Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electromyogram abnormal, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This spontaneous case was reported by a patient and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 058F21A, 045A21A and 01B21A) for COVID-19 prophylaxis.  Patient had no allergies to medications, food and other products. Patient never had COVID positive test or diagnosis. Patient had no history of both acute and chronic illnesses at the time of vaccination and no vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. Concomitant products included LEVOTHYROXINE, ATENOLOL (ATENOL) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.  On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant). The patient was treated with Physical therapy for Guillain-Barre syndrome. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) had not resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  It was reported that patient had Guillain-Barre syndrome after receiving the 2nd booster dose. Patient went to the emergency room like 4 times between the month of April and May. Patient was diagnosed with Guillain-Barre syndrome in 23May2022. Patient did not had any other side effects. In addition, due to her condition she had not been able to go to work for a couple of months. Patient treatment details were reported as getting treated for Guillain-Barre syndrome and was given the 5 IVID treatment. Patient was also getting physical therapy and patient symptoms were about the same.  Company comment: This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI event of Guillain-Barre syndrome. The event occurred 35 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. The event was reported as not resolved. It was reported patient has Guillain-Barre syndrome after receiving the second booster dose. Patient treatment details were reported as Getting treated for Guillain-Barre syndrome and was given the 5 IVID treatment of unknown dosage and frequency. Patient is also getting physical therapy. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Event seriousness is assessed as per regulatory authority's report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI event of Guillain-Barre syndrome. The event occurred 35 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. The event was reported as not resolved. It was reported patient has Guillain-Barre syndrome after receiving the second booster dose. Patient treatment details were reported as Getting treated for Guillain-Barre syndrome and was given the 5 IVID treatment of unknown dosage and frequency. Patient is also getting physical therapy. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Event seriousness is assessed as per regulatory authority's report.