Report #2878854

Overview

Sex

Male

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

Jul 17, 2025

Onset

Aug 1, 2025

Days to onset

15

Hospital days

—

Symptoms (3)

Symptom narrative

Lost 6-8 pounds in the last month; Some soreness at intramuscular injection site post vaccinations; This is a spontaneous report received from a consumer from License Party. Other Case identifier(s): 2025SA236234 (Sanofi), AE-021977 (BioNTech). Initial information received on 07Aug2025 regarding an unsolicited valid non-serious case received from the patient. This case Involves a 64-year-old male patient who had Injected DUPILUMAB [DUPIXENTI and with the use of medical device DUPIXENT SINGLEDOSE PRE-FILLED PEN, as soon as he removed it from the refrigerator, experienced pain with each injection, lost 6-8 pounds in the last month. He injected his Dupixent dose three weeks after previous dose, instead of every two weeks with no reported adverse event directly linked to Inappropriate schedule of product administration and some soreness at intramuscular injection site post vaccinations while receiving vaccines COVID-19 VACCINE, RESPIRATORY SYNCYTIAL VIRUS VACCINE, PNEUMOCOCCAL VACCINE, TETANUS TOXOID and INFLUENZA VACCINE. 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 patient. The product was not available for evaluation. Lot # unk; The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s), concomitant diseases (or) any risk factors and family history were not provided. On 17Jul2025, the patient started taking DUPIXENT (DUPILUMAB) Solution for Injection at a dose of 300 mg QOW subcutaneously for Chronic obstructive pulmonary disease (COPD) (Strength: 300 mg/2mI). In 2025, the patient developed a non-serious event "injects Dupixent, as soon as he removed It from the refrigerator" (product preparation error) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. In 2025, the patient developed a non-serious event "pain with each Injection" (Injection site pain) (unknown latency) following the first dose Intake (unknown batch number and expiry date) of DUPILUMAB. In 2025 the patient developed a non-serious event "Injected his Dupixent dose three weeks after previous dose, instead of every two weeks with no reported adverse event" (Inappropriate schedule of product administration) (unknown latency) following first dose intake (unknown batch number and expiry date) of DUPILUMAB. In Aug2025, the patient developed a non-serious event "lost 6-8 pounds in the last month" (weight decreased) (1 month approximately: latency) following the first dose Intake (unknown batch number and expiry date) of DUPILUMAB. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, expiry date and lot not reported) Via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (formulation, strength, expiry date and lot not reported) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (formulation, strength, expiry date and lot not reported) Via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect RESPIRATORY SYNCYTIAL VIRUS VACCINE not produced by Sanofi Pasteur (formulation, strength, expiry date and lot not reported) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength, expiry date and lot not reported) via unknown route in unknown administration site. In 2025, the patient developed a non-serious event "some soreness at intramuscular injection site post vaccinations" (vaccination site pain) (unknown latency) following the first dose intake (unknown batch number; expiry date) of DUPILUMAB, COVID-19 VACCINE, RESPIRATORY SYNCYTIAL VIRUS VACCINE, PNEUMOCOCCAL VACCINE, TETANUS and INFLUENZA VACCINE. Information on batch number, expiry date corresponding to the one at time of event occurrence were requested. It was reported "patient injected his Dupixent dose three weeks after previous dose (date not provided), instead of every two weeks as prescriptions reads due to setting calendar reminder wrong, no reported worsening symptoms or ill effects. MD (Doctor of Medicine) was aware. He injected Dupixent, as soon as he removed it from the refrigerator, manufacturer recommended allowing Dupixent to be removed from refrigerator allowed to reach room temperature for 45 minutes for the 300 mg pen. He reported pain with each Injection (dates of Injections unknown). He reported the pain was only during injection and goes away right after injection complete. He stated Dupixent was more viscous and did not go in as easy as other injectable medications; lot number and expiration date not provided, unknown If md (medical doctor) aware. No further details provided. unknown if product on hand for return. Upon follow up, patient states he lost 6-8 pounds in last month but reports nothing significant, on Wegovy weight loss medication, unknown if MD aware. Patient reports receiving flu, pneumonia, respiratory syncytial virus, tetanus, and COVID-19 vaccines since start of therapy (17Jul2025), dates of vaccine unknown, experienced some soreness at intramuscular injection site post vaccinations, received all 5 vaccinations at once, date of muscle soreness at injection site unknown, md aware of vaccines being administered, unknown if md aware of muscle soreness, reported no new or worsening COPD symptoms, no further information given. No titration dosing indicated. Action taken (with DUPILUMAB): unknown for all events. Action taken (with COVID-19 VACCINE, RESPIRATORY SYNCYTIAL VIRUS VACCINE, PNEUMOCOCCAL VACCINE, TETANUS TOXOID And INFLUENZA VACCINE): Not applicable for all the events. Corrective treatment: The patient was treated with Semaglutide (Wegovy) for Weight decreased and not reported for Vaccination site pain, injection site pain. Outcome: Unknown for the event injection site pain, Weight decreased, Vaccination site pain. A Product Technical Complaint (PTC) was initiated on 13Aug2025 for Dupixent (lot/batch number: unknown) with Global PTC number: COMPLAINT-546952. The PTC stated Media: No picture/video attached. Investigation: Due to the Costumers description "he injected Dupixent, as soon as he removed it from the refrigerator." No further Investigation was needed regarding the reason of complaint "he injected Dupixent, as soon as he removed it from the refrigerator". The leaflet described to let the Dupixent warm up to room temperature for at least 45 Minutes. The Patient did not follow the leaflet. Based on the complaint description "he injected Dupixent, as soon as he removed it from the refrigerator. "The AE (adverse event) (pain) was a result of a handling error, therefore no further investigation was performed. Other influences related to the therapy and lot interactions with other medications had also to be considered. The final investigation was completed on 18Aug2025 with summarized conclusion as Related to handling error. Additional information was received on 18Aug2025 from quality department. PTC details added. Narrative was updated accordingly. Additional information was received on 22Sep2025 from patient: new event weight decreased was added, clinical course updated and text amended accordingly. Additional information was received on 17Nov2025 from patient: Event was added (PT: vaccination site pain). New suspects were added. Clinical course was updated. Text amended accordingly.

Other medications

DUPIXENT

Lab data

Test Date: 202508; Test Name: Weight; Result Unstructured Data: Test Result:Lost 6 to 8 lbs