Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Outbreak of Shingles; second dose of Shingrix, received in March 2025; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included live herpes zoster vaccine (received the live herpes zoster vaccine in 2016). In MAR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In MAR-2025, an unknown time after receiving Shingrix and after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of Shingrix, received in March 2025). On an unknown date, the patient experienced shingles (Verbatim: Outbreak of Shingles). The outcome of the shingles was not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 12-SEP-2025 After receiving the first dose of Shingrix in 2025 patient had an outbreak of shingles in 2025 and was advised to receive a second dose of Shingrix, patient received a second dose in MAR-2025. Patient stated that he needs another Shingrix by 28-SEP-2025 (6 months from previous) to get maximum efficacy.