Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Suspected vaccination failure; suspected zoster sine herpete (ZSH); flank pain/ the patient had this severe pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included diabetes (female patient with diabetes). In FEB-2025, 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), zoster sine herpete (Verbatim: suspected zoster sine herpete (ZSH)) and flank pain (Verbatim: flank pain/ the patient had this severe pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain 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 zoster sine herpete and flank pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 The reporter called to speak with someone regarding Shingrix and zoster sine herpete (ZSH) and was asking whether there was an increased reaction of zoster sine herpete (ZSH) in patient who were vaccinated (not acutely/recently) with Shingrix. The reporter stated two weeks ago a female patient with diabetes probably 50ish in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint. She had no proof of zoster sine herpete (ZSH), just a clinical suspicion because all the workup was negative but the patient had this severe pain that she could not account for. Now, in retrospect she thought it was zoster sine herpete (ZSH). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for zoster sine herpete (shingles) and laboratory confirmation regarding zoster sine herpete (shingles) were unknown at the time of reporting. This case was one of the three case reported by the same reporter for different patients.; 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 Shingles vaccine. US-GSK-US2025026210:2 of 3 patient US-GSK-US2025026208:Same reporter/Different patient
Diabetes (female patient with diabetes)