Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; after vaccination with Shingrix she had one outbreak of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (she had many outbreaks of shingles.) and cancer (cancer diagnosis and received radiation as well.). Previously administered products included BCG (she received 39 treatments of BCG after cancer diagnosis) and radiation. On 13-AUG-2018, the patient received the 1st dose of Shingrix. On 18-NOV-2018, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: after vaccination with Shingrix she had one outbreak of shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. It was unknown if the reporter considered the vaccination failure and shingles 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 shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 21-OCT-2025 Consumer was unable to provide the date she was diagnosed with shingles. No further information was provided. 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 time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix (Dose 1 and Dose 2) in a 73-year-old female patient with history of shingles and cancer. 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.
Medical History/Concurrent Conditions: Cancer (cancer diagnosis and received radiation as well.); Shingles (she had many outbreaks of shingles.)