Received Jun 13, 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; I developed shingles again all across my back and now it is locating down my left buttock; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old 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 (patient had shingles twice). In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received the 1st dose of Shingrix. In MAY-2025, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I developed shingles again all across my back and now it is locating down my left buttock). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 09-JUN-2025 The patient reported that he was going to be 72 years old this August. He/she had received the two Shingrix vaccines because he/she had shingles twice before. About one month ago, he/she developed shingles again, across his/her back, and then it spread down his/her left buttock. It was extremely painful, more than his/her previous two incidents of shingles. His/her physician prescribed Valacyclovir, and he/she was taking that. His/her question was whether it would be recommended to get another booster dose of the Shingrix vaccine. This episode was so painful that he/she could hardly sleep, much worse than the previous ones. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Medical History/Concurrent Conditions: Shingles (patient had shingles twice)