Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Albumin CSF increased, Asthenia, CSF culture negative, CSF protein increased, CSF red blood cell count positive
Clinical narrative: Guillain-Barre Syndrome: Presented to the ED on 22Feb with progressive LE weakness as a pins-and-needles on her arms.; aspiration PNA; viral gastroenteritis; This is a spontaneous report received from a Pharmacist.  An 85-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Feb2024 as dose 1, single (Lot number: HN3801) at the age of 85 years for immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "COPD" (unspecified if ongoing); "NSCLC status post radiation therapy" (unspecified if ongoing); "NSCLC status post radiation therapy" (unspecified if ongoing); "chemotherapy" (unspecified if ongoing); "immunotherapy", stop date: Oct2023; "radiation pneumonitis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "PMR" (unspecified if ongoing); "PUD" (unspecified if ongoing); "Allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; FUROSEMIDE; WARFARIN; VITAMIN D [VITAMIN D NOS]; TYLENOL PM; FAMOTIDINE; SODIUM CHLORIDE; ROSUVASTATIN; ALBUTEROL [SALBUTAMOL]. Past drug history included: Prednisone for Radiation pneumonitis; Oxycodone, reaction(s): "Drug allergy"; Pravachol, reaction(s): "Drug allergy"; Vicodin, reaction(s): "Drug allergy"; Vioxx, reaction(s): "Drug allergy". The following information was reported: GASTROENTERITIS VIRAL (hospitalization, life threatening) with onset 19Feb2024, outcome "recovering", described as "viral gastroenteritis"; GUILLAIN-BARRE SYNDROME (hospitalization, life threatening, medically significant) with onset 20Feb2024, outcome "recovering", described as "Guillain-Barre Syndrome: Presented to the ED on 22Feb with progressive LE weakness as a pins-and-needles on her arms."; PNEUMONIA ASPIRATION (hospitalization, life threatening, medically significant) with onset 20Feb2024, outcome "recovering", described as "aspiration PNA". The patient was hospitalized for guillain-barre syndrome, gastroenteritis viral, pneumonia aspiration (hospitalization duration: 56 day(s)). The events "guillain-barre syndrome: presented to the ed on 22feb with progressive lower extremity weakness as a pins-and-needles on her arms." and "viral gastroenteritis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood albumin: Elevated; Computerised tomogram head: Negative; Culture: Negative, notes: protein of 104; Magnetic resonance imaging: Negative; Magnetic resonance imaging head: Negative; Red blood cell count: Elevated. Therapeutic measures were taken as a result of guillain-barre syndrome, gastroenteritis viral, pneumonia aspiration.  Clinical course: Guillain-Barre Syndrome: Presented to the ED on 22Feb with progressive LE weakness as a pins-and-needles on her arms. (Withheld) suspected GBS. Etiology unclear but thought that GBS was precipitated by viral gastroenteritis on 19Feb vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 28Feb. LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Patient was intubated as discussed, is now extubated. Her neurologic status continued to improve, and she is gaining strength in upper and lower extremities. Plan to continue working with PT/OT and transfer to acute rehab. Patient was intubated (not emergently) on 24Feb after failing BiPAP and Vapotherm. RF from GBS and aspiration PNA. Extubated 3/8.; Sender's Comments: The events Guillain-Barre syndrome, and gastroenteritis viral are conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. Based on known disease pathophysiology, the event pneumonia aspiration is assessed as not related to the suspect drug, and more likely due to circumstances brought about by the intubation.