Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
VACCINATION FAILURE; Mine is on my ears; every time I get stressed about something they start to break out; 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 and 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: VACCINATION FAILURE) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: Mine is on my ears) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: every time I get stressed about something they start to break out). The outcome of the vaccination failure, herpes zoster oticus and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster oticus and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster oticus 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: 06-NOV-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for himself. The patient had received the vaccine, and every time he became stressed about something, the breakouts started. They did not hurt as badly as they had before the shot. He also had medication to take whenever the pain began. The affected areas were on his face, hair, and ears.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
Medical History/Concurrent Conditions: Shingles; Stress