Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Supected vaccination failure; got shingles after I got the vaccination/ it was on neck and face; 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 an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Supected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles after I got the vaccination/ it was on neck and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 2 months). It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got shingles after vaccination about a month later. Patient reported that it was on neck and face. It lasted 2 long painful months. Patient ended up in the emergency room and the doctor was so excited to see it. 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. The follow-up could not be possible as no contact details were available.; 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.