Received Jan 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
had an allergic reaction to covid vaccine; bad rash; fever; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-022218 (Biontech), 2025SA382610 (Sanofi). This case involves Adult female patient (104.55 kg) who had an allergic reaction to COVID-19 VACCINE while treated with DUPILUMAB [DUPIXENT] delivered via pre-filled pen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergies: Penicillin VK 500 mg Tablet; Amox-Clav 250-125 mg Tablet; Sulfamethoxazole Powder; Singulair 10 mg Tablet; Azithromycin 250 mg Tablet. Concomitant medications included Methocarbamol (Robaxin); Zonisamide (Zonisamide); Frovatriptan Succinate Monohydrate (Frova); Lamotrigine (Lamictal XR); Frovatriptan Succinate (Frovatriptan Succinate); Salbutamol Sulfate (Proair Respiclick); Albuterol Sulfate (Albuterol Sulfate); Ondansetron (Ondansetron); Propranolol HCL (Propranolol HCL); Fluoxetine HCL (Fluoxetine HCL); Levonorgestrel (Mirena); Lamotrigine (Lamotrigine); Baclofen (Baclofen); Promethazine HCL (Promethazine HCL); Tacrolimus (Tacrolimus); and Budesonide, Formoterol Fumarate, Glycopyrronium Bromide (Breztri Aerosphere). On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW (every other week) with strength-300 mg/2ml via subcutaneous route for Severe persistent asthma uncomplicated delivered via Dupixent single dose pre-filled pen. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, dose, route: unknown). On an unknown date the patient developed a non-serious event "had an allergic reaction to covid vaccine" (hypersensitivity) (unknown latency) following the first dose intake (batch number: 5F734A and expiry date: 31-Jan-2028) of DUPILUMAB and COVID-19 VACCINE. On an unknown date the patient developed a non-serious has a bad rash and fever (rash) (unknown latency) following the first dose intake (batch number: 5F734A and expiry date: 31-Jan-2028) of DUPILUMAB and COVID-19 VACCINE. On an unknown date the patient developed a non-serious has a bad rash and fever (pyrexia) (unknown latency) following the first dose intake (batch number: 5F734A and expiry date: 31-Jan-2028) of DUPILUMAB and COVID-19 VACCINE. It was reported "Patient believes she has had an allergic reaction to a covid vaccine. She has a bad rash and fever. She also stated she is overdue for her medication." Action taken with both suspects was unknown. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was Unknown. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
ROBAXIN; ZONISAMIDE; FROVA; LAMICTAL XR; FROVATRIPTAN SUCCINATE; PROAIR RESPICLICK; ALBUTEROL SULFATE; ONDANSETRON; PROPRANOLOL HCL; FLUOXETINE HCL; MIRENA; LAMOTRIGINE; BACLOFEN; PROMETHAZINE HCL; TACROLIMUS; BREZTRI AEROSPHERE [BUDESONIDE