Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | UNK | — |
Suspeceted vaccination failure; recently had a small shingles outbreak on my lower back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. On an unknown date, the patient received Shingrix and Zostavax. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: recently had a small shingles outbreak on my lower back). 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 company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 29-APR-2025 The reporter reported that he/she fully vaccinated against shingles (Zostavax and Shingrix), and recently had a small shingles outbreak on his/her lower back. The reporter had a questioned should he/she consider getting the Shingrix vaccine and booster again. The chat bot user mentioned that they noticed that patient mentioned more than one of our products. The patient reported that he/she only recived 1 product. The chat bot user reported that Shingrix was administered as a 2-dose series. The FDA-approved schedule did not include a booster dose of Shingrix or a repeat of the series. The chat bot user reported that they could not give medical advice. It was unknown if the reporter considered the vaccination failure and shingles to be related to Zostavax. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.