Received Jan 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 5A727 | — |
mild HSV reactivation in V1 Dermatome; Drug dose administration interval too long; This non-serious case was reported by a nurse via sales rep and described the occurrence of herpes simplex in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 5A727) for prophylaxis. The patient's past medical history included herpes simplex. Previously administered products included Shingrix (received 1st dose on 25-FEB-2025, lot K2BB7). On 01-NOV-2025, the patient received the 2nd dose of Shingrix. On 01-NOV-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). In NOV-2025, the patient experienced herpes simplex (Verbatim: mild HSV reactivation in V1 Dermatome). In NOV-2025, the outcome of the herpes simplex was resolved. The outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the herpes simplex to be related to Shingrix. It was unknown if the company considered the herpes simplex to be related to Shingrix. Additional Information: GSK Receipt Date:09-JAN-2026 After receiving both doses of the Shingrix vaccine in series, the patient experienced mild HSV (Herpes simplex virus) reactivation in the left V1 dermatome. About 5 to 10 days after vaccination, a single pruritic vesicle appeared on the left forehead. It resolved within 7 days without any clinical intervention.
Medical History/Concurrent Conditions: Herpes simplex