Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Product administered at inappropriate site, Vaccination failure
Clinical narrative: had 3 outbreaks of shingles/Suspected vaccination failure; had 3 outbreaks of shingles; first shot did not take well as it was given below the deltoid muscle; red streak from the site to below my elbow; red streak from the site to below my elbow; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had 3 outbreaks of shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had 3 outbreaks of shingles), injection site erythema (Verbatim: red streak from the site to below my elbow), erythema of extremities (Verbatim: red streak from the site to below my elbow) and vaccine administered at inappropriate site (Verbatim: first shot did not take well as it was given below the deltoid muscle). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the injection site erythema and erythema of extremities were resolved (duration 1 week) and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site erythema and erythema of extremities to be related to Shingrix.     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 and Shingrix. It was unknown if the company considered the injection site erythema and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-SEP-2024 The patient was the reporter and she herself as retired nurse. The patient got both Shingrix vaccines last fall and have had 3 outbreaks of shingles since and all treated successfully with Valcyclovir.  The patient believed the first shot did not take well as it was given below the deltoid muscle, which led to vaccine administered at inappropriate site. The patient developed a red streak from the site to below her elbow and lasted a week and resolved.  The nurse asked what was recommendation regarding revaccination. The patient did not wish to continue the outbreaks. This case was considered as suspected vaccination failure as details 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 regarding disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and 2).