Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: CSF protein, CSF test, CSF white blood cell count, Electromyogram, Guillain-Barre syndrome
Clinical narrative: axonal-variant GBS; This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (axonal-variant GBS) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Ischemic stroke (Ischemic stroke with no residual deficits presented). Concurrent medical conditions included Atrial fibrillation, Type 2 diabetes mellitus and Aortic stenosis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (axonal-variant GBS) (seriousness criterion medically significant). The patient was treated with Surgery (plasmapheresis for five sessions) for Guillain-Barre syndrome. At the time of the report, GUILLAIN-BARRE SYNDROME (axonal-variant GBS) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CSF protein: 129 mg/dl 129 mg/dL. On an unknown date, CSF test: abnormal (abnormal) demonstrated albuminocytological dissociation consistent with GBS. The remainder of her CSF immunological studies was negative including protein electrophoresis, gram stain, glucose, viral PCR panel, and paraneoplastic antibody evaluation.. On an unknown date, CSF white blood cell count: < 1 cells/µl < 1 cells/µL. On an unknown date, Electromyogram: abnormal (abnormal) Confirmatory electromyography and nerve conduction studies (NCS) were performed which demonstrated low amplitude right peroneal, tibial, and ulnar motor evoked responses with normal distal latencies, segmental conduction velocities, and sensory responses, consistent with acute axonal motor neuropathy.. On an unknown date, Nerve conduction studies: abnormal (abnormal) Confirmatory electromyography and nerve conduction studies (NCS) were performed which demonstrated low amplitude right peroneal, tibial, and ulnar motor evoked responses with normal distal latencies, segmental conduction velocities, and sensory responses, consistent with acute axonal motor neuropathy.. On an unknown date, Neurological examination: abnormal (abnormal) Progressed from a subtle paraparesis to a dense lower-extremity predominant quadriparesis within one week.. On an unknown date, Serology test: negative (Negative) negative including thyroid function tests and anti-ganglioside antibodies..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GUILLAIN-BARRE SYNDROME (axonal-variant GBS) to be possibly related.    The author discussed that patient developed a progressive quadriparesis two days after receiving the second dose of the Moderna mRNA-based SARS-CoV-2 vaccine, in line with the time course of previously reported cases of post-vaccine associated GBS. The rapid progression of weakness, albuminocytological dissociation, and low amplitude motor evoked responses on NCS are all consistent with axonal-variant GBS.  The author concluded that while causality between vaccine administration and the development of GBS in our patient cannot be proved, the onset of symptoms is consistent with previously reported cases of post-vaccination GBS. Physicians should be aware of the possible temporal association between the SARS-CoV-2 vaccine and GBS since the prompt diagnosis and treatment of GBS can drastically improve outcomes.  Company comment: This literature case concerns an 86-year-old, female patient with a history of Ischemic stroke, Type 2 diabetes mellitus and Aortic stenosis, who experienced the unexpected serious AESI event of Guillain-Barre syndrome. The event occurred approximately 2 days after the second dose of mRNA-1273 vaccine. Plasmapheresis did not improve the symptoms. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available, additionally symptoms did not improve at the time of the report. The medical history of Ischemic stroke, Type 2 diabetes mellitus and Aortic stenosis remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Significant Follow up received by safety on 11-Nov-2021 included an Email with FTA received from team and contains new information. Updated lab tests and patient history.; Sender's Comments: This literature case concerns an 86-year-old, female patient with a history of Ischemic stroke, Type 2 diabetes mellitus and Aortic stenosis, who experienced the unexpected serious AESI event of Guillain-Barre syndrome. The event occurred approximately 2 days after the second dose of mRNA-1273 vaccine. Plasmapheresis did not improve the symptoms. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available, additionally symptoms did not improve at the time of the report. The medical history of Ischemic stroke, Type 2 diabetes mellitus and Aortic stenosis remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.