Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; currently having a shingles case on both arms; Stress; 2 Shingrix doses before 50 Years old; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 45-year-old female patient who received Herpes zoster (Shingrix) solution for injection for prophylaxis. The patient's past medical history included shingles (getting outbreaks since patient was 37 years old). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: currently having a shingles case on both arms), stress (Verbatim: Stress) and inappropriate age at vaccine administration (Verbatim: 2 Shingrix doses before 50 Years old). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and stress were not reported and the outcome of the shingles was not resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. Additional Information: GSK Receipt Date:22-MAY-2026 The patient had shingles for the fifth time. She had received Shingrix two years ago and, at age 45, was asking whether she would need additional Shingrix doses in the future. She had previously convinced her insurance to approve the vaccine after her third shingles outbreak. She did not have AIDS or cancer, and she believed her recurrent episodes might have been stress related. She explained that this was her fifth outbreak, and pharmacists were surprised because she developed shingles on both arms. She stated that she had been experiencing outbreaks since age 37 and was tired of them. Her doctor had prescribed Acyclovir pills and ointment. The batch number was not provided upon follow up with the reporter. This case was considered as suspected vaccination failure as laboratory confirmation and time to onset regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 1st dose and 2nd dose of Shingrix in a 45-year-old female patient. Case lacks further information on time to onset, concurrent conditions and laboratory confirmation. 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 (getting outbreaks since patient was 37 years old)