Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Shingles developed in the same area: on the Right cheek, near the eye.; Suspected Vaccination failure; Shingles developed in the same area: on the Right cheek, near the eye.; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure high. On 20-JAN-2021, the patient received the 2nd dose of Shingrix. On 20-NOV-2020, the patient received the 1st dose of Shingrix. On 03-MAR-2025, 1503 days after receiving Shingrix and 1564 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles developed in the same area: on the Right cheek, near the eye.). On 15-JUN-2025, the patient experienced facial herpes zoster (Verbatim: Shingles developed in the same area: on the Right cheek, near the eye.). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster and facial herpes zoster were unknown. It was unknown if the reporter considered the vaccination failure, facial herpes zoster 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 and facial herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-JUN-2025 The patient did not provide her date of birth but states she was 90 years old. The patient could not locate the contact information for her healthcare professional. The reporter was the patient. The patient received the first dose of Shingrix on 20 November 2020, and the second dose 20 January 2021. On 3 March 2025 the patient developed shingles.On 15 June 2025, the patient developed shingles again. Both times, the shingles developed in the same area on the Right cheek, near the eye. The patient was treated both times with valacyclovir.For the first episode of shingles the patient was given valacyclovir l gram twice daily for 7 days; the second episode the patient was given valacyclovir l gram three times daily for 7 days. The recommended dosing for valacyclovir for herpes zoster treatment was 1 gram 3 times daily for 7 days. However caution should be exercised when administering valtrex to geriatric patients, and dosage reduction was recommended for those with impaired renal function.Elderly patients were more likely to have reduced renal function and require dose reduction.The patient was 90 years of age. Captured for under dose and over dose for valacyclovir were captured to be prudent. The patient renal function was not provided at the time of this report. Adverse event of potential under dose (1 gram twice daily for 7 days) was captured as the recommended dosing was 1 gram 3 times daily; but it was important to note that the patient was 90 years of age and the decreased dose may be due to patient renal function. Potential over dose (1 gram three times daily for 7 days) were captured because the patient was 90 years of age, and maybe too high for this patient. 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) and Shingrix (dose 2).
Blood pressure high