Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
she was not feeling well; had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe; had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe; eczema flared up; eczema flared up; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): 2025SA310937 (Sanofi), AE-021614 (BioNTech). Initial information received on 14Oct2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 55 years old female patient who missed a dose of dupixent, as she was not feeling well, had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe and eczema flared up while being treated with DUPILUMAB [DUPIXENT] via prefilled syringe and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rhinitis allergic, Eczema and allergies: isovue-300 61% multipack; penicillin v potassium; ofloxacin 300 mg tablet. Concomitant medications included unspecified allergy shots biweekly. In 2019, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg QOW subcutaneous for Asthma. On an unknown date, the patient started taking COVID-19 VACCINE Unknown dosage unknown for Immunisation. In 2020 the patient developed a non-serious event "eczema flared up" (eczema) (approximately few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. On 08Oct2025 the patient developed a non-serious event "missed a dose of dupixent, as she was not feeling well" (malaise) (approximately 5 years few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. In Oct2025 the patient developed a non-serious event "had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe" (middle insomnia) (approximately 5 years few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. In Oct2025 the patient developed a non-serious event "had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe" (dyspnoea) (approximately 5 years few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. It was reported "The patient stated that since starting on dupixent "i haven't been having (asthma) crisis like i was having before". She reports having allergic rhinitis, and she stated that she gets allergy shots biweekly. She stated that she missed a dose of dupixent on 08Oct2025, as she was not feeling well. She informed that last week she had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe. She denies having to use her rescue inhaler. She stated that after the air began circulating her symptoms resolved. She reported that she had eczema when she was younger but it flared up in 2020 after she took the covid vaccine. She stated that dupixent does not help her eczema symptoms". Action taken with DUPILUMAB was drug withdrawn in 2025 for malaise, unknown for other events. Action taken with COVID-19 VACCINE was unknown for all events. It was not reported if the patient received a corrective treatment for all events. At time of reporting, the outcome was Recovering for malaise; eczema; was Recovered in Oct2025 for other events. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Eczema (When patient was younger); Rhinitis allergic
DUPIXENT