Received Apr 24, 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; I've had shingles on my face; hasn't shown, or caused the severe pain; hot to the touch; Poke on the hairline above my ear on both sides of my face months apart, I feel like slivers of glass; 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), facial herpes zoster (Verbatim: I've had shingles on my face), pain (Verbatim: hasn't shown, or caused the severe pain), feeling hot (Verbatim: hot to the touch) and tingling skin (Verbatim: Poke on the hairline above my ear on both sides of my face months apart, I feel like slivers of glass). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster, pain, feeling hot and tingling skin were not resolved. It was unknown if the reporter considered the vaccination failure, facial herpes zoster, pain, feeling hot and tingling skin to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster, pain, feeling hot and tingling skin to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had got the 2 shingles shots, and twice he/she had felt like he/she had shingles on face. It just had not shown, or caused the severe pain that it can. Poke on the hairline above ear on both sides of his/her face months apart. He/she felt like slivers of glass. It was in his/her face. It was hot to touch. But when he/she put a cold compass on it, it felt 10 times better. He/she was going through that right now. For the second time on the right side of his/her cheek near ear and hairline. He/she was told that the shingles vaccine did not prevent the shingles. It just prevents the shingles from being at its worst, any feedback. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).