Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected Vaccination failure; got shingles; have not slept much; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles) and difficulty sleeping (Verbatim: have not slept much). The outcome of the vaccination failure and difficulty sleeping were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine. The company considered the vaccination failure, shingles and difficulty sleeping to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vaccine but also got shingles going on for 4 weeks now. The patient reported he/she never really got the blisters, just a small red patch, but dealing with the burning tingly pain just the same. The patient stated it hurts more at night and she/he have not slept much. Further, patient stated that it probably would have been a lot worse if did not have the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Insomnia are unlisted events which are considered unrelated to GSK Shingles vaccine."