Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | UNK | — |
Suspected vaccination failure; had 3 additional episodes of shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. The patient's past medical history included facial herpes zoster (outbreak of shingles (on my face which is quite dangerous for my right eye) in 2008). On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Zostavax. On an unknown date, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Zostavax, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 3 additional episodes of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Zostavax. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Zostavax. It was unknown if the company considered the vaccination failure to be related to Zostavax. Additional Information: GSK Receipt Date: 09-AUG-2025 The case was self-reported by patient. The patient had received the full series of Shingrix (2 doses) and before that received Zostavax. The patient had an outbreak of shingles (on the face, which was quite dangerous for the right eye) in 2008, and after recovering received Zostavax. The patient completed the Shingrix series of two doses in 2019 and interested in a third dose, as have had three additional episodes of shingles this year (the area gets puffy, but did not blister. The reporter wanted to know did they had any research on the third dose of Zostavax. This case was considered as suspected vaccination failure since the details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine (Dose 1 & 2) and Zostavax.
Medical History/Concurrent Conditions: Facial herpes zoster (outbreak of shingles (on my face which is quite dangerous for my right eye) in 2008)