Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, CSF glucose, CSF protein, CSF red blood cell count, CSF white blood cell count
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barré Syndrome with sub-acute onset) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endotracheal intubation. Concurrent medical conditions included Hypertension, Hyperlipidemia, Hypothyroidism and Bipolar disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barré Syndrome with sub-acute onset) (seriousness criteria hospitalization, medically significant and life threatening) and HYPOTENSION (hypotension). The patient was treated with MIDODRINE for Hypotension, at an unspecified dose and frequency and Rehabilitation therapy (plasma exchange) for Hypotension. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barré Syndrome with sub-acute onset) and HYPOTENSION (hypotension) was resolving. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid (1.2 mmol/l-2.1 mmol/l): 1.6 mmol/l (normal) 1.6 mmol/L. On an unknown date, CSF glucose (50 mg/dl-70 mg/dl): 65 mg/dl (normal) 65 mg/dL. On an unknown date, CSF protein (20 mg/dl-40 mg/dl): 59 mg/dl (High) 59 mg/dL. On an unknown date, CSF red blood cell count: 0 cells / cumm Reference range is less than 1 cells /cumm Result 0 cells / cumm. On an unknown date, CSF white blood cell count (0 cells / cumm-5 cells / cumm): less than 1 cells / cumm (normal) less than 1 cells / cumm. On an unknown date, Electromyogram: abnormal Electromyography demonstrated borderline reduced recruitment with borderline high amplitude, long duration motor unit potentials in the triceps, deltoid, vastus medialis, and tensor fascia lata muscles.. On an unknown date, Forced vital capacity: abnormal (abnormal) Few hours into admission, patient's respiratory status declined with drop in forced vital capacity (FVC) requiring emergency endotracheal intubation.. On an unknown date, Lumbar puncture: albumino-cytological dissociation Spinal tap revealed albumino-cytological dissociation. On an unknown date, Magnetic resonance imaging: normal (normal) Postcontrast images demonstrated no abnormal parenchymal or meningeal enhancement.. On an unknown date, Magnetic resonance imaging head: normal (normal) Magnetic Resonance Imaging (MRI) brain showed no evidence of acute intracranial hemorrhage, ischemia/infarct, or brain edema.. On an unknown date, Magnetic resonance imaging neck: no evidence of myelopathy no evidence of myelopathy. On an unknown date, Nerve conduction studies: abnormal (abnormal) Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude.. On an unknown date, Physical examination: abnormal (abnormal) Physical examination was remarkable for decreased power of 2/5 in bilateral lower extremities involving proximal and distal muscles and 4/5 in bilateral upper extremities throughout. Muscle tone and bulk were normal. Sensations were diminished to light touch throughout in lower and upper extremities. Deep tendon reflexes were absent in the lower and upper extremities. No involuntary movements were noted during physical exam.. On an unknown date, SARS-CoV-2 test: negative (Negative) Routine screening of SARS-CoV-2 was negative. On an unknown date, Serology test: negative (Negative) Serology was negative for GQ1B antibodies. On an unknown date, Xanthochromia: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GUILLAIN-BARRE SYNDROME (Guillain Barré Syndrome with sub-acute onset) and HYPOTENSION (hypotension) to be possibly related.    Concomitant product use was not provided by the reporter. Treatment information was not provided.  Severe dysmetria was noted during the finger-nose-finger test. Patient presented to the hospital with complaints of worsening weakness involving her lower extremities for 8 weeks. Her weakness started in her bilateral feet, gradually ascended up to involve waist and upper extremities. This was associated with ataxia and falls. Numbness in lower extremities and voice changes were also reported. Patient denied history of diarrhea, rhinorrhea, cough or congestion prior to the onset of above symptoms. Patient was then admitted to the neurology service with the impression of Guillain Barré Syndrome. Plasma exchange was initiated subsequently. MRI of cervical, thoracic and lumbar spine showed no evidence of myelopathy. Plasma exchange was continued for a total of five sessions. Her symptoms gradually improved and the patient was subsequently extubated. The hospital course was further complicated by autonomic symptoms such as hypotension that was managed with midodrine. She was subsequently discharged to a facility for continued rehabilitation. Patient had developed symptoms acutely 10 days after being inoculated with the first dose of covid-19 vaccine. But, the nadir of symptoms reached sometime between 10 and 12 weeks. The presence of an antecedent event, autonomic symptoms such as hypotension and the need for ventilator support favored the diagnosis of GBS than chronic inflammatory demyelinating polyneuropathy (CIDP).  This literature review case concerns a 49 year old female with no relevant history who experienced the serious, unlisted AESI of Guillian-Barre syndrome 10 days after dose 1 of mRNA-1273. Re-challenge is not applicable as no second dose is planned. Benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received by safety 28-Oct-2021 has Email with FTA received from SARA team and does not contain any new information.; Sender's Comments: This literature review case concerns a 49 year old female with no relevant history who experienced the serious, unlisted AESI of Guillian-Barre syndrome 10 days after dose 1 of mRNA-1273. Re-challenge is not applicable as no second dose is planned. Benefit-risk relationship of mRNA-1273 is not affected by this report.