Received May 28, 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 had both vaccinations now I have shingles real bad, broke out now; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 64-year-old 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), shingles (Verbatim: I had both vaccinations now I have shingles real bad, broke out now) and sickness (Verbatim: Sickness). The outcome of the vaccination failure and sickness were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and sickness 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 shingles and sickness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient had both vaccinations and now have shingles real bad, broke out now and have them on left arm covered, left leg two just came up, and two on left side of chest. The patient said that did not took the vaccination. The patient super sick with these, this had been 100 percent worse since the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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).