Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
48 hours post dupixent injection she noticed patient had what appeared to be spider veins the size of a quarter inside of both ankles.one side had broken spider veins and other side had small spider veins in the shape of circle; has a mark on their ankle that has not disappeared for 2 months that looks like teeth bite mark; having redness in front of their ear, under their eyebrows; pain with every dupxient injection/pain while getting his injection; tissue is swollen at the injection site after each injection/has a very small swelling; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from a patient's mother. This case involves a 27 years old male patient who experienced pain with every DUPILUMAB [DUPIXENT] injection via prefilled pen/ pain while getting his injection, tissue was swollen at the injection site after each injection/has a very small swelling and having redness in front of their ear, under their eyebrows and has a mark on their ankle that has not disappeared for 2 months that looks like teeth bite mark and 48 hours post dupixent injection she noticed patient had what appeared to be spider veins the size of a quarter inside of both ankles.one side had broken spider veins and other side had small spider veins in the shape of circle after receiving INFLUENZA VACCINE and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), concomitant(s), vaccination(s) and family history were not provided. In Oct-2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection of strength 300 mg at a dose of 300 mg QW subcutaneous for Eosinophilic oesophagitis. On an unknown date, the patient received an unknown dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur, and received and unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, both with (unknown formulation, lot number, expiry date and strength: not reported) via unknown route in unknown administration site both for prophylactic vacation (Immunisation). In Oct-2023 the patient developed a non-serious event "pain with every dupxient injection/ pain while getting his injection" (injection site pain) (same day latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. In Oct-2023 the patient developed a non-serious event "tissue is swollen at the injection site after each injection/ has a very small swelling" (injection site swelling) (same day latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. On an unknown date the patient developed a non-serious event "48 hours post dupixent injection she noticed patient had what appeared to be spider veins the size of a quarter inside of both ankles.one side had broken spider veins and other side had small spider veins in the shape of circle" (spider vein) (unknown latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB. On an unknown date the patient developed a non-serious event "having redness in front of their ear, under their eyebrows" (erythema) (unknown latency) following the first dose intake (unknown batch number; expiry date) of DUPILUMAB, INFLUENZA VACCINE and COVID-19 VACCINE. On an unknown date the patient developed a non-serious event "has a mark on their ankle that has not disappeared for 2 months that looks like teeth bite mark" (scar) (unknown latency) following the first dose intake (unknown batch number; expiry date) of DUPILUMAB, INFLUENZA VACCINE and COVID-19 VACCINE. Information on batch number, expiry date corresponding to the one at time of event occurrence were requested. It was reported, "pain with every dupxient injection (dates unknown) since start of therapy (dec-2024, estimated). pain duration is the duration of each injection. patient reports the tissue is swollen at the injection site after each injection (dates unknown) since start of therapy. the swelling resolves a few hours after each injection is administered (dates unknown) md (medical doctor) is not aware. encouraged patients mother to notify the md. No further information/details provided. Patients mother reported on saturday, 48 hours post dupixent injection she noticed patient had what appeared to be spider veins the size of a quarter inside of both ankles. one side had broken spider veins and the other side had small spider veins in the shape of the circle. Patient did go into the er (emergency room) but patients mother states she was not able to go with patient. They did doppler scan to check for deep vein thrombosis and no blood clots were found. They checked complete blood count and labs were normal. Md is not aware and spider veins have gotten better, barely noticeable. Patient's mother also reported patient reports pain while getting his injection. Pt (patient) mom reported pt had flu shot and covid vaccine and 5 days later, pt started having redness in front of their ear, under their eyebrows, a small part of the temple, and their ears are red (unknown when pt got the vaccines). Pt skipped last wednesday dupixent injection as instructed by their md and a pharmacist. Pt does not have rash, no trouble breathing, no swelling in tongue, throat, or lips. Pt mom stated that the injection site of dupixent, has a very small swelling. Pt mom also stated that pt has a mark on their ankle that has not disappeared for 2 months that looks like teeth bite mark. Primary md is aware and is not concerned. No further information." Action taken (with dupilumab): No action taken for Injection site swelling and unknown for other events. Action taken: COVID-19 VACCINE (COVID-19 VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable for all the events. It was not reported if the patient received a corrective treatment for all events At time of reporting, the outcome was Recovering / Resolving for Spider vein; Not Recovered / Not Resolved for Scar and unknown for other events Additional information was received on 25-SEP-2025 from patient mother. Event Spider vein was added, event verbatim of Injection site pain was updated and text amended accordingly. Additional information was received on 26-Nov-2025 from patient mother: Events were added (PT: Erythema, scar). New suspects were added. Event verbatim was updated for injection site swelling. Clinical course was updated. Text amended accordingly.
DUPIXENT