Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Computerised tomogram head normal, Electrocardiogram, Full blood count
Clinical narrative: CSF PROTEIN INCREASED; CSF TEST ABNORMAL; ANGIOGRAM CEREBRAL NORMAL; COMPUTERISED TOMOGRAM HEAD NORMAL; MAGNETIC RESONANCE IMAGING HEAD NORMAL; GUILLAIN-BARRE SYNDROME; PARAESTHESIA; MUSCULAR WEAKNESS; This spontaneous report was received from literature:, via Regulatory authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1303022) concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included: prostatectomy, deep vein thrombosis, and pulmonary embolism, and concurrent conditions included: hypertension, non insulin-dependent diabetes mellitus, prostate cancer, and dyslipidemia, and other pre-existing medical conditions included: The patient had no known drug allergies. Current illness at time vaccination: none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine, apixaban, benazepril, gemfibrozil, metformin, oxybutynin, and sildenafil.  On 25-MAR-2021, the patient experienced Guillain-barre syndrome, paraesthesia and muscular weakness. On 28-MAR-2021, the patient experienced csf protein increased, csf test abnormal, angiogram cerebral normal, computerised tomogram head normal, and magnetic resonance imaging head normal and was hospitalized for 9 days (date unspecified). It was reported that patient with diabetes mellitus, hypertension, and prostate cancer in complete remission presented to an acute care center after experiencing 3 days of bilateral lower extremity paresthesia and weakness. During that time, he developed lower limb paresthesia followed by weakness that spread symmetrically in a distal-to-proximal pattern. As a result, he was unable to ambulate despite being physically active prior to symptoms onset. He did not recount having difficulty with chewing, swallowing, breathing, bowel movements, or voiding. Additionally, he denied having facial weakness or paresthesia, vision changes, palpitations, and back or extremity pain. There was no recent history of travel, trauma, or gastrointestinal or respiratory symptoms. Further, he never tested positive for COVID-19. He received a single dose of the Ad26.COV2.S vaccination 14 days prior to hospital admission. Upon hospital admission, neurological examination revealed decreased upper and lower extremity muscle strength, absent lower extremity deep tendon reflexes, and reduced upper and lower extremity sensory response to light touch. He demonstrated flexor planter reflex and negative clonus on exam. Due to his lower extremity weakness, he was unable to participate in gait assessment. He remained conscious, oriented, and any without mental status changes throughout hospitalization. His vitals revealed intermittent hypotension and bradycardia, but he did not report related symptoms. Brain and whole-spine MRI findings were not indicative of acute pathology. Lumbar puncture results showed normal opening pressure, elevated cerebrospinal fluid (CSF) protein 75.0 mg/dL, albumin- cytological dissociation, and no growth of organisms. Chest radiography was unremarkable, and 12-lead EKG demonstrated normal sinus rhythm. The SARS-COV-2 RT-PCR result from the nasopharyngeal swab was negative. Complete blood count and comprehensive metabolic panel were within normal limits. Serologic polyneuropathy screening tests ruled out thiamine, folate and cyanocobalamin deficiency, Lyme disease, HIV, and syphilis. Taken together, these clinical findings pointed toward a diagnosis of GBS (uillain-Barré Syndrome). While in the acute care setting, intravenous immunoglobulins (IVIG) were administered at a dose of 2 mg/kg over the course of 5 days. His lower extremity muscle strength subsequently improved, and he was transferred for inpatient rehabilitation. On day 15 of inpatient rehabilitation, he began to experience ascending bilateral upper extremity weakness and paresthesia. His lower extremity weakness simultaneously worsened. Due to his acute neurological decline, he was transferred to an acute care hospital, where he underwent plasma exchange for 10 days. Once stabilized, he returned to the inpatient rehabilitation facility for 7 days. Sequential neurological examinations during this time did not indicate changes in motor or sensory function. Owing to his lack of progress in therapy and inability to perform activities of daily living, he is continuing medical management and therapy at a long-term care facility. On 28-MAR-2021, Laboratory data included: Cerebrospinal fluid with albuminocytologic dissociation (PTs CSF protein increased, CSF test abnormal); Non contrast computerized tomogram head without acute findings (PT Computerised tomogram head normal); Magnetic resonance imaging (MRI) head/brain without acute findings (PT Magnetic resonance imaging head normal); Magnetic resonance angiography (MRA) brain without acute findings (PT Angiogram cerebral normal). The Author emphasized that the other health professional (HCP) should be aware of the temporal association between the Ad26.COV2.S (Johnson & Johnson/Janssen) vaccine and the onset of GBS was demonstrated in this case report. A feasible underlying pathogenic mechanism involves the cross-reactivity of antibodies stimulated by adenovirus vaccine components and peripheral nerve glycoproteins. However, there was currently insufficient evidence to support a causal relationship between Ad26. COV2.S and the development of GBS. Further evidence gathered from clinician surveillance and clinical trials were needed to draw these conclusions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Guillain-barre syndrome, paraesthesia, muscular weakness, csf protein increased, csf test abnormal, angiogram cerebral normal, computerised tomogram head normal, and magnetic resonance imaging head normal on 2021. This report was serious (Hospitalization Caused / Prolonged).  Additional information was received from health care professional (literature): on 16-Feb-2022. The following information was updated and incorporated into the case narrative: Added reporters (authors added), lab tests (serology test, comprehensive metabolic panel, complete blood count, SARS-CoV-2 PCR test, EKG, chest radiography, protein, lumbar puncture and neurological examination), literature details (publication date and edition added), event description, batch number statement updated and updated narrative.; Sender's Comments: V1: This follow up version updates information about- Added reporters (authors added), lab tests (serology test, comprehensive metabolic panel, complete blood count, SARS-CoV-2 PCR test, EKG, chest radiography, protein, lumbar puncture and neurological examination), literature details (publication date and edition added), event description, batch number statement updated and updated narrative. This updated information does not alter the causality of previously reported events.  This case, received from VAERS (ID# 1303022), concerns a 66 year old male patient, who was diagnosed with Guillain-Barre syndrome 12 days after receiving the Janssen COVID-19 vaccine.  He has a history of prostate cancer, hypertension, diabetes, dyslipidemia, deep venous thrombosis and pulmonary embolism.  He experienced lower extremity weakness, bilateral hand paresthesia, and areflexia, and neurologists made the diagnosis of Guillain-Barre syndrome.  Cerebrospinal fluid demonstrated albuminocytologic dissociation. Non-contrast computerized tomogram  of the head and  Magnetic resonance imaging/angiography were without acute findings.  Information regarding other potential etiologies was insufficient. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.