Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Incomplete course of vaccination, Insomnia, Loss of personal independence in daily activities
Clinical narrative: he developed a decrease in range of motion; extreme difficulty walking; extreme difficulty controlling fine motor movements; extreme difficulty sleeping at night.; fingers became puffy; painful to touch/press the extremitie muscles; opening jars/changed the way had to conduct life.; will not proceed with the 2nd vaccine.; diagnosed with Guillain-Barré Syndrome; weakness in hands and feet, progressed to muscle legs; pain in hands and feet, progressed to muscle legs; paresthesia in hands and feet, progressed to muscle legs; "weird" feeling in hands and feet muscles, it progressed; This case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix ml. In June 2021, 1 week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle discomfort. On 15th July 2021, the patient experienced muscle weakness, pain in hand and paresthesia hand. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), mobility decreased, walking difficulty, movement disorder, difficulty sleeping, swelling of fingers, muscle pain, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the guillain barre syndrome, muscle discomfort, paresthesia hand, mobility decreased, walking difficulty, movement disorder, difficulty sleeping, swelling of fingers, activities of daily living impaired and incomplete course of vaccination were unknown and the outcome of the muscle weakness, pain in hand and muscle pain were recovering/resolving.   The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the muscle discomfort, muscle weakness, pain in hand, paresthesia hand, mobility decreased, walking difficulty, movement disorder, difficulty sleeping, swelling of fingers, muscle pain and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 09 DEC 2022 Reporter's comment: This case was reported by physician (patient). The physician reported that the patient got the first Shingrix vaccine on arm and then a week following the vaccine the patient started getting a weird feeling in the muscles of his hands and feet.  Over the new few weeks, this feeling progressed and by 15th July 2021 (1 month later) the patient had weakness, pain, and paresthesia in mainly his hands and feet. Over the following weeks and months, these symptoms progressed to the larger muscle groups in his legs and hands. In the beginning, the pain occurred mainly at rest and movement helped subside the pain and paresthesia, the pain then progressed to occur during movement and the patient developed a decrease in range of motion.  Following 6 to 12 months post getting the Shingrix vaccine, the patient had extreme difficulty walking, controlling fine motor movements, opening jars, and sleeping at night. His fingers became puffy and it was very painful to touch, press on the muscles of his extremities. Over the course of the weeks and months following the Shingrix vaccine, the patient was diagnosed with Guillain-Barré Syndrome. The patient stated that it completely changed the way him and his family had to conduct life. At around the 12-month mark following the Shingrix vaccine, the patient started to see improvements in his motor skills, weakness, and pain. Currently, he was fairly pain free and his motor skills were continuing to progress back to a more normal state.  The patient would not proceed with getting the second vaccine. Reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination.