Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
feeling very sick; arm is very sore, fingers, arms and legs hurt and are swollen; arm is very sore, fingers, arms and legs hurt and are swollen; Initial information received on 20-Nov-2025 (Along with 1 live follow up processed with same CSD) regarding an unsolicited valid non-serious case received from a patient This case involves Adult male patient who felt very sick, arm was very sore, fingers, arms and legs hurt and were swollen while receiving vaccine INFLUENZA VACCINE, shingles vaccine (unknown INN) and while treated with DUPILUMAB [DUPIXENT] delivered via single dose prefilled pen The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided. the patient was allergic to penicillin, no known food allergies. On an unknown date, the patient started taking DUPILUMAB Solution for injection in prefilled pen (strength 300mg/2ml) at dose 300 mg QOW subcutaneously for Dermatitis atopic. On an unknown date, the patient received INFLUENZA VACCINE and unknown shingles vaccine (dose, route, strength, frequency, formulation: unknown) for prophylactic vaccination On an unknown date the patient developed a non-serious event "feeling very sick" (illness) (unknown latency) following the first dose intake (batch number: 5F675A and expiry date on 30-Sep-2027) of DUPILUMAB and (unknown latency) following the administration of INFLUENZA VACCINE and shingles vaccine On an unknown date the patient developed a non-serious event "arm is very sore, fingers, arms and legs hurt and are swollen" (peripheral swelling) (pain in extremity) (unknown latency) following the first dose intake (batch number 5F675A and expiry date on 30-Sep-2027) of DUPILUMAB and (unknown latency) following the administration of INFLUENZA VACCINE and shingles vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "i woke up feeling very sick, run down and my arm is very sore, i feel so bad, my fingers, arms and legs hurt and are swollen after getting vaccines for the flu and the second shot for shingles. pharmacist advised me that if i don't feel better or gets worst or arm starts to swell, i need to speak with my doctor. no other details given" Action taken with DUPILUMAB: was unknown for all events Action taken with INFLUENZA VACCINE and shingles vaccine: was not applicable for all events It was not reported if the patient received a corrective treatment for all events At time of reporting, the outcome was Unknown for all events
Penicillin allergy
DUPIXENT