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; Balance disorder; feeling numbness in fingers and legs; elevated blood glucose levels; tingling with numbness spreading up to the knees; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DT9S3) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevenar 20) (batch number HK6938) for prophylaxis.   Concurrent medical conditions included diabetic complication neurological, chronic kidney disease stage g3b and hyperlipidemia. Concomitant products included dolutegravir sodium;rilpivirine hydrochloride (Juluca), atorvastatin and metformin.   On 25-MAY-2024, the patient received the 1st dose of Arexvy (intramuscular, left arm) and the 1st dose of Prevenar 20 (intramuscular, left arm). On 27-MAY-2024, 2 days after receiving Arexvy and an unknown time after starting Juluca, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), balance disorder (Verbatim: Balance disorder), hypoesthesia (Verbatim: feeling numbness in fingers and legs), blood glucose increased (Verbatim: elevated blood glucose levels) and tingling (Verbatim: tingling with numbness spreading up to the knees). The outcome of the guillain barre syndrome and balance disorder were not reported and the outcome of the hypoesthesia and tingling were not resolved and the outcome of the blood glucose increased was resolved.   It was unknown if the reporter considered the guillain barre syndrome, balance disorder, hypoesthesia, blood glucose increased and tingling to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy. It was unknown if the company considered the balance disorder, hypoesthesia, blood glucose increased and tingling to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-AUG-2024 The patient self-reported. Patient reported feeling numbness in fingers and legs about 48 hours after receiving vaccination.  He also reported elevated blood glucose levels to (125 to 130 from his usual 95 to 99) for 3 to 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 had balance issues, so he went to his primary care doctor on 02 Jul 2024 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 reports his glucose levels returning to normal, but not had any improvement in his numbness and tingling.  It was unknown if the reporter considered the guillain barre syndrome, balance disorder, hypoesthesia, blood glucose increased and tingling to be related to Prevenar 20.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.