Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
suspected vaccination failure; Got shingles; 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. The patient's past medical history included chickenpox (had as a kid). Previously administered products included Varicella zoster vaccine (had a Shingles shot over 5 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In AUG-2024, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure and shingles were not reported. 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: 21-JAN-2025 and 24-JAN-2025 This case was reported by a patient via interactive digital media. Patient had a Shingles shot over 5 years ago. He/she also had the new 2 shots Shingles shot 2 years ago (from the date of reporting). Patient got shingles at the end of August 2024. The patient wanted to know would he/she has sensitive skin in that area forever, would he/she have to deal with nerve pain from this shingles. The patient said that the shot did not guarantee you and, how many after-affects you have to deal with. This case was considered as suspected vaccination failure as details regarding 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, laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine 1 and Shingles vaccine 2.
Medical History/Concurrent Conditions: Chickenpox (had as a kid)