Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
pain/ache; fever; suspected vaccination failure; shingles on ear; diagnosed with shingles has two sores on her tongue; shingles on her left side head, neck; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included allergy to nsaids (Ibuprofen allergy) and ragweed allergy (ragweed allergy). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 02-SEP-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles on ear) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: diagnosed with shingles has two sores on her tongue) and shingles (Verbatim: shingles on her left side head, neck). On an unknown date, the patient experienced pain (Verbatim: pain/ache) and fever (Verbatim: fever). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa, oral herpes zoster and shingles were resolving and the outcome of the pain and fever were resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, oral herpes zoster, shingles, pain and fever to be related to Shingrix and Shingrix. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the oral herpes zoster, shingles, pain and fever to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 09-SEP-2025 The reporter stated that she received the Shingrix vaccine in 2021 but she was unsure if she received both doses in the series and is sending a request for immunization history to the pharmacy who administered. She stated she does remember after getting the vaccine she developed a fever, aches, and pains in 2021. The reporter stated she recently was diagnosed with shingles on her left side head, ear, neck, and had two sores on her tongue. She was taking Valtrex and her symptoms were improving. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Herpes zoster, more than 2 years after receiving Shingrix (dose 1 and dose 2)), in a 68-year-old-female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Allergy to NSAIDs (Ibuprofen allergy); Ragweed allergy (ragweed allergy)