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From the 11/26/2021 release of VAERS data:

Found 1,797 cases where Vaccine is COVID19 and Symptom is Guillain-Barre syndrome

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Case Details

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VAERS ID: 1102639 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-02-18
Onset:2021-03-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, CSF glucose increased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Guillain-Barre syndrome, Lumbar puncture
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril, loratadine, metformin, allopurinol, atorvastatin, brimonidine, cosopt
Current Illness: None prior
Preexisting Conditions: Hypertension, glaucoma, diabetes
Allergies: None
Diagnostic Lab Data: LP/CSF (3/10): - WBC - 7 - RBC - 5302 - Glucose - 79 - Protein 399
CDC Split Type:

Write-up: Progress weakness developed over two weeks consistent with Guillain Barre


VAERS ID: 1103326 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-02-10
Onset:2021-02-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Electromyogram, Guillain-Barre syndrome, Hemiparesis, Muscular weakness, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Immune-mediated/autoimmune disorders (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: cyanocobalamin, omeprazole, cholecalciferol, tramadol, allopurinol, gabapentin, losartan, metoprolol
Current Illness: None
Preexisting Conditions: CKD, PMR, HTN, spinal stenosis
Allergies: NKDA, NKA
Diagnostic Lab Data: Unable to obtain CSF despite fluoroscopic guided LP. EMG pending.
CDC Split Type:

Write-up: Patient developed Bell''s Palsy 14 days after vaccination. Another 10 days after that, she developed symptoms of right leg weakness that have progressed to bilateral lower extremity weakness plus sensory symptoms that meet criteria for Guillain Barre Syndrome.


VAERS ID: 1110067 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-01-08
Onset:2021-01-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: School       Purchased by: ?
Symptoms: Bell's palsy, Blood test, C-reactive protein, Computerised tomogram, Guillain-Barre syndrome, Magnetic resonance imaging, SARS-CoV-2 test, Urine analysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hearing impairment (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 42 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALTACE; ASPIRIN [ACETYLSALICYLIC ACID]; CRESTOR; LORATADINE; REPATHA
Current Illness: Hypercholesterolemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Date: 20210120; Test Name: CT scan; Result Unstructured Data: Test Result:Normal; Test Date: 20210120; Test Name: CR Protein; Result Unstructured Data: Test Result:Elevated; Test Date: 20210120; Test Name: MRI; Result Unstructured Data: Test Result:Normal; Test Date: 20210120; Test Name: Covid19 test; Test Result: Negative ; Test Date: 20210120; Test Name: Urine test; Result Unstructured Data: Test Result:Normal
CDC Split Type: USPFIZER INC2021228577

Write-up: Developed Guillian Barre Syndrome with Miller Fisher variant; Bell''s palsy; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received the second dose of BNT162B2 (BNT162B2, lot number was not reported), intramuscular, on 08Jan2021 at a single dose for COVID-19 immunisation. He received the vaccine at a school/student health clinic. The patient did not have COVID prior to vaccination. He did not receive any other vaccines 4 weeks prior to receiving BNT162B2. Medical history included hypertension and hypercholesterolemia, both were from unspecified dates and ongoing. Concomitant medications included ramipril (ALTACE) for hypertension, rosuvastatin calcium (CRESTOR) for hypercholesterolemia, acetylsalicylic acid (ASPIRIN), loratadine (LORATIDINE), evolocumab (REPATHA) for hypercholesterolemia. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number was not reported), intramuscular, on 18Dec2020 for COVID-19 immunisation, at the age of 65-year-old. It was reported that patient developed Guillian Barre Syndrome with Miller Fisher variant 10 days (as reported) after receiving the 2nd dose of the COVID vaccine on 18Jan2021. He lost the ability to use his hands/legs. He received 2 g/kg of IVIG over 4 days starting on 21Jan2021. At the time of initial report (02Mar2021), he was recovering in an inpatient rehab center. The patient also experienced Bell''s Palsy on 24Jan2021. The patient further reported that all started with a headache on 18Jan2021 and then he began to lose the ability to use his hands and legs. So, he visited the ER (emergency room) on 20Jan2021 and got hospitalized. On 22Jan2021, he was completely unable to walk. On 24Jan2021, he was also diagnosed with Bell''s Palsy which was still ongoing at the time of report. The patient stated that he just got out of the inpatient rehab center on 03Mar2021. At the time of follow-up report (04Mar2021), he stated that he feels better but it is not recovered yet. The patient had undergone laboratory tests and procedures on 20Jan2021 which includes: Blood test: normal, Urine test: normal, CR Protein: elevated, Covid19 test: negative, CT (computer tomography) Scan: normal, MRI (magnetic resonance imaging): normal. It was reported that adverse event Guillain Barre Syndrome with Miller Fisher variant required visit to ER. The patient was hospitalized for Guillian Barre Syndrome with Miller Fisher variant from 20Jan2021 to 03Mar2021. The patient received treatment for Guillian Barre Syndrome with Miller Fisher variant, while he did not receive any treatment for Bell''s palsy. Outcome of the event Guillian Barre Syndrome with Miller Fisher variant was recovering, while outcome of Bell''s Palsy was not recovered. Information on batch/lot number was requested.; Sender''s Comments: Based on the available information, a possible contribution of the drug to the events Guillian Barre Syndrome with Miller Fisher variant and Bell''s palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1110534 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-02-21
Onset:2021-03-04
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007M20A / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Areflexia, CSF glucose increased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Constipation, Encephalomalacia, Fall, Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intervertebral disc degeneration, Malaise, Muscle strength abnormal, Muscular weakness, Pain in extremity, Paraesthesia, Spinal osteoarthritis, Spinal stenosis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Calcium carbonate prn, Estradiol 1 mg daily, Fenofibrate 145 mg QD, Fluoxetine 20 mg QD, Gabapentin 100-300 mg nightly, Losartan 50 mg daily, Multivitamin Daily.
Current Illness:
Preexisting Conditions: Anxiety, Depression, Hypertension, Hyperlipidemia, Tobacco dependance, Headache (due to trauma 14 years ago)
Allergies: Duloxetine (Constipation), Mango (Swelling), Pyridium (Stomach cramps)
Diagnostic Lab Data: Imaging studies performed yesterday revealed the following: MR brain: Mild chronic microvascular changes slightly progressed when compared to a prior study performed in 2013. Chronic encephalomalacia in the right frontal lobe associated with previous closed head injury. MR cervical spine: Multilevel cervical spondylosis associated with severe central canal stenosis at C3-4 and moderate-severe central canal stenosis at C4-5 without abnormal cord signal. MR thoracic spine: Abnormal enhancement of 2 ventral cauda equina nerve roots near the conus and questionable additional ventral nerve root enhancement bilaterally at the T10-T11 levels. MR lumbar spine: Multilevel degenerative changes without significant central canal stenosis.
CDC Split Type:

Write-up: MODERNA COVID-19 Vaccine EUA Patient presented to ED on 3/14/21 with new onset of inability to walk. Recalls not feeling well on 3/4/21 after receiving her COVID-19 vaccine (1st dose) on 2/21/21. She began to experience aching over the anterior thigh on the following day that progressed to involve the posterior lower extremity and forearms by Saturday, 3/6/21. She also began to experience numbness and tingling in the feet and fingers at that time. The sensory symptoms persisted over the following days in association with lower extremity weakness that culminated in a fall at home on Thursday, 3/11/21. She was unable to walk without assistance at the time of her presentation. Initial examination in the ED revealed borderline antigravity lower extremity strength and absent lower extremity reflexes. A lumbar puncture performed on 3/14/21 revealed protein ? 218.1, glucose ? 76, WBC ? 8, and RBC 1. She was admitted to the hospital with the diagnosis of Guillain-Barre syndrome and received her initial dose of IVIG that evening. She has noted some interval improvement in lower extremity muscle strength since her admission to the hospital. The pain that she had been experiencing is less intense, though she is still prone to experience discomfort if she remains in the same position too long. She is continuing to experience tingling in the feet and fingers. She is not experiencing any shortness of breath or difficulty with chewing/swallowing. She is not experiencing any urinary bladder dysfunction. She is experiencing constipation.


VAERS ID: 1111306 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-01-24
Onset:2021-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9261 / 1 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Areflexia, CSF protein increased, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Lumbar puncture abnormal, Muscular weakness, Neurological examination, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Skin test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ASPIRIN; WELLBUTRIN; CARVEDILOL; CITALOPRAM; ERGOCALCIFEROL; LANTUS; MELATONIN; METFORMIN; OMEPRAZOLE; SENNA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to analgesics (NSAIDS allergy); Coronary artery disease (CAD s/p stent x3 (2008)); Cryptogenic cirrhosis (s/p liver tx on 20Jun2020); Factor V Leiden mutation; Hyperlipidemia; Liver transplantation; Stent placement (CAD s/p stent x3 (2008)); Type 2 diabetes mellitus (T2DM on insulin)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: lumbar puncture; Result Unstructured Data: Test Result:no WBC and significantly increased protein to 107; Test Date: 20210210; Test Name: neurological exam; Result Unstructured Data: Test Result:areflexia throughout, patchy weakness in RLE $g LLE; Comments: and B/L CN 7 weakness; Test Date: 20210206; Test Name: Rapid SARS-CoV-2 (COVID-19) by PCR Nasopharyngeal swab on M4 (NASO); Test Result: Negative ; Test Date: 20210210; Test Name: Pin prick; Result Unstructured Data: Test Result:decreased sensation
CDC Split Type: USPFIZER INC2021142930

Write-up: areflexia throughout/decreased sensation to pinprick; B/L CN 7 weakness; areflexia throughout/decreased sensation to pinprick; Bilateral lower extremity weakness and pain/patchy weakness in RLE $g LLE; Bilateral lower extremity weakness and pain; paresthesia in bilateral hands and legs; acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre syndrome); lumbar puncture showed no WBC and significantly increased protein to 107; lumbar puncture showed no WBC and significantly increased protein to 107; This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261), intramuscular on 24Jan2021 at single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included ''Cryptogenic cirrhosis s/p liver tx 20Jun2020, T2DM on insulin, Factor V Leiden, CAD s/p stent x3 (2008), hyperlipidemia'', NSAIDS allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, acetylsalicylic acid (ASPIRIN), bupropion hydrochloride (WELLBUTRIN), carvedilol, citalopram, ergocalciferol, insulin glargine (LANTUS), melatonin, metformin, omeprazole, senna alexandrina (SENNA). The patient previously took atorvastatin and experienced Allergies to Atorvastatin, promethazine and experienced Allergies to promethazine, tolmetin and experienced Allergies to tolmetin, INSULIN for T2DM (Type 2 diabetes mellitus). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Bilateral lower extremity weakness and pain and paresthesia in bilateral hands and legs on 26Jan2021. Symptoms began two days after first dose of the Pfizer vaccine (received on 24Jan2021) and have continued to progress over the last 2.5 weeks. His neurological exam now (10Feb2021) includes areflexia throughout, patchy weakness in RLE $g LLE, decreased sensation to pinprick and B/L CN 7 weakness. His lumbar puncture showed no WBC and significantly increased protein to 107 in 2021. This is all consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association in 2021. The patient underwent lab tests and procedures which included lumbar puncture: no WBC and significantly increased protein to 107 in 2021, neurological examination: areflexia throughout, patchy weakness in RLE $g LLE and B/L CN 7 weakness on 10Feb2021, Rapid SARS-CoV-2 (COVID-19) by PCR Nasopharyngeal swab on M4 (NASO): negative on 06Feb2021, skin test: decreased sensation on 10Feb2021. The adverse events result in Emergency room/department or urgent care. Hospitalization for all the events. Therapeutic measures were taken as a result of events (IVIg). The outcome of the events was not recovered.; Sender''s Comments: Based on the information provided, patient developed signs and symptoms which were consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association. In addition, a contributory role of patients co-morbidities cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1113964 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-02-08
Onset:2021-02-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Guillain-Barre syndrome, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV disease; Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: Nasal Swab; Test Result: Negative ; Comments: Covid test post vaccination: [{covid test type post vaccination=Nasal Swab, covid test name post vaccination=Cepheid Xpert Xpress SARS-CoV-2 test., covid test date=18Feb2021, covid test result=Negative}]
CDC Split Type: USPFIZER INC2021257907

Write-up: Acute inflammatory demyelinating polyradiculoneuropathy; Guillain Barre Syndrome; This is a spontaneous report from a contactable Physician. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Age at vaccination was 58 years. Relevant medical history included HIV (well controlled on ART) and allergy to Sulfa antibiotics. Concomitant medications were not reported. On 13Fwb2021 the patient experienced ''Guillain Barre Syndrome Acute inflammatory demyelinating polyradiculoneuropathy'' leading to emergency room visit. Provided seriousness criteria were hospitalization, Life threatening, disability and medically significant. The patient underwent Nasal Swab SARS-CoV-2 test on 18Feb2021 which resulted negative. At the time of the reporting the patient had not yet recovered. Information about lot/batch number has been requested.; Sender''s Comments: Based on the temporal relationship, the association between the event Guillain Barre Syndrome with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1114384 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       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: USPFIZER INC2021285669

Write-up: Reaction to Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable consumer (the patient) from a Pfizer-sponsored program. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient reported reaction to Guillain-Barre Syndrome (no other details provided). The clinical outcome of reaction to Guillain-Barre Syndrome was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Patient information corrected. Follow-up (16Mar2021): This is a follow-up report to notify that case 2021157553 and case 2021285669 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number 2021285669.


VAERS ID: 1115046 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-02-24
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diplegia, Guillain-Barre syndrome, Lumbar puncture, Myelitis transverse, Pain
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Spinal tap for GBS; Test Result: Inconclusive ; Result Unstructured Data: Unknown; Test Date: 202102; Test Name: transverse myelitis; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Gullian-Barre Syndrome; Paralyzed from the waist down, lost use of both arms; Severe pain; A spontaneous report was received from a consumer (patient''s brother) concerning a 62-year-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced severe pain, was paralyzed form waist down and was diagnosed with Guillan-Barre Syndrome. The patient''s medical history was not provided. No concomitant product use was reported. On an unknown date the patient received her first dose of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient experienced severe pain in a few hours and was taken to the emergency room, then, discharged. The patient was taken back to the emergency room on 25-Feb-2021 (Thursday night), and on 26-Feb-2021 (Friday), she was paralyzed from the waist down, losing use of both arms. The patient was tested at the hospital for transverse myelitis, which was negative. Spinal tap for GBS (Guillan Barre Syndrome) was protein positive and she was given a definitive diagnosis of GBS. There was movement in fingers but could not pick up objects. Seriousness criteria for the events of Gullian-Barre Syndrome and paralyzed from the waist down, lost use of both arms was medically significant. Action taken with mRNA-1273 in response to events was not applicable. The outcome of all the events was unknown. No further information was provided.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1120517 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-02-24
Onset:2021-02-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: CSF protein increased, CSF white blood cell count, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: lisinopril, omeprazole, atorvastatin, multivitamin
Current Illness:
Preexisting Conditions: hypertension, hyperlipidemia
Allergies: nka
Diagnostic Lab Data: Lumbar puncture: CSF shows protein 89 mg/dL (upper limit of normal 45 mg/dL) and 2 WBC/mm3
CDC Split Type:

Write-up: Progressive weakness and paresthesias in BLE and BUE over 3 weeks. Workup suggests guillain-barre syndrome.


VAERS ID: 1120879 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-03
Onset:2021-03-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Areflexia, CSF cell count normal, CSF protein increased, Facial paresis, Guillain-Barre syndrome, Hyponatraemia, Inappropriate antidiuretic hormone secretion, Muscular weakness, Myalgia, Paraesthesia, Plasmapheresis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine; supplements
Current Illness: none
Preexisting Conditions: hypertension
Allergies: tetracycline (GI sx)
Diagnostic Lab Data: CSF with normal cells and protein 124. Hyponatremia 130s-- $g118--- $g 125
CDC Split Type:

Write-up: Guillain-Barre Syndrome- prosimal upper limb malgias, followed by progressive 4-limb (prox$gdistal) weakness, hand paresthesias, bifacial weakness, areflexia, over 4-5 days. Course complicated by SIADH and hyponatremia. Currently treating with plasmapheresis.


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