Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
suspected vaccination failure; potential zoster sine herpete (ZSH); flank pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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), zoster sine herpete (Verbatim: potential zoster sine herpete (ZSH)) and flank pain (Verbatim: flank 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 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 patients who were vaccinated (not acutely/recently) with Shingrix. In February 2025, 1 month ago, a female patient (also a doctor) probably 70ish in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint. This was the only one of the 3 patients the caller had potential confirmation of zoster sine herpete (ZSH) for. The patient said zoster sine herpete (ZSH) was evidently more common in vaccinated patients and the patient's zoster antibody levels were high. 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. This case is one of the three linked cases reported by the same reporter.; 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 vaccine Shingles vaccine. US-GSK-US2025026210:Same reporter/Different patient US-GSK-US2025026200:Same reporter/Different patient
Test Name: zoster antibody level; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:)