Received Mar 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included mepolizumab (Nucala) for product used for unknown indication. On an unknown date, the patient received Shingles vaccine and Nucala. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after starting Nucala, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The action taken with Nucala was unknown. The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Nucala. The company considered the vaccination failure to be unrelated to Shingles vaccine and Nucala. It was unknown if the company considered the shingles to be related to Shingles vaccine and Nucala. GSK Receipt Date: 16-FEB-2026 The patient had the shingle vaccination and had been on Nucala. She recently developed shingles and it was hesitant to continue with Nucala due to fear of shingles returning. No additional information as the question came in by CRM from sales rep. No mention of an adverse event report being submitted but this report might be known if follow up was permitted. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Nucala and Shingles vaccine, in a 70-year-old 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.
Nucala