Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Intensive care, Neck pain, Pain
Clinical narrative: Guillain-Barre Syndrome; severe pain in his head; Neck pain; Back pain; high blood pressure; emotional distress; could not work for two months; numbness in his toes and fingers, extending to both feet, hands; numbness in the right edge of his tongue; swelling at the injection site; pronounced redness at injection site; aches; chills; This serious case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-JAN-2024, the patient received Shingrix. On 30-JAN-2024, 26 days after receiving Shingrix, the patient experienced numbness of extremities (Verbatim: numbness in his toes and fingers, extending to both feet, hands) (serious criteria hospitalization) and numbness of tongue (Verbatim: numbness in the right edge of his tongue) (serious criteria hospitalization). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre Syndrome) (serious criteria hospitalization and GSK medically significant), injection site swelling (Verbatim: swelling at the injection site) (serious criteria hospitalization), injection site erythema (Verbatim: pronounced redness at injection site) (serious criteria hospitalization), pain (Verbatim: aches) (serious criteria hospitalization), chills (Verbatim: chills) (serious criteria hospitalization), headache (Verbatim: severe pain in his head) (serious criteria hospitalization), neck pain (Verbatim: Neck pain) (serious criteria hospitalization), back pain (Verbatim: Back pain) (serious criteria hospitalization), blood pressure high (Verbatim: high blood pressure) (serious criteria hospitalization), emotional distress (Verbatim: emotional distress) (serious criteria hospitalization) and inability to work (Verbatim: could not work for two months) (serious criteria hospitalization). The outcome of the guillain barre syndrome was not resolved and the outcome of the injection site swelling and injection site erythema were resolved (duration 5 days) and the outcome of the pain and chills were resolved (duration 2 days) and the outcome of the numbness of extremities, numbness of tongue, headache, neck pain, back pain, blood pressure high, emotional distress and inability to work were not reported.   The reporter considered the guillain barre syndrome, injection site swelling, injection site erythema, pain, chills, numbness of extremities, numbness of tongue, headache, neck pain, back pain, blood pressure high, emotional distress and inability to work to be related to Shingrix.     The company considered the guillain barre syndrome, injection site swelling, injection site erythema, pain, chills, numbness of extremities, numbness of tongue, headache, neck pain, back pain, blood pressure high, emotional distress and inability to work to be unrelated to Shingrix.   Additional Information: GSK Receipt date: 25-JUL-2024 A reporter reported that on 04 January 2024 a patient was administered the Shingrix vaccine at his physician's office.  Following the vaccination, he experienced severe adverse effects, including pronounced redness and swelling at the injection site, which lasted for five days, alongside aches and chills persisting for two days.  Subsequently, on 30 January 2024 the patient experience alarming symptoms, including numbness in his toes and fingers, extending to both feet, hands, and the right edge of his tongue, these symptoms escalated to include severe pain in his head, neck, and back, accompanied by dangerously high blood pressure. After multiple emergency room visits, tests, and consultations the patient was diagnosed with Guillain-Barre Syndrome by doctor. A neurologist, who directly inquired oabout recent vaccination the patient was admitted where his condition necessitated transfer to the ICU and treatment with IVIG to arrest the progression of GBS.  Yet, his condition continued to worsen, necessitating plasmapheresis in a desperate effort to save him from certain death.  Before undergoing plasmapheresis, patient condition and prognosis were so grave that his hospital team asked him what his wishes were should he need to be resuscitated.  The plasmapheresis therapy consisted of five treatments over ten days, causing patient to endure a harrowing twenty-day hospital stay characterized by escalating pain and significant emotional distress for him and his family. As a result of the injuries sustained from the Shingrix vaccine, patient had faced considerable physical, emotional, and financial hardship.  He had undergone extensive physical and speech therapy and continues to do so.  The mental and emotional toll on patient and his family had necessitated the commencement of counseling.  Furthermore, patient a self-employed sales professional, could not work for two months, resulting in a substantial loss of income.; Sender's Comments: Case of male patient  with multiple events for Shingrix vaccine. There is insufficient evidence to establish a conclusive causal relationship. The case is confounded by comorbidities.