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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: 1663231 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-11
Onset:2021-04-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysarthria, Fatigue, Gait disturbance, Guillain-Barre syndrome, Miller Fisher syndrome, Speech disorder
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Contact the Doctor
CDC Split Type:

Write-up: Patient now has the Miller Fisher Gillian barre Syndrome. I visited her on April 19th and noticed her speech was slurring and she was tired. Her speech got worse, we took her to ER Room, many tests, they thought a stroke, then to cardiologist, then neurologist. My Mom was a healthy independent 83 year old and now she can barely walk or talk, thank you Johnson and Johnson you have turned my family''s life upside down!


VAERS ID: 1665378 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Missouri  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210844560

Write-up: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a patient of unspecified age and sex, race and ethnic origin. Initial information was processed along with the additional information received on 25-AUG-2021. 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 administration not reported, batch number: Unknown, expiry: unknown) dose, one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient diagnosed with guillain barre syndrome and was paralyzed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210845247.; Sender''s Comments: V0: 20210844560 -COVID-19 VACCINE AD26.COV2.S- Guillain barre syndrome. This event is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1665384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210854750

Write-up: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via (social media) a company representative concerned a male of unspecified age, race and ethnicity. 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) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. Since MAY-2021, the patient was paralyzed from Guillain-barre syndrome from the waist down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-barre syndrome. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210854750-covid-19 vaccine ad26.cov2.s-Guillain-Barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1670081 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-29
Onset:2021-04-09
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Cardiac failure congestive, Computerised tomogram, Fall, Guillain-Barre syndrome, Hypoxia, Illness, Laboratory test, Magnetic resonance imaging, Mental status changes, X-ray
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), 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), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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? Yes
Hospitalized? Yes, 76 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen 500 mg Take 500 mg by mouth every 6 (six) hours if needed for mild pain or fever. aspirin (tablet,delayed release (DR/EC)) aspirin 81 mg Take 1 tablet (81 mg total) by mouth 1 (one) time each day. atorvastatin calcium (tabl
Current Illness: Was admitted to the hospital in February 2021 for Acute Dyspnea and Acute Kidney Injury
Preexisting Conditions: Cervicalgia back pain essential tremor Rt upper lobe lung nodule Hypertension Pulmonary hypertension Chronic diastolic heart failure Adnexal mass Osteoporosis Type II Diabetes
Allergies: fish oil - swelling Varenicline - Hives Bupropion - unknown Iodine - unknown Shellfish - unknown
Diagnostic Lab Data: Patient has had multiple CTs, xrays, and MRIs since this all began, she also of course, has had countless labs. I could not list them all here with the results . If there is something specific we need to provide, we could do that as asked. There is just too much with 76 days hospitalized
CDC Split Type:

Write-up: Sequence of events: March 29 - patient given Covid vaccine , by reports the patient started to experience progressive weakness after the vaccine April 9 - patient admitted to the hospital with Covid infection April 20 - patient still very ill with Covid April 23 - admitted again due to altered mental status, acute respiratory failure with hypoxia May 13 - Admitted for acute CHF June 12 - Admitted for altered mental status and acute respiratory failure June 21 - Admitted for altered mental status and acute respiratory failure July 8 - Admitted for altered mental status and acute respiratory failure August 6 - admitted with Guillan Barre Syndrome Currently - patient still having significant weakness, falls, etc


VAERS ID: 1671396 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-04-10
Onset:2021-04-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Endoscopy, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Paraesthesia, Paralysis, X-ray
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow), 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? Yes, 37 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Percocet , Meloxicam
Current Illness: Diverticulitis
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: He eventually was hospitalized July 14 when he became totally paralyzed they did spinal taps, MRIs, eKGs x-rays endoscopy And bloodwork
CDC Split Type:

Write-up: Patient reported numbness and tingling in his legs and eventually Had ascending paralysis from his feet all the way up to his chest. He started experiencing the numbness and tingling about a week after the injection and then a progress and got worse because we didn?t know what it was.


VAERS ID: 1672345 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Electromyogram, 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:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Electromyogram; Result Unstructured Data: confirms to be an atypical form of Guillain-Barre syndrome.
CDC Split Type: USJNJFOC20210902802

Write-up: ATYPICAL FORM OF GUILLAIN-BARRE SYNDROME/ AXONAL TYPE ACUTE INFLAMMATORY POLYNEUROPATHY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, race and ethnicity. 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 and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that 2 weeks after vaccination the patient started developing signs of a fulminant inflammatory peripheral neuropathy. On AUG-2021 the electromyogram testing performed on patient confirmed an atypical form of guillain-barre syndrome/ axonal type acute inflammatory polyneuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atypical form of guillain-barre syndrome/ axonal type acute inflammatory polyneuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210902802-covid-19 vaccine ad26.cov2.s-atypical form of Guillain-Barre syndrome/ axonal type acute inflammatory polyneuropathy. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1679017 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-25
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A216A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anion gap, Ataxia, Blood bilirubin increased, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood urea normal, C-reactive protein decreased, CSF glucose increased, CSF monocyte count increased, CSF protein increased, CSF white blood cell count increased, Carbon dioxide decreased, Carbon dioxide normal, Computerised tomogram spine, Differential white blood cell count, Electromyogram abnormal, Facet joint syndrome, Full blood count, Gait disturbance, Glomerular filtration rate decreased, Glycosylated haemoglobin increased, Guillain-Barre syndrome, Haematocrit normal, Haemoglobin normal, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Impaired work ability, International normalised ratio normal, Intervertebral disc compression, Intervertebral disc protrusion, Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell haemoglobin increased, Mean cell volume normal, Metabolic function test, Nerve conduction studies abnormal, Neutrophil count normal, Pain in extremity, Peroneal nerve palsy, Platelet count normal, Poor quality sleep, Prothrombin time prolonged, Red blood cell count decreased, Red blood cell sedimentation rate normal, Sleep disorder, Ultrasound Doppler normal, Vertebral foraminal stenosis, Walking aid user, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Arthritis (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin C, D, and zinc Amlodipine 10 mg daily Aspirin 81 mg daily Atorvastatin 40 mg daily
Current Illness: None
Preexisting Conditions: High blood cholesterol High blood pressure Benign prostatic hyperplasia
Allergies: Demerol - reaction is hiccups
Diagnostic Lab Data: August 28th - POC Basic Metabolic Panel - glomerular filtration rate $g60, calcium 9.6, chloride 105, creatinine 0.8, blood glucose 84, potassium 4.1, sodium 143, total carbon dioxide 28, BUN 18 POC Complete Blood Count - white blood cell count 7.1, red blood cell 4.66, hemoglobin 14.9, hematocrit 42, MCV 90.1, MCH 8.7, MCHC 35.5, platelet 233, neutrophil 56.1 Bilateral US doppler venous lower extremities - No ultrasound evidence for DVT in either lower extremity August 30th - C-reactive protein - <0.3 Complete blood count (CBC) with differential - WBC 7.7, RBC 4.85, hemoglobin 15.1, hematocrit 44, MCV 90.7, MCH 31.1, MCHC 34.3, platelet count 237, Comprehensive metabolic panel (CMP) - Glucose 147, sodium 135, potassium 3.5, chloride 105, carbon dioxide 23, anion gap 7, BUN 13, creatinine 0.95, calcium 9.3, total bilirubin 1.1 Creatinine kinase - 155 Sedimentation rate (ESR) - 5 CT lumbar spine without contrast - 5 mm left subarticular disc protrusion L5-S1 with left lateral recess compression, bilateral facet arthropathy with severe bilateral foraminal stenosis L5-S1, facet arthropathy with severe right recess and moderately severe right foraminal stenosis L4-5 September 3rd - EMG/ NCS of RUE and BLE consistent with Gullain-Barre syndrome September 5th - Immune globulin (human) IGG first dose at 11 pm CBC - WBC 12.87, HGB 16, HCT 46.6, platelet 235 INR - 1.05, PT 13.5 CMP - sodium 138, potassium 4.3, chloride 102, CO2 19.4, Agap 17, glucose 164, BUN 18, creatinine 0.92, calcium 9.8, A1C 6.6 September 6th - Immune globulin (human) IGG second dose at 2137 Cerebrospinal fluid - CSF WBC 10, CSF monocyte 46, CSF protein 289.9, CSF glucose 106
CDC Split Type:

Write-up: August 11th - J&J covid vaccine August 25th - not feeling well late evening better next morning, bilateral legs hurt, slight numbness in arms, legs and lips August 26th - not feeling well again late evening, bilateral legs hurt more than on the 25th, numbness in arms, legs and lips. Took 3 Tylenol for pain to sleep August 27th - continue symptoms from the prior day August 28th - bilateral leg pain sufficient not to be able to sleep. Went to Emergency room. Doctor ran blood test and ultrasound of bilateral legs. Doctor stated no acute reason for bilateral leg pain August 29th - felt fair, still have pain and numbness in bilateral legs and arms August 30th - Called in sick at work. Went to another ER and took Emergency room blood test records. ER doctor performed lower back CT scan, prescribed steroid pills, tramadol, and steroid injection August 31st - Went to spine doctor, discussed treatments including physical therapy and steroid injection, felt fair, unable to sleep due to continue bilateral leg numbness and pain September 1st - Went to another ER - ER doctor reviewed medical records, prescribed muscle relaxant Flexeril - medication did not help and did not sleep well September 2nd - went to Medical Center and discussed treatment, had minor back adjustment, started taking steroid pills September 3rd - Went to Neurologist - saw Dr. and was diagnosed with Guillain-Barre and treatment to follow with findings of impaired walking and left foot drop and ataxia September 4th - could walk with difficulty September 5th - went to assigned hospital per Dr. since not able to walk by myself - received first dose of IVIG at 11 pm - plan for IVIG treatment for total of 5 days September 6th - walking with walker and second round of IVIG at 2137


VAERS ID: 1681442 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Nerve compression
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Accidents and injuries (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure (ON MEDICATION FOR YEARS); Cholesterol (ON MEDICATION FOR YEARS); Seasonal allergy.
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: CAT scan; Result Unstructured Data: PINCHED NERVE.
CDC Split Type: USJNJFOC20210902851

Write-up: POSSIBLE GUILLAIN BARRE SYNDROME; PINCHED NERVE; This spontaneous report received from a consumer concerned a 63 year old male with unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: cholesterol, blood pressure, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, 1 in Total administered on 11-AUG-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 patient felt tired ever since. on AUG-2021 he complained of achiness and weakness in his legs, he complained of muscle pain that was not consistently in the same area, and even felt like his muscles were tight. He went to the emergency room (ER) on 28-AUG-2021 where he was treated with tramadol. On 29-AUG-2021 patient experienced tingling and numbness in both hands and arms, then developed tingling in his lips and difficulty swallowing. He went back on 30-AUG-2021 for the emergency room (ER) where his laboratory data included: CAT scan (NR: not provided) and diagnosed with a pinched nerve. On AUG-2021, the patient experienced possible Guillain Barre Syndrome and pinched nerve. They were at the third emergency room (ER) visit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible Guillain Barre Syndrome and pinched nerve was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- 20210902851- covid-19 vaccine ad26.cov2.s - Possible Guillain Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1689429 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-06-17
Onset:2021-06-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / N/A LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Computerised tomogram, Fatigue, Feeling abnormal, Guillain-Barre syndrome, Hemiplegia, Impaired work ability, Magnetic resonance imaging, Malaise, Migraine, Paraesthesia, Stress, Tremor, X-ray
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: metformin, lisinopril, aspirin 325mg, xanax prn
Current Illness: Denies any acute illnesses prior to vaccination
Preexisting Conditions: DM, HTN, Depression
Allergies: NKDA, denies allergies to foods
Diagnostic Lab Data: Unable to provide this information at this time. He will log into the patient portals and obtain this when he has time. He has had MRI''s, CT''s, x-rays and underwent PT.
CDC Split Type:

Write-up: Had migraine for the 1st 3 days following the vaccine. Over the next couple of weeks became "mentally foggy and fatigued". Patient attributed that to the recent stress of 2 deaths of close family/friend. When he came to me for a first aid/vital sign check at the occupational clinic, I observed that both of his hands were trembling and did not appear to feel well. I asked that he leave and follow up with his PCP and obtain a full medical release to return to work. He has returned back to work this week and informed me of the events /reaction that he attributes to the vaccine. Although his neurologist and PCP has not clinically diagnosed him with Guillen Barre, I highly suspect that this is what he experienced. He reports resolved left sided paralysis. He reports a tough recovery and is back to work but stills has some tingling sensations and mental fogginess.


VAERS ID: 1691299 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Antibody test, CSF protein, CSF test abnormal, Chest X-ray, Coma scale, Computerised tomogram head, Guillain-Barre syndrome, Magnetic resonance imaging head, Neurological examination, Physical examination, Sensory level
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? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Food allergy; Hyperlipidemia; Hypertension; Penicillin allergy; Type II diabetes mellitus
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Glasgow coma scale; Result Unstructured Data: 15/15; Test Name: Neurological examination; Result Unstructured Data: Bilateral CN VII lower motor neuron lesion signs present.; Test Name: Chest X-ray; Result Unstructured Data: negative; Test Name: Computerised tomogram head; Result Unstructured Data: negative; Test Name: Magnetic resonance imaging head; Result Unstructured Data: no acute infarct, hydrocephalus, acute intracranial hemorrhage; Test Name: CT angiography; Result Unstructured Data: less than 50% stenosis in left and right internal carotid arteries; Test Name: Cerebrospinal fluid protein; Result Unstructured Data: 302 mg/mL; Test Name: Cerebrospinal fluid abnormal; Result Unstructured Data: absence of white blood cell yielding albuminocytologic dissociation; Test Name: Neurological examination; Result Unstructured Data: examination of CN II to XII, the pupils reacted light bilaterally.; Test Name: Physical examination; Result Unstructured Data: normal muscle tone throughout all four extremities; Test Name: Sensory level; Result Unstructured Data: normal, and toes were down-going bilaterally; Test Name: Antibody test; Result Unstructured Data: negative, anti-GQ1b antibodies less than 1:100; Test Name: Neurological examination; Result Unstructured Data: improvement in the power in the orbicularis oculi muscles; Test Name: Physical examination; Result Unstructured Data: Muscle tone was normal in all four extremities; Test Name: Sensory level; Result Unstructured Data: intact; Test Name: Neurological examination; Result Unstructured Data: Gag reflex was weak and bilateral loss of power in facial nerve
CDC Split Type: USJNJFOC20210903117

Write-up: FACIAL DIPLEGIA RARE VARIANT OF GUILLAIN-BARRE SYNDROME; This spontaneous report was received from literature: This report concerned a 65 year old female. The objective of this study was Facial Diplegia: A Rare, Atypical Variant of Guillain-Barre Syndrome and Ad26.COV2.S Vaccine. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension, diabetes mellitus type 2, hyperlipidemia, penicillin allergy, and egg white allergy. The patient experienced drug allergy when treated with ciprofloxacin, and codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) 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 received the Ad26.COV2.S vaccine presented to the emergency department (ED) as she endorsed a headache in the frontal and periorbital regions for four days, along with left neck and shoulder pain from day 15 post-vaccination. Simultaneously, she experienced ageusia and hyposalivation. On day 19 post-vaccination, the patient woke up with dysarthria, dysphagia, dysphasia, and bilateral facial weakness, which prompted the patient to visit the ED the following day. Neurological assessment upon arrival showed that the patients'' Glasgow Coma Scale was 15/15, and the patient had significant dysarthria. Gag reflex was weak and there was a bilateral loss of power in the distribution of the facial nerve. The remainder of the central and peripheral neurological examination was normal. Chest X-ray and computed tomography (CT) of the head were negative. Magnetic resonance imaging (MRI) of the head demonstrated no acute infarct, hydrocephalus, acute intracranial hemorrhage, or mass effect. CT angiography of the head and neck demonstrated less than 50 percent stenosis in left and right internal carotid arteries. A stroke code was activated on patient arrival to the ED, which was ruled out by the neurology team. Due to the bilateral cranial nerve (CN) VII lower motor neuron lesions, the patient was promptly admitted to the intensive care unit. A lumbar puncture was performed to rule out the Miller Fisher variant of Guillain Barre Syndrome (GBS). Results of CSF showed protein of 302 mg/mL, and absence of white blood cell yielding albuminocytologic dissociation with IgA level of 163 mg/dL. Following diligent clinical and physical assessment, and analyzing CSF results via lumbar puncture, empiric treatment was initiated for GBS, and the patient was diagnosed with facial diplegia, a rare variant of GBS. The patient was administered intravenous immunoglobulin (IVIG) (0.4 g/kg) for 10 days followed by 10 sessions of plasmapheresis. She was provided with supplemental oxygen and close monitoring for potential diaphragmatic paralysis. On day 3 of hospitalization, the patient was awake, alert, oriented, and able to follow commands. She denied any respiratory distress; however, slurred speech with mild dysarthria was noted. On examination of CN II to XII, the pupils reacted light bilaterally. Extraocular muscles were intact bilaterally, and nystagmus/diplopia was absent. When asked to close her eyes, there was a bilateral loss of power in the orbicularis oculi muscles. There was a significant CN VII lower motor neuron lesion bilaterally. The patient exemplified bilateral upper and lower facial motor weakness and decreased gag reflex. The tongue and uvula were in the midline, and there was a normal, symmetric movement of the soft palate. Motor examination showed a normal muscle tone throughout all four extremities. Power was 4/5 in the left lower extremity. Deep tendon reflexes were 0 at the left upper extremity, 1 plus at the right upper extremity, bilateral knees, and left ankle were 0, and the right ankle had 2 plus reflex present. Sensory examination was normal, and toes were down-going bilaterally. Acetylcholine receptor binding and modulating antibodies were negative, and anti-GQ1b antibodies less than 1:100 (normal titer is less than 1/200). On day 9 of hospitalization, the patient showed notable improvement in her speech. CN examination showed an improvement in the power in the orbicularis oculi muscles. There was notable bilateral CN VII lower motor neuron lesion, bilateral upper and lower facial weakness, and decreased gag reflex. Muscle tone was normal in all four extremities; however, power in the left lower extremity was 4/5. Deep tendon reflexes of the left upper extremity and right upper extremity were 0 and 1 plus, respectively. Furthermore, that of bilateral knees, left ankle, and right ankle were 1 plus, 0, and 2 plus, respectively. Sensory examination was intact. The remainder of the CN exam was the same as day 3. On day 12 of hospitalization, the patient''s speech was slightly slurred with mild dysarthria, and the patient was able to close her eyes and keep them closed, which she was unable to do before. Nasolabial folds were slightly deeper. Bilateral CN VII lower motor neuron lesion signs were still present with bilateral upper and lower facial weakness and decreased gag reflex. The patient had negative titers of IgG anti-GQ1b antibody and normal findings for MRI of brain, thus ruling out Bickerstaff''s brainstem encephalitis (BBE) or Fisher syndrome. On an unspecified date, the patient experienced neck pain. On day 14, the patient was discharged and outpatient follow-up with a neurologist was recommended. Treatment with IVIG and plasmapheresis was observed to be successful with the patient being able to return to her normal baseline health at the time of discharge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from facial diplegia rare variant of guillain-barre syndrome. The purpose of the article was to bring awareness to the facial diplegia variant of GBS and the importance of reporting the potential adverse reactions post-COVID-19 vaccination. Prompt management with IVIG should be initiated if facial diplegia was diagnosed. Adverse events after vaccination must be reported as they need to be further investigated, considering the fact that vaccination was needed to control the ongoing pandemic situation. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210903117- COVID-19 VACCINE AD26.COV2.S- Facial diplegia rare variant of guillain-barre syndrome. This event is labeled per Agency and is therefore considered potentially related.


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