Received May 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; right eye to swell shut.; Shingles on right side of face; Upset stomach; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and valaciclovir hydrochloride (Valtrex) film-coated tablet for shingles. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In MAY-2026, the patient started Valtrex. In MAY-2026, an unknown time after receiving Shingrix and Shingrix and not applicable after starting Valtrex, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: right eye to swell shut.) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles on right side of face) and upset stomach (Verbatim: Upset stomach). Valtrex was discontinued. The outcome of the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and upset stomach were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix and Shingrix. The reporter considered the upset stomach to be related to Valtrex. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix and Shingrix. The company considered the upset stomach to be related to Valtrex. Additional Information: GSK receipt date: 07-MAY-2026 The patient was approximately 70 years old. The patient had developed a case of Shingles after his medical chart indicated he has received 2 doses of the Shingrix vaccine in the past (dates were unknown). This presentation of Shingles was on the right side of his face and started the week of 04-MAY-2026 and had caused his right eye to swell shut. The patient was taking an antiviral medication to help with the Shingles. He was being seen by his primary care nurse practitioner and an eye doctor. The antiviral medication upset his stomach, and he discontinued it (possible Valtrex). He then started an anti-emetic medicine to help him tolerate the antiviral. This case has been considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, on an unknown time after vaccination with the 1st and 2nd dose of Shingrix, in an elderly male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received. The company has assessed that the event Vaccination failure and Ophthalmic herpes zoster were not related to the drug Valaciclovir hydrochloride.
Valtrex