Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dyspnoea, Eyelid ptosis, Fall, Guillain-Barre syndrome, Inappropriate schedule of product administration
Clinical narrative: be paralyzed; left eye continues to droop; difficulty breathing; got up during the night and stood and fell right down; experiencing tingling in both feet; Guillain-Barre syndrome; first dose on 03 March 2023 and second dose on 23 April 2023; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 28-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 23-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose on 03 March 2023 and second dose on 23 April 2023). On 14-MAY-2023, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria hospitalization, disability, GSK medically significant and clinically significant/intervention required) and tingling of extremity (Verbatim: experiencing tingling in both feet) (serious criteria hospitalization, disability and clinically significant/intervention required). On 20-MAY-2023, the patient experienced fall (Verbatim: got up during the night and stood and fell right down) (serious criteria hospitalization, disability and clinically significant/intervention required). On 27-MAY-2023, the patient experienced paralysis (Verbatim: be paralyzed) (serious criteria hospitalization, disability, GSK medically significant and clinically significant/intervention required), ptosis (Verbatim: left eye continues to droop) (serious criteria hospitalization, disability and clinically significant/intervention required) and difficulty breathing (Verbatim: difficulty breathing) (serious criteria hospitalization, disability and clinically significant/intervention required).  The outcome of the guillain barre syndrome was not reported and the outcome of the paralysis, ptosis, difficulty breathing, fall and tingling of extremity were not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the guillain barre syndrome, paralysis, ptosis, difficulty breathing, fall, tingling of extremity and drug dose administration interval too short to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome, paralysis, ptosis, difficulty breathing, fall, tingling of extremity and drug dose administration interval too short to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-AUG-2023 Patients' wife reported when he received the first dose of Shingrix he had no issues. After administration of second dose, he experienced tingling in both feet's from which he did not recovered. When he got up in the night and stood, he felt right down. His wife called the emergency medical service and during the emergency medical service patient stared having the difficulty in breathing. After 24 hours of hospitalization spinal tab was performed which diagnosed into Guillain-Barre syndrome. He was not recovered from any of these events and continued to be paralyzed and his left eye continued to droop. He was admitted to the care of neurologist. The patient was placed on the ventilator in intensive care unit. After the discharge for 31 days, he was sent to the rehabilitation center before being sent to home. He continued to receive occupational physical therapy, at home 4 days per week. On 28th April 2023, the patient received the 2nd dose of Shingrix 5 days earlier, which led to which led to shortening of vaccinations schedule. The reporter consented to follow up.