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From the 11/12/2021 release of VAERS data:

Found 203 cases where Location is U.S., Territories, or Unknown and Vaccine is COVID19 and Manufacturer is JANSSEN and Symptom is Guillain-Barre syndrome

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Case Details

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VAERS ID: 1493368 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Oedema peripheral, Pain in extremity, Posture abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Dystonia (broad), Guillain-Barre syndrome (narrow), Haemodynamic oedema, effusions and fluid overload (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (red wine sometimes); Guillain Barre syndrome (No known allergies); Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210739096

Write-up: WORSENED GUILLAIN BARRE SYNDROME; PAIN IN FOREARMS; SWOLLEN LEGS AND FEET; FALLING AND IMBALANCE; This spontaneous report was received from a patient and concerned an 87 year old male. The patient''s height and weight were not reported. The patient''s concurrent conditions included Guillain Barre syndrome, alcohol intake red wine sometimes, non smoker, and no known allergies. Patient had no 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: 1805020) dose was not reported, administered on 16-MAR-2021 to his right arm for prophylactic vaccination. There were no concomitant medications. On an unspecified date, the patient experienced worsened Guillain Barre syndrome. In APR-2021, the patient was falling and had imbalance. In MAY-2021, the patient experienced swollen legs and feet. In JUN-2021, the patient experienced pain in forearms. Patient uses a walker to walk inside his home: " I have to walk beside the wall, otherwise I will fall on the floor and I have difficulty to getup" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen legs and feet, pain in forearms, worsened guillain barre syndrome, and falling and imbalance. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report received from a consumer concerns an 87-year-old male, with concurrent Guillain Barre syndrome (GBS) who was reported to have "worsened" GBS after an unspecified duration of receiving the Janssen Covid-19 vaccine. The worsening was described as falling and had imbalance; swelling of hands and feet; pain in forearms. No treatment reported; the events have not resolved. The information available precludes a complete and meaningful assessment. Based on the information available, and the clinical picture of concurrent GBS could represent the normal progression of the illness. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.


VAERS ID: 1493369 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Missouri  
Vaccinated:0000-00-00
Onset:2021-05-30
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Guillain-Barre syndrome, Insomnia, Parosmia, Taste disorder
SMQs:, Peripheral neuropathy (narrow), Taste and smell disorders (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hearing impairment (broad), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Smoker (6-8 cigarettes per day)
Preexisting Conditions: Comments: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210740794

Write-up: GUILLAIN BARRE SYNDROME; UNABLE TO SLEEP; BELL''S PALSY; ALTERED TASTE; ALTERED SMELL; This spontaneous report was received from a patient and concerned a 59 year old male. The patient''s weight was 152 pounds, and height was 76 inches. The patient''s concurrent conditions included high blood pressure controlled with unspecified medication, smoker 6-8 cigarettes per day, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAY-2021 to his left arm for prophylactic vaccination. Batch number was not reported. Company will perform follow up to obtain batch number. Concomitant medications included unspecified medication for blood pressure. On 30-MAY-2021, the patient experienced Guillain Barre syndrome requiring hospitalization. He also experienced altered taste and altered smell. His symptoms started off as minor leg pain as cramps, then spread to abdomen, lower back, upper back, chest, arms and feet. He also had tingling in fingers and toes and numbness in hands and feet. The patient was seen by a doctor 2 weeks after receiving vaccine because was was experiencing Bell''s Palsy. The doctor prescribed ibuprofen to help alleviate the pain, but it did not help much. The doctor continued to give him pain killers. He was unable to sleep and went days without sleep. He recently was prescribed Percocet which also did not help much either. The patient was hospitalized on an unspecified date in JUN-2021 and discharged on an unspecified date in JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre syndrome, altered taste, altered smell, unable to sleep and Bell''s Palsy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report received from a consumer concerns a 59-year-old white male patient who was hospitalized with Guillain Barre syndrome (GBS) 7 days after receiving the Janssen Covid-19 vaccine. The patient have concurrent high blood pressure and is a smoker (6-8 sticks/day). Symptoms reported were altered taste and smell, leg pain and cramps that spreads to abdomen/lower back/upper back/chest/arms/feet, tingling in fingers and toes, and numbness in hands and feet. No treatment was reported. Approximately 2 weeks after vaccination, the patient was found to have Bell''s palsy, and was prescribed with ibuprofen and Percocet. The outcome of the events was not reported. No other pertinent details reported. The information available precludes a complete and meaningful assessment. Based on the information available, the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.


VAERS ID: 1497157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-03-23
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Guillain-Barre syndrome, Headache, Myalgia, Nausea, Urinary tract infection, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Pollen allergy; Tobacco user (3-4 cigarettes per day and vaping); Type II diabetes mellitus
Preexisting Conditions: Comments: Does the patient have any allergies? :: Yes Provide details of the allergies :: pollen allergy. Was there drug abuse or illicit drug usage? :: No Does the patient consume alcohol? :: No Does the patient smoke? :: Yes Provide details of cigarettes(indicate consumption per day, week, month) :: 3-4 cigarettes per day.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210730927

Write-up: UTI; GUILLAIN BARRE SYNDROME; COUGH; MUSCLE PAIN; VOMITING; DIARRHEA; TIREDNESS; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned herself a 40 year old female. Initial information was processed with additional information received on 21-JUL-2021 via a telephone outreach with the patient. The patient''s height, and weight were not reported. The patient''s concurrent conditions included asthma, diabetes (Type II), pollen allergy, tobacco use (3-4 cigarettes daily and vaping), no drug abuse or illicit drug use, no alcohol use. She reports a semi-active lifestyle; with no recent infectious illnesses or traveling. The patient was not recently vaccinated or hospitalized 6 weeks prior to onset of the event. She also did not have any of the following prior the the events: common cold, flu, or infection with Epstein-Barr, Herpes simplex, Herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea, Lyme disease. Her HIV status was negative. The patient''s family history included maternal grandmother with ovarian and breast cancer; no known neurological or autoimmune family history. The patient''s last menstruation was 03-JUN-2021; and did not have her period last month. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, administered on 22-MAR-2021 in her right arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, 1 day after receiving the vaccine, the patient experienced diarrhea, tiredness, nausea, vomiting and headache (also reported as a week after the vaccination). She stated all symptoms worsened at night more than during the day. On 29-MAR-2021, the patient experienced cough and muscle pain. She stated muscle pain relief with a muscle relaxant. On 13-JUL-2021, the patient reported being diagnosed with Guillain-Barre Syndrome, and was not hospitalized. Both her arms and legs had pain, weakness bilateral; she was falling and dropping things from her hands due to the weakness. She reported the symptoms as starting gradually, spreading and becoming worse. The patient also had problems with her left eye blurry, shortness of breath, left jaw weak when chewing, trouble swallowing both liquids and solids. On an unspecified date, the patient also experienced urinary tract infection (UTI) and frequent urination. Laboratory data (dates unspecified) included: COVID-19 as negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome, cough, diarrhea, tiredness, nausea, headache, muscle pain and vomiting. The outcome of UTI was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report received from a consumer concerned herself, a 40-year-old female, who experienced Guillain Barre syndrome (GBS), with symptoms starting approximately 3 days after vaccine. Concurrent conditions included asthma, diabetes, tobacco use. She reports no recent infections or travel. The patient was not recently vaccinated with other products. She also did not have any of the following prior the events: common cold, flu, or infection with Epstein-Barr, Herpes simplex, Herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea, Lyme disease. Her HIV status was negative. There was no known neurological or autoimmune family history. No concomitant medications were reported. On day 1, the patient experienced diarrhea, tiredness, nausea, vomiting and headache (also reported as a week after the vaccination). She stated all symptoms worsened at night more than during the day. On day 7, the patient experienced cough and muscle pain. On day 113, the patient reported being diagnosed with Guillain-Barre Syndrome (date of diagnosis not specified) and was not hospitalized. Both her arms and legs had pain, weakness bilateral; she was falling and dropping things from her hands due to the weakness. She reported the symptoms as starting gradually, spreading and becoming worse. The patient also had problems with her left eye blurry, shortness of breath, left jaw weakness when chewing, trouble swallowing both liquids and solids. On an unspecified date, the patient also experienced urinary tract infection (UTI) and frequent urination. COVID-19 testing was negative (date unknown). The occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.


VAERS ID: 1497176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-03-11
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Electromyogram, Fall, Guillain-Barre syndrome, Insomnia, Lumbar puncture, Magnetic resonance imaging, Pain in extremity, Paralysis, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (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, 35 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness: Blood pressure; Cataract (Early stages in left eye); Non-smoker
Preexisting Conditions: Comments: No known drug allergies Generally healthy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: EMG; Result Unstructured Data: Weakness in left and upper extremity; Test Date: 2021; Test Name: Lumbar puncture; Result Unstructured Data: Not provided; Test Date: 2021; Test Name: MRI; Result Unstructured Data: not provided; Test Name: COVID-19; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210743068

Write-up: PARALYSIS; GUILLAIN BARRE SYNDROME; DIFFICULTY SLEEPING; FELL DOWN; FEVER; SORE ARM; This spontaneous report was received from a patient and concerned a 62 year old female. Initial information was processed with additional information received from the patient via an outreach telephone call on 21-Jul-2021. The patient''s height and weight were not reported. The patient''s concurrent conditions included blood pressure (not specified if high or low), early stages of cataract formation in left eye, no known drug allergies, non-smoker, did not exercise and was generally healthy. She had no infectious illness prior to the vaccination, nor any recent vaccinations or hospitalizations 6 weeks prior to the onset of events. The patient did not have any of the following: common cold, flu, or infection with Epstein-Barr, Herpes simplex, Herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea, or Lyme disease. Her HIV status was negative. There was no history in the patient or her family for any malignancies, neurologic or autoimmune diseases. There was also no recent travel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin. not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 to her left arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure. On an unspecified date the patient had the results of a COVID-19 test as negative. On 11-MAR-2021, several hours post vaccination, the patient experienced a little fever and sore arm and took 2 TYLENOL (paracetamol). One week later, (also reported as approximately 22-MAR-2021) the patient started having soreness in the lower left lower arm, felt some weakness and throbbing, "weird sensation", like a circulation issues in her lower left arm. It was not disabling but it kept coming and going for several weeks then it stopped. About 3 weeks post vaccination, she had new onset of symptoms which continued for another few weeks. She had bad fatigue that continued and got worse over time and never stopped. She had difficulty sleeping for more than a hour or two at a time. She started to feel a "weird sensation" in the calf of the right leg then at one point a week or two after, it moved to the back of her thigh (pain and weakness). The patient thought it might be "clotting" but if felt more like a circulatory problem (similar to the feeling she had in the arm) but when she took 2 paracetamol the pain would go away so she didn''t think much of it as she was busy. On 09-MAY-2021, she felt great, had a lot of energy and spend the day with her family. On 10-MAY-2021 (around 1 pm), she suddenly lost the ability to stand up, her legs gave away then later that afternoon, her legs gave away again and she fell down. The patient reported her symptoms started abruptly. On 11-MAY-2021, she called the ambulance and she was admitted to the hospital neurology floor. An electromyogram was performed (date unspecified) with results of subacute progressive weakness in left extremity and now affecting upper extremity. Motor weakness more prominent than sensory. The patient also reported having a magnetic resonance imaging (MRI) and lumbar puncture (dates and results not provided). Her symptoms kept getting worse but did not spread and she reported she had no strength in her legs and deep tendon reflexes (DTR) showed no response. The patient stated she ended up being paralyzed from her mid body down with her upper body being weak and tingling in both hands and finger. The weakness was bilateral. Her feet and ankles were swollen. At one point she was about to lose her ability to talk (she had problems talking). Left eye was blurry (history of early stages of cataract formation); no problems with breathing, chewing and swallowing. She was diagnosed with acute Guillain-Barre Syndrome on an unspecified date. She stayed in the hospital for 5 weeks and received intravenous antibody treatment which didn''t work for her, then received plasma treatment for consecutive 5 days. Few days after receiving the plasma treatment, she was still weak but felt some improvement, so she was transferred to the rehabilitation. At the rehabilitation facility, patient started to stand using a walker and started to walk little by little. She gained her strength to walk. On 10-JUN-2021, the patient was discharged home. At the time of report, she was much better and no longer paralyzed; still saw her doctors and went for outpatient treatment. She still has concerns with balance and always careful when walking. Her right ankle "feels weird" but she regained most of her upper body strength. Parts of her lower body was still a little weak, she was still using a walker outside of her house and made sure that her husband was with her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fever on 12-MAR-2021, was recovering from Guillain-Barre Syndrome, and paralysis, and the outcome of difficulty sleeping and fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report was received from a patient concerned a 62-year-old female who experienced Guillain Barre syndrome (GBS) 60 days after vaccine. Concurrent conditions included hypertension. She had no recent infections/vaccinations/hospitalization. Concomitant medications included amlodipine for blood pressure. On an unspecified date the patient had a negative COVID-19 test. On day 59, she felt great. On day 60, she suddenly lost the ability to stand up. She was admitted to the hospital neurology floor. An electromyogram was performed with results of subacute progressive weakness in left extremity and now affecting upper extremity. Motor weakness more prominent than sensory. The patient also reported having a magnetic resonance imaging and lumbar puncture (dates and results not provided). Her symptoms kept getting worse but did not spread and she reported she had no strength in her legs and deep tendon reflexes showed no response. The patient stated she ended up being paralyzed (bilateral) from her mid body down with her upper body being weak and tingling in both hands and finger. No problems with breathing, chewing and swallowing. She was diagnosed with acute Guillain-Barre Syndrome on an unspecified date. She stayed in the hospital for 5 weeks and received intravenous antibody treatment which didn''t work for her, then received plasma treatment for consecutive 5 days. Few days after receiving the plasma treatment, she was still weak but felt some improvement. She gained her strength to walk. At the time of report, she was much better and no longer paralyzed; still saw her doctors and went for outpatient treatment. Information regarding other potential etiologies was insufficient, and the occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.


VAERS ID: 1498413 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-06-18
Onset:2021-07-13
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Electromyogram, Guillain-Barre syndrome, Magnetic resonance imaging
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Gabapentin Allopurinol
Current Illness: None
Preexisting Conditions: Hypertension Lumbar degenerative disc disease Gout
Allergies: None
Diagnostic Lab Data: MRI EMG/NCS Hospitalization
CDC Split Type:

Write-up: Guillain -Barre


VAERS ID: 1502021 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-20
Onset:2021-07-03
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Balance disorder, Fall, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Accidents and injuries (narrow), Demyelination (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Furosemide, potassium, vitamins
Current Illness: Cough for two weeks
Preexisting Conditions: sleep apnea, obese
Allergies: Sulfa drugs--acutely allergic
Diagnostic Lab Data: MRI
CDC Split Type:

Write-up: severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute. Dr. primary rehab doctor. Neurologists consultants.


VAERS ID: 1502255 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-01
Onset:2021-05-28
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN J&J COVID / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin Flomax Lansoprazole Metoprolol Tamsulosin
Current Illness: Hypertension Hyperlipidemia BPH
Preexisting Conditions: Hypertension Hyperlipidemia BPH
Allergies: Enalapril Tylenol
Diagnostic Lab Data: LP has been done consistent with GBS
CDC Split Type:

Write-up: Guillain-Barre syndrome


VAERS ID: 1510697 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-08
Onset:2021-06-21
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Back pain, Balance disorder, Demyelinating polyneuropathy, Diplopia, Electrocardiogram, Full blood count, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging head normal, Muscle spasms, Neck pain, Pain in extremity, Speech disorder, X-ray
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zolpidem Citalpram
Current Illness:
Preexisting Conditions:
Allergies: Benzonatate
Diagnostic Lab Data: All 3 ER visits. Full blood panel, ecg, x-ray. Once admitted.. MRI of brain to rule out stroke, spinal tap.
CDC Split Type:

Write-up: 2 weeks out. Severe pain in neck and back. June 26 went to ER. Pain in back cramping in legs. Giving pain medication sent home . Referred to rheumatology. June 29 return to ER. For severe pain in legs. Numb right side of face, double vision, difficult speaking loss of balance. July 6 return to ER. Diagnosed with thrush Gillian Barre Syndrome. Acute Demyelinating Polyneuropathy.Admitted to hospital


VAERS ID: 1514398 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-04-16
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Bell's palsy, Blood test, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging, Muscle twitching, Neuralgia, Pain assessment, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hearing impairment (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MULTIVITAMIN [VITAMINS NOS]; VITAMIN D [ERGOCALCIFEROL]; LACTOBACILLUS ACIDOPHILUS
Current Illness: Allergic reaction to bee sting (carries an Epipen because she was "covered in hives" many years ago after being stung.); House dust mite allergy; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Comments: Does the patient have any allergies? :: Yes Provide details of the allergies :: Environmental and dust mites - experiences itchy eyes, runny nose, sneezing. Bees - carries an epipen because she was "covered in hives" many years ago after being stung. Was there drug abuse or illicit drug usage? :: No Does the patient consume alcohol? :: No Does the patient smoke? :: No Does not have any medical conditions.
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Pain scale; Result Unstructured Data: 4/10; Comments: constant ache in her lower back near the sacrum; Test Date: 20210416; Test Name: Pain scale; Result Unstructured Data: 9/10 to 10/10; Comments: lower pain pain near sacrum worsened and included a stabbing middle back pain; Test Date: 20210421; Test Name: Blood test; Result Unstructured Data: Unknown; not confirmed by caller; Test Date: 20210421; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210421; Test Name: Computerised tomogram; Result Unstructured Data: Normal; Test Date: 20210423; Test Name: Blood test; Result Unstructured Data: Normal as per patient.; Test Date: 20210426; Test Name: Pain scale; Result Unstructured Data: 9-10/10; Test Date: 20210426; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210426; Test Name: Blood test; Result Unstructured Data: CALLER IS UNSURE IF IT WAS DONE; Test Date: 20210501; Test Name: Magnetic resonance imaging; Result Unstructured Data: Result not confirmed/stated by caller; Test Date: 20210504; Test Name: Spinal tap; Result Unstructured Data: Guillain Bar Syndrome
CDC Split Type: USJNJFOC20210752736

Write-up: GUILLAIN BARRE SYNDROME; LEFT AND RIGHT SIDE OF THE FACE - BELL''S PALSY; TWITCHES; NERVE PAIN IN BILATERAL FEET AND HAND; TINGLING OF FEET AND HANDS; LOWER AND MIDDLE BACK PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient''s weight was 175 pounds, and height was 61 centimeters. The patient''s was a non smoker, non drinker, allergies included bee allergy (she carries an Epipen), environmental and dust mite allergy. There was no history of drug abuse or illicit drug use. The patient did not have any current medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, lactobacillus acidophilus, and vitamins nos. On 16-APR-2021 the patient started experiencing a constant ache in her lower back near the sacrum, with a 4/10 on a the pain scale. At night the pain worsened and also included a stabbing middle back pain, with a 9-10/10 on the pain scale. She couldn''t sleep, couldn''t stand or sit. There was no relief even after taking Tylenol and ibuprofen. On 21-APR-2021, she developed Bell''s Palsy on the left side of her face. She was drinking water and it fell out of the side of her mouth. She went to the hospital for evaluation and the doctors suspected that she had been bitten by a tick. Blood work was done to assess for a tick bite as well as a computerised tomogram (CT) scan of the head to rule out a stroke. Both results came back normal and additional blood work was sent to a larger facility for further tick bite testing. She was discharged home from the Emergency Room (ER) with prescriptions for prednisone for 1 week, 10 day course of penicillin, and tramadol every 4-6 hours for the pain as needed. On 22-APR-2021 or 23-APR-2021 she attended the hospital again. This time the right side of her face was affected with Bell''s palsy in addition to the left side. Blood work was performed which came back normal. The doctors believed the symptoms were related to a tick bite. She received an injection for the back pain which she believed was tramadol but did not provide any relief. She was discharged home with a prescription for hydrocodone to be taken for pain as needed. She received the same follow-up advice and was advised to continue with the steroid, antibiotic and pain medications. The left sided Bell''s palsy resolved on 25-APR-2021 or 26-APR-2021. On 24-APR-2021 or 25-APR-2021 the patient visited hospital due to back pain, the severity of which had prevented her from sleeping for days. She arrived at 3:00 am and was discharged by 9:00 am. She received Intravenous morphine and a ketamine infusion for 1 hour. This provided instant relief and she was able to sleep. Blood work was done and was normal. Upon discharge she was advised to stop the tramadol and she instead received a prescription for oxycodone. She was advised to take the oxycodone if the hydrocodone didn''t work. The patient stated that at this time, she felt great and hopeful that entire day until the back pain retuned at night. On 26-APR-2021 she retuned to hospital due to the severity of the back pain. Middle and lower back pain had returned at a 9-10/10 pain level. She received an injection of tramadol which didn''t provide relief. She was discharged home and the ER doctor suggested physiotherapy. She as seen by her primary care provided the same day, a nurse practitioner (NP). The NP prescribed 10 morphine pills. At this point the Bell''s palsy was resolving. On 28-APR-2021 or 29-APR-2021, she visited the hospital again for back pain and received a shot of morphine and was then discharged home. The ER physician recommended a neurologist. On 29-APR-2021, the patient noticed that her hand writing was messier and she had a hard time writing. She began dragging her right foot when walking and on 30-APR-2021 she was unable to step onto a curb and couldn''t drag either leg when getting into the car. She lost sensation and movement in both legs from the knee down. Initially her right leg was worse than the left but eventually they were the same. On 01-MAY-202 she fell because her left leg "gave out". The same day she underwent a magnetic resonance imaging (MRI) scan on her head/back. Right sided Bell''s palsy resolved on 01-MAY-2021 or 02-MAY-2021. On 03-MAY-2021 the patient spoke to her NP and discussed her concerns that her symptoms may be Guillain-Barre syndrome. She was advised to go to the ER. She was admitted to hospital and she received an intravenous injection for pain. A neurologist tested her reflexes; she was told her reflexes were absent from the knees down in both legs. This was tested on either the 03-MAY-2021 or 04-MAY-2021 and worsened on 04-MAY-2021. A lumbar puncture (Spinal tap) was performed on 04-MAY-2021 which confirmed Guillain-Barre syndrome (GBS) and a 5 day course of treatment (unspecified) was started. On 04-MAY-2021 she experienced the worst back pain, during hospitalisation she received intravenous hydromorphone hydrochoride (Dilaudid) every 6 hours and intravenous hydrocodone every 4 hours. she had some relief after the first day and gained some mobility back but had the same back pain. During the 5 days of treatment, she noticed relief. By the time she was discharged, on 09-MAY-2021, she was able to walk again with the help of a cane. She received physiotherapy whilst in hospital and has continued with treatments since discharge. The stabbing pain in the middle of the back resolved during the 5 days of treatment, approximately 06-MAY-2021 but she stated that her lower back is still achy but physiotherapy has helped. Her lower back pain comes and goes at 2-3/10 pain level and she currently takes ibuprofen as needed for prevention before periods of activity. The reported developing nerve pain on an unspecified date, in both feet describing the feeling like "when you sit on your foot for too long then the feeling returns initially". The pain started during the 5 days of treatment once feeling and mobility returned to her legs. The pain has improved over time but both feet remain tingly with the left foot feeling worse. Her movement is still impaired but she can still get around the house despite feeling shaky when using the stairs. She also experienced nerve pain in her hands during the treatment which she believes may have started sooner when her hand writing appeared messy. Her hands have improved and the nerve pain "comes and goes in stages" The pain has resolved but her hands feel tingly and a "little asleep". She also noticed her thumb and finger grip is weaker. The patient also experienced twitches in bilateral hands and legs, her face and "all over". Onset date was unspecified. The twitches "come and go" and occur 1 to 20 times per day. The patient stopped using a cane on 09-JUN-2021. The patient did not have a plan for follow-up with a neurologist. She did not see the neurologist in July. The neurologist in the hospital said that follow-up is not needed unless issues arise. The pain doctor that the patient was seeing wanted to keep an eye on the back pain in case it was not related to GBS, or if the GBS had exacerbated a previous condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left and right side of the face - bell''s palsy on 02-MAY-2021, was recovering from Guillain-Barre syndrome; nerve pain in bilateral feet and hand, tingling of feet and hands, and lower and middle back pain, and the outcome of twitches was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report from a patient concerns a 46-year-old female who developed Guillain-Barre Syndrome (GBS) which was diagnosed 34 days after receiving the Janssen COVID-19 vaccine. Symptom of lower back pain began 16 days post-vaccine which became severe and intractable over 13 days; she then developed bilateral Bell''s palsy 21 days post-vaccine and lost sensation and movement below her knees 30 days post-vaccine, prompting hospitalization 34 days post-vaccine. Reflexes were absent from the knees down and spinal tap confirmed GBS. She underwent an unspecified course of treatment, received pain medication and physiotherapy, and was discharged on the 7th hospital day. She also developed nerve pain, tingling of the hands and feet, and muscle twitches. Bell''s palsy resolved and she is recovering from the remaining events. Information regarding other potential etiologies was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.


VAERS ID: 1517892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210759407

Write-up: GUILLIAN BARRE SYNDROME; This spontaneous report was received from a consumer (patient''s son) and concerned a female of unspecified age, race and ethnicity. The patient''s weight and height 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 administration unknown, batch number: Unknown) dose, anatomical location, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, approximately two weeks after receiving vaccination, the patient experienced symptoms of Guillian Barre syndrome. She had been dealing with the symptoms since April, but the doctors missed it until two weeks ago. Since she went so long without being diagnosed, her insurance denied all treatment. At the time of report, she was bedridden and could not walk, or use her hands effectively; "each day she worsens". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillian Barre syndrome was not recovered. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report received from a consumer concerned a female, unspecified age, unknown ethnicity, who experienced symptoms of Guillain-Barre syndrome (GBS) around 2 weeks after receiving the Janssen Covid-19 vaccine. Patient was bedridden, could not walk and could not use her hands effectively. Symptoms worsened each day. Patient''s height and weight were not reported. The patient''s past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information is limited in this case, and the occurrence of the symptoms of GBS could represent background incidence of such events in the general population. Therefore, the relationship to the vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.


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