Sex: F
Vaccine: RSV, RSV
Symptoms: Facial paralysis, Facial paresis, Guillain-Barre syndrome, Headache, Loss of personal independence in daily activities
Clinical narrative: Facial droop; She feels like the closure of her left eye is somewhat delayed; Slightly acidotic; Abnormal brain MRI; dialysis; lumbar puncture; plasmapheresis; tachycardia; Guilain- Barre; has no ability to taste; bell's palsy; headache; she felt a little tingling sensation of the left side of her lip and noticed that her lip looked a little asymmetrical; she felt a little tingling sensation of the left side of her lip and noticed that her lip looked a little asymmetrical; left sided facial weakness; neck and facial pain; neck and facial pain; She was trying to drink out of a straw and had difficulty.; She did have a failed root canal on that side in Sep; Dyskinesia; electrolytes and renal function; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2745913-1 (VAERS ID).  A 28-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Dec2023 as dose 1, single (Lot number: HF5012) intramuscular for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization) with onset 19Dec2023, outcome "unknown", described as "She was trying to drink out of a straw and had difficulty."; FACIAL PARESIS (hospitalization) with onset 19Dec2023, outcome "unknown", described as "left sided facial weakness"; FACIAL PAIN (hospitalization) with onset 19Dec2023, outcome "unknown", NECK PAIN (hospitalization) with onset 19Dec2023, outcome "recovered" and all described as "neck and facial pain"; HEADACHE (hospitalization) with onset 20Dec2023, outcome "recovered"; PARAESTHESIA ORAL (hospitalization), FACIAL ASYMMETRY (hospitalization) all with onset 20Dec2023, outcome "unknown" and all described as "she felt a little tingling sensation of the left side of her lip and noticed that her lip looked a little asymmetrical"; BELL'S PALSY (hospitalization, medically significant) with onset 21Dec2023, outcome "recovering"; AGEUSIA (hospitalization) with onset 28Dec2023, outcome "unknown", described as "has no ability to taste"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 02Jan2024, outcome "unknown", described as "Guilain- Barre"; RENAL IMPAIRMENT (medically significant) with onset 02Jan2024, outcome "unknown", described as "electrolytes and renal function"; LUMBAR PUNCTURE ABNORMAL (hospitalization, medically significant) with onset 03Jan2024, outcome "unknown", described as "lumbar puncture"; PLASMAPHERESIS (hospitalization, medically significant) with onset 03Jan2024, outcome "unknown"; TACHYCARDIA (hospitalization) with onset 03Jan2024, outcome "unknown"; FACIAL PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "Facial droop"; EYELID FUNCTION DISORDER (hospitalization), outcome "unknown", described as "She feels like the closure of her left eye is somewhat delayed"; ACIDOSIS (hospitalization), outcome "unknown", described as "Slightly acidotic"; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL (hospitalization), outcome "unknown", described as "Abnormal brain MRI"; DIALYSIS (hospitalization, medically significant), outcome "unknown"; ROOT CANAL INFECTION (non-serious), outcome "unknown", described as "She did have a failed root canal on that side in Sep"; DYSKINESIA (non-serious), outcome "unknown". The patient was hospitalized for guillain-barre syndrome, facial paralysis, facial paresis, facial pain, neck pain, eyelid function disorder, acidosis, headache, paraesthesia oral, facial asymmetry, ageusia, magnetic resonance imaging head abnormal, lumbar puncture abnormal, plasmapheresis, tachycardia, dialysis, loss of personal independence in daily activities (hospitalization duration: 7 day(s)); for bell's palsy (start date: 29Dec2023, hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: Blood albumin: 2, notes: Plasma exchange number 2 out of 5 today Replacing with 5% albumin; Magnetic resonance imaging: Okay, MRI, CT, CTA and lumbar puncture. Therapeutic measures were taken as a result of lumbar puncture abnormal, plasmapheresis, renal impairment. Additional information: On 19Dec2023 2343 - The patient complains of left sided facial weakness. She was trying to drink out of a straw and had difficulty. She also has some neck and facial pain. She does not have any weakness in her arms or legs. She feels like the closure of her left eye is somewhat delayed. She has no history of similar symptoms. She did have a failed root canal on that side in Sep. She has no chest pain or shortness of breath. No arm pain. 20Dec2023 1348 - Neurology consult - She states prior to delivery yesterday morning she felt a little tingling sensation of the left side of her lip and noticed that her lip looked a little asymmetrical. She was also having a little bit of left-sided neck pain and a mild headache. The neck pain and headache have since resolved since delivery. She states last night she noticed she was having trouble holding the straw in her mouth. Review of MRI looks okay, no obvious intracranial abnormalities or areas of restricted diffusion. 21Dec2023 0906 - Dr - For Bell's patient was seen and evaluated by Neuro. Home on steroids and Valtex. 28Dec2023 2009 - Dr - Patient called physician call line. She is currently completing tx for left-sided Bell's Palsy which has improved, however this evening she developed new onset right sided facial drooping. She also now has no ability to taste. She denies other weakness, difficulty talking or other signs of stroke. Discussed with her that while this does sound like possible Bell's palsy on the right side. Recommend that she proceed to the emergency department for evaluation and confirmation. She will go in tonight. 29Dec2023 0936 - Hospitalist Dr- Bilateral Bell's palsy in the third trimester/early puerperium. Most likely idiopathic. Recent RSV vaccine. Differential diagnosis includes GBS, Lyme or other atypical infection, other autoimmune disease. She has no previous history of autoimmune disease, no other significant exposures. 02Jan2024 1359 - Dr - Assessment & Plan GBS (Guillain Barre syndrome) Bell's palsy NSVD (normal spontaneous vaginal delivery) Facial droop Abnormal brain MRI Plan: Plasma exchange number 2 out of 5 today Replacing with 5% albumin, additional IV calcium with treatment Slightly acidotic today but volume, electrolytes and renal function otherwise stable Her tunneled catheter will need to be removed once her treatment course is complete Will monitor calcium, renal function, volume and blood counts closely with pheresis treatment D/C 03Jan2024 1528 - Patient is a 28 y.o. female with a history of recent spontaneous vaginal delivery and diagnosis of Bell's palsy who presented to hospital initially complaining of right facial weakness. Please see the admitting history and physical for further details. She was found to have Guillain-Barre and was admitted to the hospital for further evaluation and treatment. Following the delivery of her child she had left-sided facial weakness. She was evaluated by neurology and diagnosed with Bell's palsy. She was treated appropriately and discharged home however she came back into the emergency room with right-sided facial weakness and had a lumbar puncture performed consistent with Guillain-Barre syndrome. A tunneled catheter was placed and she was started on plasmapheresis. She had a few episodes of tachycardia not consistent with SVT was seen by cardiology who recommended no further workup at this time. Neurology and nephrology assisted with management and arrange for her to complete her pheresis in the outpatient setting. Arrangements are being made for her to have her tunneled dialysis catheter removed following her last pheresis session. She should follow-up with neurology in 4 to 6 weeks and follow- up with her primary care physician in 2 to 3 weeks.  No follow-up attempts are possible.  Amendment: This follow-up report is being submitted to amend previously reported information: Product coding was updated to allow appropriate reporting to health authorities.