Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | RA |
maybe GBS-type symptoms; CRPS-like symptoms/CRPS; synovitis/synovitis in distal radius of the dominant (clarified to be right) hand/ It was in left toe, in right arm especially, the left anterior groin, back, thorax; This serious case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 14-SEP-2024, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: maybe GBS-type symptoms) (serious criteria GSK medically significant), complex regional pain syndrome (Verbatim: CRPS-like symptoms/CRPS) and synovitis (Verbatim: synovitis/synovitis in distal radius of the dominant (clarified to be right) hand/ It was in left toe, in right arm especially, the left anterior groin, back, thorax). The outcome of the guillain barre syndrome and complex regional pain syndrome were unknown and the outcome of the synovitis was not reported. It was unknown if the reporter considered the guillain barre syndrome, complex regional pain syndrome and synovitis to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the complex regional pain syndrome and synovitis to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025, 22-JAN-2025 & 23-JAN-2025 The patient is the reporter. Called about Shingrix and personally, as a patient, was experiencing CRPS-like symptoms, maybe GBS-type symptoms in the right arm, which is the arm it was injected into. When she received the first injection she did not have any issues. After receiving the second injection on 14th September 2024 she started having problems two weeks later. She stated it started as synovitis in distal radius of the dominant (clarified to be right) hand. Then she consulted her hand sub-specialist colleagues (clarified outside of her own practice), and she got a magnetic resonance imaging etc, and it was confirmed there was synovitis that happened concurrently to CRPS and GBS. It was in her left toe, in her right arm especially, the left anterior groin, her back, her thorax. It popped up in random places ever since the second injection. It started two weeks after the injection, then she noticed the growth was getting bigger, she had numbness and tingling in the first two digits, palmar and radial side, and the growth is on the central radial nerve. She have had shoulder aching, cold sensitivity or temp sensitivity, when she pick up her water bottle or her coffee. She had weakness of range of motion with a blank spot when she was lowering a weight, all of a sudden there was a give-way. She dropped something yesterday on her knee. She was an extremely healthy person, a pillar of health, her specialty was physical medicine and rehab, with interventional spine subspecialty, there was a lot of sensory symptoms, and it felt like she was cramping and she had gotten massages and they say she was really tight, had chiro adjustment and they agreed it was tight. It was a problem both personally, and for the community she serve. She was a subspecialist and she need to inject and need to be able to feel if she was in the subdural space. This was a community of 75,000 people potentially impacted by this. She granted permission for safety to follow up at the address above, which is her personal address. She did not give safety permission to follow up at her professional address, as she was concerned for her privacy. She had to end this conversation to see patients, but may provide further details via follow up call or email to the Medical Information team.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Test Name: MRI; Result Unstructured Data: (Test Result:Synovitis,Unit:unknown,Normal Low:,Normal High:) confirmed synovitis