Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected Vaccination failure; I have shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 92-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had the chicken pox at age 3). Concurrent medical conditions included chickenpox (having chicken pox). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The patient was treated with aciclovir (Acyclovir) and lidocaine. The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 09-JUL-2025 Last year (in 2024) the patient had the 2 vaccinations for shingles. Now at the age of 92 patient had shingles with the pain itches discomfort and fin for its treatment which consists of a very expensive ointment and an oral tablet. The ointment Acyclovir 5 percent, 500 milligrams, antihistamine levocetir 50 milligrams and lidocaine patch for the pain. After 89 years and having chicken pox patient would have chanced not get the shingles. But with all your propaganda on getting vaccinated patient got the pain, the itch, the suffered the high cost. Patient felt the GlaxoSmithKline company should take some responsibility for this patient took advantage the big push to get the 2 injections only for your product to fail. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Chickenpox (having chicken pox)
Medical History/Concurrent Conditions: Chickenpox (had the chicken pox at age 3)