Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM |
Shingles; Shingles; Suspected vaccination failure; Shingles; had active shingles at the time of the vaccination; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypercholesterolemia, sinusitis, hypertension and shingles (had active shingles at the time of the 1st vaccination). Concomitant products included atorvastatin calcium (Lipitor), montelukast sodium (Singulair) and lisinopril. In JUL-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, the patient received Shingrix (intramuscular). In MAR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: had active shingles at the time of the vaccination). In MAR-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In SEP-2024, the patient experienced shingles (Verbatim: Shingles). In DEC-2024, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure was not resolved and the outcome of the shingles, shingles and shingles were resolved and the outcome of the drug use for unapproved indication was not applicable. It was unknown if the reporter considered the vaccination failure, shingles, shingles and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles, shingles and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-FEB-2025 The patient self-reported this case for himself. The patient stated that he received the two doses of Shingrix vaccine. The patient stated that he received his first Shingrix dose and had active shingles at the time of the vaccination which led to drug use in unapproved indication. The patient had experienced 4 shingles outbreaks. In March 2024, between 8 and 9 months after 2nd dose and between 1 and 2 years after 1st dose, the patient had shingles. In September 2024 and December 2024, between 1 and 2 years after 1st and 2nd dose, the patient had two more shingles. This case was considered as suspected vaccination failure 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. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Hypercholesterolemia; Hypertension; Shingles (had active shingles at the time of the 1st vaccination); Sinusitis
LIPITOR; SINGULAIR; LISINOPRIL