Received May 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 425CR | — |
Respiratory failure ventilated; significant ataxia in all 4 extremities; Guillain Barre syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 425CR) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 20-NOV-2025, the patient received the 2nd dose of Shingrix .5 ml. On 31-MAY-2025, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced respiratory failure (Verbatim: Respiratory failure ventilated) (serious criteria hospitalization and GSK medically significant) and ataxia (Verbatim: significant ataxia in all 4 extremities) (serious criteria hospitalization). The outcome of the guillain barre syndrome was not resolved and the outcome of the respiratory failure and ataxia were not reported. It was unknown if the reporter considered the guillain barre syndrome, respiratory failure and ataxia to be related to Shingrix. The company considered the guillain barre syndrome, respiratory failure and ataxia to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 18-MAY-2026 The reporter seriousness for event guillain barre syndrome was intervention required.; Sender's Comments: A case of Guillain-Barre syndrome (not meeting BC criteria), Respiratory failure and Ataxia, unknown time after receiving wnd dose of Shingrix in a 62-year-old male patient. Causal relation is indeterminate considering multiple vaccines given concomitantly. Case lacks further information on medical history, concurrent conditions and laboratory confirmation. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
SHINGRIX