Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
headaches and body aches; headaches and body aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 2025SA281951 (Sanofi). A 65-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 08Sep2025 at 600 mg (600 mg ( 1x)), subcutaneous for dermatitis atopic; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset 16Sep2025, outcome "not recovered" and all described as "headaches and body aches". The action taken for dupilumab was unknown. Additional information: On 16Sep2025 the patient developed a non-serious event "headaches and body aches" (pain) (headache) (latency: 8 days following the first dose intake of DUPILUMAB, (unknown latency Covid-19 Vaccine, Influenza Vaccine and Shingles Vaccine. (unknown batch number and expiry date for all events). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient reports headaches and body aches since 16Sep2025 after receiving shingles, influenza, and covid-19 vaccines, ongoing, unknown if md (medical doctor) is aware." It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Not Recovered / Not Resolved for both the events. Company causality for drug DUPIXENT and events reported as related. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
DUPIXENT