Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
developed Guillain Barre syndrome; This serious case was reported by a non-health professional via sales rep and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain Barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolving. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-APR-2025 The patient received in office administration of Shingrix (unknown if this was first or second dose). The reporter stated that, three weeks after administration the patient developed Guillain Barre syndrome. The patient continued to try to recover and is receiving infusion therapy. The causality was believed by the physician office to be related as they could not identify any other precipitating event.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.