Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Magnetic resonance imaging head normal, Mobility decreased, Plasmapheresis, Pneumonia
Clinical narrative: Collapsed on the floor at her home and was transported to the hospital; Diagnosed with Guillain-Barre Syndrome; Is a quadriplegic at this time / cannot move her arms or legs; Is a quadriplegic at this time / cannot move her arms or legs; Breathing difficulty; Recurrent UTI's during her hospital stay; Treated for pneumonia; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 20th March 2021, 7 days after receiving Shingrix, the patient experienced passed out (serious criteria hospitalization, disability, GSK medically significant and life threatening), guillain barre syndrome (serious criteria hospitalization, disability, GSK medically significant and life threatening), quadriplegia (serious criteria hospitalization, disability, GSK medically significant and life threatening) and mobility decreased (serious criteria hospitalization, disability, GSK medically significant and life threatening). On 2nd April 2021, the patient experienced pneumonia (serious criteria hospitalization, disability, GSK medically significant and life threatening) and urinary tract infection (serious criteria hospitalization, disability and life threatening). On an unknown date, the patient experienced difficulty breathing (serious criteria hospitalization, disability and life threatening). The patient was treated with immunoglobulins nos (Ivig) and operations and procedures (Plasmapheresis (Nos)). On an unknown date, the outcome of the passed out was unknown and the outcome of the guillain barre syndrome, quadriplegia, pneumonia and mobility decreased were not recovered/not resolved and the outcome of the difficulty breathing was recovered/resolved and the outcome of the urinary tract infection was recovering/resolving.   It was unknown if the reporter considered the passed out, guillain barre syndrome, quadriplegia, pneumonia, difficulty breathing, urinary tract infection and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's daughter. The patient received the Shingrix vaccine into her right arm.  Exactly one week later, on 20th March 2021, the patient collapsed on the floor at her home and was transported to the hospital.  Eight hours after arriving at the hospital the patient was intubated.  A stroke was ruled out by magnetic resonance Imaging and computerized tomography scans.  The patient was on IVIG (intravenous immunoglobulins) therapy starting 20th March 2021 for 5 days with no improvement.  On 26th March 2021, the neurologist started plasmapheresis therapy and the patient started showing signs of improvement by being able to move her toes.  The patient was diagnosed with Guillain-Barre Syndrome and was a quadriplegic at the time of reporting.   The intubation tube was removed on 2nd April 2021 and then was able to breath on her own.  The patient was treated for pneumonia on the same day.  The reporter stated that her mother was able to speak and eat solid food, could also move her fingers and hold a pencil but could not move her arms or legs as of 7th April 2021. The patient also had been treated for recurrent urinary tract infections during her hospital stay. The reporter did not give permission to contact the healthcare professional, but she did give a permission to contact her on behalf of her mother. The reporter asked for the address and fax number of GlaxoSmithKline Legal Department, which was provided to her. She inquired how long it would take to hear from legal department and was informed that she would be contacted within 6 to 8 weeks.