Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
Suspected vaccination failure; had shingles in one arm; 2 doses in Oct; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. In OCT-2024, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: 2 doses in Oct). In FEB-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles in one arm). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too short was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she was vaccinated, 2 doses in October. At the time of reporting patient have had shingles in one arm for 2 months now. The patient stated that it was intense burning, slowly spreading up to underarm. No rash were reported. The patient stated it took a while to diagnose it. All internal and guess mild compared to most because patient did. The patient suggested to get the vaccine, patient had encouraged everybody to get it. The patient received 2nd dose of Shingrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. This case was considered as suspected vaccination failure as laboratory test 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 Shingles vaccine (dose 1) and Shingles vaccine (dose 2).