Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; seemed to think it was related to shingles; burning sensation; got this pain on the back of neck; neck felt numb to the touch; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: seemed to think it was related to shingles), burning sensation (Verbatim: burning sensation), neck pain (Verbatim: got this pain on the back of neck) and neck numbness (Verbatim: neck felt numb to the touch). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure, shingles and neck numbness were not reported and the outcome of the burning sensation was resolved and the outcome of the neck pain was resolving. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, neck pain and neck numbness 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, burning sensation, neck pain and neck numbness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUL-2025 This case was reported by a patient via interactive digital media. The patient decided to get the Shingles shot a year ago and a couple of weeks ago a got this pain on the back of neck as if he/she had slept the wrong way. Well, it got worse and then the back of neck felt numb to the touch and then periodically the patient got this burning sensation as if someone was using a hot poker on the back of neck and that would come and go just about every hour or so. The patient made an appointment to see doctor and he/she was told that it was not muscle related but had more to do with skin. The patient had no redness whatsoever, but the doctor seemed to think it was related to shingles. The patient was prescribed Valacyclovir to fight the virus and so far after taking this after a few days the pain has subsided and that burning sensation has gone away. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming 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.