Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Peripheral sensory neuropathy
Clinical narrative: suspect that he may have had a mild Guillian-Barre episode from his Covid booster; bilateral sensory neuropathy in just his toes/ 3/31/22 visit the mild neuropathy was 80 % resolved; This spontaneous case was reported by a physician and describes the occurrence of GUILLAIN-BARRE SYNDROME (suspect that he may have had a mild Guillian-Barre episode from his Covid booster) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PERIPHERAL SENSORY NEUROPATHY (bilateral sensory neuropathy in just his toes/ 3/31/22 visit the mild neuropathy was 80 % resolved). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (suspect that he may have had a mild Guillian-Barre episode from his Covid booster) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (suspect that he may have had a mild Guillian-Barre episode from his Covid booster) outcome was unknown and PERIPHERAL SENSORY NEUROPATHY (bilateral sensory neuropathy in just his toes/ 3/31/22 visit the mild neuropathy was 80 % resolved) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In late Dec 2021 patient  described a bilateral sensory neuropathy in just his toes. His symptoms did not progress and at our 3/31/22 visit the mild neuropathy was 80 % resolved. He was not a Diabetic and was otherwise healthy. It was suspected that he may have had a mild Guillian-Barre episode from his Covid booster (his third Moderna shot). His Infuenza shot was given AFTER the onset of his symptoms. No treatment information was reported. Company comment: This spontaneous case concerns 64-year-old male patient, with no medical history reported, who experienced the unexpected, serious (due to medically significant) AESI of GUILLAIN-BARRE SYNDROME (reported as a suspect Guillain-Barre episode), after the booster dose of mRNA-1273 vaccine. No details about primary doses were provided. The month after the vaccination he started with a bilateral sensory neuropathy in his toes, and three months later the neuropathy was almost resolved. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 64-year-old male patient, with no medical history reported, who experienced the unexpected, serious (due to medically significant) AESI of GUILLAIN-BARRE SYNDROME (reported as a suspect Guillain-Barre episode), after the booster dose of mRNA-1273 vaccine. No details about primary doses were provided. The month after the vaccination he started with a bilateral sensory neuropathy in his toes, and three months later the neuropathy was almost resolved. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.