Received Oct 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Patient got eosinophils /EGPA reacted; Patient got eosinophils /EGPA reacted; eosinophils due to the flu vaccine entering patient's system; This serious case was reported by a pharmacist via call center representative and described the occurrence of eosinophilic granulomatosis with polyangiitis in a female patient who received mepolizumab (Nucala) for eosinophilic granulomatosis with polyangiitis. Co-suspect products included Flu unspecified (Flu vaccine) for product used for unknown indication. Concurrent medical conditions included eosinophilic granulomatosis with polyangiitis. On an unknown date, the patient started Nucala and Flu vaccine. On an unknown date, an unknown time after receiving Nucala and Flu vaccine, the patient experienced eosinophilic granulomatosis with polyangiitis (Verbatim: Patient got eosinophils /EGPA reacted) (serious criteria hospitalization and GSK medically significant), condition aggravated (Verbatim: Patient got eosinophils /EGPA reacted) (serious criteria hospitalization) and vaccination adverse reaction (Verbatim: eosinophils due to the flu vaccine entering patient's system) (serious criteria hospitalization). The action taken with Nucala and Flu vaccine was unknown. The outcome of the eosinophilic granulomatosis with polyangiitis, condition aggravated and vaccination adverse reaction were not reported. It was unknown if the reporter considered the eosinophilic granulomatosis with polyangiitis, condition aggravated and vaccination adverse reaction to be related to Nucala. The reporter considered the eosinophilic granulomatosis with polyangiitis, condition aggravated and vaccination adverse reaction to be related to Flu vaccine. The company considered the eosinophilic granulomatosis with polyangiitis, condition aggravated and vaccination adverse reaction to be unrelated to Nucala and Flu vaccine. GSK receipt date: 07-OCT-2025 Pharmacist called and mentioned for patient on Nucala with EGPA indication. Patient got a flu shot several years ago and patient had to go to the hospital because patient's EGPA reacted and patient got eosinophils due to the flu vaccine entering patient's system. Did not consent to follow-up. Call Notes: No clarification on which flu vaccine was given. No consent to follow-up asked, decision to report was made after the call ended.; Sender's Comments: The company has assessed that it is unlikely that Eosinophilic granulomatosis with polyangiitis, Condition aggravated and Immunisation reaction were caused by the Nucala drug. Based on the available information a possible causality that the event(s) was caused by the product cannot be ascertained. Consent for further follow up has not been received. A case of Eosinophilic granulomatosis with polyangiitis, Condition aggravated and Immunisation reaction, an unknown time after receiving a dose of Flu vaccine, in a female subject. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Eosinophilic granulomatosis with polyangiitis
Nucala