Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | BP74J | — |
accidentally administered a third dose of Shingrix on March 4th 2025; suffered from dementia; This serious case was reported by a pharmacist via call center representative and described the occurrence of dementia in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis. Previously administered products included Shingrix (received 2 doses on an unknown date). On 04-MAR-2025, the patient received the 3rd dose of Shingrix. On 04-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: accidentally administered a third dose of Shingrix on March 4th 2025). In MAR-2025, the patient experienced dementia (Verbatim: suffered from dementia) (serious criteria GSK medically significant). The outcome of the dementia was not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the dementia to be related to Shingrix. The company considered the dementia to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2025 The patient was accidentally administered a third dose of Shingrix, which led to extra dose administered. The reporter mentioning that the patient suffered from dementia and that they were experiencing undisclosed adverse events. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Dementia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.