Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown. It was unknown if 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: 07-APR-2025 The reporter reported that he found a on line group of consumers posting they had been diagnosed with Guillain-Barre syndrome after vaccination with Shingrix. This case is linked with US2025041538, reported by same reporter.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025041538:Same reporter 1 of 2