Received May 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
Suspected vaccination failure/lack of effectiveness; Got the virus (shingles); Third dose prescribed by physician; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis. On 17-NOV-2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/lack of effectiveness) (serious criteria GSK medically significant), shingles (Verbatim: Got the virus (shingles)) and drug prescribing error (Verbatim: Third dose prescribed by physician). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the drug prescribing error 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, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date 04-MAY-2026 The pharmacist called to informed that a patient had finished the series of Shingrix and received the 2nd dose back in but now got a prescription from the physician to receive another dose of Shingrix. The reporter mentioned that this was prescribed by the physician because the patient got the virus shingles, and she recovered. No further details provided. The batch number was not provided upon follow- up with the reporter. This case has been considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving 1st, 2nd and 3rd dose of Shingrix, in a elderly 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.