Received Dec 19, 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 | — | — |
cough after covid and flu shots; This is a spontaneous report and received from Consumer or other non HCPs from License Party. Other Case identifier(s): AE-021978 (Biontech), 2025SA351636 (Sanofi). This case involves a 60 year old female patient who experienced cough while being treated with DUPILUMAB (DUPIXENT) delivered via Dupixent single dose pre-filled pen, COVID-19 vaccine, and flu (influenza vaccine). The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s), family history were not reported. On 26-Jul-2025, the patient started taking dupilumab solution for injection (strength: 300mg) with dosage 600 mg, 1X subcutaneous use and then started maintenance dose of 300 mg QOW (every other week) for prurigo nodularis. On unknown dates the patient received COVID-19 vaccine, and flu (influenza vaccine) injections (dose, route, frequency : unknown). In Sep-2025, the patient developed a non-serious event "cough after covid and flu shots" (cough) (latency: approximately 2 months) following the first dose intake of (batch number and expiry date: unknown) of dupilumab, COVID-19 vaccine (batch number: unknown), and influenza vaccine (batch number: unknown). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient reports ongoing cough since September after covid and flu shots, physician now aware." Action taken: unknown for Dupixent and not applicable for COVID-19 vaccine, and flu (influenza vaccine). Correction treatment: not reported. Event outcome: not recovered/not resolved/ongoing (Cough). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Prurigo nodularis
DUPIXENT