Received Jun 18, 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; shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included psoriatic arthritis, gastroesophageal reflux disease, depression and hyperlipidemia. Concomitant products included upadacitinib (Rinvoq), omeprazole, vortioxetine hydrobromide (Trintellix), evolocumab (Repatha) and tirzepatide (Mounjaro). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 30-MAY-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: shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 12-JUN-2025 The patient received both doses of her Shingrix vaccine beginning in April 2023. Also stated that received both doses in appropriate time frame. She began experiencing pain in her back on 29-May 2025 and she described the pain as like being punched in the kidney her skin was sensitive to touch and the pain radiated from her low back spine around the right side of abdomen to her navel. This is where the shingles lesions erupted as well. Some of the lesions started to open and drain, but the majority of the lesion remain as intact blisters or bumps. This case was considered as suspected vaccination failure as details regarding 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).
Depression; Gastroesophageal reflux disease; Hyperlipidemia; Psoriatic arthritis
RINVOQ; OMEPRAZOLE; TRINTELLIX; REPATHA; MOUNJARO