Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
injection site irritation/from the covid vaccine; fall after receiving covid shot; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2021SA282813 (SANOFI), AE-022688 (BIONTECH). Initial information received on 23Aug2021 regarding an unsolicited valid case received from a Non-Healthcare Professional; this case became serious on 25Mar2024. This case involves Adult female patient who was in the hospital, was sick, had a fall after receiving covid shot, injection site irritation with this medication and from the covid vaccine and it was painful while being treated with dupilumab [Dupixent] via dupilumab prefilled syringe and covid-19 vaccine. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), concomitant medication(s) and family history were not provided. On 10Jul2020, the patient started taking dupilumab Solution for injection at a dose of 300 mg every other week subcutaneously (strength: 300 mg/2ml) for unspecified asthma/ severe persistent asthma, uncomplicated. On 13Nov2020 the patient restarted the therapy at dose of 300 mg QOW (every other week). On an unknown date, the patient started taking covid-19 vaccine (with an unknown form, dose, frequency, strength, route) for COVID-19 vaccination. Patient had injection site irritation with this medication and from the covid vaccine (injection site irritation) (vaccination site irritation) (unknown batch number and expiry date). Patient also had a fall (unknown batch number and expiry date) after receiving covid shot unknown if MD (Doctor of Medicine) was aware. Pt (patient) stated that dupixent was painful (injection site pain) (onset and latency unknown for all events) (unknown batch number and expiry date). Pt was in the hospital (hospitalisation) (onset and latency unknown) (unknown batch number and expiry date) and had missed an injection, date unknown. md was aware. Hospital dates, reason, and duration not provided. Pt would resume therapy on unknown date. Pt was due for dose 01Nov2024, was sick (illness) (onset: 2024; unknown latency, batch number and expiry date), hadn't taken dose all of Nov. Patient reported missed dose on 15Nov. Patient took next dose on 22Nov. No further information given. Unknown if and was aware. All known information is contained on this form. Consent to contact the reporter has not been received, for follow up please contact the prescriber. The patient reported that they had not had their prescription as they had been sick and could not take it. The duration of the gap in therapy was unknown. It was unknown if the patient was aware. No additional information was available. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was unknown if there were lab data/results available. Action taken: dupilumab was withdrawn on an unknown date for hospitalization and illness, no action taken for other events; with covid-19 vaccine: unknown for all events. Corrective treatment: Not reported for all events. Outcome: Unknown for all events. Seriousness criteria: Hospitalization for hospitalization. Additional information was received on 25Mar2024 from the patient via specialty pharmacy: additional event hospitalization was added, additional therapy was added. Text amended accordingly. Additional information was received on 22Nov2024 from patient: New event illness added, indication updated, clinical course updated and text amended accordingly. Company (Sanofi) Agent Causal was noted as yes. Case listedness was noted as listed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
DUPIXENT