Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included COVID-19 vaccine (received a COVID-19 vaccine on an unknown date). On an unknown date, the patient received 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) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be possibly related to Shingrix. Additional Information: GSK receipt date: 18-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her aunty had the COVID vaccine, then six months later received the shingles vaccine. After that, she developed shingles the sickest she had ever been. She went back to the physician and said, did not said the vaccine could give him/her shingles and the physician said, oh yeah, that can occur. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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 the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix