Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
fever; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019548 (BioNTech SE), 2024SA035670 (SANOFI). A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since Oct2023) at 600 mg (600 mg, once) and second regimen since Oct2023 (ongoing)) at 300 mg (300 mg, every other week), all subcutaneous for eczema, urticaria. The patient's relevant medical history was not reported. Concomitant medication(s) included: XOLAIR (ongoing). The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". The action taken for dupilumab was dosage not changed. Additional information: This case involves a patient who developing fever about 2.5 days after covid injection and dupixent for urticaria with no reported adverse event while being treated with dupilumab (Dupixent) with the use of medical device prefilled syringe and covid-19 vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant nedications included OMALIZUMAB (XOLAIR). In October 2023, the patient started treatment with initial loading dose of dupilum ab solution for injection 600 mg once subcutaneous followed by maintenance dose of 300 mg every other week subcutaneous (with an unknown batch number and expiration date) for Eczema and Urticaria(product use in unapproved indication) (latency: same day). Information regarding batch number and expiration date were requested. On an unknown date, patient stared treatment with covid-19 vaccine injection (with an unknown strength, dose, route, frequency, batch number and expiration date) for Prophylactic vaccination On an unknown date the patient developed a non-serious event "developing fever about 2.5 days after covid injection" (pyrexia) (unknown latency). It was reported "patient reported current xolair and dupixent therapy, patient reports xolair therapy was being slowly weaned off and will continue with dupixent therapy, dupixent therapy started beginning of oct-2023 with samples from md office, unknown xolair therapy start date or estimated end date, currently taking xolair every 6 weeks, unknown xolair dose, no new or worsening eczema symptoms reported by patient, patient reported feeling more energy and "younger", unknown if prescribing md was same for both medications, unknown if md (Doctor of medicine) aware. patient reported received covid injection afte: start of dupixent therapy, palient reported developing fever about 2.5 days after covid injection, unknown date, patient reports no missed doses, md aware, md recommends a slower wean off of xolair." DUPILUMAB (DUPIXENT) was continued for dupilumab and Not applicable for covid-19 vaccine. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown Batch/lot number is not provided, and it cannot be obtained.
XOLAIR; DUPIXENT