Report #2860360

Overview

Sex

Female

Age

Age unknown

State

MA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (5)

Symptom narrative

Suspected vaccination failure; Recent shingles breakthrough on the HCP (that is also the patient); intense pain confirmed as PHN; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recent shingles breakthrough on the HCP (that is also the patient)) and post herpetic neuralgia (Verbatim: intense pain confirmed as PHN). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 and 17-SEP-2025 The GlaxoSmithKline's sales representative transfers a medical doctor called to ask about advise due to a recent breakthrough of shingles. The medical doctor received the two doses of Shingrix back on twenty twenty no vaccination dates were specified by the medical doctor end. The patient was not taking gabapentin or medication to prevent recurrence, however, every few months she had one or two vesicles come up, but it was very intense pain confirmed post herpetic neuralgia that occurred with that. It was like a recurrence of shingles with only a mild breakout, all 3 of them. The patient would not have known it was shingles had she not just happened to have a dermatology appointment. The patient demographics were obtained in this call. The patient looked for any advice on this matter. No further information was obtained in this call. No specific vaccination date and no vaccine detail were obtained in this call. The vaccine administration facility was the same as primary reporter. 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: A case of Vaccination failure, unknown time after receiving 1st dose of Shingrix and the 2nd dose of Shingrix, in a adult 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.