Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome six weeks after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome six weeks after booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 028L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, High cholesterol and Muscle spasms. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cardiovascular event prophylaxis, INFLUENZA VACCINE (FLU) for Flu, ROSUVASTATIN CALCIUM (CRESTON) for High cholesterol, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Muscle spasms, FAMOTIDINE (PEPCID AC) for Stomach discomfort.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome six weeks after booster dose) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 06-Dec-2021 to 22-Dec-2021 due to GUILLAIN-BARRE SYNDROME. In January 2022, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome six weeks after booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no history of COVID-19. 6 weeks after the booster dose of Moderna vaccine, patient developed Guillain Barre syndrome. Patient was admitted to the hospital on 06-Dec-2021 and discharged on 22-Dec-2021. Patient has recovered at home. Patient believes she had already recovered since the middle of JAN-2022. Patient has not experienced a similar event in the past. Patient received the Flu vaccine with the booster at the same time. Patient had no information about the Flu vaccine. Treatment given for symptoms: Contact information from Medical Center provided with full medical history. Consent for Safety follow-up with patient, HCP and vaccine facilities was provided. Patient can also provide primary care doctor and a neurologist contact information.  Company Comment: This is a spontaneous case concerning a 71-year-old, female patient with no medical history reported, who experienced the unexpected, serious (Hospitalized and Medically Significant), AESI event of Guillain-Barre syndrome. The event occurred 40 days after the third dose of mRNA-1273 vaccine. At the time of report, outcome of the event was Resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old, female patient with no medical history reported, who experienced the unexpected, serious (Hospitalized and Medically Significant), AESI event of Guillain-Barre syndrome. The event occurred 40 days after the third dose of mRNA-1273 vaccine. At the time of report, outcome of the event was Resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.