Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included herpes virus infection (had in the 70s due to unprotected sex, for decades then it was settled down), stress (herpes came back when the patient was stressed) and feels awful. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 23-SEP-2025 This was reported by the patient via (Open field AE monitoring) interactive digital media. The patient experienced shingles for the first time ever and they were horrible. Patient got prescribed for additional medications. However, several days into the treatment, there were no changes. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in an adult 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: Feels awful; Herpes virus infection (had in the 70s due to unprotected sex, for decades then it was settled down); Stress (herpes came back when the patient was stressed)