Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypotension, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Diagnosed with Guillain Barre Syndrome; Pain from low back up to armpits; Weakness in legs (worsened)/ losing strength in legs; Pain progressed to both legs, hospitalized for 3 days (worsened); Brought back to hospital, diagnosed with Bell's Palsy; Lost balance in legs; Pain at injection site; Redness at injection site; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 31st January 2023, the patient received the 2nd dose of Shingrix. On 31st January 2023, several hours after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization), injection site erythema (serious criteria hospitalization) and injection site swelling (serious criteria hospitalization). In February 2023, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), radiating pain (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization), leg pain (serious criteria hospitalization), bell's palsy (serious criteria hospitalization and GSK medically significant) and loss of balance (serious criteria hospitalization). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and radiating pain were recovered/resolved and the outcome of the guillain barre syndrome and bell's palsy were unknown and the outcome of the lower extremities weakness of, leg pain and loss of balance were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, guillain barre syndrome, radiating pain, lower extremities weakness of, leg pain, bell's palsy and loss of balance to be related to Shingrix.     Additional Information: GSK receipt date: 10-FEB-2023, 13-FEB-2023 Reporter's comment: The reporter was the patient's son.  The reporter stated that his mom received 2nd dose of Shingrix in left arm. The reporter stated that patient had a history of high blood pressure.  The reporter reported that hours after vaccination patient experienced pain, redness and swelling at injection site and now resolved. The days later patient experienced pain from low back up to armpits. The day 7 after vaccine patient had weakness in legs and the pain progressed to both legs (more on left than right).  The patient was hospitalized for 3 days.  On day 20 after vaccine, patient was brought back to hospital and diagnosed with Bell's palsy. On day 22 leg strength and pain worse and she also stated that she had lost balance in her legs.  The reporter also stated that her oxygenation and her blood pressure had gone down.  The patient was diagnosed with guillain barre syndrome on 10th February 2023. The patient had an appointment with HCP(health care professional) today.  The reporter spoke per content. The medical disclaimer and MI phone number was provided. The reporter consent to follow up.