Received Dec 17, 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; Vaccine failure: shingles outbreak; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 13-OCT-2020, the patient received the 2nd dose of Shingrix. On 28-JUL-2020, the patient received the 1st dose of Shingrix. On 21-OCT-2025, 1834 days after receiving Shingrix and 1911 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Vaccine failure: shingles outbreak). In NOV-2025, the outcome of the vaccination failure and shingles were resolved (duration 3 weeks). 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: 10-DEC-2025 The patient self-reported this case for herself. The patient was prescribed unspecified medication to treat the shingles and to help with the pain. She felt that it was a mild case, because it bothered her for only about three weeks. The shingles was resolved. Additionally, the patient reported an intercepted inappropriate schedule of vaccination. Her healthcare professional advised her to get a third Shingrix shot. She attempted to make an appointment at a pharmacy, but the pharmacist noted that she had already received two doses and was unsure if a third dose was appropriate. Therefore, the patient did not receive a third shot at the time of this report. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Vaccination failure, 1834 days after receiving 2nd dose of Shingrix, in a 84-year-old female patient. Causal association is indeterminate. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.