Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; I also had shingles for the first time at about age 22 and have had shingles about 10 times and I'm now 72. Had first vaccine, and later had the newer two vaccine and still have gotten break thru shingles; later had the newer two vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 72-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles first time at about age 22 and had shingles about 10 times). On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I also had shingles for the first time at about age 22 and have had shingles about 10 times and I'm now 72. Had first vaccine, and later had the newer two vaccine and still have gotten break thru shingles) and extra dose administered (Verbatim: later had the newer two vaccines). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she also had shingles for the first time at about age 22 and had shingles about 10 times and he/she was now 72. Had first vaccine, and later had the newer two vaccines and still had got breakthrough shingles, his/her doctor now had given a daily low dose of Valtrex. This case was considered as suspected vaccination failure as details regarding completion time to onset for shingles and laboratory confirmation regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, 2 & 3).
Medical History/Concurrent Conditions: Shingles (had shingles first time at about age 22 and had shingles about 10 times)