Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Cough, Neuropathy peripheral, Throat irritation
Clinical narrative: having neuropathy while on Dupixent; had some GI upset; experienced cough and throat irritation; experienced cough and throat irritation; Initial information on 20-Jun-2024 (processed as non-case) with follow-up on 16-Jul-2024 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 70-year-old male patient who had neuropathy, cough and throat irritation, experienced cough and throat irritation and had some GI (gastrointestinal) upset while on dupilumab [Dupixent] delivered via dupilumab single dose pre-filled pen and while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient started taking dupilumab Solution for injection at a dose of 300 mg QOW subcutaneously, strength: 300MG/2ML for atopic dermatitis via pre-filled pen.  On an unknown date in Sep-2024, the patient took influenza vaccine (dose, strength, route of administration, indication and device used for administration).  Patient had neuropathy (neuropathy peripheral) (onset date and latency: unknown, batch number, expiry date: unknown) while on dupixent. It was unknown if the patient experienced any additional symptoms/events. It was unknown if the patient had any medical history, concomitant disease or risk factor. It was unknown if there were lab data/results available.   Patient mentioned he experienced cough (cough; onset date: sep-2024; latency: unknown) and throat irritation (throat irritation; onset date: sep-2024; latency: unknown) after his flu shot 3 weeks ago, and he also had some GI (abdominal discomfort; onset date; latency: unknown) (batch number and expiry date: unknown) upset where he had to take Miralax.   Information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  Action taken: unknown for all the events with dupilumab and influenza vaccine.  Corrective treatment: Patient was treated with macrogol 3350 (miralax) and not reported for rest of the events.  Outcome: unknown for all the events.  Seriousness criteria: medically significant for the event.  Additional information was received on 16-Jul-2024 from patient: case was updated from non-case to valid case; new event added- neuropathy peripheral; text amended accordingly.  Additional information was received on 01-Oct-2024 form the patient.  New events (abdominal discomfort, cough and throat irritation), suspect (influenza vaccine) and indication added were added. Corresponding fields and narrative amended accordingly.; Sender's Comments: Sanofi company comment follow up dated on 01-Oct-2024: New follow up version received does changes the previous assessment of the case and it is considered as medically relevant. This case involves a 70-year-old male patient who had neuropathy while on dupilumab [Dupixent] delivered via pre-filled pen. However, lack of information regarding event details, patient's compliance, treatment received, lab data, medical history and concomitant medications precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow up information.