Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
nerve pain; Suspected Vaccination failure; Have them in my right ear and face; Have them in my right ear and face /plisters were all around my ear and in my hair /My face half way over and my lips and neck stay numb, like a hundred needles are jabbing me; 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. On an unknown date, the patient received Shingles vaccine. On 24-DEC-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Have them in my right ear and face) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Have them in my right ear and face /plisters were all around my ear and in my hair /My face half way over and my lips and neck stay numb, like a hundred needles are jabbing me). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: nerve pain). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa, facial herpes zoster and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported to have shingles started on 24 December 2024. The patient had them right ear and face . The blisters were all around the ear and in my hair. The pain was so bad. The patient stated his/her face was half way over and my lips and neck stay numb, like a hundred needles are jabbing. The patient had the Shingles shot 4 years ago. Had been on medication for the virus, and Gabapentin for the nerve pain. This has been 4 months already and still have a lot of pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.