Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Guillain-Barre syndrome, Inflammation, Insomnia
Clinical narrative: Her GP thought it was just a case of inflammation; Cardiologist thought it was the Gillian Barre; During the night, going from the bed to bathroom caller experienced leg weakness, difficulty walking; Difficulty walking/ legs were not working well; Not being able to sleep very well; Had to grab the cane by the bed for times her back gives out; About 7 or 8 hours later caller had some body aches and muscle aches; About 7 or 8 hours later caller had some body aches and muscle aches; Her legs were very weak, fatigued, tired; This spontaneous case was reported by a patient and describes the occurrence of GUILLAIN-BARRE SYNDROME (Cardiologist thought it was the Gillian Barre) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02UD2114, 039B21A and 0021321A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcer (She cannot take any NSAIDS and can only take Tylenol.). Concurrent medical conditions included Fibromyalgia (Diagnosed about 15 years ago so she is used to the body aches and achiness).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MUSCULAR WEAKNESS (During the night, going from the bed to bathroom caller experienced leg weakness, difficulty walking), GAIT DISTURBANCE (Difficulty walking/ legs were not working well), INSOMNIA (Not being able to sleep very well), MUSCULOSKELETAL DISCOMFORT (Had to grab the cane by the bed for times her back gives out), PAIN (About 7 or 8 hours later caller had some body aches and muscle aches), MYALGIA (About 7 or 8 hours later caller had some body aches and muscle aches) and FATIGUE (Her legs were very weak, fatigued, tired). In August 2022, the patient experienced GUILLAIN-BARRE SYNDROME (Cardiologist thought it was the Gillian Barre) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLAMMATION (Her GP thought it was just a case of inflammation). In November 2021, MUSCULAR WEAKNESS (During the night, going from the bed to bathroom caller experienced leg weakness, difficulty walking), GAIT DISTURBANCE (Difficulty walking/ legs were not working well), INSOMNIA (Not being able to sleep very well), MUSCULOSKELETAL DISCOMFORT (Had to grab the cane by the bed for times her back gives out), PAIN (About 7 or 8 hours later caller had some body aches and muscle aches), MYALGIA (About 7 or 8 hours later caller had some body aches and muscle aches) and FATIGUE (Her legs were very weak, fatigued, tired) had resolved. At the time of the report, GUILLAIN-BARRE SYNDROME (Cardiologist thought it was the Gillian Barre) and INFLAMMATION (Her GP thought it was just a case of inflammation) outcome was unknown.            No concomitant and treatment medications were reported.  About 7 or 8 hours later she had some body aches and muscle aches. During the night, going from the bed to bathroom she experienced leg weakness, difficulty walking. Patient also reported legs were very weak, fatigued, tired, not being able to sleep very well, legs were not working well. Most of her doctor (GP) said that they think it was just a case of inflammation and to take Tylenol next time. The patient went to their cardiologist and the first thing they thought was the Guillain-Barre and would not considered the leg weakness as a side effect and to not take any more shots. Patient had no leg weakness with the first two shots. No other leg weakness since that night.  Company comment: This is a spontaneous case concerning a 77-year-old female patient with no relevant medical history, who had the unexpected serious (medically significant) adverse event of special interest of Guillain-Barre syndrome, which occurred approximately 9 months after receiving a dose of mRNA-1273 vaccine (reported as third dose). On the same day after the vaccination, the patient started to have body aches, muscle aches, leg weakness, difficulty walking, back discomfort, fatigued, and unable to sleep very well. The next day the symptoms were resolved. patient sought consult with physicians who told her that it was a case of inflammation and was advised to take paracetamol. Patient also sought consult with a cardiologist and was told it could be related to Guillain-Barre syndrome. However, no diagnostic workup to support the diagnosis and treatment medication were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-637960 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 77-year-old female patient with no relevant medical history, who had the unexpected serious (medically significant) adverse event of special interest of Guillain-Barre syndrome, which occurred approximately 9 months after receiving a dose of mRNA-1273 vaccine (reported as third dose). On the same day after the vaccination, the patient started to have body aches, muscle aches, leg weakness, difficulty walking, back discomfort, fatigued, and unable to sleep very well. The next day the symptoms were resolved. patient sought consult with physicians who told her that it was a case of inflammation and was advised to take paracetamol. Patient also sought consult with a cardiologist and was told it could be related to Guillain-Barre syndrome. However, no diagnostic workup to support the diagnosis and treatment medication were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.