Received Sep 29, 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; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old 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. Concurrent medical conditions included hyperlipidemia. Concomitant products included evolocumab (Repatha). On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Zostavax. On 11-SEP-2025, 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: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 15-SEP-2025 The patient reported that she received both Shingrix vaccine doses 3 or 4 years ago. She also received Zostavax vaccine a few years prior to the Shingrix vaccine. On 11-SEP-2025 she broke out with shingles. She states that it started with a headache, fatigue, and generally feeling bad. Then a small rash consisting of 10 to 15 very small lesions appeared on her right ribcage area. They were blistered but now are scabbed over. The patient was on antihypertensive drug. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving Shingrix(1st and 2nd), in a 67-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Hyperlipidemia
REPATHA