Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Asthma flare; experiencing hot flashes during the first injection of the medication; used the pen, it hurts; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2023SA276982 (SANOFI), AE-017842 (LLP-BioNTech SE). This case Involves a 72-years- old female patient who experienced hot flashes during the first Injection of the medication, flare and used the pen, it hurts, and the medication did not enter her body, it spilled all over the floor while being treated with dupilumab [Dupixent) delivered via dupilumab single dose pre-filled pen and Covid-19 vaccine. The patient's past medical treatment(s), concomitant medication(s), vaccination(s), family history and any additional medical history, concomitant disease or risk factor were not provided. Concomitant medications included buspirone hydrochloride (Buspar); and venlafaxine hydrochloride (Effexor). On an unknown date, the patient started taking dupilumab solution for Injection at a dose of 300 mg every other week subcutaneously (Strength: 300mg/2mL, with an unknown batch number and expiry date) via dupilumab single dose pre-filled pen for Severe persistent asthma, uncomplicated. On an unknown date, the patient started taking covtd-19 vaccine (with an unknown strength, formulation, dose, frequency, route, batch number and expiry date) for Covid-19 vaccination. Product used for first time: No. On an unknown date the patient developed a non-serious event "experiencing hot flashes during the first Injection of the medication" (Hot flush) (unknown batch and expiry date) (latency: unknown) (unknown batch and expiry date) following the first dose Intake of dupilumab and (unknown latency) following the first dose intake of covtd-19 vaccine. On an unknown date the patient developed a non-serious event "flare" (Asthma) (latency: unknown) (unknown batch and expiry date) following the first dose intake of dupilumab and (unknown latency) (unknown batch and expiry date) following the first dose Intake of covtd-19 vaccine. On an unknown date the patient developed a non-serious event "used the pen, it hurts and the medication did not enter her body, it spilled all over the floor" (Injection sue pain) (latency: unknown)(lot-4F462A and expiry- 30 April 2026) following the first dose intake of dupilumab and (unknown latency)(unknown batch and expiry date) following the first dose Intake of covtd-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "experiencing hot flashes during the first Injection of the medication. Patient states that the hot flashes would last around 24-48 hours, however "she didn't care that she was experiencing hot flashes, the drug is a miracle drug!" Patient reports no longer taking Effexor, as it was replaced by Buspar. Upon follow-up caller reported she received the covid vaccine which caused a flare. Has been on prednisone since 11/22. She is doing well now, and asthma almost completely controlled. It was unknown if the patient experienced any additional symptoms/events. It was unknown If there were lab data/results available. The patient stated that her pen did not work as it was dull. The patient further stated, "I used it and it hurts and the medication did not enter my body, it spilled all over the floor." The patient Is unaware If any part of her body was exposed to the medication. The pen is available for return and patient will be expecting to receive a prepaid mailer. Action taken with dupilumab (Dupixent) was continued for Injection site pain and unknown for Asthma, Hot flush. Action taken with covid-19 vaccine was not applicable for all the events. Corrective: The patient was treated with prednisone for the event (asthma) and not reported for rest of the events. Outcome: Recovering for the event (asthma) and unknown for the rest of the events. Additional information was received on 01Dec2023 from the patient via specialty pharmacy: new event (asthma), new suspect, indication and corrective drug added. Corresponding fields and narrative amended accordingly. Additional information was received on 10Jan2025 from the patient. New event: Injection site pain was added. Action taken updated. Clinical course updated and text amended accordingly. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Asthma
BUSPAR; EFFEXOR; DUPIXENT