Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like symptoms such as cough, chills, night sweats, and phlegm; his left arm, the injection site is red, swollen and hot to the touch; his left arm, the injection site is red, swollen and hot to the touch; his left arm, the injection site is red, swollen and hot to the touch; has a cough again; injection site reactions such as swelling, itching, and pain for 2-3 days after dupixent administration; injection site reactions such as swelling, itching, and pain for 2-3 days after dupixent administration; Initial information received on 20-Aug-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 80 years old male patient who had a cough again, his left arm, the injection site was red, swollen and hot to the touch, experienced flu like symptoms such as cough, chills, night sweats, and phlegm, injection site reactions such as swelling, itching, and pain for 2-3 days after DUPILUMAB [DUPIXENT] administration via prefilled syringe and after receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Mar-2025, the patient started taking DUPILUMAB Solution for injection in prefilled syringe (strength 300mg/2ml) at dose 600 mg once as loading dose followed by maintenance dose 300mg QOW subcutaneously for Chronic obstructive pulmonary disease. On 20-AUG-2025 the patient developed a non-serious his left arm, the injection site is red, swollen and hot to the touch (injection site erythema) (injection site swelling), (injection site warmth) (latency 5 months 2 days) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB. On 16-Sep-2025, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. In SEP-2025 the patient developed a non-serious event "experienced flu like symptoms such as cough, chills, night sweats, and phlegm" (influenza like illness) (chills) (night sweats) (productive cough) (approximately 6 months latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB and (unknown latency) after the administration of INFLUENZA VACCINE. In 2025 the patient developed a non-serious event "has a cough again" (cough) (unknown latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB. In 2025 the patient developed a non-serious event "injection site reactions such as swelling, itching, and pain for 2-3 days after Dupixent administration" (injection site pruritus) (injection site pain) (unknown latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB and (unknown latency) after the administration of INFLUENZA VACCINE. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "that has a cough again (onset unknown) symptom that has been improving, but continues occasionally, unknown if md is aware. patient indicated that his doctor injected the medication yesterday 19-Aug-2025 in his left arm and today 20-Aug-2025 the injection site is red, swollen and hot to the touch, md (Doctor of Medicine) not aware. Patient reports that after receiving the influenza vaccine (16-Sep-2025), has experienced flu-like symptoms such as cough, chills, night sweats, and phlegm that is improving. patient reports that he is having injection site reactions such as swelling, itching, and pain for 2-3 days after Dupixent administration, are resolved, and the md is not aware. no further information was provided." Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken with dupilumab: Unknown for all events; However, therapy was ongoing. Action taken with influenza vaccine: Not applicable for all events. It was not reported if the patient received a corrective treatment for all events At time of reporting, the outcome was Recovered / Resolved in 2025 for injection site pruritus, injection site pain, injection site swelling, Recovering / Resolving for cough and influenza like illness along with symptoms and unknown for other events. Additional information was received on 23-Sep-2025 from patient: new events injection site pruritus, injection site pain and influenza like illness along with symptoms chills, night sweats and productive cough added, new suspect influenza vaccine added, clinical course updated, and text amended accordingly.
DUPIXENT