Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Internal shingles; Foot infection; 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 (had 20 years ago) and rash. 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), zoster sine herpete (Verbatim: Internal shingles) and foot infection (Verbatim: Foot infection). The patient was treated with gabapentin. The outcome of the vaccination failure and foot infection were not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and foot infection 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 zoster sine herpete and foot infection to be related to Shingles vaccine. Additional Information: GSK receipt date: 06-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine a couple years ago. And just had to be on several antibiotics for a foot infection, which wiped out the immune system and now had internal shingles. The patient did not have rash because he/she had vaccine but had the pain and burning sensation. He/she was on gabapentin. It sounded like everyone got on that. The patient asked if anyone had the internal shingles. 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: 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.
Medical History/Concurrent Conditions: Rash; Shingles (had 20 years ago)