Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Died; Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Died) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolved. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Shingrix. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the unknown cause of death and guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK receipt date: 15-OCT-2025 The case was received from the patient's sibling via interactive digital media. The reporter stated that Shingrix gave guillain barre syndrome to his sister. It was horrible and she ended up passing from a complication few months later. The reporter asked if reaction to the shot could be genetic. The batch number was not provided, and unable to contact the reporter. The case was linked with case US2025AMR135492, reported by the same reporter.; Sender's Comments: A case of Death and Guillain-Barre syndrome, several months after receiving Shingrix, in an unknown aged adult female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR135492:Same reporter different patient; Reported Cause(s) of Death: Unknown cause of death