Received Feb 14, 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; got shingles on his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Family history included shingles (patient's wife had shingles before Shingrix was available) and pain (patient's wife still had to hurt for a while). 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 facial herpes zoster (Verbatim: got shingles on his face). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient's wife via interactive digital media. The reporter reported that sorry but the only way to avoid getting shingles in later life was to have the chickenpox vaccine as a child. Most of the adult's had chickenpox as children, and that virus, herpes zoster, never goes away. It hides out at the base of the spine, and when we were older it comes back as shingles. The reporter had shingles before Shingrix was available. Her doctor gave her an antiviral, but still had to hurt for a while. Better believe got the 2 shot Shingrix vaccine as soon as it was available. The patient got it too. He got shingles late last year, but it was a mild case. It was on his face, but he had no pain and no permanent damage. He had an antiviral which helped him heal faster. He was given Gabapentin for pain, but never needed it. He believes in vaccines. Even if they did not totally stop the infection, they make it milder. It was proved that husband had shingles, by an antibody test. He had antibodies to herpes zoster, but not to herpes simplex which causes cold sores and genital herpes. This case was considered as suspected vaccination failure as details regarding time to onset for 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 time to onset and laboratory confirmation of herpes zoster) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Medical History/Concurrent Conditions: Pain (patient's wife still had to hurt for a while); Shingles (patient's wife had shingles before Shingrix was available)
Test Name: antibody test; Result Unstructured Data: (Test Result:shingles,Unit:unknown,Normal Low:,Normal High:)