Received May 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
suspected vaccination failure; double mastectomy recently; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), mastectomy (Verbatim: double mastectomy recently) (serious criteria clinically significant/intervention required) and shingles (Verbatim: shingles). The outcome of the vaccination failure, mastectomy and shingles were not reported. It was unknown if the reporter considered the vaccination failure, mastectomy and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and mastectomy to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAY-2026 This case was reported by a patient via interactive digital media. The patient had received both of shots several years ago. The patient underwent a double mastectomy and subsequently developed shingles. The batch number was not provided and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Mastectomy, more than 2 years after vaccination with the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.