faint. These events are 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 events.


VAERS ID: 1157496 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-03-21
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Cellulitis
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: Quadriplegia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210342988

Write-up: ANKLE SWELLING, DISCOMFORT AND REDNESS/CELLULITIS; This spontaneous report received from a consumer concerned a 61 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included quadriplegia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031) dose was not reported, administered at left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient had swelling with in his right ankle with significant discomfort. On 18-MAR-2021, the had redness in his ankle. On 21-MAR-2021, the patient went to emergency room where the treating physician mentioned he had cellulitis. On MAR-2021, the patient received treatment medications clindamycin hydrochloride (Cleocin 300mg IV) and would be on unspecified antibiotics for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankle swelling, discomfort and redness/cellulitis. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210342988-COVID-19 VACCINE AD26.COV2.S-Cellulitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE


VAERS ID: 1157499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-19
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Facial paralysis, Feeling hot, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: Bell''s palsy (History of Bells Palsy 7 years ago.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210345589

Write-up: BELL''S PALSY EXACERBATED; TINGLING IN PALMS OF HANDS; HOT IN PALMS; PAIN IN BETWEEN SHOULDER BLADES; EXTREME WEAKNESS; 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 bells palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right arm. 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 19-MAR-2021, the patient stated that she experienced extreme weakness and pain in between shoulder blades within 48 hours of vaccination and ambulance took her to the emergency room where she got tested for stroke but confirmed bell''s palsy diagnosis. She has bell''s palsy seven years ago and it was reported that vaccine seemed to exacerbated the condition. Patient also experienced tingling and hotness in palms of hands within 48 hours of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme weakness, and had not recovered from bell''s palsy exacerbated, pain in between shoulder blades, tingling in palms of hands, and hotness in palms of hands. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 23/Mar/2021. Upon review, the following information was amended: Age group updated as unknown, Reporter causality updated as possible, narrative updated.; Sender''s Comments: V1: Version created to amend age group, reporter causality and narrative. This updated information does not alter the causality of previously reported event. 20210345589-Covid-19 vaccine ad26.cov2.s-Bell''s palsy exacerbated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE


VAERS ID: 1157501 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-03-23
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Haematemesis, Heart rate, Hypoaesthesia, Nausea, Oxygen saturation decreased, Paraesthesia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: Body temperature; Result Unstructured Data: 102 F; Test Date: 20210323; Test Name: Oxygen saturation low; Result Unstructured Data: 97; Test Date: 20210323; Test Name: Pulse rate; Result Unstructured Data: 130
CDC Split Type: USJNJFOC20210346726

Write-up: BLOOD IN VOMIT (VOMITING); ASTHMA (PULSE 130, BLOOD OXYGEN DOWN TO 97); TINGLING ALL OVER BODY; BODY WENT NUMB; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on Left Deltoid around 10-12 p.m. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced blood in vomit (vomiting), asthma (pulse 130, blood oxygen down to 97), tingling all over body, body went numb, fever, nausea. After vaccination It was reported that patient experienced vomiting along with some blood in vomit, pulse at 130 and blood oxygen went down to 97 along with that started experiencing asthma. The consumer had to visit to emergency room with patient. Laboratory data included: Body temperature (NR: not provided) 102 F, Oxygen saturation low (NR: not provided) 97 (units unspecified), and Pulse rate (NR: not provided) 130 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, blood in vomit (vomiting), tingling all over body, fever, asthma (pulse 130, blood oxygen down to 97) and body went numb was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210346726-covid-19 vaccine ad26.cov2.s-Blood in vomit. 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: 1157508 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

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

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

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


VAERS ID: 1157512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-03-24
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210349284

Write-up: LOSS OF VISION; 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 and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient had symptoms of loosing vision. and at 19:30, she experienced loss of vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of vision. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210349284-COVID-19 VACCINE AD26.COV2.s-loss of vision. 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: 1157513 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-03-22
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Blood test, Body temperature, Chills, Computerised tomogram, Headache, Loss of consciousness, Nausea, Pain, Pyrexia, Urine analysis abnormal, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: Blood test; Result Unstructured Data: Negative; Test Date: 20210323; Test Name: Vital signs measurement; Result Unstructured Data: Not reported; Test Date: 20210323; Test Name: Adverse event NOS; Result Unstructured Data: Negative; Test Date: 20210323; Test Name: Urine analysis abnormal; Result Unstructured Data: Negative; Test Date: 20210323; Test Name: CAT scan; Result Unstructured Data: Negative; Test Name: Body temperature; Result Unstructured Data: Not reported
CDC Split Type: USJNJFOC20210349895

Write-up: BLACKED OUT/FAINTED AGAIN; BODY ACHE; CHILLS; NAUSEA; FEVER; HEADACHE; 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 non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: Unknown) dose was not reported, administered on 22-MAR-2021 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, patient experienced chills, body ache, nausea, Fever, Headache. On 23-Mar-2021, Tuesday patient woke up in am - had few glasses of water, went back to bed, at 10 am had cup of tea and around 2 pm setting in chair and blacked out. Patient did not fall, daughter tried to wake up however after no response daughter called ambulance, when EMT (Emergency Medical Technicians) came patient woke up and told EMT that she did not want to go to hospital however patient fainted again in front of EMT and they took her to ER (emergency room), checked vitals, boold work, urine test , CAT Scan, moitored heart, IV saline administered twise. All reports came to negative so ER concluded it as reaction to COVID vaccine. Patient was in ER for total 6 hours. On 24-Mar-2021, patient felt much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body ache, nausea, fever, headache and blacked out/fainted again was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: 20210349895-COVID-19 VACCINE AD26.COV2.S -Blacked Out/Fainted Again. 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: 1157514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:2021-03-24
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210350143

Write-up: ANAPHYLAXIS (SEVERE HEADACHE, NAUSEA, COUGHING, RAPID INCREASING SHORTNESS OF BREATH LEADING TO RESTRICTION OF BREATHING, PALE, DIAPHORETIC); This spontaneous report received from a health care professional concerned a female of unspecified age. 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 tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 24-MAR-2021 at 10:31, the patient experienced Anaphylaxis (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). On 24-MAR-2021 at 10:40 epinephrine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Anaphylaxis (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210350143-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.


VAERS ID: 1157518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fluid retention, Gastrointestinal pain, Generalised oedema, Rash, Respiratory tract oedema, Suffocation feeling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker; Seasonal allergy
Preexisting Conditions: Comments: The patient had no drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210350470

Write-up: SWELLING OF AIRWAY; FEELING OF SUFFOCATION; SWELLING OF ENTIRE BODY; SHORTNESS OF BREATH; RASHES THROUGHOUT BODY; HIVES THROUGHOUT BODY; WATER RETENTION; GI PAIN; This spontaneous report received from a consumer concerned a female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non alcoholic, non-smoker, and seasonal allergy, and other pre-existing medical conditions included the 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the Patient experienced water retention, gi pain, rashes throughout body and hives throughout body. On 20-MAR-2021, the patient experienced swelling of airway, feeling of suffocation, swelling of entire body and shortness of breath. Treatment medications included: epinephrine and antihistamines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of airway, and feeling of suffocation, had not recovered from swelling of entire body, water retention, gi pain, rashes throughout body, and hives throughout body, and the outcome of shortness of breath was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210350470-covid-19 vaccine ad26.cov2.s- Rashes throughout body, Hives throughout body. This events are labeled and is therefore considered potentially related. 20210350470-covid-19 vaccine ad26.cov2.s-Swelling of airway, Shortness of breath ,Swelling of entire body ,Feeling of suffocation, Water retention ,GI Pain. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1157522 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Feeling of body temperature change, Headache, Musculoskeletal chest pain, Pain, 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210351965

Write-up: RIB PAIN; SEVERE GENERAL BODY PAIN; FEELING HOT AND COLD; BODY CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient initiated treatment with COVID-19 vaccine AD26.COV2.s (suspension for injection, route of administration was not reported, batch number: 1808609, expiry date: unknown) dose was not reported, on 25-MAR-2021 at 15:00, for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, about 19:00, she experienced severe side effects that included rib pain, severe general body pain, felt hot and cold, had body chills, headache and fever. On 26-MAR-2021, at 1:00, she was admitted to the hospital. In the emergency room, she received treatment with ketorolac and sodium chloride intravenously and was instructed to purchase Motrin for home use. On 27-Mar-2021, at 4:00, she was discharged. Number of days of hospitalization was 1. At the time of discharge, around 4:00, she felt better with some improvement of pain but, the symptoms started again. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient had not recovered from body chills, fever, rib pain, severe general body pain, headache, and feeling hot and cold. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: 20210351965-Covid-19 vaccine ad26.cov2.s-Rib pain, Severe general body pain, Feeling hot and cold, Body chills. 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). 20210351965-Covid-19 vaccine ad26.cov2.s-Headache, Fever. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1157524 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-26
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Hyperpyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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: 202103; Test Name: Body temperature; Result Unstructured Data: 110 F
CDC Split Type: USJNJFOC20210353896

Write-up: FEVER OF 110 DEGREE; FELT BAD (FELT LIKE DEATH); This spontaneous report received from a consumer 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, reporter stated that the patient "felt bad" felt like death. Reporter also stated that patient had a fever of 110 degrees and wanted to know could give patient aspirin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 110 degree, and felt bad (felt like death). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210353896-covid-19 vaccine ad26.cov2.s-fever of 110 degrees. 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: 1157533 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dizziness, Fall, Injury, Oxygen consumption decreased, Renal disorder, SARS-CoV-2 test positive, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Oxygen consumption decreased; Result Unstructured Data: 87; Test Date: 20210322; Test Name: COVID-19 virus test positive; Result Unstructured Data: Positive; Test Date: 20210325; Test Name: Body temperature; Result Unstructured Data: Over 103
CDC Split Type: USJNJFOC20210355610

Write-up: DIZZINESS; FELL; HURT HIMSELF; SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the patient became ill with COVID like symptoms, and got tested for COVID on 22-Mar-2021 and received results that he was COVID positive on 25-Mar-2021 and was running high temperatures (fevers over 103), On 27-MAR-2021, the patient became dizzy, fell and hurt himself, was rushed to the hospital and was admitted same day. He did some damage to his kidneys in the process. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Over 103. Laboratory data included: Oxygen consumption decreased (NR: not provided) 87. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 positive, dizziness, fell, injury to kidney, hurt himself and blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition) This report was associated with product quality complaint : 90000174591.; Sender''s Comments: V0: 20210355610- Covid-19 Vaccine Ad26.Cov2.S-Confirmed Covid-19 Positive. 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. 20210355610- Covid-19 Vaccine Ad26.Cov2.S - Dizziness, Fell, Hurt himself, Some damage to his kidneys in the process (blood clot). This events are considered Unassessable. 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: 1157661 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Heart rate increased, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, birth control, vitamin C
Current Illness:
Preexisting Conditions:
Allergies: Amoxicillin and penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): emergency room visit


VAERS ID: 1157673 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-29
Onset:2021-03-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1085020 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Mobility decreased
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), Parkinson-like events (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? No
Previous Vaccinations:
Other Medications: Wellbutrin 150mg/day Zoloft 50mg/day
Current Illness: none
Preexisting Conditions: none
Allergies: Sulphur, adhesive, bisphosphates
Diagnostic Lab Data: information above
CDC Split Type:

Write-up: Less than two minutes after J & J vaccine I was unconscious and unable to move my entire body. I could not move my eyelids, mouth, arms, legs...entire body . Upon becoming mentally alert it was more than two hours until I could move all of my body. I was taken by ambulance to an emergency room. IV fluids, potassium, and released 3 hours later.


VAERS ID: 1157774 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Feeling hot, Hypoaesthesia, Laboratory test, Seizure, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: mangoes
Diagnostic Lab Data: Went to ER immediately after side effects. Blood work, ECG, and vital tests showed nothing out of the ordinary. Blood pressure - 140/96; Temperature - 97.9F; Pulse - 60; O2 Saturation - 94%
CDC Split Type:

Write-up: Numbness in left arm and face, overheating, fainting, Medical personal fist on site noticed shaking due to Seizure.


VAERS ID: 1157924 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Pyrexia, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? Yes
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:
CDC Split Type:

Write-up: Syncope, fever, tachycardia


VAERS ID: 1157994 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Dizziness, Electrocardiogram, Nausea, Sinus rhythm
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: Unknown
Current Illness: None
Preexisting Conditions: The patient was screened and was found to have multiple medical allergies but no allergies to any of the components to the Janssen vaccine. As a precaution, the nurses advised a 30 minute observation. She received the vaccine without complication and then was being observed and they called me over and the paramedics were also with the patient. About 17 minutes into observation, the patient started developing chest pressure (4/10), lightheadedness, and nausea. No shortness of breath, stridor, diaphoresis, back pain, abdominal pain, vomiting, neurologic changes, and any signs or symptoms of anaphylaxis. She was very anxious. Further history revealed that the patient had been discharged from the hospital 6 week prior. She initially went in for an abdominal laproscopic surgery and woke up to having 32 staples closing an abdominal incision. They had to change from a laproscopic approach to an open abdomen approach due to complications. She ended up with sepsis and a colostomy and was hospitalized for 2 weeks getting antibiotics. She lives by herself and was overwhelmed before coming into the clinic for her vaccine. The paramedics did a 12-lead ECG that showed sinus rhythm. Vital signs and blood glucose were within normal limits. The paramedics recommended that she go to the hospital to be checked out but she was very resistant and was tearful because she was traumatized from her previous hospitalization. After some time, the paramedics convinced her to go to the hospital. The paramedics hung around the emergency department and then came back once they found out that she was fine.
Allergies: Antibiotics
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient was screened and was found to have multiple medical allergies but no allergies to any of the components to the Janssen vaccine. As a precaution, the nurses advised a 30 minute observation. She received the vaccine without complication and then was being observed and they called me over and the paramedics were also with the patient. About 17 minutes into observation, the patient started developing chest pressure (4/10), lightheadedness, and nausea. No shortness of breath, stridor, diaphoresis, back pain, abdominal pain, vomiting, neurologic changes, and any signs or symptoms of anaphylaxis. She was very anxious. Further history revealed that the patient had been discharged from the hospital 6 week prior. She initially went in for an abdominal laproscopic surgery and woke up to having 32 staples closing an abdominal incision. They had to change from a laproscopic approach to an open abdomen approach due to complications. She ended up with sepsis and a colostomy and was hospitalized for 2 weeks getting antibiotics. She lives by herself and was overwhelmed before coming into the clinic for her vaccine. The paramedics did a 12-lead ECG that showed sinus rhythm. Vital signs and blood glucose were within normal limits. The paramedics recommended that she go to the hospital to be checked out but she was very resistant and was tearful because she was traumatized from her previous hospitalization. After some time, the paramedics convinced her to go to the hospital. The paramedics hung around the emergency department and then came back once they found out that she was fine.


VAERS ID: 1158200 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-03-22
Onset:2021-03-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Decreased appetite, Dyspnoea, Fatigue, Gait disturbance, Laboratory test, Nausea, Non-cardiac chest pain, Palpitations
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

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

Write-up: Started with fatigue on March 25. Increased fatigue, Nausea, stomach tighness, lack of appetite began on the 26th. By March 30th my heart start beating out of my chest and I felt like I was having a heart attack. I could barely breath. Went to get something to eat, walked half way and felt like I would fall on the ground, and returned to my room. Called my parents because I wasn''t sure if I would wake up the next morning. My team leader gave me a ride to the emergency room. They drew my blood and it was dark and thick. They sent me home. Still feel fatigue.


VAERS ID: 1158269 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-03-22
Onset:2021-03-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone normal, Diplopia, Disorder of orbit, Headache, Muscle swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Ocular motility disorders (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? No
Previous Vaccinations:
Other Medications: metoprolol, aspirin
Current Illness: Rotator cuff tendinopathy
Preexisting Conditions: Thyrotoxicosis - 5 years prior Endocarditis treated 3 years prior Essential hypertension - 2 years prior
Allergies: none
Diagnostic Lab Data: TSH checked 3/29 2.248
CDC Split Type:

Write-up: 4 days after vaccination, suffered diplopia that resolved, recurred again 7 days after vaccination, lasted 20 minutes and then recurred 8 days after vaccination with associated headache. Patient to emergency department and noted to have orbitopathy with asymmetric swelling of rectus muscles of left eye.


VAERS ID: 1158283 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-29
Onset:2021-03-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Dehydration, Fatigue, Feeling cold, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Lupus, psoriatic arthritis, asthma
Allergies: Raglan/Peppers/latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had high fever of 104.6 night of vaccine with extreme fatigue and chills. Next morning collapsed due to lack of blood to the brain due to dehydration. Doctor said it was a side effect of the side effect (fever) not directly from vaccine. Fully recovered within 48 hours


VAERS ID: 1158803 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-03-12
Onset:2021-03-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Vertigo
SMQs:, Vestibular disorders (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Acute vertigo lasting for three days with some lessening after 3 days but but normal activity has not resumed. It is not accompanied by tinnitus or hearing loss.


VAERS ID: 1159103 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-19
Onset:2021-03-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Chest discomfort, Cough, Dysphagia, Dyspnoea, Ear pain, Headache, Oropharyngeal pain, SARS-CoV-2 test positive, Spinal X-ray normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: Hydroxychloroquine, Oracea, Finasteride, Loratadine, Meloxicam, Omeprazole, Vitamin D.
Current Illness: None.
Preexisting Conditions: Autoimmune disease.
Allergies: Penicillin..
Diagnostic Lab Data: COVID test positive on 3/31/21.
CDC Split Type:

Write-up: She got the vaccine, the next day she had a headache behind her ears, pain behind the ear to the back of her head. On 3/26/21 she started having severe headache and sharp pains in her head behind her ear, started feeling heaviness in her chest. On saturday also had heaviness in her chest, headaches. On Sunday she could not breath and felt the heaviness in her chest. Sunday night she had bad sore throat and could not swallow. On Monday she could not swallow, coughing, heaviness in her chest. On Monday night she went to the ER and they did a chest x-ray, neck x-ray and all her tests were ok. She lost her voice on Monday, and hasn''t had it back since then. She is coughing up phlegm, but not much but still having the heaviness in her chest. She was diagnosed with COVID. They told her to drink a lot of tea and to hydrate. She then went to a different facility and got monoclonal therapy. She was throwing up Wednesday night and she is feeling better, her throat still hurts, she can swallow better, but is still hoarse. Her headache went away yesterday.


VAERS ID: 1159150 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Diplopia, Pruritus, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Ocular motility disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Client received vaccine at approx 530pm. at 551 client complained of itching. Benadryl 50 mg administered. Client then complained of seeing double. Client remained alert and responsive to staff during time. V/s -BP- 110/70 86 18 97% EMS called and arrived. client left facility at approx 615pm accompanied by two EMT technicians


VAERS ID: 1159170 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Diplopia, Pruritus
SMQs:, Anaphylactic reaction (broad), Ocular motility disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Client received vaccine at approx 530pm. at 551 client complained of itching. Benadryl 50 mg administered. Client then complained of seeing double. Client remained alert and responsive to staff during time. V/s -BP- 110/70 86 18 97% EMS called and arrived. client left facility at approx 615pm accompanied by two EMT technicians


VAERS ID: 1159384 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-29
Onset:2021-03-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

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? 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: During the 15 minute observation (post-vaccination), patient fainted. EMS was called and patient was transported.


VAERS ID: 1159385 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-03-15
Onset:2021-04-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, 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: aspirin 81 mg oral enteric coated tablet atorvastatin (LIPITOR) 80 mg oral tablet baclofen (LIORESAL) 10 mg oral tablet BRILINTA 90 mg oral tablet Cholecalciferol, Vitamin D3, (VITAMIN D3) 5,000 unit oral tablet losartan (COZAAR) 25 mg oral
Current Illness: Unknown
Preexisting Conditions: Multiple sclerosis
Allergies: No
Diagnostic Lab Data: SARS-CoV-2 by PCR positive 4/1/2021
CDC Split Type:

Write-up: Patient received Janssen vaccine 3/15/2021. Tested positive for COVID-19 on 4/1/2021. Reported known exposure to COVID-19 positive person, however meets criteria to review for vaccine breakthrough as $g14 days post vaccine.


VAERS ID: 1159450 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Unknown       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? 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: fainting


VAERS ID: 1159475 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-03-30
Onset:2021-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Chills, Incoherent, Laboratory test, Pyrexia, SARS-CoV-2 test, Somnolence, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Chest X-rays Covid test Blood tests
CDC Split Type:

Write-up: Feverish chills and vomiting on day 1. On 4/1/21 at 1:00 am patient fainted and had incoherent speech and then went ?lights out? for less than a minute. He was taken to ER. They gave him fluids anti nausea medicine and ran many blood tests. Patient still feeling dizzy and groggy on day 2


VAERS ID: 1159508 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-17
Onset:2021-03-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: neurontin, zyrtec, lofribra, catapress, lopressor, norvasc, lantus, humalog, synthroid, vitamin c &d, zinc, magnesium, lovenox
Current Illness: n/a
Preexisting Conditions: HTN, diabetes type 2, hypothyroidism, BMI 45-49, GERD,
Allergies: lostartan, hydralazine, ace inhibitors, metformin
Diagnostic Lab Data: SARS-COV-2
CDC Split Type:

Write-up: Patient developed COVID symptoms on 3/29/2021. Diagnosed COVID + on 4/1/2021


VAERS ID: 1159539 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Cardiac arrest, Dizziness, Electrocardiogram normal, Fatigue, Feeling abnormal, Hyperhidrosis, Hypertension, Immediate post-injection reaction, Injection site paraesthesia, Loss of consciousness, Monoplegia, Paraesthesia, Skin discolouration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Pre-diabetic
Allergies: None
Diagnostic Lab Data: Not sure of blood work. EKG
CDC Split Type:

Write-up: immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.


VAERS ID: 1159723 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood sodium, Head injury, Muscular weakness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), 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: Losartan 100 mg od, Symbicort 160/4.5 1 puff bid
Current Illness: No
Preexisting Conditions: Hypertension, Asthma
Allergies: NO
Diagnostic Lab Data: Na 135 Glu 124 Lactic Acid 2.o
CDC Split Type:

Write-up: Syncope, minor head trauma, muscular weakness.


VAERS ID: 1159860 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Condition aggravated, Diabetes mellitus inadequate control, Fatigue, Hyperglycaemia
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: CHF, poorly controlled DM, AKI, elevated troponin, hyperglycemia on admission
Preexisting Conditions: CHF, poorly controlled DM
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to ED via ambulance with fatigue weakness, poorly controlled Diabetes, hyperglycemia and abdominal pain. still in hospital on this date


VAERS ID: 1159886 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Confusional state, Dizziness, Fall, Feeling guilty, Loss of consciousness, Vital signs measurement
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: None
Preexisting Conditions: None
Allergies: Milk
Diagnostic Lab Data: B/P 132/74 HR 70 RR 18 Glucose 120
CDC Split Type:

Write-up: Vaccine was administered at 10:25am. Patient walked over to the waiting area and as he was walking he passed out and fell to the ground. Vitals were taken at about 10:28am: B/P 132/74 HR 70 RR 18, glucose 120. Patient was able to state his name and where he was located, but kept his eyes closed and kept stated he felt "confused and dizzy" and was apologetic. EMS was called at 10:30AM and when EMS was here pt was noted to have another syncopal episode. Patient was transported to Hospital via ambulance.


VAERS ID: 1159889 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Fall, Head injury, Syncope, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), 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: Reports prior vasovagal events
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient sustained a vasovagal syncope event about 3 to 4 minutes subsequent to vaccine administration. Struck back of head on chair with fall to ground. Evaluated by medical staff and referred to medical center via ER non-emergent transport. Subsequent to ER staff evaluation for syncope and head injury, she was treated and released from the ER without need for further work-up or imaging.


VAERS ID: 1159892 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: vasovagal reactions
Other Medications: N/A
Current Illness: no known illnesses
Preexisting Conditions: Irritable bowel syndrome
Allergies: no known allergies
Diagnostic Lab Data: vitals taken- all within normal limits
CDC Split Type:

Write-up: Patient had a vasovagal response. Patient observed another person feeling anxious and then he fainted. Patient immediately recovered without any further concerns.


VAERS ID: 1160203 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / N/A LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chest X-ray, Chest discomfort, Dysphonia, Dyspnoea, Electrocardiogram, Erythema, Feeling cold, Full blood count, Headache, Hypoaesthesia oral, Limb discomfort, Metabolic function test, Paraesthesia oral, Pruritus, Rash, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Protonix, Cellebrex
Current Illness: unknown
Preexisting Conditions: Crohn''s disease, arthritis
Allergies: Avelox, Solumedrol
Diagnostic Lab Data: CBC w/ diff, CMP, chest x-ray, 12-lead EKG: 04/02/2021; per patient hospital did not advise her of any abnormal results
CDC Split Type:

Write-up: Approximately 10 minutes into the patient''s 15 minute after vaccine monitoring time, she reported redness of upper extremities bilaterally. Patient taken to emergency medical area of public health vaccine clinic where she then reported numbness/tingling to the lips, Patient started to experience a "funny feeling in legs/feet", hives on chest and lower extremities. Blood pressure was 226/139. IV established LAC 20 gauge with EMS/Fire called. Patient transported to Campus via EMS. Patient contacted on 04/02/2021 via phone to obtain patient''s current status: patient stated she was kept in hospital ER for 6 hours, developed further rash to face and back,felt really cold/freezing, and had shortness of breath while at hospital. Patient states she was given pepcid, prednisone, benadryl while at hospital; had lab work-CBC w/ diff, CMP, chest x-ray, 12 lead EKG. Patient discharged home with prescriptions for an Epi-Pen, benadryl, prednisone and pepcid. Patient reports she has a raspy voice, itchiness, some chest tightness, throat feels "a little tight like you are starting to come down with something" and headache that started morning of 04/02/2021.


VAERS ID: 1160350 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-26
Onset:2021-04-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic valve incompetence, Brain natriuretic peptide increased, Chest X-ray abnormal, Chills, Dyspnoea, Echocardiogram abnormal, Muscle tightness, Myalgia, Oedema peripheral, Pericardial effusion, Pneumonitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Echocardiogram was completed showing preliminary findings of small to moderate pericardial effusion and trace aortic insufficiency.
CDC Split Type:

Write-up: He is a 37-year-old active male with no significant medical history. One week ago, on Friday, March 26, he received the Johnson and Johnson vaccine for Covid 19. That day he felt fine. The following day he had some muscle aches. Sunday he states he had some slight shortness of breath, only for that day. Then he had some fever and chills feeling. That resolved. The only symptoms that persisted was his muscle aching and tightness. Then yesterday, the day of his presentation to the ER, he noted some bilateral lower extremity edema which prompted his visit. He is feeling mostly fine except a bit of muscle tightness. BNP was 154. Chest x-ray showed pneumonitis. He received antibiotics. Echocardiogram was completed showing preliminary findings of small to moderate pericardial effusion and trace aortic insufficiency. Will treat with colchicine and ibuprofen.


VAERS ID: 1160473 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Immediate post-injection reaction, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (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:
Preexisting Conditions:
Allergies: PEANUT ALLERGY
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATINT WAS LIGHT HEADED AS SOON AS SHE WAS VACINATED PUT HER HEAD DOWN BETWEEN HER LEGS FOR A FEW MINUTES AND THEN SAID SHE WAS GOING TO LIE DOWN IN THE CAR . HER HUBAND TOOK HER TO THE CAR AND A FEW MINUTES LATER IS CALLING OUT TO US THAT HIS WIFE WAS NOT BREATHING WE GAVE HER AN EPIPEN AND CALLED 911


VAERS ID: 1160543 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness
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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received Janssen Vaccine around 11:30 am. Patient was told to wait around 15 minutes to make sure everything was ok. Patient got my attention a few minutes later saying she felt dizzy. As i was guiding her back to the chair she passed out and i guided her to the floor. In a few minutes she was able to sit upright in the chair. EMS was called and she later went to hospital for further evaluation.


VAERS ID: 1160779 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-19
Onset:2021-03-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Chest discomfort, Chills, Headache, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Chest X-ray
CDC Split Type:

Write-up: Fast heart beat, chills, headache, and chest pressure.


VAERS ID: 1160996 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-10
Onset:2021-03-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Carotid artery stenosis, Dysarthria, Facial asymmetry, Facial paralysis, Fatigue, Muscular weakness, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: simvastatin, HCTZ, albuterol
Current Illness:
Preexisting Conditions: Advanced liver fibrosis, HTN, Thrombocytopenia, Opioid use disorder in sustained remissinon, alcohol use disorder
Allergies: NKDA
Diagnostic Lab Data: Pt refused MRI but CTA neck and brain were reassuring aside from symmetrical short MCAs and mild calcifactions. Carotid arteries showed < 50% stensosis on US.
CDC Split Type:

Write-up: Patient received the J&J vaccine on 3/10. On 3/13 he developed slurred speech, unilateral lower facial droop, weakness of extremities, generalized fatigue. On 3/15 he sought medical attention and was sent to ER -- $g diagnosed w/ TIA. Pt sent back to jail where simvastatin -- $g atorvastatin, pt started lisinopril, ASA. Pt denies deficits today


VAERS ID: 1161073 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN O43A21A / UNK LA / IM

Administered by: School       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (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: none reported
Current Illness: patient reports history of hypotension
Preexisting Conditions: none reported
Allergies: none reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported dizziness while in observation area. EMS took a blood pressure of 90/58. Blood pressure did not improve and patient continued to feel symptomatic. City Fire Rescue was called for transport.


VAERS ID: 1161228 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Panic attack
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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: EPILEPSY, DIABETES
Allergies: CECLOR
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt like she was going to faint, so we helped her move from the chair to the floor, bp was normal, 02 sat was 100, normal pulse, patient. Called 911 to have patient evaluated at the ER. Mother called after leaving the ER to say patient had a panic attack. According to mother ER physician advised the patient that she did not have a reaction to the Vaccine but had a panic attack. Mom stated that she thought she had grown out of having anxiety around needles etc.


VAERS ID: 1161942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Arkansas  
Vaccinated:0000-00-00
Onset:2021-03-09
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, Rash, Seizure
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient is not on any medication and has no known drug allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210325468

Write-up: RASH ON ARMS AND HANDS; EXTREME PAIN IN BOTH HANDS AND ARMS; SEIZURE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient is not on any medication and has no known drug allergy. 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 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. patient got the Janssen Covid shot on March 9th Tuesday and then experienced headache started same day and Wednesday10th march, took Tylenol and headache recovered, then seizure on 11th mar, went to the ER and spoke to the doctor on reporting day. consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210325468 - Covid-19 Vaccine Ad26.Cov2.S - Seizure. 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: 1161949 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram, Echocardiogram, Heart rate, Hypotension, Pain in extremity, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: 100.8 F; Test Date: 20210316; Test Name: Blood pressure; Result Unstructured Data: 80/30 mmHg; Test Date: 20210316; Test Name: Blood pressure; Result Unstructured Data: 70/20 mmHg; Test Date: 20210316; Test Name: Heart rate; Result Unstructured Data: 110 OR 115 BPM; Test Date: 20210317; Test Name: COVID-19 virus test; Result Unstructured Data: NEGATIVE; Test Date: 20210317; Test Name: CT scan; Result Unstructured Data: NORMAL; Test Date: 20210317; Test Name: Echocardiography; Result Unstructured Data: FINE; Test Date: 20210317; Test Name: Echocardiogram; Result Unstructured Data: FINE; Test Date: 20210317; Test Name: Blood pressure; Result Unstructured Data: 98/38 mmHg; Test Date: 20210318; Test Name: Heart rate; Result Unstructured Data: 70, BPM; Test Date: 20210318; Test Name: Blood pressure; Result Unstructured Data: 120/90 mmHg
CDC Split Type: USJNJFOC20210339790

Write-up: SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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: 1161955 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2021-03-13
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Blood pressure fluctuation, Blood pressure increased, Blood pressure measurement, Body temperature increased, Computerised tomogram, Fatigue, Gait disturbance, Groin pain, Insomnia, Magnetic resonance imaging, Migraine, Mobility decreased, Muscular weakness, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Non-smoker; Seasonal allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Bulbar polio (diagnosed at age of 15)
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: SARS-CoV-2 rapid diagnostic test; Result Unstructured Data: NEGATIVE; Test Date: 20210316; Test Name: Blood pressure; Result Unstructured Data: 130/111; Test Date: 20210316; Test Name: MRI; Result Unstructured Data: Not reported; Test Date: 20210316; Test Name: CAT scan; Result Unstructured Data: Not reported; Comments: Along with IODINE
CDC Split Type: USJNJFOC20210353871

Write-up: ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN''T SLEEP; UNABLE TO WALK; This spontaneous report received from a patient concerned an 83 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn''t move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn''t sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. 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). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. 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 of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1161959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-27
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Immunocompromised
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210356059

Write-up: SEVERE ANAPHYLACTIC REACTION; This solicited report received from a patient via RRA-4549: PriCara social media Account concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cancer, and immunocompromised. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 27-MAR-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 27-MAR-2021, the patient experienced severe anaphylactic reaction and went twice to emergency room by an ambulance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe anaphylactic reaction was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction as related. Company causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction was related. This report was serious (Other Medically Important Condition).; Sender''s Comments: Covid-19 vaccine ad26.cov2.s-Severe anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.


VAERS ID: 1161971 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: patient had no known allergies and no significant past medical history.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210401417

Write-up: vasovagal syncope; This spontaneous report received from a health care professional concerned a 46 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient had no known allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, a couple minutes later of vaccination, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. The patient was then transported to emergency department next door by the emergency department staff where patient was monitored and ultimately discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syncope on 2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0. 20210401417 -COVID-19 VACCINE AD26.COV2.S-VASOVAGAL 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: 1162624 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache, Injection site pain, Myalgia, Pyrexia, Somnolence, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Not applicable.
Current Illness: None.
Preexisting Conditions: None.
Allergies: Only allergy - bananas.
Diagnostic Lab Data: No tests or labs taken.
CDC Split Type:

Write-up: Day of shot (April 1): Immediately after shot, left arm was sore. Developed fatigue at 2pm. A few hours later, I had a 101 fever, chills, stronger fatigue, strong headache, muscle aches. Around 6pm, I began vomiting continuously. I spoke with an advice nurse and she told me to go to the emergency room. I continued to vomit until about 11:30pm, I was weak and felt like passing out a few times. Later in the evening, I took a Tylenol and finally went to sleep. On April 2nd (day after shot), I woke up with fatigue and headache, but fever was gone and I no longer vomited. I took another Tylenol and headache went away.


VAERS ID: 1162665 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (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: Albuterol Inhaler
Current Illness: none
Preexisting Conditions: Asthmatic
Allergies: N/A
Diagnostic Lab Data: None reported at this time since patient is in E.R. now
CDC Split Type:

Write-up: Male patient took Janssen vaccine and approximately 1 hour or so later was feeling chest tightness where it exacerbated to the point of needing emergency care. Patient was taken to E.R., but do not have outcome as of yet


VAERS ID: 1162690 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Headache, Hypertension, Rhinorrhoea, Tinnitus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bupropion, Advair, Atenolol, Albuterol inhaler, Trazodone
Current Illness: no illnesses
Preexisting Conditions: Diabetes, hypertension
Allergies: N/A
Diagnostic Lab Data: none known since patient is in hospital at time of this report
CDC Split Type:

Write-up: Male patient received vaccine in the morning, then around lunch time started feeling symptoms of headache, runny nose and ringing in ears. He then got shortness of breath, which got exacerbated so Pharmacy called ambulance and because patient became hypertensive , it was recommended he go to the E.R. Patient is currently at the E.R. at time of this report


VAERS ID: 1162763 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad)

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

Write-up: No Epipen given. Patient was hyperventilated. EMS was onsite and transported to hospital in abundance of caution.


VAERS ID: 1162869 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Feeling cold, Malaise, Slow speech
SMQs:, 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: Patient stated she has a history of vasovagal reactions, did not specify date or type of injection/vaccine
Other Medications: None per patient
Current Illness: None per patient
Preexisting Conditions: None per patient
Allergies: None per patient
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 04/02/21 12:45 pm ? At approximately 12:45 pm I was called to vaccine tent #1 after reports from staff that a patient was feeling sick after receiving her Janssen injection. I discovered the patient slumped in her chair, head back with eyes closed, skin clammy and cool. Alert and oriented x3, speaking slowly but clearly. Per vaccine nurse, she administered the Janssen injection to patient at 12:41 pm (Lot 1805020, exp 5/25/2021, Left Deltoid) and a few minutes later the patient started to close her eyes and leaned back in chair requiring assistance to sit up. Nurse was able to stabilize patient in chair and then called for help and that is when I came to assist. Patient remained in this state for several more minutes. Activated EMS for further evaluation as patient did not stabilize immediately. Measured vital signs ? Blood Pressure 98/62, O2SAT 97, Pulse 68. I continued to monitor the patient until EMS arrived. EMS evaluated patient and cleared but advised to continue to monitor for an additional 15 minutes before leaving the site. Patient verbalized understanding and agreed with plan. Patient remained in observation for an additional 15 minutes with no incident.


VAERS ID: 1162918 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: Patient complained feeling faint and felt like she was going to pass out. Patient was observed to have heavier breathing than normal. She also complained of numbness in her left arm. EMS was activated immediately. Patient''s blood pressure was 51/38 mmHg . Oxygen was measured at 99 % Sp O2, PRbpm 45. Emergency contact for patient was notified. EMS arrived and took over. Patient returned hours later to pharmacy to informed us she was okay. She was told she had experienced vasovagal syncope.


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