Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; ot shingles again at 49; got the vaccine at 48; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 49-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (got a a mild case of shingles at the age of 47 years old). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: ot shingles again at 49) and inappropriate age at vaccine administration (Verbatim: got the vaccine at 48). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated he/she got the vaccine at the age of 48-years old, which led to an inappropriate age at vaccine administration and got shingles again at the age of 49-years-old and so far, patient was 50-years of age and was shingles free. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Medical History/Concurrent Conditions: Shingles (got a a mild case of shingles at the age of 47 years old)