Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; she had Guillain-Barre; followed by axonal demyelinating polyneuropathy; I still get shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In APR-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: she had Guillain-Barre) (serious criteria GSK medically significant), axonal and demyelinating polyneuropathy (Verbatim: followed by axonal demyelinating polyneuropathy) (serious criteria GSK medically significant) and shingles (Verbatim: I still get shingles). The outcome of the vaccination failure, guillain barre syndrome and shingles were unknown and the outcome of the axonal and demyelinating polyneuropathy were not resolved. It was unknown if the reporter considered the vaccination failure, guillain barre syndrome, axonal and demyelinating polyneuropathy and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure, guillain barre syndrome and axonal and demyelinating polyneuropathy to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date : 04-JUN-2025 Reporter reported that patient was she was terribly ill. She had Guillain-Barre followed by axonal demyelinating polyneuropathy. During the call, Member of Public, also mentioned she could not felt her feet, she was crippled and she still got shingles. She claimed that back in 2023 there was no warning that these adverse effects could happened. She indicated that she did not want to share her address. She did not want to answer any further questions. During the conversation she made statements such as she had been crippled by your 'rubbish' vaccination. It was prescribed to her by her doctor because she was getting shingles. Full disclosure would have been good in January 2023 before she had the shot, that would have been good but she did not get it. If she had been told that she could get Guillain-Barre GB or any other ailment she would not have your vaccination. -January 2023 was when she had her first shot there was no [GBS] warning. She did got the second shot in April 2023. The warning on TV about the risk of Guillain-Barre did not come about until about 18 months ago. She was very ill, crippled. She had axonal demyelinating polyneuropathy. She could not felt her feet. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure and Guillain-Barre syndrome are listed events which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2). Axonal and demyelinating polyneuropathy is an unlisted event which is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2).