Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3k743 | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | PEY93 | — |
Suspected vaccination failure; Facial Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3k743) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number PEY93) for prophylaxis. Concurrent medical conditions included heart disease, unspecified, diabetes mellitus and thyroid disorder. Concomitant products included tirzepatide (Mounjaro), metoprolol, metformin and levothyroxine sodium (Synthroid). On 01-JUL-2022, the patient received the 2nd dose of Shingrix. On 26-JAN-2022, the patient received the 1st dose of Shingrix. On 11-SEP-2025, 1168 days after receiving Shingrix and 1324 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Facial Shingles). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-SEP-2025 Patient could not contact to the physician and the emergency department physician misdiagnosed with cellu. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 1324 days after receiving the first dose of Shingrix and 1168 days after receiving the second dose of Shingrix, in a 67-year-old female patient. 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.
Diabetes mellitus; Heart disease, unspecified; Thyroid disorder
MOUNJARO; METOPROLOL; METFORMIN; SYNTHROID