Sex: M
Vaccine: RSV
Symptoms: Pupillary reflex impaired, Red blood cell count, Unresponsive to stimuli, Upper motor neurone lesion, White blood cell count normal
Clinical narrative: GUILLAIN BARRE SYNDROME/ AIDP variant; ascending paralysis; unresponsive to verbal, tactile and noxious stimuli; Acute motor and sensory axonal neuropathy/AMSAN; lower extremity weakness/bilateral lower extremity weakness/reported mild drift of the lower extremity; dyspnea; paresthesias in the distal upper extremities; Weakness rapidly progressed; Plantar responses are mute bilaterally; myoclonus; reported mild drift of the lower extremity; anterior spinal artery syndrome; Weakness in cranial nerves; absent DTRs; chronically ill; pupil sluggishly reactive to light; Oculocephalic reflex absent/No corneal reflexes; This serious case was reported by a consumer via regulatory authority and described the occurrence of guillain barre syndrome in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included hyperlipidemia and tobacco user (previous tobacco smoker). Concurrent medical conditions included hypertension (Chronic medical conditions reported as hypertension,) and seasonal allergy. Additional patient notes included No known allergies to medications, food, or other products. No documented home medications, dietary supplements, or herbal remedies in medical records. The patient drink 2 to 3 beers per day. No documented illnesses reported for client in medical records..   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: GUILLAIN BARRE SYNDROME/ AIDP variant) (serious criteria hospitalization and GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria hospitalization and GSK medically significant), unresponsive to stimuli (Verbatim: unresponsive to verbal, tactile and noxious stimuli) (serious criteria hospitalization and GSK medically significant), acute motor-sensory axonal neuropathy (Verbatim: Acute motor and sensory axonal neuropathy/AMSAN) (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (Verbatim: lower extremity weakness/bilateral lower extremity weakness/reported mild drift of the lower extremity) (serious criteria hospitalization), dyspnea (Verbatim: dyspnea) (serious criteria hospitalization), paresthesia distal (Verbatim: paresthesias in the distal upper extremities) (serious criteria hospitalization), weakness (Verbatim: Weakness rapidly progressed) (serious criteria hospitalization), extensor plantar response (Verbatim: Plantar responses are mute bilaterally) (serious criteria hospitalization), myoclonus (Verbatim: myoclonus) (serious criteria hospitalization), pronator drift (Verbatim: reported mild drift of the lower extremity) (serious criteria hospitalization and GSK medically significant), anterior spinal artery syndrome (Verbatim: anterior spinal artery syndrome) (serious criteria hospitalization and GSK medically significant), paresis cranial nerve (Verbatim: Weakness in cranial nerves) (serious criteria hospitalization), tendon disorder (Verbatim: absent DTRs) (serious criteria hospitalization), illness (Verbatim: chronically ill) (serious criteria hospitalization), pupillary reflex impaired (Verbatim: pupil sluggishly reactive to light) (serious criteria hospitalization) and absent reflex (Verbatim: Oculocephalic reflex absent/No corneal reflexes) (serious criteria hospitalization). The outcome of the guillain barre syndrome, paralysis ascending, unresponsive to stimuli, acute motor-sensory axonal neuropathy, lower extremities weakness of, dyspnea, paresthesia distal, weakness, extensor plantar response, myoclonus, pronator drift, anterior spinal artery syndrome, paresis cranial nerve, tendon disorder, illness, pupillary reflex impaired and absent reflex were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, unresponsive to stimuli, acute motor-sensory axonal neuropathy, lower extremities weakness of, dyspnea, paresthesia distal, weakness, extensor plantar response, myoclonus, pronator drift, anterior spinal artery syndrome, paresis cranial nerve, tendon disorder, illness, pupillary reflex impaired and absent reflex to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, unresponsive to stimuli, acute motor-sensory axonal neuropathy, lower extremities weakness of, dyspnea, paresthesia distal, weakness, extensor plantar response, myoclonus, pronator drift, anterior spinal artery syndrome, paresis cranial nerve, tendon disorder, illness, pupillary reflex impaired and absent reflex to be related to Arexvy.   Additional Information: GSK receipt date: 09-NOV-2023 The patient age was between 65 to 79 years old. The patient was initially seen at hospital on 19th October 2023 and transferred to another hospital.  He was admitted that same day and required intubation on 23rd October 2023. He was then transferred to third hospital on 27th October 2023 for escalation of care and neuromuscular evaluation and EMG.  As per medical records client presented at hospital emergency department as a transfer from another hospital secondary to abrupt onset of lower extremity weakness upon awakening on 19th October 2023.  The patient initially reported mild drift of the lower extremity.  As per Telehealth neurology, he was recommended to be seen at hospital for possible anterior spinal artery syndrome and requested MRI brain and spine.  Upon arrival to hospital patient was noted to have bilateral lower extremity weakness, absent DTRs, eventually developed dyspnea and required intubation.  He was reportedly also complaining of paresthesias in the distal upper extremities.  Weakness rapidly progressed and is now currently involving cranial nerves.  Prior to leaving facility, patient was able to move his head and open eyes.  The patient had five rounds of plasma exchange with no significant improvement.  As per report MRI and spine unremarkable in facility. A neurology consult was placed for ascending paralysis with concern for GBS. Most recent neurology note from 30th October 2023 stated suspect AIDP variant, likely AMSAN. EMG consistent with diagnosis. Neurology note from 30th October 2023 also reported, in bed, not on sedation chronically ill appearing.  The patient was unresponsive to verbal, tactile, and noxious stimuli, breathing synchronous with the ventilator.  The pupils were equal and sluggishly reactive to light and oculocephalic reflex absent.  No gaze preference or pathologic nystagmus noted, no corneal reflexes, no facial asymmetry noted, no gag or cough reflex per RN, no spontaneous movements, no withdrawal to noxious stimuli applied to any extremities, no posturing, no tremors, myoclonus, adventitious movements noted.  Tone was decreased throughout, reflexes absent throughout, plantar responses were mute bilaterally,  prognosis for a functional neurologic recovery was poor and multiple other medical conditions being monitored.