Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; Had them in my eye, ear and mouth; Had them in my eye, ear and mouth; herpes zoster on mouth; Shingles on right side of face and mouth; Scars; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Had them in my eye, ear and mouth) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Had them in my eye, ear and mouth) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: herpes zoster on mouth), facial herpes zoster (Verbatim: Shingles on right side of face and mouth) and scar (Verbatim: Scars). The outcome of the vaccination failure and herpes zoster otitis externa were not reported and the outcome of the ophthalmic herpes zoster, oral herpes zoster and facial herpes zoster were resolved with sequelae and the outcome of the scar was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa, oral herpes zoster, facial herpes zoster and scar to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, ophthalmic herpes zoster and herpes zoster otitis externa to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the oral herpes zoster, facial herpes zoster and scar to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 24-MAR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she was a person that avoids vaccinations at all cost but after having the shingles patient got the shots. Be sure to check your insurance first. Patient had and mine were not covered even though patient called first and were told they were. It ended up costing almost 900 dollar for the two shots. Patient was still glad patient did because patient got them on the right side of face, and had them in eye, ear and mouth. So very painful. Now patient had scars on face from them. This case was considered as suspected vaccination failure as details regarding completion 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 details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Ophthalmic herpes zoster and Herpes zoster oticus are unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).