Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Vaccination failure; Shingles; Shot stung at 1st; Shot stung at 2nd; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), injection site pain (Verbatim: Shot stung at 1st) and injection site pain (Verbatim: Shot stung at 2nd). The outcome of the vaccination failure, shingles, injection site pain and injection site pain were not reported. It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and injection site pain to be related to Shingrix. It was unknown if the company considered the shingles and injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 16-JUL-2025 The patient received both doses of Shingrix vaccine a few years ago. The patient had 6 cases of Shingles since vaccination. Not effective for patient. Shot stung at 1st, but tolerate both well. Hope works better for others. This case was considered as suspected vaccination failure as details regarding 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 completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).