Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; ear shingles; This serious case was reported by a physician via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (years ago). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster otitis externa (Verbatim: ear shingles) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa was not resolved. The reporter considered the vaccination failure and herpes zoster otitis externa to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 24-DEC-2025 About six months ago, the patient was offered a shingles vaccine. The patient informed the healthcare professional that they had shingles years ago, and the healthcare professional advised that shingles could occur again. The patient stated that he took the shot without any more questions and that cost was not a concern and emphasized the severity of the pain. 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 a request for this information has been made.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, an unknown time after receiving Shingles vaccine, in an adult male 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.
Medical History/Concurrent Conditions: Shingles (years ago)