Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Suspected vaccination failure; I start developing shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I start developing shingles). The outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingles vaccine. Additional Information: GSK receipt date: 02-APR-2025 Patient reported that she received vaccine for shingles, she got the original vaccine in 2015, and then she got both Shingrix vaccine in 2020 and 2021. Reporter stated that she started developing shingles, she thought the 1st time she had a case was in 2017, and it was never been severe. Since 2017 that she had it at least 2 or maybe 3 more times. She was trying to see if she should get another dose of Shingrix. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Dose 1, Shingrix Dose 2 and Shingles vaccine.