Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
agitated nerves are just calming down now; Suspected vaccination failure; Shingles last month; 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. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles last month). On an unknown date, the patient experienced agitation (Verbatim: agitated nerves are just calming down now). The outcome of the vaccination failure and shingles were not reported and the outcome of the agitation was resolving. It was unknown if the reporter considered the vaccination failure, shingles and agitation to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and agitation to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported he/she got Shingles vaccine and got shingles last month (from the date of reporting) but thankfully a milder case and patient thanked to the vaccine. The patient was put on an antiviral medication which shortened the rash time, but the agitated nerves were just calming down now (at the time of reporting) 6 weeks later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 Shingles vaccine.