Received Aug 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Contraindicated drug combination administered; received the polio and Dtap vaccines, is red; received the polio and Dtap vaccines, is red and inflamed; area around his bicep is hot; area around his bicep is hot and painful to touch; Initial information received on 05-Aug-2025 regarding an unsolicited valid non-serious case received from the patient's mother. This case involves a 4 years old male patient who received the polio and dtap vaccines, is red and inflamed, and area around his bicep is hot and painful to touch while receiving vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and POLIOMYELITIS VACCINE (INACTIVATED) and while treated with DUPILUMAB [DUPIXENT] via a prefilled pen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection(strength:300 mg) at a dose of 300 mg Q4W subcutaneous for Product used for unknown indication. On 04-Aug-2025, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. On 04-Aug-2025, the patient received a dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) On 04-AUG-2025 the patient developed a non-serious event "received the polio and dtap vaccines, is red and inflamed" (vaccination site inflammation) (Vaccination site erythema ) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB,POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. On 04-AUG-2025 the patient developed a non-serious event "area around his bicep is hot and painful to touch" (vaccination site pain) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB,POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "contraindicated drug combination administered" (contraindicated product administered) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB,POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. Information regarding the batch number and expiration date corresponding to the one at the time of event occurrence was requested. It was reported "he was given four vaccines on 0814/2025. Two shots on each shoulder. Mother reported the patient left shoulder where he received the polio and Dtap vaccines, is red and inflamed. Mother reported the area around his bicep is hot and painful to touch. Mother consented for the provider to be contacted and provided both the dermatologist and pediatrician information" Action taken with DUPILUMAB (DUPIXENT) was unknown for all events. Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (POLIOMYELITIS VACCINE (INACTIVATED)) and DIPHTHERIA, TETANUS AND PERTUSSIS (NOS) VACCINE was not applicable for all events. Corrective treatment:Not reported for all events. Outcome: Unknown for all events This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DUPIXENT