Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; shingles/quarter-sized lesion; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Varicella zoster vaccine for prophylaxis. On an unknown date, the patient received Shingrix and Varicella zoster vaccine. On an unknown date, an unknown time after receiving Shingrix and an unknown time after receiving Varicella zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/quarter-sized lesion). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The reporter considered the vaccination failure and shingles to be not reported if related to Varicella zoster vaccine. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be not reported if related to Varicella zoster vaccine. Additional Information: GSK Receipt Date: 18-NOV-2025 Patient stated that it had been about 10 years since he/she had the original vaccination plus the Shingrix vaccine and this year had a very small outbreak of shingles about a quarter-sized lesion. The batch number was not provided, and we are unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix and Varicella zoster vaccine, in a 72-year-old 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.