Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; shingles/most painful experience; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included aneurysm (in 2008 and operated 8 times). On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/most painful experience). 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 Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles for 6 times, and it was the most painful experience that I've ever had. The patient had an aneurysm in 2008 and was operated on eight times but still the patient can't remember this pain at all. I could not anything more painful This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, on an unknown after receiving Herpes Zoster vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Medical History/Concurrent Conditions: Aneurysm (in 2008 and operated 8 times)