Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected Vaccination failure; had additional outbreaks; 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. The patient's past medical history included shingles. Concurrent medical conditions included lyme disease (have chtonic lyme disease). 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: had additional outbreaks). The patient was treated with duloxetine hydrochloride (Cymbalta). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 20-APR-2025 This case was reported by a patient via interactive digital media. He/she had chronic Lyme disease which activated shingles and herpes. Pain and suffered unbearable. He/she took cymbalta. He/she did get the shots but also have had additional outbreaks. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding disease) is considered unrelated to GSK vaccine Shingles vaccine.
Lyme disease (have chtonic lyme disease)
Medical History/Concurrent Conditions: Shingles