Received Jan 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
"over the past month they had a flare up" (chronic obstructive pulmonary disease); "over the past month they had a flare up" (chronic obstructive pulmonary disease); had one week of feeling unwell; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-022217 (Biontech), 2025SA379019 (Sanofi). A 65-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Nov2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Jul2025 (ongoing) at 300 mg (300 mg, once every other week (qow)), subcutaneous for chronic obstructive pulmonary disease; influenza vaccine (INFLUENZA VACCINE), in Nov2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Chronic Obstructive Pulmonary Disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Nov2025, outcome "unknown" and all described as ""over the past month they had a flare up" (chronic obstructive pulmonary disease)"; MALAISE (non-serious) with onset Nov2025, outcome "recovered" (2025), described as "had one week of feeling unwell". The action taken for dupilumab was unknown. Additional information: Initial information received on 16Dec2025 regarding an unsolicited valid non-serious case received from the patient. This case involves "an approximately" a 65-year-old male patient who reported that over the past month they had a flare up and took flu and covid vaccines within 2 days of each other and had one week of feeling unwell. while being treated with DUPILUMAB [DUPIXENTI delivered via pre-filled pen and flu and covid vaccines. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In Jul2025, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at the dose of 300 mg QOW subcutaneous for Chronic obstructive pulmonary disease (strength: 300 mg). In Nov2025 the patient developed a non-serious event "over the past month they had a flare up" (chronic obstructive pulmonary disease) (4 months approximately latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB. In Nov2025 the patient developed a non-serious event" took flu and covid vaccines within 2 days of each other and had one week of feeling unwell" (malaise) (4 months approximately latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient reports that over the past month they had a flare up but patient advised they took flu and covid vaccines within 2 days of each other and had one week of feeling unwell. Patient just had a appointment with pulmonologist and they stated patient is doing well. date of onset unknown, no further information reported ". Action taken with DUPILUMAB (DUPIXENT) was unknown for both the events (although therapy was ongoing), not applicable for flu and covid vaccines for all the events. It was not reported if the patient received a corrective treatment for the events (over the past month they had a flare up, took flu and covid vaccines within 2 days of each other and had one week of feeling unwell.). At time of reporting, the outcome was Unknown for the event over the past month they had a flare up and was Recovered in 2025 for the event took flu and covid vaccines within 2 days of each other and had one week of feeling unwell. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. COMIRNATY is under agreement with BIONTECH SE.
Chronic obstructive pulmonary disease
DUPIXENT