Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
body ache; fever; Initial information received on 08-Nov-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 54 years old female patient who had body ache and fever while being treated with DUPILUMAB [DUPIXENT] delivered via single dose pre-filled pen, Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s), concomitant disease or risk factor and family history were not provided. On an unknown date in July 2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength 300 mg) at loading dose of 600 mg 1X followed by 300 mg QOW since 2023 subcutaneously for Asthma. On 11-Jun-2025, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer via unknown route in unknown administration site; On the same day, the patient received a unknown dose of suspect Covid-19 Vaccine not produced by Sanofi Pasteur via unknown route in unknown administration site; On the same day, the patient received a unknown dose of suspect Pneumococcal Vaccine not produced by Sanofi Pasteur (strength, expiry date and lot number not reported for all vaccines) via unknown route in unknown administration site as prophylactic vaccination (immunization) On 06-Nov-2025 the patient developed a non-serious event "body ache" (pain) (approximately 2 years 4 months latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB and (latency: 4 months 26 days) following the administration of Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. On 06-Nov-2025 the patient developed a non-serious event "fever" (pyrexia) (approximately 2 years 4 months latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB and (latency: 4 months 26 days) following the administration of Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient reported she received vaccines: covid, flu and pneumonia on 06-Nov-2025 and had had body aches and fever after receiving the vaccines, ongoing but improving. patient reports using tylenol for symptom relief. Md (Doctor of medicine) aware". Action taken: Unknown for DUPILUMAB and not applicable for Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. The patient was treated with PARACETAMOL (TYLENOL) for Pain and Pyrexia. At time of reporting, the outcome was Recovering / Resolving for both events.
DUPIXENT