Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; I had one of the worst breakouts I had in a long time; Post herpetic neuralgia; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had one of the worst breakouts I had in a long time) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The outcome of the vaccination failure, shingles and post herpetic neuralgia were not reported. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be possibly related to Shingrix and Shingrix. It was unknown if the company considered the post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a patient via interactive digital media. The patient developed shingles, a painful, blistering rash usually on one side of the face or body that can last for weeks. But the pain did not stop when the rash cleared. It lasted for three long months. Patient took the new one and after the booster patient had one of the worst breakout patient had in a long time. Patient experienced a painful condition known as postherpetic neuralgia as a complication of shingles. PHN occurred in about 10 to 18 percent people who had shingles. 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: A case of Vaccination failure, unknown time after receiving Shingrix (Dose 1 and Dose 2) in a adult male patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.