Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Shingles; Suspected vaccination failure; Shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 14-JAN-2021, the patient received the 2nd dose of Shingrix (left deltoid). On 06-NOV-2020, the patient received the 1st dose of Shingrix (left deltoid). In NOV-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In MAY-2025, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure, shingles and shingles were unknown. It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 12-JUN-2025 The reporter was the patient who was also a Dentist. The patient received the first dose of Shingrix on 6th November 2020, and the second dose on 14th January 2021. Both doses were received in the left deltoid. In November 2024 the patient developed Shingles and developed Shingles again in May 2025. The patient stated that the patient did not think that the Shingrix vaccine was effective. The patient had a Varicella Zoster IgG and IgM antibody tests obtained. The IgG was reactive, but a titer was not done. The IgM was negative. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was 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 vaccine Shingrix (Dose 1 & 2).
Test Name: Varicella Zoster IgG; Result Unstructured Data: (Test Result:Reactive,Unit:unknown,Normal Low:,Normal High:) IgG was reactive but a titer was not done; Test Name: Varicella Zoster IgG; Result Unstructured Data: (Test Result:negative result,Unit:unknown,Normal Low:,Normal High:)