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; diagnosed with shingles; Head cold; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 19-AUG-2024, the patient received the 2nd dose of Shingrix. On 07-MAY-2024, the patient received the 1st dose of Shingrix. In APR-2026, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles). On an unknown date, the patient experienced head cold (Verbatim: Head cold). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the head cold was resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, shingles and head cold 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 and head cold to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2026 The reporter stated that a couple of weeks ago she developed an underarm itch and bumps on her skin. The patient was diagnosed with shingles and the doctor gave her some cream for it. The patient also stated she has had a head cold for the past week. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, between 1 and 2 years after receiving 1st dose and 2nd dose of Shingrix in a 65-year-old female patient. Case lacks further information on exact time to onset, medical history, concurrent conditions and laboratory confirmation. 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.