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From the 11/19/2021 release of VAERS data:

Found 8,669 cases where Vaccine is COVID19 and Manufacturer is JANSSEN and Emergency Room/Doctor Visit

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1633064 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-11
Onset:2021-05-27
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin Atorvastain Fenofibrate Lisinopril B12
Current Illness: None
Preexisting Conditions: High blood pressure High cholesterol Type 2 diabetic
Allergies: N/a
Diagnostic Lab Data: 05/27/2021. 05/29/2021 CT scan at hospital 06/05/2021 _ 06/07/2021 ct scan at hospital
CDC Split Type:

Write-up: Shortness of breathe blood clots


VAERS ID: 1633121 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: Patient states he has had a similar reaction to influenza vaccine before
Other Medications: Albuterol Sulfate 8.5gm Proair HFA
Current Illness: ETOH
Preexisting Conditions:
Allergies: azithromycin (Verified Allergy, Mild, rash, 8/24/21) cefixime (Verified Allergy, Mild, rash, 8/24/21) Amoxicillin (Verified Allergy, Unknown, UNK, 8/24/21) PCN (penicillin) (Verified Allergy, Unknown, UNK, 8/24/21) Promethazine (Verified Allergy, Unknown, UNK, 8/24/21) erythromycin base (Verified Allergy, Unknown, Unknown, 8/24/21) mold (Verified Allergy, Unknown, Unknown, 8/24/21) prochlorperazine (Verified Allergy, Unknown, Unknown, 8/24/21) ragweed pollen (Verified Allergy, Unknown, Unknown, 8/24/21) C-CHLOR (Allergy, Mild, rash, 4/30/15) fluroquinolones (Allergy, Unknown, Unknown, 1/26/18)
Diagnostic Lab Data:
CDC Split Type:

Write-up: lightheadedness and dizziness, hypotensive at BP 80/63, diaphoretic


VAERS ID: 1633359 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 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? 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 got dizzy and passed out about 5 minutes after the shot


VAERS ID: 1633599 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-14
Onset:2021-07-31
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Seasonique Amitriptyline Omeprazole Magnesium B12
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Venous ultrasound
CDC Split Type:

Write-up: On August 6 I was diagnosed with a DVT to my right leg. The clot went from my calf to my mid thigh.


VAERS ID: 1633772 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-07
Onset:2021-07-28
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Body temperature increased, COVID-19, Chest X-ray normal, Dyspnoea, Fatigue, Feeling hot, Fibrin D dimer normal, Headache, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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? No
Previous Vaccinations:
Other Medications: Daily Multicap Vitamin D3 with K1 & K2 Vitamin B-12 Broad Spectrum Magnesium Caps De3 Dry Eye Omega Benefits with Vitamin D3 Sudafed
Current Illness: Seasonal allergies
Preexisting Conditions: Seasonal allergies Lactose Intolerant to the extreme (developed from previous surgery: injectable antibiotics took away my ability to process lactose)
Allergies: Allergic to cephalosporins and sulfa drugs
Diagnostic Lab Data: Chest x-ray, 8/9/2021 D-dimer test, 8/9/2021
CDC Split Type:

Write-up: Contracted COVID-19 through work place (co-worker) on Wednesday 07/21/2021; we were in same office, neither had a mask on and she was coughing an extraordinary amount. She had already been out of the office Monday and Tuesday of that same week and was feeling ill on the previous Friday. She was told the night before at urgent care it was a sinus and ear infection, but they did not test her for COVID-19. I became ill on Wednesday night, 07/28/2021 with slight headache and general not feeling well around 8:30pm. Took some Tylenol and Ibuprofen, went to bed. Thursday, 07/29/2021, woke up still feeling not quite right, took Tylenol and Ibuprofen again and went to work early at 6:30am to cover since my co-work was out ill. By 7:30am on Thursday morning I felt super warm in my office that only had a temperature of 73 degrees. I gathered my work stuff, sprayed Lysol all over my office and left to go home. Took my temperature when I arrived home and it was 100.8. I let my employer know I had a fever, would schedule a COVID test and work from home for the day. COVID-19 test was done at 9:30am. Positive test results were received around 5:00pm that evening. On Friday, 7/30/21 I lost all sense of taste and smell. During the course of the next 11 days, I was home with severe pounding headache anytime I moved from sitting to standing, standing to sitting, walking, bending over and laying flat. Fatigue set in on day 4 of being home. I isolated as much as I could from my 2 other family members and wore a 3 layered face mask all day long except for eating and drinking. At day 9, I called my insurance Doc who prescribed for me: Benzonatate 100 MG CAP EPIC, Flovent HFA 220 MCG/ACT AER GLAX and Albuterol 108 MCG/ATC AER LUP. I started the Benzonatate and Flovent that night on 08/05/2021. At day 11-12 I became super short of breath and went back to urgent care (PCP would not see me). Urgent care recommended I get re-tested anytime after day 15 and sent me to the ER for a chest x-ray to rule out pneumonia and for a D-dimer test to rule out any blot clot issues. The chest x-ray showed my lungs were good and the D-dimer test showed no signs of any blot clotting occurrences. I returned to work on Friday 08/13/2021 but not at 100% better and still not return of taste & smell. I continued the Flovent inhaler through Friday 08/20/21 which when taken helped my sense of taste and smell to return slightly. I am still to date, 08/25/2021, experiencing major fatigue, long lingering and painful headaches that build throughout the day and my sense of smell and taste is faint every morning and slowly returns through each day. I am hoping soon to be rid of all these lingering effects of having this virus.


VAERS ID: 1634195 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-27
Onset:2021-07-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821281 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Blood test, Chest pain, Clumsiness, Computerised tomogram, Dizziness, Drooling, Electrocardiogram, Feeding disorder, Feeling abnormal, Headache, Hypoaesthesia, Immediate post-injection reaction, Nausea, Pain in extremity, Presyncope, Vertigo, Weight decreased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Tetanus age 52 02/21 neuropathy, pneumonia vaccine couldn?t breathe , rash , heart racing in 2015, 1973 Bell?s palsy as a child
Other Medications: Multivitamin, levothyroxine , klonopin
Current Illness: PTSD since 1989 , mild low thyroid
Preexisting Conditions: Osteoarthritis, anxiety
Allergies: Antibiotics, PEG, red dye , sulfa medicine, neomycin, antidepressants, herbal tea, nuts and seeds , shellfish, wheat gluten,
Diagnostic Lab Data: Blood tests , cat scan , ekg, 7/28/21 7/31/21 8/2/21 8/15/21
CDC Split Type:

Write-up: Arm pain and numbness, chest pain , heart pain was immediately after the shot Face numbness, legs numb , arms numb, left side of body goes numb then right side intermittently, massive headache next day , spinning extreme vertigo , extreme nausea almost passed out , 12 lb weight loss , can?t eat all this in the first 6 days. Still now have face numbness, arms , legs , hands , feet , brain fog . Drooling with face numbness that comes and goes. Dizziness and clumsy.


VAERS ID: 1634219 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-09
Onset:2021-05-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram, Magnetic resonance imaging, Migraine, Muscle spasms, Neurological symptom
SMQs:, Dystonia (broad)

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

Write-up: Partial stroke like effects. Complex migraines, muscle spasms


VAERS ID: 1634845 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Haemoglobin, Heart rate, Ophthalmic herpes zoster, Physical examination, Platelet count, Respiratory rate, Visual acuity tests, White blood cell count
SMQs:, Guillain-Barre syndrome (broad), Ocular infections (narrow), Opportunistic infections (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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox (Admitted to the history of chickenpox at the age of 10.); Comments: The patient denied any sick contacts, recent emotional or physical stress, recent travel, or steroid usage in the past one year.
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: 151/89; Test Name: Respiratory rate; Result Unstructured Data: 18; Test Name: Heart rate; Result Unstructured Data: 93; Test Name: Physical examination; Result Unstructured Data: Erythematous grouped vesicles on the left side of the face; Test Name: Visual acuity tests; Result Unstructured Data: limited; Test Name: Hemoglobin; Result Unstructured Data: 15 g/dL; Test Name: Platelet count; Result Unstructured Data: 274000 cells/microL; Test Name: Body temperature; Result Unstructured Data: Afebrile; Test Name: White blood cells; Result Unstructured Data: 5.50 cells/microL
CDC Split Type: USJNJFOC20210832958

Write-up: IPSILATERAL HERPES ZOSTER OPTHALMICUS; GENERALIZED WEAKNESS; This spontaneous report was received from literature: . This report concerned a 42 year old male of an unspecified race and ethnicity. The objective of this study was to describe Ipsilateral HZO (Herpes Zoster Ophthalmicus), an opthalmological emergency of herpes zoster (HZ) seen post Covid-19 vaccination in healthy young adults. The patient''s height, and weight were not reported. The patient''s past medical history included: admitted chickenpox at the age of 10, and concurrent conditions included: asthma. The patient denied any sick contacts, recent emotional or physical stress, recent travel, or steroid usage in the past one year. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, frequency time 1 total administered at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, post COVID-19 vaccination the patient experienced generalized weakness for two days. One week after receiving the vaccination, the patient noticed that skin lesions started appearing as small pimples on the left side of his forehead that were associated with burning pain and itching. The lesions had then rapidly progressed to the left side of the scalp, the tip of the nose, and the left upper eyelid. Associated symptoms were watery discharge from the eyes and blurred vision. He denied having any other complaints. On an unspecified date, the patient presented to the emergency room with the above mentioned complaints. Laboratory data included: blood pressure which was found to be 151/89, body temperature was found to be afebrile, heart rate was found to be 93, hemoglobin (NR: 13.5 - 17.5) was found to be 15 g/dL. Physical examination revealed erythematous grouped vesicles on the left side of the patient''s forehead, left upper eyelid, left side of the scalp and tip of his nose. The left eyelid appeared to be edematous with conjunctival injection and watery discharge, with no visible corneal endothelial decompensation. There was restricted ocular movement noticed due to edema of his upper eyelid. Visual acuity test was also found to be limited. Platelet count (NR: 150000 - 450000) was found to be 274000 cells/microL, Respiratory rate was 18, and White blood cells (NR: 4500 - 11000) were 5.50 cells/microL. Based on clinical examination findings, the diagnosis of ipsilateral HZO (Herpes Zoster Ophthalmicus) was made. He was started on systemic antiviral (antivirals for systemic use) and antiviral eye drops, which halted the progression of vesicles and improved his vision. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized weakness, and the outcome of ipsilateral herpes zoster opthalmicus was not reported. The authors emphasized on the awareness that must be created among physicians, as well as the general public by reporting any associations with the COVID-19 vaccine and HZ (Herpes zoster) to CDC (Centers for Disease Control and Prevention). It was recommended that immunocompromised individuals greater than 50 years of age be vaccinated against HZ (Herpes zoster). Early recognition and antiviral usage can halt the progression of the disease and thus prevent debilitating complications. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210832958-Covid-19 vaccine ad26.cov2.s-ipsilateral herpes zoster ophthalmicus. 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: 1634850 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal faeces, Antiphospholipid antibodies, Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Computerised tomogram, Decreased appetite, Deep vein thrombosis, Fatigue, Haemorrhage, Headache, Intestinal ischaemia, Lethargy, Magnetic resonance imaging, Malaise, Mesenteric vein thrombosis, Platelet count, Platelet count decreased, Portal vein thrombosis, Post thrombotic syndrome, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Splenic vein thrombosis, Ultrasound scan, Vomiting, Weight decreased, X-ray
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypertension (narrow), Noninfectious diarrhoea (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: 99.2 F; Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 170/110 mmHg; Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 202108; Test Name: Antiphospholipid antibodies; Result Unstructured Data: Positive; Test Date: 20210803; Test Name: Platelet count; Result Unstructured Data: 37,000; Test Date: 20210813; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: The bowel lining was compromised by the blood clot and was sloughing.; Test Date: 20210816; Test Name: CT scan; Result Unstructured Data: Various locations of clots as per report; Comments: major clots in portal vein.; Test Date: 20210819; Test Name: Platelet count; Result Unstructured Data: 230,000; Test Name: X-ray; Result Unstructured Data: unspecified; Test Name: Diagnostic ultrasound; Result Unstructured Data: not reported.
CDC Split Type: USJNJFOC20210840439

Write-up: BILATERAL CLOTS IN THE LEFT AND PROXIMAL MAIN PORTAL VEIN/ MULTIPLE BILATERAL CLOTS IN THE LUNGS; CLOTS IN SPLENIC VEIN; BOWEL LINING COMPROMISED BY THE BLOOD CLOT; BLEEDING (SLOUGHING OFF); MULTIPLE DVTS RIGHT LEG; MULTIPLE BILATERAL CLOTS IN LUNGS/ BILATERAL PULMONARY EMBOLISM; SMALL CLOTS WITHIN THE SMV (SUPERIOR MESENTERIC VEIN); ABDOMINAL MESENTERIC ISCHEMIA; PLATELET COUNT DECREASED 37 000; POST THROMBOTIC SYNDROME; BLOOD PRESSURE INCREASED; WEIGHT LOSS (15 LBS); CHILLS/ SHAKING; VOMITING/THREW UP; LETHARGIC; FELT SICK; FEVER OF 99.2; SEVERE HEADACHE; EXTREMELY TIRED; APPETITE IMPAIRED (NEVER ATE, COULD NOT KEEP ANYTHING DOWN); This spontaneous report received from a consumer concerned a 54 year old, not Hispanic or Latino, white male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension. The patient was previously treated with lisinopril for hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 around 05:30 a:m, the patient experienced severe shaking/chills, felt terrible and sick, vomiting/threw up, lower back pain, fever of 99.2 F, blood pressure increased, lethargic, severe headache, appetite impaired (never ate, could not keep anything down), extremely tired, felt sick. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg. On 31-JUL-2021, the patient felt horrible and saw a teledoc. Teledoc said to get the antibodies done, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, Antiphospholipid antibodies (NR: not provided) Positive. On 03-AUG-2021, the patient experienced platelet count decreased 37000 unspecified units. On AUG-2021, the patient experienced post thrombotic syndrome. On 09-AUG-2021, the patient experienced abdominal mesenteric ischemia, multiple bilateral clots in lungs/ bilateral pulmonary embolism, small clots within the SMV (superior mesenteric vein), thrombosis pulmonary, severe abdominal pain and for that visited emergency department, flank pain, dry heaves in ICU (Intensive Care Units). The patient was hospitalized. On 10-AUG-2021, the patient experienced multiple deep vein thrombosis right leg and bleeding (sloughing off). On 13-AUG-2021, the patient experienced bowel lining compromised by the blood clot. Would take 2-3 weeks to heal. Laboratory data included: Nuclear magnetic resonance imaging (NR: not provided) The bowel lining was compromised by the blood clot and was sloughing. On 16-AUG-2021, Laboratory data included: Computed tomography (CT) scan (NR: not provided) Various locations of clots as per report. His clots were still there but some had improved. On 17-AUG-2021, the patient experienced bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs and clots in splenic vein. On 19-AUG-2021, the patient experienced weight loss (15 lbs.). Laboratory data included: Platelet count (NR: not provided) 230, 000 unspecified units. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) not reported, and X-ray (NR: not provided) unspecified. Other diagnostic data included PT and PTT. On 20-AUG-2021, the patient was still hospitalized. Blood pressure was still not under control and had fluctuated in hospital due to pain. At the time of report patient was on blood thinners which his wife indicated he would likely be on for the rest of his life. He was being followed by hematology. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from dry heaves in ICU, and chills/ shaking, and fever of 99.2 on 30-JUL-2021, was recovering from vomiting/threw up, feels terrible/felt horrible, lethargic, severe headache, flank pain, extremely tired, bowel lining compromised by the blood clot, small clots within the SMV (superior mesenteric vein), bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs, clots in splenic vein, multiple bilateral clots in lungs/ bilateral pulmonary embolism, severe abdominal pain, low back pain, blood pressure increased, and platelet count decreased 37000, had not recovered from appetite impaired (never ate, could not keep anything down), multiple DVTS right leg, and felt sick, and the outcome of weight loss (15 lbs.), bleeding (sloughing off), post thrombotic syndrome and abdominal mesenteric ischemia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from a consumer concerned a 54-year-old white man who experienced thrombocytopenia (day 11) and multiple sites of thrombosis in pulmonary, intra-abdominal, and peripheral sites (day 17) after vaccine. Medical history included hypertension treated with lisinopril. On day 7, the patient experienced severe shaking/chills, felt terrible and sick, vomiting, lower back pain, blood pressure increased, lethargic, severe headache, appetite, extremely tired. On day 8: COVID-19 virus test Negative, Antiphospholipid antibodies Positive. On day 11, platelets were 37,000. On day 17, the patient experienced abdominal mesenteric ischemia, multiple bilateral pulmonary emboli, small clots within the SMV (superior mesenteric vein), thrombosis pulmonary, severe abdominal pain and was admitted to intensive care. On day 18, the patient experienced multiple deep vein thrombosis right leg and bleeding. On day 21, the patient experienced bowel lining compromised by the blood clot with sloughing. On day 22, CT scan confirmed many clots. On day 23, the patient experienced bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs and clots in splenic vein. On day 24, the patient experienced weight loss (15 lbs.). Laboratory data included: Platelet count improved to 230,000. On day 25, the patient was still hospitalized. Blood pressure was still not under control and had fluctuated in hospital due to pain. At the time of report patient was on blood thinners which his wife indicated he would likely be on for the rest of his life and he was being followed by hematology. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from-BC), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination. Additional information is requested.


VAERS ID: 1634857 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-06-17
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Feeling abnormal, Head discomfort, Heart rate increased, Malaise, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: PREDNISONE; VENLAFAXINE; NAPROXEN; METHOCARBAMOL; BUTALBITAL; ACETAMINOPHEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210844586

Write-up: FELT ILL FROM THE VACCINE; HEAD SPASMS; TREMORS; RAPID HEARTBEAT; FELT LIKE STROKE/FELT LIKE LEANING TO RIGHT; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient''s weight was 140 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 16-JUN-2021 16:30 for prophylactic vaccination. Concomitant medications included butalbital, methocarbamol, naproxen, paracetamol, prednisone, and venlafaxine. On 17-JUN-2021, the patient experienced felt like stroke/felt like leaning to right. On 17-JUN-2021, the patient experienced weakness. On 23-JUN-2021, the patient experienced tremors. On 23-JUN-2021, the patient experienced rapid heartbeat. On 26-JUN-2021, the patient experienced head spasms. On an unspecified date, the patient experienced felt ill from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tremors, rapid heartbeat, head spasms, felt like stroke/felt like leaning to right, and weakness, and the outcome of felt ill from the vaccine was not reported. This report was non-serious.; Sender''s Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1634858 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Contusion, Erythema, Feeling hot, Headache, Hyperaesthesia, Hyperhidrosis, Myalgia, Pain, Pain in extremity, Pyrexia, Thrombosis, Varicose vein, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient had no medical history to share and was generally in good health.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210844617

Write-up: BLURRED VISION; POTENTIAL BRUISE; CONCERNED ABOUT A BLOOD CLOT; BODY PAIN IN DIFFERENT AREAS; RIGHT UPPER LEG MORE SENSITIVE; POTENTIAL REDNESS ON SKIN OF LEG; LOT OF PAIN BEHIND RIGHT LEG MOSTLY FROM THE KNEE UP BUT LITTLE BELOW THE KNEE ALMOST TO THE TOP OF THE LEG (MOSTLY IN THE MIDDLE OF THE UPPER LEG); CHILLS, SHIVERING; HEADACHE; MUSCLE AND BODY ACHES; SWEATY; LOW GRADE FEVER; VARICOSE VEINS AT BACK OF LEG TURNED MORE BLUE AND MIGHT BE LITTLE RED; HOT ON AND OFF; This spontaneous report received from a patient concerned a 46 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non alcohol user, and non smoker. The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient had no medical history to share and was generally in good health. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 20-AUG-2021 15:50 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, twelve hours after vaccination, like clockwork, the patient woke up at 3 AM shivering and had various body pain in different areas. By morning time, when she got up she felt that area (right upper leg) was more sensitive and then on the morning of 22-AUG-2021, it was much worse instead of getting better. On 21-AUG-2021, the patient had a headache, muscle and body aches, lot of pain behind right leg, mostly from the knee up but starting a little below the knee almost to the top of the leg, mostly in the middle of the upper leg and potential redness on skin of leg. The pain was like a bruise, it felt like she was touching a bruise when she was not (potential bruise). She was unable to confirm the appearance of the back of leg when questioned if there was a visible bruise. She was also unable to confirm if there was any swelling or heat present in the affected area. When she tried to see the back of leg she had varicose veins which had turned more blue and it might turned a little red back there. She was concerned about a blood clot as she read about that being a potential with the Janssen COVID-19 vaccine. She had chills and got sweaty. In AUG-2021, the patient felt like she had a low grade fever in general but she did not have a thermometer to measure. The patient was hot on and off. Her usual or expected side effects such as shivering, fever, various pains in other areas and headache went away. On 22-AUG-2021, her vision was blurred, she couldn''t drive without glasses and usually she did not bother putting them on. The patient visited emergency room and physician''s office. She did not know if this was related to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, body pain in different areas, chills, shivering, low grade fever, and headache on AUG-2021, had not recovered from lot of pain behind right leg mostly from the knee up but little below the knee almost to the top of the leg (mostly in the middle of the upper leg), muscle and body aches, right upper leg more sensitive, and concerned about a blood clot, and the outcome of blurred vision, potential bruise, hot on and off, potential redness on skin of leg and varicose veins at back of leg turned more blue and might be little red was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.


VAERS ID: 1634869 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 0421A21 OR 042A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Chills, Computerised tomogram, Eye pain, Full blood count, Headache, Injection site pain, Lymphadenopathy, Pain, Pain in extremity, Paraesthesia, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Swollen lymph nodes (Patient developed lymph node swelling of both armpits last year when received his flu shot (but not nearly as bad as the Covid vaccine)); Comments: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: CT scan; Result Unstructured Data: Negative for blood clot; Test Date: 20210822; Test Name: CBC; Result Unstructured Data: Normal; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: 220/110 mmHg; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: 168/98 mmHg; Test Date: 20210822; Test Name: Ultrasound scan; Result Unstructured Data: Lymphatic mass in the left axilla
CDC Split Type: USJNJFOC20210846459

Write-up: TINGLING SENSATION/ PINS AND NEEDLES IN THE FINGERS OF LEFT ARM; JOINT ACHES; EYES HURTED; BODY ACHES; ARM SORE; CHILLS; A BASE BALL SIZE LYMPHATIC MASS IN THE LEFT AXILLA; SLIGHT HEADACHE; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: lymph node swelling of both armpits, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0421A21, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced painful injection. On 22-AUG-2021, the patient experienced eyes hurted. On 22-AUG-2021, the patient experienced body aches. On 22-AUG-2021, the patient experienced arm sore. On 22-AUG-2021, the patient experienced chills. On 22-AUG-2021, the patient experienced a base ball size lymphatic mass in the left axilla. On 22-AUG-2021, the patient experienced slight headache. Laboratory data included: Blood pressure (NR: not provided) 220/110 mmHg, 168/98 mmHg, CBC (NR: not provided) Normal, CT scan (NR: not provided) Negative for blood clot, and Ultrasound scan (NR: not provided) Lymphatic mass in the left axilla. On 23-AUG-2021, the patient experienced tingling sensation/ pins and needles in the fingers of left arm. On 23-AUG-2021, the patient experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 22-AUG-2021, was recovering from painful injection, and arm sore, had not recovered from body aches, slight headache, eyes hurted, a base ball size lymphatic mass in the left axilla, and joint aches, and the outcome of tingling sensation/ pins and needles in the fingers of left arm was not reported. This report was non-serious.


VAERS ID: 1634872 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac stress test, Chest X-ray, Chest discomfort, Chills, Computerised tomogram, Dyspnoea, Electrocardiogram, Fibrin D dimer, Headache, Heart rate, Hyperhidrosis, Injection site pain, Myalgia, Oxygen saturation, Oxygen saturation decreased, Pain in extremity, Pyrexia, SARS-CoV-2 test, Troponin, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis (The patient had a chest infection and ended up with bronchitis in her late 30s and was treated with Albuterol.); Chest infection; Short of breath (When the patient was a teenager and was active in sports sometimes would get short of breath and was treated with nebulizer.); Comments: The patient had no known prior history and did not have any drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 rapid diagnostic test; Result Unstructured Data: negative; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: negative; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: negative; Comments: 2 times; Test Date: 202108; Test Name: EKG; Result Unstructured Data: negative; Comments: 5 times; Test Date: 202108; Test Name: Fibrin D dimer; Result Unstructured Data: negative; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: negative; Comments: 2 times; Test Date: 202108; Test Name: Stress test; Result Unstructured Data: negative; Test Date: 202108; Test Name: Oxygen saturation; Result Unstructured Data: 100 but with movement it goes down to 70-80%; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: 100; Test Date: 202108; Test Name: Diagnostic ultrasound; Result Unstructured Data: negative; Comments: Did ultrasound for the possibility of fluid around the lung which was negative.
CDC Split Type: USJNJFOC20210846641

Write-up: CHRONIC CHEST TIGHTNESS; LABORED BREATHING UPON MOVEMENT; WITH MOVEMENT OXYGEN LEVEL WENT DOWN TO 70 TO 80 PERCENTAGE; SWEATS; CHILLS; SORE ARM FOR 1 WEEK; BURNED INTENSELY AT THE TIME OF INJECTION; HEADACHE; MUSCLE ACHES ALL OVER THE BODY; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old female. The patient''s weight was 155 pounds, and height was 67 inches. The patient''s past medical history included chest infection and ended up with bronchitis in her late 30s. When the patient was a teenager and was active in sports sometimes would get short of breath. The patient''s concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included no known prior history and did not have any drug abuse/illicit drug use. The patient was previously treated with salbutamol for bronchitis and with nebulizer for short of breath. The patient experienced hives all over body when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 09-AUG-2021 at around 15:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced intense burning at the time of injection and had sore arms for one week. Half an hour later the patient had a headache and 2 hours later had muscle aches all over her body, low grade fever, chills and sweating which all were resolved in morning after 48 hours. The next morning on 10-AUG-2021 the patient felt tight chest, something that had not gone away and she had chronic chest tightness and labored breathing. The patient visited ER (emergency room) twice. On 14-AUG-2021, the patient visited ER for second time and got admitted. The patient underwent lab tests such as blood clots (negative for pulmonary embolism), troponin, D-Dimer, COVID (rapid tests), 5 times EKGs (electrocardiogram), 2 times CT (computerised tomogram) scans, 2 times chest X-Rays, Stress test with lexiscan (because the patient could not perform on treadmill) and they all were negative. They ruled out myocarditis or pericarditis and did ultrasound for the possibility of fluid around the lung which was negative. They found mitral valve thickening which were told it was not significant. They also pointed out to anxiety but the reporter said that she knew that was not anxiety. The patient''s main concern was that she had labored breathing with any movement or positioning and she had chronic chest tightness that she said she had been in intermittent ambulatory distress. The patient''s oxygen level at rest was 100 but with movement oxygen level went down to 70 to 80 percentage and her heart rate went up to 100. They treated her with IV (intravenous) saline drip on the first day in the hospital and nothing was given orally for the tests. They offered heparin and steroids but the patient declined. She will also be seen by a pulmonary specialist. At the time of reporting the patient was in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, chills, headache, muscle aches all over the body, and low grade fever on 11-AUG-2021, and sore arm for 1 week, and burned intensely at the time of injection on 16-AUG-2021, had not recovered from chronic chest tightness, and labored breathing upon movement, and the outcome of with movement oxygen level went down to 70 to 80 percentage was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210846641 -covid-19 vaccine ad26.cov2.s- chronic chest tightness, labored breathing upon movement, with movement oxygen level went down to 70 to 80 percentage. 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: 1634892 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-06-07
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acne, Blood test, Fatigue, Heart rate, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Menstrual disorder, Migraine, Pain in extremity, Ultrasound scan, X-ray
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]
Current Illness: Abstains from alcohol; Low pulse rate; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Vaccination adverse reaction; Comments: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Pulse rate; Result Unstructured Data: over 150 bpm; Test Date: 20210702; Test Name: X-ray; Result Unstructured Data: Unknown; Test Name: Blood test; Result Unstructured Data: exact tests and results were not accessible; Test Name: Diagnostic ultrasound; Result Unstructured Data: could not see anything
CDC Split Type: USJNJFOC20210849152

Write-up: MENSTRUAL CHANGES; ACNE; NUMBNESS IN LEGS; ACHINESS AND PAIN IN HER LEGS; FATIGUE; MIGRAINES; HIGH PULSE RATE; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: reaction to flu vaccine, and concurrent conditions included: low pulse rate, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cyanocobalamin. On 07-JUN-2021, the patient experienced high pulse rate. Laboratory data included: Pulse rate (NR: not provided) over 150 bpm. On 07-JUN-2021, the patient experienced sweating. On 07-JUN-2021, the patient experienced migraines. On 07-JUN-2021, the patient experienced fatigue. On 08-JUN-2021, the patient experienced numbness in legs. On 08-JUN-2021, the patient experienced achiness and pain in her legs. On 24-JUN-2021, the patient experienced menstrual changes. On 24-JUN-2021, the patient experienced acne. On 02-JUL-2021, Laboratory data included: X-ray (NR: not provided) Unknown. Laboratory data (dates unspecified) included: Blood test (NR: not provided) exact tests and results were not accessible, and Diagnostic ultrasound (NR: not provided) could not see anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines on 11-JUL-2021, was recovering from fatigue, high pulse rate, and menstrual changes, and the outcome of sweating, numbness in legs, acne and achiness and pain in her legs was not reported. This report was non-serious.


VAERS ID: 1636141 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Gait disturbance, Headache, Hemiplegia, Hypoaesthesia, Migraine, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no medical history.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210848879

Write-up: BECAME PHYSICALLY RIGHT SIDE PARALYZED (COULD NOT FEEL HALF OF HER BODY); CHEST PAIN; BARELY WALK FLUCTUATES BACK AND FORTH; MIGRAINES; TINGLING; NUMBNESS ALL OVER HER BODY; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 28 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total, administered on 16-AUG-2021 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Patient took vaccine on 16-AUG-2021 since then she experienced chest pain, migraine, headache, tingling, numbness all over her body, fever and can barely walk fluctuates back and forth. On 20-AUG-2021, the patient became physically right side paralyzed (could not feel half of her body). Patient went to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, migraines, headache, became physically right side paralyzed (could not feel half of her body), tingling, numbness all over her body, fever and barely walk fluctuates back and forth was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210848879- covid-19 vaccine ad26.cov2.s - Became physically right side paralyzed (could not feel half of her body). 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: 1636144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Alabama  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Hypertension, Influenza like illness, Injection site nodule, Rash erythematous, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (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: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: 190/120 mmHg; Comments: high
CDC Split Type: USJNJFOC20210849527

Write-up: THROAT HAS CLOSED; DIFFICULTY BREATHING; FULL BODY RASH BRIGHT RED AND PUFFY (LIKE A BAD CASE OF POISON IVY); FLU-LIKE SYMPTOMS; KNOT AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 42 year old female of unspecified ethnic origin and race. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: sulfa allergy, and penicillin allergy. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced flu-like symptoms, headache and fever. On 20-AUG-2021, the patient experienced full body rash bright red and puffy (like a bad case of poison ivy). On 22-AUG-2021, the patient experienced throat has closed and difficulty breathing On AUG-2021, the patient experienced knot at injection site and high blood pressure Laboratory data included: Blood pressure (NR: not provided) 190/120 mmHg. The patient visited hospital and visited emergency room (8 times). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body rash bright red and puffy (like a bad case of poison ivy), difficulty breathing, high blood pressure, knot at injection site, flu-like symptoms and throat has closed was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210849527-Covid-19 vaccine ad26.cov2.s- High 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: 1636387 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-12
Onset:2021-07-23
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Anosmia, Chest X-ray, Cough, Dyspnoea, Rhinitis allergic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (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:
Current Illness:
Preexisting Conditions: Asthma
Allergies: NKA
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: SOB, dry cough, nasal congestion, loss of smell.


VAERS ID: 1636420 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-14
Onset:2021-07-24
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Chest X-ray, Condition aggravated, Cough, Dizziness, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Anxiety
Allergies: NKA
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: Dizziness, cough, anxiety.


VAERS ID: 1636426 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Migraine
SMQs:

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

Write-up: caused recurrent migraine. more severe than typical


VAERS ID: 1636434 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-07-09
Onset:2021-07-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Blood test, Computerised tomogram, Dizziness, Dizziness postural, Dysarthria, Eye disorder, Fatigue, Gait disturbance, Headache, Migraine, Mobility decreased, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (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: Adderall 30 mg
Current Illness: none
Preexisting Conditions: no
Allergies: none
Diagnostic Lab Data: blood test CT test
CDC Split Type:

Write-up: 4-days after getting the vaccine shot, I was really tired and had extreme fatigue. This lasted a couple of days and then on July 18, I woke up in horrible pain with a migraine. I could barely walk and was slurring my speech. We went to urgent care where I was told to go immediately to the ER for a CT scan and stroke test. For more than 36-hours, I couldn''t open my eyes or do anything. It was the most crippling headache I have ever had and I didn''t even get out of bed for those two-days. In the five-weeks since, I am regularly dizzy or lightheaded when walking or standing up - never experienced this before. I also don''t have near the energy I had prior to getting the vaccine and some days are extremely fatigued. The migraine left after 48-hours, mild headaches from time-to-time, the fatigue and dizziness is what I am still experiencing.


VAERS ID: 1636442 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-06
Onset:2021-07-26
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Chest X-ray, Chills, Cough, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (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:
Current Illness:
Preexisting Conditions: Hep C, seizure
Allergies: NKA
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: Cough, chills, myalgias, lost of taste and smell.


VAERS ID: 1636466 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-13
Onset:2021-08-24
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Pain in extremity, Polymerase chain reaction positive
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: PCR test came back positive on 8/24/21.
CDC Split Type:

Write-up: Patient presented to facility with chest pain radiating to left arm. Patient ruled out non-infectious.


VAERS ID: 1636475 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-14
Onset:2021-07-26
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Myalgia, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions: Aortic regurgitation, aortic stenosis, BPH, carotid stenosis, CAD, hyperlipidemia, HTN, murmur, OA, PVC''s, PAC''s.
Allergies: NKA
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: Nasal congestion, rhinorrhea, sore throat, myalgias.


VAERS ID: 1636488 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-15
Onset:2021-07-27
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Cough, Nasal congestion, SARS-CoV-2 test, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Bronchitis, Coronary bypass, DM, HTN, hypercholesterolemia, sleep apnea, smoker.
Allergies: NKA
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: URI, dry cough, nasal congestion.


VAERS ID: 1636517 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-07-29
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Chest X-ray, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chicken pox, measles, mumps, osteoporosis.
Allergies: Contrast dye, feldene, prinvil, voltaren
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: Fever and right knee pain.


VAERS ID: 1636530 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray, Chest discomfort, Chills, Cough, Discomfort, Dyspnoea, Electrocardiogram normal, Fatigue, Fibrin D dimer, Headache, Human chorionic gonadotropin, Hyperhidrosis, Laboratory test normal, Menstruation irregular, Pain, Pyrexia, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Fertility 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: none
Current Illness: none
Preexisting Conditions: none
Allergies: latex
Diagnostic Lab Data: d-dimer, troponin 1, hcg, serum, qualitative istat 8 profile: Normal ecg 12 lead, x ray chest 1 view: Normal poct troponin, poct, istat chem 8: Normal Normal the doctor told me.
CDC Split Type:

Write-up: At 9pm of the day of the vaccination (Monday August 16) I came down with a fever, body aches, chills, headache, extreme fatigue, pain, shortness of breath, and pressure in my chest/heart/lungs/upper back area. On Thursday the symptoms resolved EXCEPT for a continued headache, shortness of breath, unproductive cough, and pressure in my chest/heart/lungs/upper back area and they continue even today, August 26. I started my menstral cycle a week early, The Thursday after vaccination instead of the following week. I bled for 6 days instead of 3 days and before this, my periods have been consistent to the exact day for a solid 12+ years, since after my last pregancy, every 28 days. Every day since the vaccination, multiple times a day, I break into a sweat as if I have a fever for no apparent reason and then it passes. The pressure in my chest is still present as I am typing now, it has not subsided.


VAERS ID: 1636531 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-08
Onset:2021-08-22
   Days after vaccination:136
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / IM

Administered by: Public       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested positive for COVID19 on 8/22/2021


VAERS ID: 1636544 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-07-30
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chest X-ray, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

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

Write-up: Nausea, vomitting, weakness.


VAERS ID: 1636566 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Diarrhoea, Headache, Oropharyngeal pain, Pain, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Endometriosis, hypothyroid, migraine.
Allergies: Darvocet, Darvon, Demerol
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: Headache, diarrhea, body aches, sore throat.


VAERS ID: 1636649 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 06986225 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hypoaesthesia, Neuralgia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Patient stated that the moment that she got the shot it left like her arm went numb. Since she has gotten the vaccine she has been experiencing server nerve pain. She has seen a DR. The DR. prescribed her gabapentin. The medication helps but, the patient stats that she does not want to be dependent on a drug to use her arm.


VAERS ID: 1636697 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cardiac arrest, Resuscitation, SARS-CoV-2 test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications: TRAZODONE, LISINOPRIL, LEVOTHYROXINE, ATORVASTATIN, ASPIRIN
Current Illness:
Preexisting Conditions: Hypercholesterolemia Hypertension
Allergies: PENICILLIN, SINGULAIR, SULFA DRUGS
Diagnostic Lab Data: POSITIVE COVID TEST 08/18/2021 @ 1928
CDC Split Type:

Write-up: cardiac arrest - cpr in progress. COVID POSITIVE


VAERS ID: 1636734 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-03
Onset:2021-08-04
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Chest discomfort, Cough, Nasal congestion, Pyrexia, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN, SOB, Asthma, obesity.
Allergies: NKA
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: tighness in chest, wheezing, dry non productive cough, nasal congestion, fevers.


VAERS ID: 1636739 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: U07.1 - COVID-19


VAERS ID: 1636753 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-07
Onset:2021-07-12
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Cough, Diarrhoea, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, hypercholesterolemia, HTN, kidney disease, nephrectomy.
Allergies: NKA
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: Fever, nausea, vomiting, diarrhea, cough.


VAERS ID: 1636757 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-08-05
Onset:2021-08-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Borrelia test, Condition aggravated, Hypoaesthesia, Intervertebral disc protrusion, Laboratory test, Muscle spasms, Paraesthesia, Skin discolouration
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (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: none
Diagnostic Lab Data: seen at Hospital - r/o blood clot - Lyme blood test drawn. Pt shares ER felt leg symptoms were r/t her bulging disk in her back (chronic issue she gets cortisone shots for)
CDC Split Type:

Write-up: pt reported numbness, tingling, cramping to back of calf muscle and discoloration dots on feet (smaller than pencil eraser)


VAERS ID: 1636797 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diarrhoea, Influenza like illness, Myalgia, Palpitations, Peripheral swelling, Pruritus, Pyrexia, Swelling, Swelling face, Throat tightness
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), 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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zimtat One a Day Women''s, Caltrate, Baby Aspirin
Current Illness:
Preexisting Conditions: Epilepsy, Sick Sinus Syndrome Hypoglycemia
Allergies: Penicillin, Doxycycline Hyclate, Codeine Opiate Derivatives, Bee and Ant Venom
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: Forty minutes after getting the vaccine I was in the car and I felt like I was having heart palpitations. I then started to itch all over and I noticed that my arms were swelling. My chest started to swell too and my face was huge. My throat was starting to close, and the itching was intense but I could not really feel where I was scratching. I drove straight to the Urgent Care. I was not treated quickly with Benadryl so I took some myself. They advised Hydroxyzine. The swelling started to come back after the Benadryl started to wear off and I took two more. The next day I took more Benadryl and the Hydroxyzine. I still have no feeling in my chest after almost one week. The numb feeling is mostly close to the area of the shot and most of the swelling went down. I did have flu-like symptoms the following day which lasted for three days. I had a fever of 103, muscle aches and some diarrhea.


VAERS ID: 1636957 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-02
Onset:2021-08-03
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: Covid test, chest xray.
CDC Split Type:

Write-up: Cough, congestion, fever.


VAERS ID: 1636958 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-09
Onset:2021-06-21
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Dizziness, Fatigue, Headache, Myalgia, SARS-CoV-2 test positive, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Amlodipine Besylate 6 mg, Hydrochlorothiazide 25mg, Losartan Potassium 100mg, Sertraline HCI 50mg, Multi vitamin, probiotic, anti-inflammatory
Current Illness: Granuloma Annular, Lichen Sclerosis, and joint pain
Preexisting Conditions: Granuloma Annular, Lichen Sclerosis, and joint pain
Allergies: none
Diagnostic Lab Data: No testing for vertigo. 7/13/21 SARS-VOV-2 (COVID-19) RAPID - POSITIVE
CDC Split Type:

Write-up: 6/21/21 Vertigo - lightheaded, dizziness that lasted 36 hours and continued with milder symptoms coming and going until 7/5/2021. 7/11/21 deep cough, 7/12/21 severe headache and fatigue and muscle aches...diagnosed Covid-19 on 7/13/21 at ER.


VAERS ID: 1636981 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-10
Onset:2021-08-03
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Atrial tachycardia, Chest X-ray, Chills, Cough, Fall, Nasal congestion, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Accidents and injuries (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN, hyperlipidemia
Allergies: Biaxin, clarithromycin, PCN
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: Shivering, nasal congestion, dry cough, fall, fevers, tachycardic.


VAERS ID: 1636999 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Paraesthesia oral, Pruritus, Rash, Throat clearing, Tryptase
SMQs:, Anaphylactic reaction (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 30 min post vaccine, patient started to experience throat clearing, itching on the left side of her face and per chart notes, rash on her chest. She had premedicated with Benadryl before her injection. She went back to the hospital emergency room as she started having tongue tingling and more throat symptoms. She reports receiving epinephrine, more Benadryl, and Pepcid, and not sure about steroids. Within an hour, her symptoms started to resolve. She was back to baseline the following day. Tryptase level was normal. ED attending documentation suggests possible vocal cord dysfunction as confounding the presentation.


VAERS ID: 1637387 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea, Feeling abnormal, Head discomfort, Immediate post-injection reaction, Ocular hyperaemia, Somnolence, Swollen tongue, Tremor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), 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), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? No
Previous Vaccinations:
Other Medications: Dilantin
Current Illness: Unknown
Preexisting Conditions: Seizures
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Client reported feeling dizzy immediately after administration of the COVID vaccine Janssen. Noted the client was rubbing his forehead and eyes. The client''s eyes were closed. When the client opened his eyes. Noted the client''s eyes appeared red. Noted that this redness was not present prior to receiving the vaccine. The client was deliberately shaking his hands bilaterally and squeezing his hands into fists. Asked the client what his current symptoms were and he did not verbally respond. Repeated the question. A few seconds later the client stated he felt "dizzy and weird." The client stated that he felt something in his right leg, but RN was unable to discern what the client said. RN noted shaking of the client''s right leg. The client stood up with the assistance of his cane and support of the arm of the anti-gravity chair and transferred into the anti-gravity chair. The client appeared unsteady on his feet to RN. The anti-gravity chair was reclined. The client was verbally unresponsive for a few seconds. RN noted the client''s head leaned against the anti-gravity chair and the client''s eyes were closed. The client then opened his eyes. The client was alert and oriented to person, place, and time. The client reported feeling "dizzy, weak, and sleepy, like when you have surgery." The client denied any chest pain or shortness of breath. Vitals obtained at 1:39PM were as follows: BP 147/94 and HR 84. The client stated he felt thirsty, RN offered the client water. The client did not drink the water. At 1:43PM the client reported "my tongue feels like when you take medicine." The client subsequently clarified that his tongue felt "swollen." RN assessed the client''s tongue and did not note any swelling and noted the client''s tongue was pink. The client has a history of seizures and takes Dilantin. The client states he took his Dilantin this morning as prescribed. The client stated his current status feels different than his seizures. The client states that when he has a seizure he "shakes a lot and then I can''t talk." Vitals obtained at 1:46PM were as follows: BP 134/90 and HR 90. The client stated that his tongue still felt "swollen." The client stated that he took the trolley to the vaccination site and does not have anyone who could come and pick him up. The client stated his throat felt "itchy." Offered the client Diphenhydramine IM. The client reported a history of an allergy to Keppra where he developed a rash. The client denied any history of anaphylaxis. Oxygenation status obtained via pulse oximeter at 1:52PM was 97%. The client stated that he would like to receive Diphenhydramine IM. RN educated the client regarding Diphenhydramine including risk of drowsiness. The client voiced understanding of this education and gave verbal consent to receive Diphenhydramine IM. The client stated his dizziness was improving and that he still felt tired at 1:52PM. RN administered 50mg/1ml Diphenhydramine (Lot# 020020 exp 02/2022) in the right deltoid muscle at 1:53PM. The client was verbally non-responsive for a several seconds after receiving the Diphenhydramine. RN noted shaking of the client''s right leg. The client''s head was heavy on the anti-gravity chair. The client then attempted to sit up quickly. RNs reassured the client of the situation and the client relaxed in the chair. RN activated EMS at 1:55PM. The client stated "I can''t breathe". RN noted the client clutching his chest. The client reported repeated difficulty with respirations. Prepared to administer Ephinephrine by removing the cap and safety release. RN prepared to administer the Epinephrine when the client moved quickly and stated "no." RN did not administer Ephinephrine. RN educated the client regarding Ephinephrine and continued to question the client regarding his respiratory symptoms. The client appeared more alert to RN and began to respond to questions more clearly. RN noted no pallor or use of accessory muscles. The client stated that his breathing was improving. Vitals obtained at 2:00PM were as follows: BP 146/88 and HR 84. The client denied any persistent weakness. The client appeared disoriented to RN. The client stated that his right arm hurt. RN explained that was likely related to the Diphenhydramine administered IM into the right deltoid. The client asked RN, "I received another injection?" RNs educated the client regarding the administration of Diphenhydramine IM. The client voiced understanding of this education. EMS assumed care at approximately 2:03 PM. The client was transported to ER 2:09PM.


VAERS ID: 1637413 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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:
Current Illness: None reported
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called pharmacy approximately 1 hour after vaccination to report he could see and feel swelling in his face. Upon further questioning, the patient stated he was not having difficulty breathing, but was having slight "shortness of breath". Patient was advised by pharmacist that this could be sign of serious allergy/angioedema and recommended patient seek immediate attention at PCP, urgent care, or ER. Pharmacist also suggested that Benadryl may help to alleviate the symptoms of allergy, but due to the risk for severe allergy, it was best to be further evaluated in person as soon as possible. It is unknown at this time where the patient was seen for follow up care.


VAERS ID: 1637609 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-04
Onset:2021-08-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Back pain, Blepharospasm, Blood test, Electrocardiogram normal, Heart rate increased, Hypoaesthesia, Lymph node pain, Muscle twitching, Nervousness, Pain, Pain in extremity, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Norethindrone 2.5mg daily and omeprazole 20mg daily
Current Illness: Asthma
Preexisting Conditions: Asthma, trigeminal neuralgia
Allergies: Allergic to iodine, shellfish
Diagnostic Lab Data: Ekg was normal. Bloodwork has not been reported yet.
CDC Split Type:

Write-up: Starting late Friday night/ early Saturday morning (8/7/21) I started feeling numbness in my mouth, cheek and eyelid on my left side. I also experienced numbness and tingling on the tops of my feet on both sides, hands, forearms, and other places around my limbs. I also have eye twitching on my left side and twitching at the corner of my mouth on the same side. Additionally, I have had a low grade fever off and on through today, 8/26/21. Random seeming and short lived bursts of pain throughout the body, including the right hand, right knee, shoulders, thighs and back. The pain only lasts 15-30 seconds. I still have all of these symptoms today. I also feel shaky and have had a higher than normal heart rate on and off. In addition I have had sore lymph nodes in the underarms, groin area and clavicle. I have treated with supplements including turmeric, glutathione, quercetin as well as ibuprofen. I received an ekg and bloodwork at my provider. Prior to seeing her I went to urgent care on 8/8/21 but they did not do or say anything and I received no treatment.


VAERS ID: 1637635 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-10
Onset:2021-08-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood urine present, Computerised tomogram thorax normal, Contusion, Diarrhoea, Erythema, Fibrin D dimer increased, Inflammation, Pain in extremity, Platelet count normal, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DextroAmphetamine 20mg
Current Illness: None
Preexisting Conditions: Occasional acute pancreatitis
Allergies: None
Diagnostic Lab Data: D Dimer - elevated Platelet count - normal Chest CT - clear Other labs and tests were taken, but I did not receive paperwork with results for any of them. All occurred on 8/26
CDC Split Type:

Write-up: 8/14, four days after vaccination, developed unusual bruising with red spots on the opposite arm of injection. 8/18 began passing bright red blood with loose stools consistently. 8/24 began passing dark blood clots with loose stools, no bright blood present. During this time, began noticing small red and purple spots on different parts of the body, three on the right arm, two on right thigh, one small raised patch on left forearm. 8/24 developed a deep cramp like pain in the hand which persisted and a vein became inflamed and red on the night of the 25th. Checked into the ER early morning on 8/26. Chest CT was clear, platelets were normal range, D-Dimer test was elevated. Was given fluids and sent home after a few hours with a referral to a gastroenterologist. Symptoms still present.


VAERS ID: 1638059 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Swollen tongue, Therapy non-responder, Transfusion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Lack of efficacy/effect (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 1743/Vaccine administered , 1800 Pt''s husband reported that pt was having a reaction of a swollen tongue. Prior to vaccine administration, Pt and her husband communicated pt''s medical history of Hereditary Angioedema and were well prepared for such reaction. Pt had an IV in her left hand, saline locked and was ready to administer CI Esterase Inhibitor which is the only medication that will help aside Plasma. Medical lead and EMT on the bus arrived to the scene. Pt''s tongue was swollen, pt was alert and pushing the medication through the IV. V/S checked, BP 137/,87 HR 118, O2 93%, RR 18. 911 called since med was not helping. EMS arrived after 5 minutes. Pt transported to the ER via ambulance for Plasma infusion.


VAERS ID: 1638426 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-04-01
Onset:2021-05-25
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1INKNOWN / 1 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Catheterisation cardiac, Dyspnoea exertional, Echocardiogram, Electrocardiogram, Fatigue, Muscular weakness, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: Lipitor
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EKG, X-ray, Echo cardio gram, heart cath
CDC Split Type:

Write-up: Leg fatigue/weakness Overall loss of energy Shortness of breath with exertion


VAERS ID: 1638446 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-01
Onset:2021-03-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cellulitis, Oedema, Rash, Skin exfoliation, Thermal burn
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None no known auto.immune disorder
Allergies: Inflammation history allergic psych meds only
Diagnostic Lab Data: ER in June 2021 and July 2021
CDC Split Type:

Write-up: Burn shed skin rashes Cellulitis and edema


VAERS ID: 1638447 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose normal, Disorientation, Dyskinesia, Fall, 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), Dementia (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: none per pt
Current Illness: none per Pt
Preexisting Conditions: none per Pt
Allergies: NKA per pt
Diagnostic Lab Data: random blood sugar 98 per paramedic
CDC Split Type:

Write-up: Patient was siting in the observation area after received J&J vaccine. 2 minutes after talked to him and walked away from him, a noise was heard and found patient on the flood in prone position unconscious. Quickly reached to his side and noticed he has mild ( not violent) jerking movement. 911 was called. His ABC ( airway, breathing, circulation ) intact. No external injury was found. Patient regained consciousness He was disoriented for a moment but soon became oriented. His initial vital signs P 95; BP 146/64; Second one P96; BP 118/64; O2 Sat 98%. Paramedic arrived and patient was traported to hospital to be evaluated.


VAERS ID: 1638892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: West Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood folate, Blood glucose, Blood thyroid stimulating hormone, CSF cell count, CSF glucose, CSF protein, CSF test, Chest X-ray, Chills, Computerised tomogram head, Electromyogram, Fatigue, Fibrin D dimer, Gram stain, Guillain-Barre syndrome, HIV test, Liver function test, Magnetic resonance imaging, Magnetic resonance imaging head, Neurological examination, Pain in extremity, Physical examination, Red blood cell sedimentation rate, Renal function test, Vitamin B12, White blood cell count
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (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: Medical History/Concurrent Conditions: Morbid obesity; Comments: No significant medical history
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: EMG; Result Unstructured Data: See Result Unstructured Data field; Test Name: MRI; Result Unstructured Data: See Result Unstructured Data field; Test Name: Neurological examination; Result Unstructured Data: See Result Unstructured Data field; Test Name: MRI; Result Unstructured Data: Cervical and thoracic: did not show any abnormal T2 signal changes; Test Name: MRI; Result Unstructured Data: lumbar: no significant degenerative disc disease; Test Name: CSF cell count; Result Unstructured Data: See Result Unstructured Data field; Test Name: CSF protein; Result Unstructured Data: 562 mg/dL; Test Name: CSF glucose; Result Unstructured Data: 67 mg/dL; Test Name: CSF gram stain; Result Unstructured Data: negative; Test Name: CSF test; Result Unstructured Data: See Result Unstructured Data field; Test Name: WBC count; Result Unstructured Data: 15.0 10*9/L; Test Name: Fibrin D dimer; Result Unstructured Data: borderline elevated; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: within normal values; Test Name: Creatine phosphokinase; Result Unstructured Data: within normal values; Test Name: Blood glucose; Result Unstructured Data: within normal values; Test Name: Liver function test; Result Unstructured Data: within normal values; Test Name: Renal function test; Result Unstructured Data: within normal values; Test Name: Vitamin B12; Result Unstructured Data: within normal values; Test Name: Folate; Result Unstructured Data: within normal values; Test Name: TSH; Result Unstructured Data: within normal values; Test Name: HIV test; Result Unstructured Data: Negative; Test Name: Chest X-ray; Result Unstructured Data: Unremarkable with no hilar or mediastinal lymphadenopathy.; Test Name: MRI brain; Result Unstructured Data: See Result Unstructured Data field; Test Name: Head CT; Result Unstructured Data: colloid cyst; Test Name: Physical examination; Result Unstructured Data: vital signs were stable
CDC Split Type: USJNJFOC20210837750

Write-up: BIFACIAL DIPLEGIA VARIANT OF GUILLIAN- BARRE SYNDROME; ARM SORENESS; CHILLS; MILD FATIGUE; This spontaneous report was received from literature: A Novel Case of Bifacial Diplegia Variant of Guillain-Barre Syndrome Following Janssen COVID-19 Vaccination. Neurology International. 2021 Aug 13; 13404-409. This report concerned a 41 year old male, race and ethnic origin not reported. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: morbidly obese, with no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient presented to the emergency department (ED) with acute onset of urinary retention twelve days after vaccine administration. The patient only reported arm soreness, mild fatigue, and chills three days after the vaccination which were self-resolving in a few days. He underwent evaluation in the ED followed by urinary catheterization and was followed up with urology as an outpatient. On day 15 following his COVID-19 vaccination, he returned to the ED with a new onset of left-sided facial droop. He was diagnosed with Bell''s palsy and was discharged with prednisone and valacyclovir. His CT brain showed a colloid cyst and, hence, he was referred to see neurosurgeons as an outpatient. On day 21 post-vaccination, he presented to the ED with subjective weakness and paresthesias in all extremities. He had difficulty feeding himself and ambulating due to his weakness. He also had new onset of right facial weakness. His urinary retention had resolved. He denied any blurry vision, dysphagia, and headache. Upon physical examination, his vital signs were stable. Neurological examination, including a cranial nerve examination showed bilateral lower motor neuron facial nerve palsy, more prominent on the left compared to right. His deep tendon reflexes were absent bilaterally at the patella and the Achilles with mute plantar responses. Motor strength was 4+/5 (Medical Research Council grade) in all four extremities. An MRI of the cervical and thoracic spine did not show any abnormal T2 signal changes and his lumbar spine showed no significant degenerative disc disease. He underwent lumbar puncture due to suspicion for Guillain-Barre syndrome (GBS) and showed albumino-cytological dissociation with a CSF cell count of 50/uL (lymphocytes 91%, monocyte 9%, red blood cell counts of 123) and CSF protein of 562 mg/dL. Further corrected cerebrospinal fluid (CSF) protein for the presence of RBC was significantly elevated to 562 mg/dL. Other CSF findings included glucose of 67 mg/dL (serum glucose 109 mg/dL) and negative CSF gram stain, CSF lyme polymerase chain reaction (PCR), and viral PCR testing on CSF, including herpes simplex virus, varicella zoster virus, Epstein-Barr virus, cytomegalovirus (CMV) and Borrelia burgdorferi IgM and IgG. Given the classic clinical picture of GBS in absence of other identifiable etiology for his neurologic disease, additional supportive testing with EMG showed a prolonged distal latency with conduction block and slow conduction velocity in bilateral tibial, peroneal nerve, and absent F waves were supportive for demyelinating GBS. He was started on intravenous immunoglobulin (IVIG) at 2 g/kg over 5 days. Other notable laboratory findings included a white cell count of 15.0 10*9/L, possibly due to recent steroid use and borderline elevated D-dimer. The erythrocyte sedimentation rate, creatine phosphokinase, blood glucose, hepatic and renal function, vitamin B12, folate levels, and thyroid-stimulating hormones were all within normal values, whereas the serum HIV test was negative. Chest X ray was unremarkable with no hilar or mediastinal lymphadenopathy. Clinically, the patient showed significant improvement after the first dose of 400 mg/kg of IVIG. The patient strength was 5/5 in all muscle groups one day after IVIG treatment. He showed recurrence of his right patellar reflex on day 4 of IVIG treatment and trace right ankle reflex with continued absence of left patellar and ankle reflex. The patient finished 5 days of IVIG treatment with mild side-effects, including nausea and headache. It was reported the patient responded very well to IVIG treatment with improvement of his symptoms. He continued to be significantly ataxic and was intended to be placed in a rehabilitation facility. Patient followed in outpatient clinic had MRI imaging of brain showed incidental finding of colloid cyst, no facial nerve enhancement, no mass lesion, no abnormal leptomeningeal. Repeat MRI lumbar spine with contrast showed thickening of cauda equina nerve roots suggestive of inflammatory demyelinating neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, chills, and mild fatigue, and the outcome of bifacial diplegia variant of guillian- barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This 41-year-old male patient having morbid obesity with no other significant medical history, with incidental finding of Colloid brain cyst on CT brain, about 15 days after prophylactic vaccination and also experienced bifacial diplegia variant of Guillian-Barre syndrome(GB syndrome) within 3 weeks of vaccination. Initial symptom of acute onset of urinary retention started about 12 days after vaccination which was treated with catheterization. Later patient presented with new onset of left-sided facial droop and initial diagnosis made as Bell''s palsy and found to have colloid cyst in CT brain; treated with prednisone and valacyclovir. On day 21 post-vaccination, patient presented with weakness and paresthesias in all extremities, new onset of right facial weakness with neurological findings of bilateral lower motor neuron facial nerve palsy, more prominent on the left compared to right, deep tendon reflexes absent bilaterally at the patella and the Achilles with mute planter responses. Motor strength was 4+/5 in all four extremities. An MRI of cervical, thoracic and lumbar spine did not reveal any degenerative disease. CSF examination revealed albumin-cytological dissociation with CSF cell count of 50/uL and CSF protein of 562 mg/dL with negative CSF gram stain, CSF lyme polymerase chain reaction (PCR), and viral PCR testing on CSF, including herpes simplex virus, varicella zoster virus, Epstein-Barr virus, cytomegalovirus and Borrelia burgdorferi IgM and IgG; negative serum HIV test and chest X-ray unremarkable. Additional testing with EMG was supportive for demyelinating GB syndrome. Patient was treated with intravenous immunoglobulin over 5 days and responded well clinically. Considering the temporal relationship and lack of other reported potential etiologies, GB syndrome is assessed to have a plausible relationship with vaccination.


VAERS ID: 1638893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chills, Electrocardiogram, Full blood count, Haemodynamic test, Magnetic resonance imaging heart, Myalgia, Myocarditis, Troponin, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Obstructive sleep apnea syndrome
Preexisting Conditions: Comments: The patient was previously healthy, had no known cardiac history. The patient did not have any known allergies, and he was up-to-date with all standard vaccinations with no prior history of adverse reactions. The patient denied any sick contacts or exposure to COVID-19 patients in the weeks prior to vaccination or travel.
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: normal sinus rhythm with normal intervals; Test Name: Troponin T; Result Unstructured Data: 0.041 ng/mL; Test Name: Full blood count; Result Unstructured Data: normal; Test Name: Haemodynamic test; Result Unstructured Data: stable and afebrile; Test Name: Troponin; Result Unstructured Data: 10.2 ng/mL; Test Name: Myocardial late gadolinium enhancement MRI; Result Unstructured Data: small focal area of myocarditis with a scar size of 2 percent; Test Name: C-reactive protein; Result Unstructured Data: 40.4 mg/L
CDC Split Type: USJNJFOC20210839098

Write-up: MYOCARDITIS; CHILLS; MYALGIAS; This spontaneous report was received from literature: Temporal association between the COVID-19 Ad26.COV2.S vaccine and acutemyocarditis: A case report and literature review. Cardiovascular Revascularization Medicine. This report concerned a 33 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: asthma, and obstructive sleep apnea, and other pre-existing medical conditions included: The patient was previously healthy, had no known cardiac history. The patient did not have any known allergies, and he was up-to-date with all standard vaccinations with no prior history of adverse reactions. The patient denied any sick contacts or exposure to COVID-19 patients in the weeks prior to vaccination or travel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date, two days after vaccination the patient went to the emergency department with acute onset substernal chest pain. The patient initially noted myalgias and chills which resolved 24 hours following vaccination. This was followed by a constant, retrosternal, non-radiating, non-exertional chest pain. The pain was not positional, pleuritic, nor exertional. Patient was hospitalized on unspecified date. Upon admission, the patient was hemodynamically stable and afebrile. Laboratory data included: Electrocardiogram (ECG) showed normal sinus rhythm with normal intervals. Laboratory tests were remarkable for high-sensitivity (hs) troponin T 0.041 ng/mL (Normal range less than 0.014 ng/mL). The complete blood cell count with differential was normal and C reactive protein was 40.4 mg/L (Normal range 3.0 mg/L). Over the course of 24 hours, the troponin peaked to 10.2 ng/mL. A gadolinium enhanced cardiac magnetic resonance imaging showed a small focal area of myocarditis in the mid to apical lateral region of the left ventricle with a scar size of 2 percent. Overall, systolic function of the left ventricle was normal with no hypokinesis noted. The myocarditis was presumed to be due to the vaccine administered due to the strong chronological association. The patient was treated symptomatically, and he endorsed significant improvement in his symptoms. The patient was discharged home in stable condition with close follow-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and myalgias, and was recovering from myocarditis. Authors concluded that, the case highlighted the second possible case of vaccine induced myocarditis in an individual following administration of the Janssen vaccine. Authors believed that though they might see more cases of myocarditis following vaccination as millions were vaccinated worldwide, it was still a rare phenomenon for which the benefits of the vaccines far outweigh the risks. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839098- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Myocarditis. 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: 1638894 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood sodium, Body temperature, Chest X-ray, Computerised tomogram, Fibrin D dimer, Full blood count, Heart rate, Influenza A virus test, Influenza B virus test, Liver function test, Lymphocyte count, Lymphocyte morphology abnormal, Mean platelet volume, Metabolic function test, Neutrophil count, Polymerase chain reaction, Respiratory viral panel, SARS-CoV-2 test, Smear test, Suspected COVID-19, Vaccination failure, Viral test
SMQs:, Lack of efficacy/effect (narrow), Malignant lymphomas (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (very rarely); Allergic reaction to antibiotics (burning sensation all over his body); Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Ileostomy; Pericarditis (The patient had it which ended up in emergency room.); Surgery (relating to ostomy which were catastrophic with many infections); Comments: The patient did not have any drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Complete blood count; Result Unstructured Data: unknown; Comments: patient did not have the results but was told they were okay; Test Date: 202108; Test Name: PCR; Result Unstructured Data: Unknown; Comments: patient did not have the results but was told they were okay; Test Date: 202108; Test Name: Comprehensive metabolic panel; Result Unstructured Data: unknown; Comments: patient did not have the results but was told they were okay; Test Date: 202108; Test Name: Fibrin D dimer; Result Unstructured Data: unknown; Comments: patient did not have the results but was told they were okay; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: Unknown; Test Date: 202108; Test Name: Liver function test; Result Unstructured Data: Elevated; Test Date: 20210809; Test Name: Body temperature; Result Unstructured Data: 104 F; Test Date: 20210810; Test Name: Viral swab; Result Unstructured Data: Negative; Comments: two swabs for Covid which both came back negative; Test Date: 20210813; Test Name: Alkaline phosphatase; Result Unstructured Data: 269 U/L, High; Test Date: 20210813; Test Name: Bilirubin total; Result Unstructured Data: 1.4 mg/dL, High; Test Date: 20210813; Test Name: Pulse rate; Result Unstructured Data: 129; Test Date: 20210813; Test Name: Body temperature; Result Unstructured Data: 101 F; Test Date: 20210813; Test Name: Respiratory viral panel; Result Unstructured Data: No abnormal detection; Test Date: 20210813; Test Name: Viral swab; Result Unstructured Data: No flu and no covid; Test Date: 20210813; Test Name: Alanine aminotransferase; Result Unstructured Data: 111 U/L, High; Test Date: 20210813; Test Name: Aspartate aminotransferase; Result Unstructured Data: 85 U/L, High; Test Date: 20210813; Test Name: Creatinine; Result Unstructured Data: 1.4 mg/dL, High; Test Date: 20210813; Test Name: Sodium; Result Unstructured Data: 133 mEq/L, Low; Test Date: 20210813; Test Name: Atypical lymphocytes; Result Unstructured Data: 7.7 %, High; Test Date: 20210813; Test Name: Mean platelet volume; Result Unstructured Data: 10.2 fL, High; Test Date: 20210813; Test Name: Lymphocyte count; Result Unstructured Data: 13.7 %, Low; Test Date: 20210813; Test Name: Neutrophil count; Result Unstructured Data: 70.9 %, High; Test Date: 20210813; Test Name: Chest X-ray; Result Unstructured Data: no flu and no covid; Comments: revealed the lungs were clear and the heart was of normal size. No change from 19-Mar-2020; Test Date: 20210818; Test Name: Smear; Result Unstructured Data: unknown; Test Date: 20210818; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: unknown; Test Date: 20210818; Test Name: Influenza A virus test; Result Unstructured Data: unknown; Test Date: 20210818; Test Name: Influenza B virus test; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210841156

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 63 year old male. The patient''s weight was 71.7 kilograms, and height was 66 inches. Patient had numerous surgeries relating to ostomy in 1996 which were catastrophic with many infections. In 2019, patient changed from J-pouch to ostomy. patient had pericarditis in 2020 which ended up in emergency room (ER). Concurrent conditions included: sulfa allergy (burning sensation all over his body), alcohol user (very rarely), and non smoker, and patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on left arm on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-AUG-2021, patient had headache in the evening along with chills (sheet wet), fever of 104 degrees F and body temperature was going up and down (suspected covid-19 infection and suspected clinical vaccination failure). On 10-AUG-2021, the next morning, patient had two swabs for covid which both came back negative. His symptoms continued and also included fatigue, body ache, pain, some vomiting and nonproductive cough when talked to the degree that his chest hurt when he coughed. On 13-AUG-2021, patient went to hospital and was there for 6-7 hours. They did swab, blood work, X-ray, metabolic panel. They said there were no flu and no covid and sent him home with the instruction to rest and to have fluids. On 13-AUG-2021, Laboratory data included: Alanine aminotransferase (NR: 12 - 78) 111 U/L, Alkaline phosphatase (NR: 45 - 117) 269 U/L, Aspartate aminotransferase (NR: 15 - 37) 85 U/L, Atypical lymphocytes (NR: 0 - 0) 7.7 %, Bilirubin total (NR: 0.2 - 1.0) 1.4 mg/dL, Body temperature (NR: not provided) 101 F, Chest X-ray (NR: not provided) no flu and no covid (revealed the lungs were clear and the heart was of normal size. No change from 19-MAR-2020), Creatinine (NR: 0.6 - 1.3) 1.4 mg/dL, Lymphocyte count (NR: 28 - 48) 13.7 %, Mean platelet volume (NR: 6.0 - 10.0) 10.2 fL, Neutrophil count (NR: 34 - 64) 70.9 %, Pulse rate (NR: not provided) 129, Respiratory viral panel (NR: not provided) No abnormal detection, Sodium (NR: 136 - 145) 133 mEq/L, and Viral swab (NR: not provided) No flu and no covid. On 13-AUG-2021, procalcitonin and urinalysis, macroscopic urinalysis was performed whose results were within normal range. Patient was given Tylenol and sodium chloride. On 18-AUG-2021, patient went back ER and came out morning at 5.00. On 18-AUG-2021, influenza A PCR, influenza A PCR, blood smear and SARS-COV-2 PCR (COVID-19) test were in progress and results were not known. They also did CT Scan, full metabolic panel, PCR, CBC, D-Dimer, which the patient did not have the results but was told they were okay. Patient had elevated liver function tests. They also said there were no clot in the lung but they did not have the results. They gave him Toradol, Zofran, and Ns (Normal Saline) in the hospital and sent him home with a prescription for Naprosyn. The patient''s symptoms were continuing. The patient was under assumption that they tested for covid and not sure whether they tested for antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190611; Sender''s Comments: V0:20210841156-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210841156-COVID-19 VACCINE AD26.COV2.S-Suspected COVID-19 infection. 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: 1638902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypertension (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: The patient was healthy and fit.
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: High
CDC Split Type: USJNJFOC20210846293

Write-up: MICRO BLOOD CLOT; HIGH BLOOD PRESSURE; This spontaneous report received from a company representative concerned a male of an unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient was healthy and fit. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date after vaccination, the patient''s blood pressure was increased and he was taken to the emergency room (ER). Later, he was diagnosed with micro blood clots and he was hospitalized . As per his doctor, micro blood clots might be linked with vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the micro blood clot and high blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210846293-COVID-19 VACCINE AD26.COV2.S-micro blood clot, high 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: 1638914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction, Asthenia, Chest pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: USJNJFOC20210849932

Write-up: BODY ACHES; CHEST PAIN; A LOT OF THINGS; WEAKNESS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on AUG-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 AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced chest pain. On AUG-2021, the patient experienced a lot of things. On AUG-2021, the patient experienced weakness. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, weakness, body aches, chest pain and a lot of things was not reported. This report was non-serious.


VAERS ID: 1638939 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Oxygen saturation, SARS-CoV-2 test
SMQs:, 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:
Current Illness: Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Oxygen saturation; Result Unstructured Data: low; Test Name: COVID-19 virus test; Result Unstructured Data: negative
CDC Split Type: USJNJFOC20210851989

Write-up: PRESUMED DIAGNOSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (COUGH/WHEEZE/COULDN''T BREATHE); This spontaneous report received from a patient concerned a 51 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the patient experienced presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn''t breathe). On 12-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) low. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn''t breathe) was not reported. This report was non-serious.


VAERS ID: 1640946 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-05-03
Onset:2021-08-11
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204AZ1A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Back pain, Chest X-ray normal, Cough, Dyspnoea, Fibrin D dimer increased, Flank pain, Painful respiration, Pneumonia, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ 25mg daily Diovan 80mg daly Ventolin inh 2 puffs Q4hrs prn SOA/wheezing
Current Illness: none
Preexisting Conditions: HTN
Allergies: NKDA
Diagnostic Lab Data: COVID positive 1/21 and Covid vaccine 5/21
CDC Split Type:

Write-up: on August 11, 2021 pt was cleaning out a horse stall and began having pain to his back and stabbing pain in his right side with breathing. Pt unable to lay down due to difficulty breathing. Pt was seen in the clinic on 8/14/21 and prescribed Flexeril 10mg prn, Toradol 60mg IM and Depomedrol 80mg IM. Pt was instructed on risk of PNA and PE and instrcuted to go to ER with worseing symptoms. Pt presented to my office on 8/20/21 with continued symptoms as above. I ordered a CXR which was negative adn a D-Dimer which was elevated at 1.5. Pt was instructed to go to the ER for further eval for a CTA chest to r/o PE and was found to have RLL PE and PNA. Pt was started on Eliquis 5mg BID, Norco 5/325mg QID prn pain, Mucinex DM 1 BID prn cough, Decadron 4mg daily for 10 days, Levaquin 500mg daily for 10 days and to f/u with PCP. I saw the pt in the office on 8/23/21 and ordered at BLE venous doppler and hematology referral


VAERS ID: 1640991 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A/09-21-2 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electrocardiogram, Heart rate increased
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl Breo Allegra Montelukast Escitalopram Vitamin D Tagamet
Current Illness:
Preexisting Conditions: asthma nasal polyps
Allergies: NSAIDs shellfish alliums (garlic, onion) mango nitrile gloves (the accelerant used to blow them off the molds, inside the gloves) bandage tape cumin mint (very mild) trees mold
Diagnostic Lab Data: 8/25/21 - ECG, nothing found
CDC Split Type:

Write-up: Heart rate spiked approximately 30+ bpm consistently for any movement, and 15 bpm at rest, per data. (It may not be as accurate as medical testing, but is sufficient to show changes within its own data-set, which go back several years.) Heart rate would spike to 150 gently walking up a flight of steps. Drinking a soda also spiked my heart rate for 5-6 hours, which is abnormal. (On the plus side, I now know how long before bedtime to avoid caffeine, since it apparently processes out of my system in 5-6 hours.) Over four days, gradual improvement back to normal. However, for the first two days, I couldn''t do anything more than lay down and avoid anything even slightly stressful to avoid a dangerously high heart rate. The simple act of standing took it up 15 points, to the area it would normally have been if I was running up and down the steps with full baskets of laundry. Shot was Sunday afternoon, reaction started shortly after midnight on Monday. I was woken up by my cardiac response, so this wasn''t anxiety-induced. I also wasn''t particularly worried about the shot so, again, not anxiety-induced. And I was doing slow breathing and such to calm my heart rate, so not anxiety-induced. At about 3 am on Tuesday morning, I was laying down and my heart rate abruptly jumped 15 points out of nowhere, which was the final straw and I went to the ER. Of course, it was the final straw - my heart rate had started normalizing, so they found nothing on the ECG. The next day, my heart rate was nearing normal. The day after (Thursday), it was seemingly completely back to normal. However, if I had been TOLD that an extreme racing heart was a potential side effect and should normalize within 3-4 days, rest if it happened and see a cardiologist if it doesn''t normalize within four days, take these precautions if it exceeds XXXX bpm, visit the ER if YYYYY happens, I would have been spared an ER visit.


VAERS ID: 1641079 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-01
Onset:2021-08-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / UNK RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Anosmia, Arthralgia, Back pain, Chills, Hyperhidrosis, Injection site pain, Malaise, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Strong initial reaction, which was not unexpected. Fever, chills, extreme sweating, painful arm/injection site lasting 4 days. Subsequent feeling ill, loss of smell, lower back pain, hip joint pain, leg pain.


VAERS ID: 1641152 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-08-17
Onset:2021-08-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Axillary pain, Blood test, Contusion, Facial paresis, Headache, Hypoaesthesia, Muscular weakness, Musculoskeletal chest pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan, Multivitamin
Current Illness: N/A
Preexisting Conditions: Hypertension (controlled by mediciation)
Allergies: Penicillin, Lisinopril
Diagnostic Lab Data: In office examination (8/15 and 8/17), blood work (8/15).
CDC Split Type:

Write-up: Rib cage pain, particularly in sides, sternum and front of armpits. Bruising on chest/front of armpit on right side. Numbness/Pins and Needles/Weakness that comes and goes in arms, thighs and face from nose down through neck. Headache.


VAERS ID: 1641207 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-21
Onset:2021-07-18
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bilevel positive airway pressure, COVID-19, Condition aggravated, Cough, Dyspnoea, Endotracheal intubation, Fatigue, Intensive care, Myasthenia gravis, Palpitations, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (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), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), 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: albuterol, cetirizine, ferrous sulfate, Flonase, CellCept...
Current Illness:
Preexisting Conditions: asthma, CAD, hyperlipidemia, hypertension, myasthenia gravis, former smoker
Allergies: NKA
Diagnostic Lab Data: SARS COV2 PCR positive 7/18/2021
CDC Split Type:

Write-up: 55 years old female, seen and examined on July 19, 2021 1:00 a.m., with history of asthma, CAD, hyperlipidemia, hypertension, myasthenia gravis. Here for evaluation of progressive short of breath, dry cough, generalized weakness for which she believes might having a MG flare up, started about 5 days ago, per patient she received Johnson & Johnson vaccine back in March. She also developed subjective fever, palpitations. 7/23/21: intubated due to increased fatigue while on BiPAP 7/30/21: transferred to Hospital ICU 8/15/21: remains intubated, not tolerating weaning of sedation, afebrile 8/22/21: awaiting Trach/PEG


VAERS ID: 1641214 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / N/A - / -

Administered by: Private       Purchased by: ?
Symptoms: Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: throat swelling


VAERS ID: 1641251 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-19
Onset:2021-08-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / N/A - / -

Administered by: Private       Purchased by: ?
Symptoms: Flushing, Pharyngeal paraesthesia
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (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:
Preexisting Conditions: unknown
Allergies: midazolam
Diagnostic Lab Data:
CDC Split Type:

Write-up: throat tingling, flushing


VAERS ID: 1641299 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-22
Onset:2021-08-02
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Oropharyngeal pain, SARS-CoV-2 test positive, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin, benzonatate, lisinopril, metformin, pantoprazole
Current Illness:
Preexisting Conditions: Type 2 diabetes, chronic kidney disease
Allergies: No known drug allergies
Diagnostic Lab Data: SARS CoV2 PCR COVID-19 detected on 8/2/21
CDC Split Type:

Write-up: 8/2/21: The is a 70 year old female that came to the emergency room on 8/2/2021 complaining of coughing and shortness of breath. She has had signs of an upper respiratory infection sore throat then followed by a non productive cough for the last week. Her oxygen level was 90% u[on arrival and 3 Liters of O2 was stated. 8/7/21: completed remdesivir, on baricitinib; on heated-high flow 90% 60L supplemental O2 8/16/21: She was discharged home with 4L oxygen and home healthcare. Note: patient previously vaccinated with J&J COVID-19 vaccine on 3/22/2021 Lot Number 1805029.


VAERS ID: 1641351 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Electric shock sensation, Hypersensitivity, Influenza like illness, Pain in extremity, Paraesthesia, Paraesthesia oral, Peripheral coldness, Skin discolouration, Swelling, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: MMR
Other Medications: Iron vitamin, baby aspirin, omega 3
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Aug 26 Vital Signs were stable
CDC Split Type:

Write-up: Allergic reaction that had a slow onset, began with tingling in lips, hands and toes. Felt like small electric shocks through arms and legs. By 7am next morning extremities where white and cold, face and neck were swollen and difficulty breathing. Benadryl 25mg was taken, and again at 1100 on Aug 25, symptoms were relieved and returned in evening. Benadryl continued. On Aug 26, went to Urgent care as symptoms not relieved by Benadryl. Received Decadron . Symptoms of flu like symptoms and arm pain were also noted. Continued use of Benadryl. Symptoms still present at time of report.


VAERS ID: 1641380 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-14
Onset:2021-08-23
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Afib, HTN, Thyroid disease.
Allergies: Amoxicillin
Diagnostic Lab Data: Covid test-positive.
CDC Split Type:

Write-up: Pt called to return to hospital for covid testing as her husband tested positive. Dry cough and nasal congestion.


VAERS ID: 1641441 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness, Pallor
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: multi vitamin
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported dizziness five min after getting shot. She turned white and lost conscience for a couple seconds. Response team was called and patient was taken to the ER


VAERS ID: 1641470 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-15
Onset:2021-08-24
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Exposure to SARS-CoV-2, Nasal congestion, 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:
Current Illness:
Preexisting Conditions: None.
Allergies: Contrast dye
Diagnostic Lab Data: Covid test-positive.
CDC Split Type:

Write-up: Pt came to ED to be covid tested b/c her grandson recently tested positive. C/O of some nasal congestion.


VAERS ID: 1641513 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-23
Onset:2021-08-01
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN EL3246 / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Condition aggravated, Dyspnoea, Hypercapnia, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prednisone, metoprolol, formoterol, buspirone, lovastatin
Current Illness:
Preexisting Conditions: COPD, CVA, afib, chronic respiratory failure
Allergies: no known allergies
Diagnostic Lab Data: SARS COV2 Covid 19 PCR 08/01/2021, result positive
CDC Split Type:

Write-up: Admitted on 8/1/21. Received J&J vaccine on 1/23/21. Patient presents with SOB that started that morning. Diagnosed with acute respiratory failure with hypoxia and hypercapnea and COVID pneumonia. Treated with COVID protocol, steroids, antibiotics and remdesivir. Patient improved and was transferred to a rehab facility on 8/9/21.


VAERS ID: 1641605 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Computerised tomogram, Condition aggravated, Eye pain, Migraine, Pain, Tinnitus, Vertigo, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: candesartan, levothyroxine, botox injections for migraine
Current Illness: no
Preexisting Conditions: asthma, chronic migraines
Allergies: sulfa
Diagnostic Lab Data: ct scan
CDC Split Type:

Write-up: woke up next morning with a migraine had it for 5 days went to the ER , ringing in ears, eyeballs having shooting pain and vision is all blurry, vertigo problems


VAERS ID: 1641633 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-19
Onset:2021-08-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral swelling, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient came in for a visit, 8 days post vaccine administration, with a chief complaint of a rash. No rash noted but right lower leg swelling noted. Out of abundance of caution, patient advised to go to emergency room to rule out DVT.


VAERS ID: 1641742 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-05-12
Onset:2021-08-21
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Pericarditis, Pleurisy
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: pleurisy/pericarditis


VAERS ID: 1642039 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray normal, Confusional state, Differential white blood cell count, Dizziness, Dyspnoea, Electrocardiogram normal, Fibrin D dimer normal, Full blood count normal, Headache, Metabolic function test normal, Pyrexia, Tremor, Troponin normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular 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: Multivitamin, krill oil, vitamin d, probiotic
Current Illness: Fever 2 weeks beforehand.
Preexisting Conditions: leukopenia,
Allergies:
Diagnostic Lab Data: Basic metabolic panel, CBC with Diff, D Dimer deep vein thromb level, TROPONIN 1 ECG 12 Lead, XR: Chest PA & Lateral All taken on 08/26/2021, all normal
CDC Split Type:

Write-up: Started experiencing shortness of breath, fever with severe/uncontrollable shaking in arms and legs, and confusion and dizziness around 6 hours after receiving the vaccine. Also experienced painful headache around 3 hours after receiving vaccine.


VAERS ID: 1642302 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fatigue
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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient became very faint and almost collapsed minutes after being vaccinated. Her partner caught her and we ran to her and asked her if she felt like her throat was closing and if she wanted an epipen injection, she said no. she said she felt very tired, we asked her if she wanted an ice pack, and she said yes, so we gave her a cold compress, we also gave her a graham cracker and room temperature water per her request and called the paramedics


VAERS ID: 1642480 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-03
Onset:2021-08-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Blindness, Burning sensation, Cough, Eye swelling, Fatigue, Formication, Hypersensitivity, Ophthalmological examination abnormal, Rash, Rash pruritic, Swelling face, Swollen tongue, Throat tightness, Urticaria, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Armour 120mg
Current Illness: None
Preexisting Conditions: Hashimoto''s Disease, Erosive Sacroiliitis, vitiligo.
Allergies: None
Diagnostic Lab Data: To many to list at this time. I do not have all the oficial reports of all of them in my hands yet. I can follow up with these.
CDC Split Type:

Write-up: Extreme fatigue, whole body rashes (urticaria from scal to feet), facial swelling, tongue swelling, eye swelling, tightness in throat, cough, Rashes itch, were painful and felt like fire, and something crawling on my skin that came and went in waves. I rceived IM decadron x2, IV benadryl x3, epinefrine x 2 , normal saline IV infusion during less than 48 hours on four visits to the Urgent care and Emergency Room and left with a few prescription. The results lasted fot 12 hours and would come back. I have myself a shot of epinefrine for the 3rd time.. I than was seein by my primary care that put on all the folowing medications to try to stop the allergy reaction I am having. I am now on Prednisone, Benadryl, Hydoxizine, Singulair, Pepcid, Cromolyn Sodium, Naltodrexone and cannot stop any that I feel the symptoms coming back. I also started having loss and blurry vison and it has gottend progressively worse. I saw my eye docuter the diagnosed acute changes in my vison and prescribed me eye drops and to follow up in a week to continue to monitor,.


VAERS ID: 1642681 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation
SMQs:, Peripheral neuropathy (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: Burning sensation to palm of both hands, duration about 12-14 hours. No treatment recommended by ER physician.


VAERS ID: 1642852 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-17
Onset:2021-08-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: HYPERTENSION
Allergies: NONE
Diagnostic Lab Data: EMERGENCY ROOM VISIT WITH APPROPRIATE TESTING AND TREATMENT.
CDC Split Type:

Write-up: PATIENT HAS NOW TESTED POSITIVE FOR COVID 4 DAYS AFTER RECEIVING HIS JOHNSON & JOHNSON VACCINE AND IS HAVING A DIFFICULT CLINICAL COURSE THAT IS DEVELOPING A SARS-LIKE ILLNESS.


VAERS ID: 1642958 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Blood test, Computerised tomogram, Computerised tomogram head, Facial paralysis, Gait disturbance, HIV test, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Magnetic resonance imaging spinal, Muscular weakness, Pain, Paraesthesia, SARS-CoV-2 test, Urinary retention, Urine analysis, Vertebral lesion, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use; Non-smoker
Preexisting Conditions: Comments: the patient had no infectious illnesses nor any recent vaccinations or hospitalizations 6 weeks prior to onset of the event. The patient did not suffer from common cold, flu, or infection with epsteinBarr, herpes simplex, herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea and lyme disease.
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Lumbar puncture; Result Unstructured Data: unknown; Test Date: 202106; Test Name: MRI; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: MRI; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: CT scan; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: Urinalysis; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: Blood test; Result Unstructured Data: unknown; Test Date: 20210625; Test Name: Brain CT; Result Unstructured Data: Bell''s Palsy and Guillain Barr? Syndrome; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Name: HIV test; Result Unstructured Data: negative; Test Name: Magnetic resonance imaging spinal; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210840901

Write-up: FACIAL PALSY; RIGHT EYE HAD BLURRY VISION; URINARY RETENTION; NUMBNESS IN FEET WHICH ADVANCED TO COLLAR BONE; TINGLING IN FEET WHICH ADVANCED TO COLLAR BONE; BILTERAL WEAKNESS/BILTERAL LEG WEAKNESS; WALK WITH SUPPORT; PAIN; TWO LESIONS ON THORACIC SPINE AND ON LUMBAR; STROKE SYMPTOMS; This spontaneous report was received from a patient of unspecified age, sex. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: alcohol use and the patient was non-smoker. The patient had no infectious illnesses nor any recent vaccinations or hospitalizations 6 weeks prior to onset of the event. The patient did not suffer from common cold, flu, or infection with epsteinBarr, herpes simplex, herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea and lyme disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose, vaccination site, and batch number not reported), 1 total, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the patient experienced numbness and tingling in feet and urinary retention. The bowel was normal. The symptoms were started abruptly. The patient had bilateral weakness. The same day patient was referred to the ER, where blood and urine samples were taken, and multiple magnetic resonance imaging (MRIs) and computerized tomography (CT) scans were done. The ER doctor came back and said it was multiple sclerosis (MS), and patient was admitted to the hospital. An infectious disease (ID) doctor and a neurologist were assigned. Within 24 hours numbness and tingling had advance from feet to collar bone. The ID doctor prescribed treatments with unspecified intravenous anti viral and anti bacterial medications. The neurologist ordered a lumbar puncture with dozens of tests of the cerebral spinal fluid and more MRIs. Within 48 hours after receiving the anti viral patient was able to walk with support for short distances. Another 36 hours later patient could walk unassisted. After 9 days in the hospital, patient was feeling better and was released on 25-JUN-2021 and within an hour of being released, patient started having stroke symptoms and was rushed back to the ER. Brain CT scan was done, and it was determined that it was not a stroke but it was belle''s palsy and guillain barr? syndrome. Symptoms and parts of the body affected were bilateral leg weakness and facial palsy. Patient was then released again for outpatient treatment. Patient immediately saw a neurologist who reviewed medical records, gave a shot of unspecified steroids, ordered more MRIs of spine, and gave an initial diagnosis of multiple sclerosis. Once he reviewed the MRIs with and without contrast he detected two lesions on thoracic spine along with lesions on lumbar spine. He then gave a diagnosis of thoracic myopathy and prescribed a five day infusion of Solu-Medrol (methylprednisolone sodium succinate). The treatment did not work, and patient was referred to the University for more research and another diagnosis. After more than two months, the patient still had no relief from pain and symptoms. The patient had difficulty in chewing and right eye had blurred vision. The patient tested negative for HIV and covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in feet which advanced to collar bone, urinary retention, stroke symptoms, two lesions on thoracic spine and on lumbar, bilteral weakness/bilteral leg weakness, facial palsy, right eye had blurry vision, walk with support, pain, and tingling in feet which advanced to collar bone. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0- 20210840901- covid-19 vaccine ad26.cov2.s - Urinary retention , Facial palsy, Right eye blurry vision, Walk with support, Pain, two lesions on thoracic spine along with lesions on lumbar spine 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). 20210840901- covid-19 vaccine ad26.cov2.s - Bilateral weakness/Bilateral leg weakness, Numbness had advance from feet to collar bone, Tingling had advance from feet to collar bone-. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1642959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dysarthria, Fatigue, Feeling hot, Neck pain, Pain in extremity
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE
Current Illness: Non-smoker
Preexisting Conditions: Comments: The patient is healthy. The patient work and exercise.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210841218

Write-up: MESSED UP / SLURRED SPEECH; HAND PAIN LIKE HITTING A NERVE; FELT TIRED; STROKE; FEELING REALLY HOT; NECK PAIN FOR 4 HOURS; This spontaneous report received from a patient concerned a 60 year old female of unspecified race and origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: Non-smoker, and other pre-existing medical conditions included: The patient was healthy. The patient work and exercise. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total administered, start therapy date were not reported (3 to 4 months ago) for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included covid-19 vaccine for prophylactic vaccination which the patient mentioned taking after JANSSEN Vaccine. On JUN-2021, the patient experienced stroke, feeling really hot, neck pain for 4 hours, hand pain like hitting a nerve and felt tired. The patient took medical attention for it but only they treated her hand pain and referred her to a hospital which she refused to do. On AUG-2021, the patient experienced messed up / slurred speech. The patient refused and said ,she did not want to go to a doctor or hospital because she might get more sick (she mentioned Covid in her area was bad). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really hot, neck pain for 4 hours, and felt tired, and the outcome of messed up / slurred speech, hand pain like hitting a nerve and stroke was not reported This report was serious (Other Medically Important Condition).; Sender''s Comments: V0.20210841218-covid-19 vaccine ad26.cov2.s -Stroke. 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: 1642960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Fall, Fatigue, Head injury, Hypersensitivity, Loss of consciousness, Malaise, Pneumonia, Sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (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), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: JAKAFI
Current Illness: Urinary tract infection (was hospitalized for about 6 days).
Preexisting Conditions: Medical History/Concurrent Conditions: Delirious; Impaired driving ability; Pneumonia viral (Patient had emergency room visit and hospital admission from 24-MAR-2020 to 28-MAR-2020. During hospital stay Jakafi therapy was on hold); Short-term memory loss; Sickness.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210841850

Write-up: PNEUMONIA; SEPTIC; DON''T FEEL GOOD; ALLERGIES; FATIGUE; PASSED OUT; FELL; HIT HER HEAD; WASN''T GIVEN FLUIDS AFTER THEY TOOK BLOOD; This spontaneous report received from a patient concerned a 73 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: respiratory syncytial virus/pneumonia, delirious, short term memory loss, can no longer drive, and very severe sick period, and concurrent conditions included: urinary tract infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number: 8053457 expiry: 31-DEC-2021, batch number: 8782351 expiry: 31-DEC-2021, batch number: 8434861 expiry: 28-FEB-2020, batch number: 1135785 expiry: 28-FEB-2023, batch number: 1135785 expiry: 28-FEB-2023, batch number: 1135784 expiry: 28-FEB-2023) 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 09-FEB-2018, and 20 mg, 2 times every 1 day, from 10-FEB-2018 for polycythemia vera. No concomitant medications were reported. On an unspecified date, the patient, experienced allergies and pneumonia. The patient also missed doses (unspecified). It was reported that the patient had urinary tract infection (UTI) back in the winter that made her septic. The patient did not know what was going on. The patient did not feel good. On an unknown date in APR-2021, the patient passed out, fell, and hit her head because she was not given fluids after they took blood. The emergency medical services (EMS) transported patient to the emergency room (ER) where she was given fluids and was discharged home. On 13-AUG-2021, the patient mentioned she was now given 1000mL of saline when getting blood drawn. On an unspecified date, the patient experienced fatigue since coronavirus disease (COVID) shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ruxolitinib phosphate was withdrawn. The outcome of the passed out, fell, hit her head, wasn''t given fluids after they took blood, pneumonia, septic, fatigue, don''t feel good and allergies were not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210841850 - covid-19 vaccine ad26.cov2.s -Pneumonia , Septic. 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 20210841850 - covid-19 vaccine ad26.cov2.s -Passed out , Fell ,Hit her head, Wasn''t given fluids after they took blood. 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: 1642967 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 093A2112 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza like illness, Malaise, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Diagnostic ultrasound; Result Unstructured Data: blood clot
CDC Split Type: USJNJFOC20210851502

Write-up: NOT FEELING WELL; HEADACHE; BLOOD CLOT IN LEFT THIGH; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 77 year old male. The patient''s weight was 170 pounds, and height was 71 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 093A2112, and expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced flu-like symptoms, chills, the night of the vaccination for about 3 days. The patient was not feeling well after the vaccination. On 04-AUG-2021, the patient noticed a lump on his left thigh. On 05-AUG-2021, patient experienced headache which still present. On 17-AUG-2021, the patient went to the emergency room, did an ultrasound, waited there for 6 hours and was told that he had a blood clot in left thigh. He was seen by his primary health care professional on reporting date and instructed to report his symptoms. The patient was started on Eliquis (apixaban) for 3 months till further assessed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 09-APR-2021, and had not recovered from blood clot in left thigh, headache, and not feeling well. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210851502-COVID-19 VACCINE AD26.COV2.S-Blood clot in left thigh. 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: 1642983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Utah  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hypotension, Nausea, Overdose, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: USJNJFOC20210853057

Write-up: RECEIVED FULL VIAL OF VACCINE (5 TIMES OF THE NORMAL DOSE); HYPOTENSION; CHILLS; VOMITING; FEVER; NAUSEA; This spontaneous report received from a physician concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were 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 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient experienced received full vial of vaccine (5 times of the normal dose). On 25-AUG-2021, the patient experienced hypotension. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced vomiting. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypotension, fever, chills, nausea, and vomiting, and the outcome of received full vial of vaccine (5 times of the normal dose) was not reported. This report was non-serious.


VAERS ID: 1643003 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Blepharospasm, Herpes zoster, Neuralgia, Pain in extremity
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Tendinopathies and ligament disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210855183

Write-up: CLOTHES AND BODY NERVE PAIN; RIGHT EYELID TREMBLING FOR 3 WEEKS; INTENSE PAIN IN LOWER BACK; DIAGNOSED WITH HERPES ZOSTER; INTENSE PAIN IN WAIST; LEG PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, intense pain in waist, and leg pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from leg pain, clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, and intense pain in waist. This report was non-serious.


VAERS ID: 1645954 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-03-03
Onset:2021-03-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diplopia, Hypertension, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Ocular motility disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Double vision,high blood pressure,bad rash


VAERS ID: 1651267 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose normal, Electrocardiogram, Hypoaesthesia oral, Swollen tongue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: DARVON
Diagnostic Lab Data: EKG - SINUS RYTHMN BLOOD GLUCOSE - LOW NORMAL
CDC Split Type:

Write-up: 9:00 AM - TOUNGE STARTED FEELING NUMB 10:00 AM - TOUNGE CONTINUED TO FEEL NUMB AND A SWELLING FEELING STARTED 11:00 AM - TOUNGE CONTINUED TO FEEL NUMB AND STARTED FEELING SIGNIFICANTLY LARGER 11:30 - FAINTING OCCURED WHILE PATIENT WAS LAYING FLAT ON FLOOR NOON - TRANSPORTED TO HOSPITAL 1PM - EKG, BLOOD GLUCOSE PERFORMED - PATIENT RECIEVED BENEDRYL AND ORAL HYDRATION 1:30 PM - PATIENT FELT SWELLING WAS SUBSIDING BUT NUMBNESS STILL OCCURING 2PM - PATIENT STATED SWELLING AND NUMBNESS WAS GONE REMAINED IN OBSERVATION 5PM - DISCHARGED FROM ER


VAERS ID: 1651270 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-05-14
Onset:2021-05-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 2 UN / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial thrombosis, Ultrasound scan abnormal, Venous thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Poor nutrition
Allergies: NKDA
Diagnostic Lab Data: Ultrasound confirmation. Surgical intervention needed.
CDC Split Type:

Write-up: Arterial and Venous blood clots7.29.2021


VAERS ID: 1651353 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-31
Onset:2021-08-28
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN RS-AD26 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Demyelination, Facial paralysis, Hypoaesthesia, Myelitis transverse, Neurological symptom, Specialist consultation
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Hearing impairment (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Prostate cancer S/P prostatectomy, Hypertension, Hyperlipidemia, GERD, Osteoarthritis,
Allergies: NKDA
Diagnostic Lab Data: MRI ordered 8/25/21, Consult to neurology includes impression of transverse myelitis with etiology yet to be determined.
CDC Split Type:

Write-up: Patient now admitted to Hospital. At direction of the Provider currently taking care of patient I am entering this report. Per providers note and conversation - patient is experiencing facial droop, numbness and migrating neurologic symptoms severe enough to present to emergency room and then be admitted to Hospital floor for further monitor and testing. Demyelinating disease with possible transverse myelitis is suspected.


VAERS ID: 1651359 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-08-28
Onset:2021-08-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Condition aggravated, Malaise, Nervousness, Palpitations, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), 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: Anti-Anxiety meds, no other information
Current Illness: Hx of Anxiety
Preexisting Conditions: Unknown
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient became anxious after receiving the dose. He stated he has a hx of anxiety and takes medication. He said he had taken his medication this am but had not eaten. He then complained of racing heart, arm tingling, heart palpitations. and became shaky. BP 180/90 and HR= 90. Patient was given water and a protein bar. He still complained of not feeling well and at that time EMS was alerted. They arrived within 15min. and took over this patient.


VAERS ID: 1651361 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-03-11
Onset:2021-08-01
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cerebrovascular accident, Lymphadenopathy, Magnetic resonance imaging, Positron emission tomogram
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Finastride
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI 08/01/21 PET Scan
CDC Split Type:

Write-up: 2 strokes Enlarged lymph nodes


VAERS ID: 1651369 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fibrin D dimer, Full blood count, Headache, Metabolic function test, Muscle tightness, Pain
SMQs:, Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Gabapentin Cyclobenzaprine Elatriptan Daily vitamin Magnesium glyphosate Complex b vitamin Fish oil Bone maximizer Probiotics
Current Illness:
Preexisting Conditions: Migraines Chronic pain
Allergies: Latex Lactose Eggs
Diagnostic Lab Data: 8/27/21 - blood drawn for metabolic panel, CBC, d dimmer, vital signs
CDC Split Type:

Write-up: At midnight It felt like my brain was going to explode like a had a brick being dropped on my head MUCH different than my typical migraines. I had so much muscle and nerve tension in my jaw and neck radiating down into my spine and body aches everywhere! Called my family dr and they recommended me going to the ER. At the ER one liter of IV fluid , IV Benadryl, IV toradol, IV raglan , Tylenol , ibuprofen ,


VAERS ID: 1651371 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-04-09
Onset:2021-08-18
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19 pneumonia, X-ray
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: xrays
CDC Split Type:

Write-up: Patient admitted with Covid Pneumonia lots of oxygen steroids etc Not much info from the facility


VAERS ID: 1651395 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bladder dysfunction, Chills, Dizziness, Dysstasia, Functional gastrointestinal disorder, Limb discomfort, Speech disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Vestibular disorders (broad)

Life Threatening? Yes
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: vit c , fish oil tablet,
Current Illness: no
Preexisting Conditions: no
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1. COULD NOT STAND UP 8 HRS LATER 2. 4/29/21 COULD NOT TALK RIGHT, LEFT ARM ERATIC, CHILLS, BOWEL & BLADDER ISSUES , WENT TO ER 3. 5/22/21 LIGHT HEADED ,DIZZY ,CHILLS BOWEL & BLADDER WENT TO ER 4 . 5/22 /21 TO 8/17/21 ON AND OFF LIGHT HEADED AND DIZZY BOWEL & BLADDER ISSEUES EARLY NOT BAD NO MORE JUST LIGHT EFFECTS NOW AND THEN


VAERS ID: 1651426 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Aphonia, Cardiac monitoring, Cough, Dysphagia, Enlarged uvula, Hypoaesthesia oral, Inflammation, Injection site reaction, Oropharyngeal pain, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Throat irritation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), 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: Similar with Flu shots and extreme reactions to infant/childhood vaccines
Other Medications: Synthroid, singulair, thyroid support supplement with iodine, quercitin supplement, elderberry supplement with vit d, vit c and zinc.
Current Illness: None
Preexisting Conditions: Reactive airway, no recent issues
Allergies: Gluten sensitive, only known medication allergy is Dilaudid; I get fevers and rashes with long standing muscle pain after flu shots
Diagnostic Lab Data: No tests were done beyond exam, pulse ox and heart monitor.
CDC Split Type:

Write-up: Within a few minutes began having tingling in my lips and throat. Over approx 20 minutes progressed to feeling of increased throat irritation and pronounced numb/tingly sensation in lips, dry cough. Within 30 minutes the cough and throat irritation was significant. Uvula was swollen. They told me to the ER. ER started IV and gave me 125mg methyl prednisone, 25 IV benedryl and IV Pepsid. Cough and mild difficulty with swallow continued approx 30 minutes more and then began to dissipate. Uvula inflammation receded, pulse ox was good, no heart rate issues, no fever. My voice was nearly gone until 24hrs. It is improving but my throat is still sore. No issues at this time with swallowing and voice is at about 3/4 strength. Pins-n-needles type sensation at the injection site.


VAERS ID: 1651500 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-28
Onset:2021-08-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fall, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (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: None per patient''s report
Current Illness: none per patient''s report
Preexisting Conditions: TB diagnosed 2012 but was treated per patient''s report
Allergies: None per patient''s report
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received Janssen Covid-19 vaccine at 1435 and approximately 1436 patient fell onto floor and began having seizure-like activity. 911 called and EMS assumed care of patient


VAERS ID: 1651521 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal rigidity, Arthralgia, Back pain, Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills, Computerised tomogram thorax normal, Cough, Dizziness, Dysphonia, Dyspnoea, Ear pain, Electric shock sensation, Electrocardiogram normal, Eye pain, Fatigue, Feeling abnormal, Feeling cold, Headache, Initial insomnia, Injection site pain, Myalgia, Pain in extremity, Painful respiration, Pyrexia, SARS-CoV-2 test negative, Sinus arrhythmia, Tension headache, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Disorders of sinus node function (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zinc
Current Illness:
Preexisting Conditions: Autoimmune disease-colitis Autoimmune disease-unconfirmed pots Non epileptic seizures
Allergies: Flexeril, flagyll, keflex, cyclozeprenine, latex, gluten, all nuts
Diagnostic Lab Data: 08/27/2021-08/28/2021 Bloodwork done EKG three different times CAT scan of my chest to check for pulmonary embolism l- came back negative Covid test-came back negative Chest x ray- came back negative
CDC Split Type:

Write-up: After received Johnson and Johnson vaccine at 12:30, I felt dizzy and a little spacey. Arm was only sore for a couple minutes. Some soreness in my shoulder muscle too. Felt a little tired. 3:36 pm- chills, shaking, teeth chattering, 4:30 pm-felt tired and laid down but didn?t fall asleep. Sudden electric shock like spasm in abdomen. 5:09 pm-throat feels a bit hoarse 5:56 pm-Running a 99.1 fever 6:48 pm-Chest pain 7:10 pm-left leg pain 10:59 pm-headache and 99.2 fever 11:45-worsening headache, pain behind my eyes, muscle aches, chills, took quercentin and a zinc lozenges 12:11 am-chills worsening, muscle aches, super cold, sore left arm where shot was given, just took 500 mg of Tylenol 1:25 am-100.6 fever, squeezing headache, chest pain like someone is sitting on my chest 1:52 am-101.1 fever, pulse 126 when standing up, heaviness on my chest is not dissipating 2:01 am-102 2:35 am-normal ekg at house but sinus Arythmia 3:30 am-arrived at ER 3:42 am- just got triaged, saw two nurses , got blood work taken, and an ekg done. Chest feels great. Only feel heaviness when I breathe in deeply and then I have to cough. Cough is dry. 5:21 am-99.1 fever came back, chills, muscle aches, chest pain, tightness in chest 7:12 am-102.5 fever now, pressure squeezing headache, chest pain, lower back pain, shortness of breathe, ear pain in both ears 9:30-given a bag of fluids via iv, toradol pain reliever and zofran. All tests came back normal! So yay!


VAERS ID: 1651531 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20BA21A / UNK RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion, Epistaxis, Full blood count abnormal, Headache, Muscle spasms, Myositis, Pain in extremity, Petechiae, Platelet count decreased, Thrombocytopenia, Ultrasound Doppler abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: lisinopril as needed: Metamucil
Current Illness: appendectomy on 6/24
Preexisting Conditions: hypertension cervical spondylosis degenerative cervical spinal stenosis
Allergies: n/a
Diagnostic Lab Data: July 24th ER visits, ultrasound to check for DVT CBC showed low platelets diagnosed with myositis August 18th PCP followup CBC drawn to recheck low platelets diagnosed with thrombocytopenia
CDC Split Type:

Write-up: night of vaccination - headache, nosebleed two days post vaccination - muscle cramping in right leg, "Charlie horse" feeling. & left foot pain constant nosebleeds ever since & leg muscle cramping one month post vaccination - bruising on arms, legs, stomach august 18th primary care drs visit - dr noticed petechiae on head


VAERS ID: 1651617 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-18
Onset:2021-08-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (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: amlodipine, aspirin, atorvastatin, meloxicam
Current Illness: none
Preexisting Conditions: hypertension, hypercholesterolemia
Allergies: no known allergies
Diagnostic Lab Data: CT angiography
CDC Split Type:

Write-up: large bilateral pulmonary thromboemboli


VAERS ID: 1651620 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Burning sensation, Chest X-ray normal, Dizziness, Electrocardiogram normal, Erythema, Fatigue, Feeling abnormal, Fibrin D dimer normal, Headache, Heart rate increased, Laboratory test normal, Pain, Pain in extremity, Palpitations, Paraesthesia, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (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: I was not taking anything at the time.
Current Illness: None
Preexisting Conditions: None
Allergies: Allergy to coconut, sesame, and lactose intolerant
Diagnostic Lab Data: We did a D-dimer, EKG, X-ray of my lungs, and motor function tests, and normal blood work. Everything came back normal on tests, but currently my feet are swollen and red with no answers to the pain throughout my body. I had these tests done on Thursday, August 26, 2021.
CDC Split Type:

Write-up: My symptoms started the second day after the shot. I started getting tingly in my hands and then my toes, which then the next day I had horrible pain in my legs. Every single day it would get worse, and also added fatigue, brain fog, and lightheadedness. We are now at day 8 and I am still having horrible pain in my legs, head pain, lightheadedness, brain fog, rapid heart beat etc. I went to the hospital on day 6 because I woke up with a racing heart, and feeling like I was going to pass out. They ran tests for blood clots and did not find any. However, we are still going now on day 8 with horrid side effects. My legs constantly feel like they are inflamed and on fire.


VAERS ID: 1651624 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-26
Onset:2021-08-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Haematochezia, Headache, Neck pain, Pyrexia, Renal pain, Urinary sediment present
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft 25 MG Montelukast 10 MG Slynd 4 MG
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: CAT scan 8/28/21 Bloodwork 8/28/21
CDC Split Type:

Write-up: Kidney pain Fever Diarrhea Blood in stool Sediment in urine Borderline enlarged spleen Headaches Neck pain


VAERS ID: 1653740 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-28
Onset:2021-08-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Confusional state, Hyperhidrosis, Posture abnormal, Seizure like phenomena, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: About 1-2 minutes after IM injection, pt was seated in the chair and I was getting his paperwork together. Pt stopped talking, his head slumped back and he began having seizure like activity. Pt was completely unresponsive for about 1 minute. When patient came to, he was confused about where he was and what had happened. 911 was activated. Patient remained slightly confused, bradycardic, and diaphoretic while waiting on and once EMS had arrived. They started on IV and took him to the ER


VAERS ID: 1653885 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Anxiety, Blood pressure fluctuation, Blood thyroid stimulating hormone decreased, Condition aggravated, Diarrhoea, Electric shock sensation, Feeling jittery, Feeling of body temperature change, Flushing, Heart rate abnormal, Impaired work ability, Nausea, Palpitations, Paraesthesia, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine, singular, allegra, buspar, atenolol, magnesium, Vitamin D, vitamin B12,
Current Illness: none.
Preexisting Conditions: asthma Hypothyroidism (total thyroidectomy in 2010 multiple environmental allergies
Allergies: levaquin Tequin Epinephrine
Diagnostic Lab Data: TSH July 9 was 2.6 TSH Aug 10 was 1.5 TSH Aug 14 was 2.3
CDC Split Type:

Write-up: About an hour after I got it I felt an odd shock all over my body, then a cold and hot flushing sensation all over. I was jittery the rest of the day. Five days later I had more of the cold shot flushes and realized they were adrenaline surges, accompanied by severe anxiety. It has progressively worsened and I am having loose stools, a 10 lb weight loss, and have been increasingly unable to work (I am a Public Health RN). I am having symptoms of POTS syndrome. I wish I had never taken the vaccine. This is absolutely horrible. My heart pounds when I get up and move about. My BP and heart rate are fluctuating wildly. I am nauseated. Having flushing. Went to the ER because my arms and legs were tingling so badly and the adrenaline surges.


VAERS ID: 1653908 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-12
Onset:2021-08-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: CSF protein increased, CSF white blood cell count increased, Dissociation, Facial paresis, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Immune-mediated/autoimmune 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin D3, Flaxseed, Zinc, ketorolac
Current Illness: None
Preexisting Conditions: None
Allergies: Shellfish allergy
Diagnostic Lab Data: Lumbar puncture performed 8/28 showed albuminocytologic dissociation with a protein count of 217 and a white count of 18. Starting on IVIG therapy on 8/28.
CDC Split Type:

Write-up: Ascending paresthesias and paralysis; started one week after vaccination in back and legs and by the time of presentation had ascending up to abdomen and bilateral arms, now with facial weakness.


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