Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; now on my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (first time was about 4 years ago). Concurrent medical conditions included stress (job always brought some stress). 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 facial herpes zoster (Verbatim: now on my face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAY-2025 This case was reported by a patient via interactive digital media. Patient went through his/her second round of shingles. The first time was about four years ago. Then, he/she got the shots and thought he/she had been protected about two years ago. Well, it came back, and this time, it was on his/her face. He/she had completed week one and had hoped it would not last too long. He/she was fatigued and stressed and could not understand why he/she had been feeling that way, but then it made sense. His/her job had always brought him/her some stress. He/she had needed a good, long week off work just to crawl into a dark hole somewhere and sleep. He/she was not young anymore, so he/she had hoped to get through it quickly. 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 Shingles vaccine.
Stress (job always brought some stress)
Medical History/Concurrent Conditions: Shingles (first time was about 4 years ago)