Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
body aches; fever; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): 2025SA336138 (Sanofi), AE-021890 (BioNTech). A 54-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since Jul2023 at 600 mg (600 mg (loading dose)) and second regimen since 2023 at 300 mg weekly, all subcutaneous for asthma; influenza vaccine (INFLUENZA VACCINE), from 11Jun2025 to 11Jun2025 at single (dose number unknown, single) for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), from 11Jun2025 to 11Jun2025 at single (dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 06Nov2025, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 06Nov2025, outcome "recovering", described as "fever". The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of pain, pyrexia. Additional information: It was reported that the patient received COVID-19, influenza, and pneumococcal vaccines. On 06Nov2025, following vaccination, the patient experienced body aches and fever, which were ongoing but improving. The patient reported using acetaminophen (Tylenol) for symptom relief. The physician (MD) was aware. Action taken was unknown for dupilumab and not applicable for the influenza, pneumococcal, and COVID-19 vaccines. The patient was treated with acetaminophen for pain and pyrexia Batch/lot number is not provided, and it cannot be obtained.
DUPIXENT