Sex: F
Vaccine: VARZOS
Symptoms: Hepatitis viral test negative, Magnetic resonance imaging head normal, Muscular weakness, Neurological examination abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Guillain-Barre Syndrome; leg weakness/decreased strength in lower extremities; falls; dysphagia; diffuse areflexia of the biceps, triceps, brachioradialis, patellar and ankles; decreased sensation in the calves; hypophonia; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer.   On an unknown date, the patient received Shingrix. On an unknown date, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), fall (serious criteria hospitalization), dysphagia (serious criteria hospitalization), areflexia (serious criteria hospitalization), loss of sensation (serious criteria hospitalization) and hypophonia (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Ivig). On an unknown date, the outcome of the guillain barre syndrome, fall, loss of sensation and hypophonia were unknown and the outcome of the lower extremities weakness of and areflexia were recovering/resolving and the outcome of the dysphagia was recovered/resolved.   The reporter considered the guillain barre syndrome, lower extremities weakness of, fall, dysphagia, areflexia, loss of sensation and hypophonia to be related to Shingrix.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome (GBS), in a female patient aged 66-year-old, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis.     The patient was an old physically active woman with a history of breast cancer in remission. No information on patient family history or concurrent conditions or concomitant medication was reported.   On an unknown date, the patient received Shingrix (administration route or site not reported; dosage unknown, batch number not provided). The age at vaccination was not reported but it could be between 65 years or 66 years at the time of vaccination.  On an unknown date, 9 days after vaccination, the patient experienced sudden onset of leg weakness. On an unknown date, the patient presented with a sudden onset of leg weakness, which spread proximally over two days resulting in 3 falls and a mild associated dysphagia. She denied recent travel or sick contacts.  The patient neurological exam revealed decreased strength in lower extremities (4/5 hip flexion, 4/5 knee extensors/flexors), decreased sensation in the calves and diffuse areflexia of the biceps, triceps, brachioradialis, patellar and ankles. Human Immunodeficiency Virus (HIV), Rapid Plasma Reagin (RPR) and a viral hepatitis panel were non-reactive. glycosylated hemoglobin (A1c), creatine kinase (CK), B12, CK, serum protein electrophoresis (SPEP), angiotensin- converting enzyme (ACE), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were all within normal limits. A contrast magnetic resonance imaging (MRI) of the complete spine and MRI brain were without acute pathology. Analysis of her cerebro-spinal fluid (CSF) revealed cytoalbuminologic dissociation concerning for GBS: protein-53.2 mg/dL, WBCs 1. Therapy with IVIG was initiated but on the second day, the patient's weakness progressed to the upper extremities, her dysphagia worsened and hypophonia developed. The patient was transferred to the intensive care unit. With completion of 5 days of IVIG, the NIF normalized, dysphagia resolved, mild improvement was seen in hip flexion strength bilaterally and her upper extremity strength remained stable. The patient was ultimately discharged to an acute rehabilitation facility.  The case was considered as serious due to hospitalization.  The authors commented "In 2004, causality was confirmed between the 1976 influenza vaccine and GBS. The association between GBS and other vaccines remains anecdotal due to a paucity of available data. The adjuvant recombinant zoster vaccine (RZV) was first marketed in October 2017 for the prevention of herpes zoster in individuals aged more than or equal to50 years. A pooled analysis of two large randomized trials in 2019 did not show an increased risk of developing a new potential immunemediated disease (pIMD) or exacerbation of an underlying pIMD in RZV recipients aged more than equal to 50. Our patient's GBS onset developed 9 days after vaccine administration. To our knowledge, there is only one other reported case of Zoster vaccination associated GBS in the literature.".  The authors concluded "Although there is no established connection between RZV and GBS, our case should alert clinicians to recognize this serious adverse effect and promptly advise their patients for hospitalization. As more post vaccination GBS cases are recognized and reported worldwide, providers will be more primed to discuss this potential side effect with their patients prior to vaccination".   Upon SERM review on 1 MARCH 2021,following correction has been performed  Breast cancer was updated as medical history instead of concurrent condition as it is in healed state.