Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; Very painful and I couldn't eat; Got shingles and it lasted for 3 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles and it lasted for 3 months) and unable to eat (Verbatim: Very painful and I couldn't eat). The outcome of the vaccination failure and unable to eat were not reported and the outcome of the shingles was resolved (duration 3 months). It was unknown if the reporter considered the vaccination failure, shingles and unable to eat to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and unable to eat to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-DEC-2025 This case is received form the patient via interactive digital media. The condition was extremely painful. The batch number was not provided, and unable to contact the reporter. 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 1st dose of Shingles vaccine., in a patient. Causal association is indeterminate. 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. The company has assessed that it is unlikely that Vaccination failure was caused by the vaccine 2nd dose of Shingles vaccine. Study vaccine is not administered.