Received Jul 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
increase frequency of humlra due to frequent flare ups; not feeling well; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020032 (BioNTech). This case involves elderly female patient who was not feeling well and increase frequency of Humira due to frequent flare ups while being treated with DUPILUMAB [DUPIXENT] delivered via Single dose Pre-Filled Pen and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In Sep2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for Injection at a strength and dose of 300 mg QOW subcutaneously delivered via Single dose Pre-Filled Pen for Asthma. On an unknown date, the patient started taking COVID-19 VACCINE with unknown strength, dose, frequency, route and indication. On an unknown date, the patient developed a non-serious event "not feeling well" (malaise) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. On an unknown date, the patient developed a non-serious event "increase frequency of Humira due to frequent flare ups" (asthma) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. Information regarding batch number and expiration date corresponding to the one at the time of event occurrence was requested. It was reported "The patient (pt) reports had covid vaccines yesterday and not feeling well. Md (medical doctor) Is aware and md Is working to increase frequency of Humira due to frequent flare ups. Unknown If md aware. Action taken with DUPILUMAB: No action taken for both events. Action taken with COVID-19 VACCINE was unknown for both events. The patient was treated with ADALIMUMAB (HUMIRA) for Asthma and was not reported for malaise. At time of reporting, the outcome was Unknown for both events. BNT162b2 is under agreement with BIONTECH SE. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
DUPIXENT