Received May 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Though I had gotten shingles/ rash on my right ear; Though I had gotten shingles/ rash on my neck; right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains; rash on my right ear and my neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In MAY-2025, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: Though I had gotten shingles/ rash on my right ear) (serious criteria GSK medically significant), herpes zoster (Verbatim: Though I had gotten shingles/ rash on my neck), ear pain (Verbatim: right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains) and rash (Verbatim: rash on my right ear and my neck). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster oticus, herpes zoster, ear pain and rash were not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAY-2025 This case was reported by a patient via interactive digital media. Patient was 69 and had Shingles vaccines years ago (from the date of reporting). Two days ago (from the date of reporting) patient's right ear lobe, from top to bottom, began paining him/her with excruciating sharp shooting pains. This morning (on the day of reporting morning), patient saw his/her physician and it seemed as though he/she has got shingles. There was the start of a rash on his/her right ear and neck and had he/she not been seen today it could have moved to his/her face which they call Ramsay Hunt syndrome which affects the facial nerves. He/she hoped the antiviral medication would work quickly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding herpes zoster oticus and herpes zoster 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 vaccine Shingles Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingles "