Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | N2954 | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 49Y35 | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7RK7K | IM / RA |
Suspected vaccination failure; had shingles; patient that received a third dose of Shingrix on 30-SEP-2024; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number N2954, expiry date 30-APR-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 49Y35, expiry date 31-OCT-2020) for prophylaxis and Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 31-OCT-2020) for prophylaxis. On 30-SEP-2024, the patient received the 3rd dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, right arm). On 30-SEP-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered (Verbatim: patient that received a third dose of Shingrix on 30-SEP-2024). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles and extra dose administered were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingrix. Additional Information: GSK Receipt Date: 31-JAN-2025 The pharmacist reported that the female patient that received a third dose of Shingrix which led to extra dose administered. The pharmacist also states that the patient mentioned that she recently (no specific date was provided) had shingles. No further information was available about the case of shingles. The pharmacist reported all that was provided about this adverse event. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1, Shingrix dose 2 and Shingrix dose 3.