Sex: M
Vaccine: PNC20, RSV, PNC20, RSV, PNC, RSV
Symptoms: Balance disorder, Blood glucose normal, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: guillain-barre syndrome; feeling numbness in fingers and legs about 48 hours after receiving vaccination/ worsening numbness; elevated blood glucose levels to (125-130 from his usual 95-99); tingling with numbness spreading up to the knees; have balance issues; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2777180-1 (VAERS ID), 2785711-1 (VAERS ID). Other Case identifier(s): USGSKUS2024AMR102770 (GSK).  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25May2024 as dose 1, single (Lot number: HK6938) intramuscular, in left arm for immunisation; rsv vaccine prot. subunit pref3 (AREXVY), on 25May2024 as dose 1, single (Lot number: DT9S3) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes with neurologic complications" (ongoing); "stage 3b chronic kidney disease" (ongoing); "hyperlipidemia" (ongoing); "underactive thyroid" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; JULUCA; METFORMIN. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 27May2024, outcome "recovered" (2024), described as "elevated blood glucose levels to (125-130 from his usual 95-99)"; HYPOAESTHESIA (non-serious) with onset 27May2024, outcome "not recovered", described as "feeling numbness in fingers and legs about 48 hours after receiving vaccination/ worsening numbness"; GUILLAIN-BARRE SYNDROME (medically significant) with onset 27May2024, outcome "unknown"; BALANCE DISORDER (non-serious) with onset 2024, outcome "unknown", described as "have balance issues"; PARAESTHESIA (non-serious) with onset 2024, outcome "not recovered", described as "tingling with numbness spreading up to the knees". The events "guillain-barre syndrome" and "have balance issues" required physician office visit. The patient self-reported feeling numbness in fingers and legs about 48 hours after receiving vaccination. He also reported elevated blood glucose levels to (125-130 from his usual 95-99) for 3-4 weeks after receiving vaccination. Over a period of a few weeks, patient had worsening numbness and tingling with numbness spreading up to the knees. Patient began to have balance issues, so he went to his primary care doctor on 02Jul2024 where the doctor suspected Guillain-Barre syndrome. The primary care doctor gave a referral to a neurologist for the patient to follow-up with. The patient reported his glucose levels returning to normal, but has not had any improvement in his numbness and tingling. The company (GSK) considered the guillain barre syndrome to be unrelated to Arexvy. It was unknown if GSK considered the balance disorder, hypoesthesia, blood glucose increased and tingling to be related to Arexvy. The patient underwent the following laboratory tests and procedures: Blood glucose: (unspecified date) 95-99, notes: usual; (27May2024) 125-130, notes: elevated blood glucose levels to (125-130 from his usual 95-99) for 3-4 weeks; (2024) normal, notes: glucose levels returning to normal. Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.  No follow-up attempts are possible.  Follow-up (11Sep2024): This is a spontaneous report received from a consumer (patient) via Agency. Regulatory number: 2777180-1 (VAERS ID), 2785711-1 (VAERS ID). Other Case identifier(s): USGSKUS2024AMR102770 (GSK). Updated information: medical history (ongoing updated), event details (onset date added, outcome of blood glucose increased updated to recovered), causality assessment (from GSK).  No follow-up attempts are possible.