Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | — | — |
severe hives; Atopic dermatitis flare; a lot of stress; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): US-SA-2024SA365896 (SANOFI). Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a patient. This case involves a 63 years old female patient who had a lot of stress, severe hives and had flare up of symptoms/ minor flare up while receiving vaccine COVID-19 VACCINE and DUPILUMAB [DUPIXENT] via dupilumab pre-filled syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In Sep-2024, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg QOW (strength: 300 mg/2mL) subcutaneous for other atopic dermatitis. On an unknown date, the patient started taking COVID-19 VACCINE at an unknown dose, strength, frequency, route for prophylactic vaccination. In NOV-2024 the patient developed a non-serious event "flare up of symptoms/ minor flare up" (dermatitis atopic) (latency: 2 months approximately) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. In 2024 the patient developed a non-serious event "a lot of stress" (stress) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. On an unknown date the patient developed a non-serious event "severe hives" (urticaria) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. Information on batch number and expiration date corresponding to the one at time of event occurrence were requested. It was reported "patient reports since the last fill they don't feel as if the medication is helping. patient also reports over the past month having had a flare-up of symptoms. and started taking glp-1 since the last fill. Patient states she is under a lot of stress, having minor flare up. Applies clobetasol. Dupixent controls eczema. Unknown if md (doctor of medicine) aware. Patient reported Pfizer covid slots caused severe hives, since their last fill. Unknown if md aware. No further information provided". Action take with DUPILUMAB (DUPIXENT) was continued for stress, dermatitis atopic and was unknown for urticaria. Action taken with COVID-19 VACCINE (COVID-19 VACCINE) was not applicable for stress, dermatitis atopic and urticaria. Corrective treatment: Clobetasol propionate (Clobetasol) for Dermatitis atopic and not reported for stress and urticaria. At time of reporting, the outcome was Unknown for dermatitis atopic, stress and urticaria. Additional information was received on 18-Feb-2026 from patient: new event- urticaria; cosuspect added and text amended accordingly. Reporter causality between events and Dupixent was Related. Medical Causality assessed by Sanofi for all events and Dupixent was Possible.
DUPIXENT