Received May 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
sleep disturbance; suspcted vaccination failure; shingles/rash/pain; This serious case was reported by a consumer via interactive digital media 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 and Varicella zoster vaccine for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 1st dose of Varicella zoster vaccine. In APR-2026, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Varicella zoster vaccine, the patient experienced vaccination failure (Verbatim: suspcted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/rash/pain). On an unknown date, the patient experienced sleep disorder due to a general medical condition (Verbatim: sleep disturbance). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving and the outcome of the sleep disorder due to a general medical condition was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and sleep disorder due to a general medical condition to be related to Shingrix, Shingrix and Varicella zoster vaccine. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and sleep disorder due to a general medical condition to be related to Shingrix, Shingrix and Varicella zoster vaccine. It was unknown if the company considered the vaccination failure to be related to Varicella zoster vaccine. Additional Information: GSK Receipt Date: 10-MAY-2026 This case was reported by patient via interactive digital media. Patient had the first shot in 2017 and 2 of the Shingrix shots that included a booster in 2019, got shingles 3 weeks ago. Also stated that the rash mostly subsided, had intermittent pain which was disrupting the sleep, nothing seemed to be helpful. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, more than 2 years after vaccination with the 2nd dose of Shingrix, the 1st dose of Shingrix, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.