Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; I have them right now; nerve pain on all day; felt under the weather all last week; 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. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt under the weather all last week). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have them right now) and post herpetic neuralgia (Verbatim: nerve pain on all day). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia was resolved and the outcome of the feeling abnormal was resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and feeling abnormal to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she had them right at the time of reporting. The reporter had the shots last fall thank goodness. The reporter felt under the weather all last week. Experience the nerve pain on all day Saturday and erupted Saturday night. The eruptions were minor for me but the pain, fatigue and fever were still very uncomfortable. The reporter was on anti-virals. The reporter thanked goodness for the vaccine. The reporter was sure he/she would have been very sick without it. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles 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.