Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Surgery; I've had the vaccination and just got them again/ Three weeks later I go to my PCP and she tells me that I have shingles; 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. The patient's past medical history included shingles (worst) and pain (painful shingles). 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), surgery (Verbatim: Surgery) (serious criteria clinically significant/intervention required) and shingles (Verbatim: I've had the vaccination and just got them again/ Three weeks later I go to my PCP and she tells me that I have shingles). The outcome of the vaccination failure, surgery and shingles were not reported. It was unknown if the reporter considered the vaccination failure, surgery and shingles to be related to Shingles vaccine. The company considered the vaccination failure and surgery to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles three times. The first time was the worst. The patient had the vaccination and just got shingles again. He/she thought that they injured his/her back during surgery. Three weeks later, the patient went to the PCP (primary care physician) and she told the patient that he/she had shingles. It was not nearly as painful as the first time. The patient guessed that was why the patient just thought it was sciatica. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of 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. Surgery is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Medical History/Concurrent Conditions: Pain (painful shingles); Shingles (worst)