Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | E7335 | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | FA95N/4Z4JG | — |
Extra dose; Late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number E7335, expiry date 15-JUN-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number FA95N/4Z4JG, expiry date 28-JUL-2023) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 28-APR-2021 expiry date 30-OCT-2022). On 24-OCT-2024, the patient received the 3rd dose of Shingrix. On 16-AUG-2022, the patient received the 2nd dose of Shingrix. On 16-AUG-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On 24-OCT-2024, the patient experienced extra dose administered (Verbatim: Extra dose). The outcome of the extra dose administered and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 07-MAY-2025 The registered Nurse who requested to remain anonymous and declined consent to follow up with Safety, explained that a patient received a late second dose and a third extra dose of Shingrix which led to extra dose administered. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.