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 |
had shingles in June 2025/ red rash in a line on left side of abdomen; Suspected vaccination failure; in late February 2025 she was diagnosed with shingles/ a red rash on left back torso; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 10-JAN-2019, the patient received the 2nd dose of Shingrix (left arm). On 06-NOV-2018, the patient received the 1st dose of Shingrix (left arm). In FEB-2025, 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: in late February 2025 she was diagnosed with shingles/ a red rash on left back torso). In JUN-2025, the patient experienced shingles (Verbatim: had shingles in June 2025/ red rash in a line on left side of abdomen). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the shingles was not resolved. 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: 10-JUN-2025 The patient self-reported this case for herself. The patient had other conditions and used other products. The patient reported that she received Shingrix dose 1 and dose 2 both in left arm. She stated in late February 2025 she was diagnosed with shingles. She had a red rash on left back torso. She was given an antiviral for 10 days. At the time of reporting, she was out of town and stated she had red rash in a line on left side of abdomen. She would refer to HCP (health care professional) when she gets back home. This case was considered as suspected vaccination failure as 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 vaccine Shingrix (Dose 1 & 2).