Reporte zur Charge J352N

Symptomtext

Postherpetic neuralgia.; Weakened immune system; Got 2 doses, got shingles/ suspected Vaccination failure; Shingles; COVID; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number A4D72, expiry date 23-MAY-2021) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number J352N, expiry date 11-DEC-2021) for prophylaxis. Concurrent medical conditions included immunosuppression. On 11-SEP-2020, the patient received the 2nd dose of Shingrix (left deltoid). On 19-MAY-2020, the patient received the 1st dose of Shingrix (left deltoid). In DEC-2022, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID). On 06-FEB-2023, the patient experienced vaccination failure (Verbatim: Got 2 doses, got shingles/ suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Postherpetic neuralgia.) and decreased immune responsiveness (Verbatim: Weakened immune system). The outcome of the vaccination failure and decreased immune responsiveness were unknown and the outcome of the shingles was resolved and the outcome of the post herpetic neuralgia was not resolved and the outcome of the covid-19 was not reported. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, covid-19 and decreased immune responsiveness to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, covid-19 and decreased immune responsiveness to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter enquired regarding any data on revaccination or giving an additional dose of Shingles after 2 doses. The reporter reported that an immunocompromised adult patient over 55 years old two years after receiving the 2 doses of Shingrix had Shingles and asked for guidance. The patient did have COVID and thought this may have contributed to the weakened immune system as well. The patient had recovered from Shingles but had Postherpetic neuralgia. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.