Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | x7z52 | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7557J | — |
Suspected vaccination failure; 3 episodes of shingles after receiving both doses of Shingrix; second dose of SHINGRIX was administered outside of the recommended window of 2 to 6 months; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) (batch number x7z52, expiry date 05-NOV-2022) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 7557J, expiry date 05-NOV-2022) for prophylaxis. The patient's past medical history included uveitis and shingles (her first outbreak of shingles was in 2013. After uveitis she was diagnosed with shingles around her eye and on her forehead.). Previously administered products included flu vaccine (in 2013, had a flu shot administered (unknown name/manufacturer) and was diagnosed with uveitis). On 22-FEB-2021, the patient received the 2nd dose of Shingrix. On 18-JUL-2020, the patient received the 1st dose of Shingrix .5 ml. On 22-FEB-2021, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of SHINGRIX was administered outside of the recommended window of 2 to 6 months). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 3 episodes of shingles after receiving both doses of Shingrix). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-MAR-2026 The consumer reported having three episodes of shingles after receiving both doses of Shingrix, indicating a lack of effect. She stated that with each episode or outbreak, she had approximately five bumps or lesions. Based on the vaccination dates, the second dose of Shingrix had been administered outside the recommended 2-to-6-month window, reflecting an improper vaccine schedule. The consumer stated that she had not been treated for the outbreaks and that the lesions had been resolved without treatment. 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, an unknown time after receiving the 2nd dose of Shingrix vaccine, in a female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
Medical History/Concurrent Conditions: Shingles (her first outbreak of shingles was in 2013. After uveitis she was diagnosed with shingles around her eye and on her forehead.); Uveitis