Received Feb 4, 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; he has had 4 outbreaks of shingles; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 42-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (Biktarvy) for product used for unknown indication. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Biktarvy. On 20-JAN-2026, less than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Biktarvy, the patient experienced shingles (Verbatim: Shingles). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he has had 4 outbreaks of shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The action taken with Biktarvy was unknown. The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix. The reporter considered the vaccination failure, shingles and shingles to be not reported if related to Biktarvy. It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles and shingles to be not reported if related to Biktarvy. Additional Information: GSK Receipt Date: 22-JAN-2026 The reporter reported that patient who received both doses of Shingrix last year. The reporter stated that since then, he had had 4 outbreaks of shingles. The patient last outbreak started 2 days ago and was at the same site inner thigh near the groin on his left side. The patient has also been taking Biktarvy for about 4 years and he was prescribed Valtrex 1000 mg for his shingles outbreak. 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. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Vaccination failure, less than 2 years after receiving 2nd dose of Shingrix, the 1st dose of Shingrix and Biktarvy., in a 42-year-old male 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.
Biktarvy