Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 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 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles at the age of 53 years old). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, 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. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 27-SEP-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she had received the vaccine afterwards but now have shingles again just one shingle. The patient stated that one could get shingles again, and that it was a current condition which could recur. The batch number was not provided, and we are unable to contact the reporter. 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.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix, in a 57-year-old 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.
Medical History/Concurrent Conditions: Shingles (had shingles at the age of 53 years old)