Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; Shingles; driving me out of my mind; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included dry skin (history of (moderate) dry skin). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling abnormal (Verbatim: driving me out of my mind). The outcome of the vaccination failure and feeling abnormal were not reported and the outcome of the shingles was resolving. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles and feeling abnormal to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 The patient self reported this case for himself Patient does not remember having chicken pox (as a child). Reporter thought he might have had a possible after effect from the shingles shot. he had a rash that he had been getting off and on since he had received the shingles shot. The reporter had received the Shingrix shot 1 and shot 2. He did not know the dates or lot numbers of the injections. About a month or so after receiving the second shot, he went to see his physician for a rash on his left leg. His doctor diagnosed it as shingles. When he first saw the physician, there had been about a dozen spots. About 3 to 5 spots remained. The spots were itchy and felt a bit scabby. He had also experienced fluid filled blisters on his left butt cheek, which had been driving him out of his mind. He said that the blisters had been somewhat similar to what he had on his leg. Additionally, he had developed a rash on the top of his head that he had never had before. He had been seeing a dermatologist and had been using 3 to 4 unspecified creams and salves, as well as taking showers with liquid soap, but the event had not resolved. This case was considered as suspected vaccination failure as details 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster and Feeling abnormal are unlisted events which are considered unrelated to GSK Shingrix.
Medical History/Concurrent Conditions: Dry skin (history of (moderate) dry skin)