Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
injection site reaction and it began spreading; it hurt really bad; Initial information received on 04-Apr-2025 regarding an unsolicited valid non-serious case received from a patient's relative. This case involves an Adolescent male patient (154.94 cm and 61.82 kg) who had injection site reaction and it began spreading and it hurt really bad while receiving vaccine MENINGOCOCCAL VACCINE and while treated with DUPILUMAB [DUPIXENT] delivered via dupilumab prefilled syringe. 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: johnson grass 1:20 vial. Concomitant medications included Levocetirizine dihydrochloride (Levocetirizine dihydrochloride). On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 200mg/1.14ml) at a dose 200 mg QOW subcutaneous for undefined delivered via dupilumab prefilled syringe. On 31-Mar-2025, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date the patient developed a non-serious event "injection site reaction and it began spreading" (injection site reaction) (unknown latency) following the first dose intake (batch number: 4L240Z and expiry date on 31-Mar-2027) of DUPILUMAB and (with unknown batch number and expiry date) of MENINGOCOCCAL VACCINE . On an unknown date the patient developed a non-serious event "it hurt really bad" (injection site pain) (unknown latency) following the first dose intake (batch number: 4L240Z and expiry date on 31-Mar-2027) of DUPILUMAB and (with unknown batch number and expiry date) of MENINGOCOCCAL VACCINE . It was reported "meningococcal vaccine was taken on 31-Mar and patient did not respond well per mother. patient had injection site reaction and it began spreading. it was getting better. patient told his mom it hurt really bad". Action taken with DUPILUMAB: Unknown for both the events. Action taken with MENINGOCOCCAL VACCINE: Not applicable for both the events. Corrective treatment: Not reported for both the events. Outcome: Recovering / Resolving for the event injection site reaction and Unknown for the event injection site pain.
Drug allergy
Levocetirizine dihydrochloride; DUPIXENT