Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Still in extreme pain; Suspected vaccination failure; have had the shingles since February 16th; 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 16-FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have had the shingles since February 16th). On an unknown date, the patient experienced pain (Verbatim: Still in extreme pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the pain was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain 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 and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and had the shingles since 16th February and had worst pain ever with still in extreme pain. This case was considered as suspected vaccination failure since the details regarding the 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.