Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
patient's preexisting alopecia was completely bald, improved since start of therapy with no repported adverse event; experiencing arm swelling, redness, tenderness, limited movement, low-grade fever; experiencing arm swelling, redness, tenderness, limited movement, low-grade fever; experiencing arm swelling, redness, tenderness, limited movement, low-grade fever; experiencing arm swelling, redness, tenderness, limited movement, low-grade fever; experiencing arm swelling, redness, tenderness, limited movement, low-grade fever; Initial information received on 27-Jan-2026 regarding an unsolicited valid non-serious case received from a patient. This case involves a 5 years old female patient who had arm swelling, redness, tenderness, limited movement, low-grade fever while being treated with Dupilumab [Dupixent] delivered via Dupilumab singledose prefilled pen, Influenza vaccine and diphtheria, tetanus and nos pertussis vaccine and had preexisting alopecia was completely bald, improved since start of therapy with no reported adverse event directly linked to therapeutic response unexpected. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s), concomitant disease, risk factors and family history were not provided. At the time of the event, the patient had ongoing Alopecia. In Jul-2025, the patient started taking Dupilumab solution for injection, strength 200mg/1.14ml at a dose of 200 mg every four week (Q4W) subcutaneously for eczema. On 20-Nov-2025, the patient received a dose of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE at an unknown strength, dose, frequency, route for prophylactic vaccination. On 20-Nov-2025 the patient developed a non-serious event "experiencing arm swelling, redness, tenderness, limited movement, low-grade fever" (peripheral swelling) (hypokinesia) (pyrexia) (pain of skin) (erythema) (approximately 4 months latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB, DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "patient's preexisting alopecia was completely bald, improved since start of therapy with no reported adverse event" (therapeutic response unexpected) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB, DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and INFLUENZA VACCINE. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "Patients mother reports the patient experiencing arm swelling, redness, tenderness, limited movement, low-grade fever occurred 20-Nov-2025 after tetanus/diphtheria/ pertussis and flu vaccines given on 20-Nov-2025, lasting 1.5 weeks. patient's mother reports that the patient's dupixent dose was delayed 1 week due to vaccines and that she informed and via message. patient's mother also reports that the patient's preexisting alopecia was completely bald, improved since start of therapy, almost total hair regrowth, couple of bald patches ongoing. no further information was provided". Action taken with DUPILUMAB (DUPIXENT): was unknown for peripheral swelling, hypokinesia, pyrexia, pain of skin, erythema and therapeutic response unexpected. Action taken with DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and INFLUENZA VACCINE: was not applicable for peripheral swelling, hypokinesia, pyrexia, pain of skin, erythema and therapeutic response unexpected. It was not reported if the patient received a corrective treatment for peripheral swelling, hypokinesia, pyrexia, pain of skin, erythema. At time of reporting, the outcome was Recovered / Resolved in 2025 for peripheral swelling, hypokinesia, pyrexia, pain of skin, erythema.
Alopecia
DUPIXENT