Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Got the 2 dose shot and has gotten shingles 3 times in a 2-year span; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (patient had them in early 30s). On an unknown date, the patient received the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the 2 dose shot and has gotten shingles 3 times in a 2-year span). 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 Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 20-OCT-2025 This case was reported by a patient via interactive digital media. Patient stated that stress usually brings them out. Got them 2 to 3 times in a 12-year span. 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: A case of Vaccination failure, less than 2 years after receiving 1st and 2nd dose of Shingles vaccine, in a male patient. 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: Shingles (patient had them in early 30s)