Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; 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. Family history included shingles (patient's father had it for 4 years), emotional distress (too much), neuropathy (destroyed for 30 years after recovery, meditation, relaxation was ticket out of the cycle) and death (patient's mother died). 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) and shingles (Verbatim: 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. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 The patient had discovered he/she get shingles very mild if he/she put his/her body in stress mode such as too much exercise or emotional stress. The patient had the Shingles vaccine in 2019. It would be a lot worse if patient did not have the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary 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 is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Medical History/Concurrent Conditions: Death (patient's mother died); Emotional distress (too much); Neuropathy (destroyed for 30 years after recovery, meditation, relaxation was ticket out of the cycle); Shingles (patient's father had it for 4 years)