Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood folate, Blood pressure measurement, Body temperature, CSF glucose, CSF lymphocyte count
Clinical narrative: Guillain-Barre syndrome (GBS); Diarrhea; This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome (GBS)) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:    Concurrent medical conditions included Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome (GBS)) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was hospitalized for 309 days due to GUILLAIN-BARRE SYNDROME. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) (intravenous) at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome (GBS)) had resolved with sequelae and DIARRHOEA (Diarrhea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood folate: 14.27 ng/mL. On an unknown date, Blood pressure measurement: 119/68. On an unknown date, Body temperature: 36.8 degree Celsius. On an unknown date, CSF glucose: 67 mg/dl. On an unknown date, CSF lymphocyte count: 1 cells per cubic millimetre. On an unknown date, CSF protein: 417 mg/dl. On an unknown date, CSF red blood cell count: 20 cells per cubic millimetre. On an unknown date, CSF test: demonstrated albuminocytologic dissociation. On an unknown date, Cardiovascular examination: regular rate and rhythm with a normal S1/S2 without murmurs, rub, or gallop. On an unknown date, Computerised tomogram head: Unremarkable. On an unknown date, Gram stain: NGTD. On an unknown date, Heart rate: 86. On an unknown date, Lumbar puncture: demonstrated an elevated protein level of 417 mg/dl and normal white blood cell count of 1 cell/mm3, consistent with albuminocytologic dissociation. On an unknown date, Magnetic resonance imaging head: showed no acute diffusion or abnormal enhancement.. On an unknown date, Magnetic resonance imaging neck: showed degenerative changes with some stenosis, most significant at C5/6.. On an unknown date, Mini mental status examination: demonstrated normal attention, language, memory, concentration, and knowledge. On an unknown date, Physical examination: Bilateral upper-extremity strength was rated 3/5 and bilateral lower-extremity strength was 1/5. The patient had intact sensation to touch in the upper extremities and paresthesia of the fingertips and plantar surface of the foot. On an unknown date, Respiratory rate: 17. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Treponema test: Non reactive. On an unknown date, Vitamin B12 (208-964): 1994 pg/ml.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome (GBS)) and DIARRHOEA (Diarrhea) to be related.    No concomitant medications were reported.  Three days after receiving the vaccine, patient experienced concurrent diarrhea and symmetric weakness in lower extremities and patient also presented with paraesthesia.The weakness was constant and prohibited patient from walking or participating in activities of daily living, therefore necessitating use of a wheelchair.patient did not have history of COVID-19 prior to vaccination, and also tobacco, alcohol, or drug use. Patient had a past medical history for hypertension but was not currently taking any medications. Patient did not have family history of neurologic, cardiac, or kidney disorders. The combination of the patient CSF findings and clinical symptoms was concerning for Guillain-Barre syndrome. Given the clinical findings 3 days following COVID-19 vaccination, there was a high concern for COVID-19 vaccine-induced Guillain-Barre syndrome. The patient was treated with IVIG (intravenous immunoglobulin) followed by plasmapheresis but failed to show significant improvement from either treatment. Patient  received physical therapy and inpatient rehabilitation with moderate improvement in symptoms.  On examination patient's cranial nerves I-XII were intact. The patient was areflexic in the bilateral upper and lower extremities. Patient  had a normal finger-to-nose test but was unable to perform a heel-to-shin test due to weakness The patient had an MRI of the lumbar, thoracic, and cervical spine as well, which showed degenerative changes with some stenosis, most significant at C5/6. The patient was categorized as Brighton Criteria level 2 based on absent deep-tendon reflexes. On examination of  CSF color was coloress.  Company comment: This literature case concerns a male patient aged 58 years, with no relevant medical history reported, who experienced the unexpected serious (medically significant/Hospitalization) AESI of Guillain-Barre Syndrome that occurred after the first dose of mRNA-1273 vaccination. Patient experienced concurrent diarrhoea and symmetric weakness in lower extremities 3 days after vaccination. Diarrhoea was resolved with persisting weakness which came in the way of his day today activities necessitating use of a wheel¬chair. Patient presented to the hospital 4 weeks later due to complex social reason. Vitals, cardiac status and mental assessment were within normal limits, Bilateral upper-extremity strength was rated 3/5 and bilateral lower-extremity strength was 1/5. The patient had intact sensation to touch in the upper extremities and paresthesia of the fingertips and plantar surface of the foot. Cranial nerves I-XII were intact. The patient was areflexic in the bilateral upper and lower extremities. He had a normal finger-to-nose test but was unable to perform a heel-to-shin test due to weakness. He tested negative for COVID-19. Patient had a non-reactive treponemal, folate of 14.27 ng/ml, and elevated B12 of 1994 pg/ml, so ruled out B12 deficiency and polyradiculopathy due to HIV. A lumbar puncture performed showed an elevated protein level of 417 mg/dl and normal white blood cell count of 1 cell/mm3, consistent with albuminocytologic dissociation A computed tomography (CT) scan and magnetic resonance imaging (MRI)  of the brain was unremarkable. MRI of the lumbar, thoracic, and cervical spine showed degenerative changes with some stenosis, most significant at C5/6. The patient was categorized as Brighton Criteria level 2 based on absent deep-tendon reflexes, 72-h onset, bilateral weakness of limbs, cerebrospinal fluid (CSF) white blood cell count < 50, and CSF protein count greater than accepted normal values.Based on the patient's clinical symptoms and CSF findings, a diagnosis of GBS was made. Patient was treated with intravenous immunoglobulin for 5 days, for which no improvement was seen. Hence given a 5-day treatment of plasma exchange. Inspite of this not much improvement was seen, so continued with physical therapy and inpatient rehabilitation with moderate improvement in his symptoms. He was discharged after 309 days of hospitalization without any notable events and without the need for ICU level of care. He was able to ambulate using a walker on discharge.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2022: Live Follow-up received by safety on 18-Aug-2022 has email with full text article received and contains significant information. Reporter information, Literature information, medical history, laboratory data,   and event information were updated.; Sender's Comments: This literature case concerns a male patient aged 58 years, with no relevant medical history reported, who experienced the unexpected serious (medically significant/Hospitalization) AESI of Guillain-Barre Syndrome that occurred after the first dose of mRNA-1273 vaccination. Patient experienced concurrent diarrhoea and symmetric weakness in lower extremities 3 days after vaccination. Diarrhoea was resolved with persisting weakness which came in the way of his day today activities necessitating use of a wheel¬chair. Patient presented to the hospital 4 weeks later due to complex social reason. Vitals, cardiac status and mental assessment were within normal limits, Bilateral upper-extremity strength was rated 3/5 and bilateral lower-extremity strength was 1/5. The patient had intact sensation to touch in the upper extremities and paresthesia of the fingertips and plantar surface of the foot. Cranial nerves I-XII were intact. The patient was areflexic in the bilateral upper and lower extremities. He had a normal finger-to-nose test but was unable to perform a heel-to-shin test due to weakness. He tested negative for COVID-19. Patient had a non-reactive treponemal, folate of 14.27 ng/ml, and elevated B12 of 1994 pg/ml, so ruled out B12 deficiency and polyradiculopathy due to HIV. A lumbar puncture performed showed an elevated protein level of 417 mg/dl and normal white blood cell count of 1 cell/mm3, consistent with albuminocytologic dissociation A computed tomography (CT) scan and magnetic resonance imaging (MRI)  of the brain was unremarkable. MRI of the lumbar, thoracic, and cervical spine showed degenerative changes with some stenosis, most significant at C5/6. The patient was categorized as Brighton Criteria level 2 based on absent deep-tendon reflexes, 72-h onset, bilateral weakness of limbs, cerebrospinal fluid (CSF) white blood cell count < 50, and CSF protein count greater than accepted normal values.Based on the patient's clinical symptoms and CSF findings, a diagnosis of GBS was made. Patient was treated with intravenous immunoglobulin for 5 days, for which no improvement was seen. Hence given a 5-day treatment of plasma exchange. Inspite of this not much improvement was seen, so continued with physical therapy and inpatient rehabilitation with moderate improvement in his symptoms. He was discharged after 309 days of hospitalization without any notable events and without the need for ICU level of care. He was able to ambulate using a walker on discharge.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report