Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; received both shots a few years ago and still get outbreaks; crippling nerve pain; fibromyalgia; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: received both shots a few years ago and still get outbreaks), nerve pain (Verbatim: crippling nerve pain) and fibromyalgia (Verbatim: fibromyalgia). The outcome of the vaccination failure and shingles were not reported and the outcome of the nerve pain and fibromyalgia were not resolved. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and fibromyalgia to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, nerve pain and fibromyalgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-AUG-2025 This case was reported by a patient via interactive digital media. The patient received both shots a few years ago and still get outbreaks. The doctor said that it did not stop breakouts in everyone, and the patient was one of the ones it did not stop. It had lessened the duration and severity of the breakout. The patient was given daily antibiotics. The nerve pain was debilitating, and the patient was endlessly frustrated with crippling nerve pain. The patient was told it was fibromyalgia. The patient wondered if it had something also to do with patient's shingles history. This case was considered as suspected vaccination failure as details regarding time to onset 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 (doses 1 and 2).
Medical History/Concurrent Conditions: Shingles