Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
few small scars; Suspected Vaccination failure; developed Shingles again in February 2025; first dose of Shingrix in October 2023 and second dose in October 2024; in August 2024 diagnosed with Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 vaccine for prophylaxis, Influenza vaccine for prophylaxis, Pneumococcal vaccine for prophylaxis, COVID-19 vaccine for prophylaxis and Influenza vaccine for prophylaxis. In OCT-2024, the patient received the 2nd dose of Shingrix (unknown arm) .5 ml. In OCT-2023, the patient received the 1st dose of Shingrix (unknown arm) .5 ml, COVID-19 vaccine, Influenza vaccine and Pneumococcal vaccine. In OCT-2024, the patient received COVID-19 vaccine and Influenza vaccine. In AUG-2024, not applicable after receiving Shingrix and between 9 and 11 months after receiving Shingrix, the patient experienced shingles (Verbatim: in August 2024 diagnosed with Shingles). In OCT-2024, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in October 2023 and second dose in October 2024). In FEB-2025, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles again in February 2025). On an unknown date, the patient experienced scar (Verbatim: few small scars). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and scar were not reported and the outcome of the shingles was resolved and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles and scar to be related to 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. It was unknown if the company considered the shingles and scar to be related to Shingrix. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient self-reported this case. The patient received the first dose of Shingrix vaccine in October 2023 and received three other vaccines at the same time which were Covid, Flu and Pneumonia vaccine and in August 2024 he was diagnosed with shingles and had painful itching bumps on his upper thigh, groin and abdomen all located on the left side. The physician gave him Acyclovir and the shingles resolved leaving a few small scars. The patient received his second dose of Shingrix in October 2024 and received two other vaccines at the same time which were Covid and Flu vaccine and developed shingles again in February 2025 that were not resolved. The patient had second episode of shingles bumps present the same as the first episode and were located center back neck to buttocks and the bumps were thicker near the buttocks area. The reporter did not remembered in what arm the first and second dose was administered and did not had a lot number or National Drug Code (NDC) number for the both doses of Shingrix vaccine. It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Covid-19, Influenza and Pneumococcal vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of 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, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).