Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis. In APR-2023, the patient received the 2nd dose of Shingrix (left arm). In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On 27-OCT-2024, the patient received Influenza vaccine (left arm). In NOV-2024, the patient received COVID-19 vaccine (right arm). In OCT-2024, less 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). The patient was treated with prednisone acetate (Prednisone). 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: 27-MAR-2025 The patient reported he received SHINGRIX dose 1 in Jan 2023 and dose 2 in April 2023 in the left arm. He stated on 27 October 2024, He received the regular flu shot (no name) in left arm. Had Covid shot in right arm in Nov 2024. He states he experienced itchy rash bumps (10 to 20) in a band/line, on front of left shoulder since October 2024. He was diagnosed with shingles and thinks SHINGRIX did not work for him. He stated a week later Nov 2024 he received the COVID shot in right arm. He still had not fully recovered from shingles. He stated he was given medicines like prednisone pills, prednisone shot, a cream for the itch and a gel that had silver in it, he purchased for the rash. Medical disclaimer provided. This case was considered as suspected vaccination failure as details regarding completion of laboratory confirmation regarding shingles were unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure and shingles to be related to Flu vaccine and Covid-19 vaccine.; 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).