Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Sub-acute Onset of Guillain-Barre Syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (Sub-acute Onset of Guillain-Barre Syndrome) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy).    No Medical History information was reported.  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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GUILLAIN-BARRE SYNDROME (Sub-acute Onset of Guillain-Barre Syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Sub-acute Onset of Guillain-Barre Syndrome) outcome was unknown.      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 (Sub-acute Onset of Guillain-Barre Syndrome) to be related.    No concomitant and treatment medications were reported.  Patient had a gradual onset of lower extremity weakness with a nadir of symptoms reached 10 and 12 weeks after the onset. This protracted course (sub-acute) is atypical for a "classical" GBS. The presence of an antecedent event, autonomic symptoms such as hypotension, and the need for ventilator support favored the diagnosis of GBS.  Company comment: This case concerns a 49-year-old female patient with no medical history provided who experienced serious unexpected event of Guillain-Barre syndrome. The event occurred 10 days after the first dose of mRNA-1273. The patient had a gradual onset of lower extremity weakness with a nadir of symptoms reached 10 and 12 weeks after the onset. Authors speculated that this protracted course (sub-acute) is atypical for a "classical" GBS, however, the presence of an antecedent event, autonomic symptoms such as hypotension, and the need for ventilator support favored the diagnosis of GBS. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. The Reporter assessed the event as related to the Company product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 49-year-old female patient with no medical history provided who experienced serious unexpected event of Guillain-Barre syndrome. The event occurred 10 days after the first dose of mRNA-1273. The patient had a gradual onset of lower extremity weakness with a nadir of symptoms reached 10 and 12 weeks after the onset. Authors speculated that this protracted course (sub-acute) is atypical for a "classical" GBS, however, the presence of an antecedent event, autonomic symptoms such as hypotension, and the need for ventilator support favored the diagnosis of GBS. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. The Reporter assessed the event as related to the Company product. The benefit-risk relationship of mRNA-1273 is not affected by this report.