Received May 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
headache and congestion; headache and congestion; having flare ups symptoms; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019422 (Biontech SE), 2025SA123612 (Sanofi), AE-019425 (Biontech SE). A 53-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Mar2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Dec2024) at 300 mg (strength: 300 mg/2ml at a dose of 300 mg qow) for dermatitis atopic, eczema. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "headache and congestion"; DERMATITIS ATOPIC (non-serious), outcome "recovered" (2025), described as "having flare ups symptoms". The action taken for dupilumab was unknown. Additional information: This case involved a 53-year-old male patient who experienced burning at the injection site when dupilumab [Dupixent] was initially administered while still cold at the doctor's office, reported headaches, congestion, and flare-up symptoms while being treated with dupilumab delivered via pre-filled pen, as well as receiving COVID-19 vaccine, Pneumonia, Shingles, and Hepatitis vaccines (INNs unspecified). Patient did not receive a loading dose at start of therapy with no ae (adverse event) directly linked to incorrect dose administered. The DUPIXENT SINGLEDOSE PRE-FILLED PEN component of the combination product DUPIXENT (Single-entity for initial use) has been identified with a device issue. The product was not stored or used properly. The device was operated by the Health Care Professional. The patient's past medical history, medical treatment(s), concomitant medication(s), diseases or risk factors, vaccination(s) and family history was not provided. In Dec-2024, the patient started taking DUPIXENT (DUPILUMAB) solution for injection via pre-filled pen (strength: 300 mg/2ml) at a dose of 300 mg QOW with no loading dose (incorrect dose administered) (same day latency) (unknown batch number and expiry date) subcutaneously for dermatitis atopic and eczema. In Dec-2024 the patient developed a non-serious event "when he first began dupixent, md office administered dupixent while it was still cold, burning to injection site" (injection site pain and product preparation error) (same day latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. In Mar-2025, the patient started taking Hepatitis, COVID-19, pneumonia and shingles vaccines with unknown formulation, dosage, route, strength, frequency, device and indication. In Mar-2025 the patient developed a non-serious event "having flare ups symptoms" (dermatitis atopic) (latency: 03 months approximately) following the first dose intake (unknown batch number and batch number) of DUPILUMAB, (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines. In 2025 the patient developed a non-serious event "headache and congestion" (nasal congestion and headache) (latency: more than 01 month approximately) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB, (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines. Information regarding batch number and expiry date corresponding to the one at time of event occurrence was requested. It was reported "Patient reported over the past month, having flare ups symptoms. He states he keeps in touch with medical doctor regularly. Flare has since subsided with dose of Dupixent. No dates were reported. patient states he did not receive a loading dose at start of therapy, patient states he received 1-300 mg injection on day 1 (Dec-2024), manufacturer recommends a loading dose of 2-300 mg injections on day 1 for atopic dermatitis, unknown if md (Doctor of medicines) aware. Patient states around 6-8 weeks ago (patient unable to provide exact date) he had covid, hepatitis, pneumonia and shingles vaccines administered (unknown if all vaccines administered the same date), patient states after receiving vaccines, he developed headache and congestion, patient unable to provide date and duration of ill effects, md unaware, no further details provided. Patient states when he first began dupixent, md office administered dupixent while it was still cold, patient reports he had burning to injection site, (exact date of occurrence is unknown) unknown if md aware, no further details provided". Action taken: unknown for incorrect dose administered, product preparation error and no action taken for rest of the events. Action taken with COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines: unknown for all the events. Corrective treatment: Not reported for dermatitis atopic, injection site pain. Outcome: Recovered in 2025 for dermatitis atopic and unknown for injection site pain. 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. Additional information was received on 29-Apr-2025 from the patient. New suspects (COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines), events of injection site pain, incorrect dose administered, product preparation error, nasal congestion and headache were added. Text amended accordingly.
DUPIXENT