Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
Suspected vaccination failure; fighting shingles at the moment; Nerve pain; 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In SEP-2025, 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: fighting shingles at the moment) and nerve pain (Verbatim: Nerve pain). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles and nerve pain were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-OCT-2025 This case was reported by a patient via interactive digital media. Patient received both vaccines a few years ago (from the date of reporting) and right now (at the time of reporting) was fighting with shingles. It was horrible. Patient got the Antiviral and Gabapentin for nerve pain. It was going on 4-weeks, the rash was clearing but the pain was unreal, patient could not even stand clothes touching his/her skin. It was from patients' back, under arm and breast. He/she could not even imagine what it would be like without the vaccine. Patient thought that might be vaccines were filled with water. This case was considered as suspected vaccination failure as details of 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, unknown time after receiving Shingles vaccine (Dose 1 and Dose 2) in a patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.