Age: 74.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: Guillain-BarrT Syndrome; CSF protein 148 mg/dL; CSF glucose89 mg/dL; numbness in 2 fingers/followed over next 5 days with lower leg & perioral numbness; followed over next 5 days with lower leg & perioral numbness; ascending paralysis of all 4 extremities and left facial paralysis; ascending paralysis of all 4 extremities and left facial paralysis; This is a spontaneous report received from a Physician from Regulatory Authority. Regulatory number: 2702333-1 (VAERS ID).  A 74-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for immunisation; rabies vaccine (IMOVAX), on 09Sep2023 as dose 4, single) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; XARELTO; LOSARTAN; STELARA; XYZAL; NASACORT; VITAMIN D NOS; CALCIUM. The patient also took other concomitant therapy(Probiotic, Multivitamin). Past drug history included: Naproxen, reaction(s): "Drug intolerance"; Quinolones, reaction(s): "Drug intolerance". Vaccination history included: Imovax (Dose 1), for immunization; Imovax (Dose 2), for immunization; Imovax (Dose 3), for immunization. Other illnesses at the time of vaccination and up to one month prior: None. The patient ever did not have an adverse event following any previous vaccine. The following information was reported: CSF GLUCOSE INCREASED (hospitalization) with onset 20Sep2023, outcome "recovering", described as "CSF glucose89 mg/dL"; CSF PROTEIN INCREASED (hospitalization) with onset 20Sep2023, outcome "recovering", described as "CSF protein 148 mg/dL"; ASCENDING FLACCID PARALYSIS (hospitalization), FACIAL PARALYSIS (hospitalization) all with onset 20Sep2023, outcome "recovering" and all described as "ascending paralysis of all 4 extremities and left facial paralysis"; HYPOAESTHESIA ORAL (hospitalization) with onset 20Sep2023, outcome "recovering", described as "followed over next 5 days with lower leg & perioral numbness"; HYPOAESTHESIA (hospitalization) with onset 20Sep2023, outcome "recovering", described as "numbness in 2 fingers/followed over next 5 days with lower leg & perioral numbness"; GUILLAIN-BARRE SYNDROME (hospitalization) with onset 25Sep2023, outcome "recovering", described as "Guillain-BarrT Syndrome". The patient was hospitalized for hypoaesthesia, hypoaesthesia oral, ascending flaccid paralysis, facial paralysis, guillain-barre syndrome, csf protein increased, csf glucose increased (hospitalization duration: 11 day(s)). The patient underwent the following laboratory tests and procedures: CSF glucose: (20Sep2023) 89 mg/dl, notes: Increased; CSF protein: (20Sep2023) 148 mg/dl, notes: Increased. Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia oral, ascending flaccid paralysis, facial paralysis, guillain-barre syndrome, csf protein increased, csf glucose increased. (hospitalization duration: 11 day(s)). The events didn't result in existing hospitalization prolonged, or Emergency Room/Office visit. The patient underwent the following laboratory tests and procedures: CSF glucose: 89 mg/dl, notes: Increased; CSF protein: 148 mg/dl, notes: Increased. Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia oral, ascending flaccid paralysis, facial paralysis, guillain-barre syndrome, csf protein increased, csf glucose increased. Clinical course: Onset 20Sep2023 with numbness in 2 fingers, followed over next 5 days with lower leg and perioral numbness progressing to ascending paralysis of all 4 extremities and left facial paralysis. Diagnosis of Guillian-BarrT syndrome made on 25Sep2023. Treated with Immunoglobulin therapy IVIG 25Nov2023-29Nov2023. Currently recovering in rehabilitation facility. The patient did not recovered from the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (01Oct2024): This is a spontaneous follow-up report received from same Physician via FDA (2702333-1). This Physician reported for a patient that: Updated information: Updated patient details and concomitant drugs. Vaccine Facility Information captured.