Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
cataract; Patient's autoimmune system has never been correct; asthmatic flare up; cough; panic attack; confusion; loses her voice; weather changes will affect her voice; voice is noted to be hoarse and raspy; shortness of breath upon exertion; migraine; nausea; fever (pyrexia); chills; PROGRAM NAME NOT AVAILABLE This is a solicited report received from a Consumer or other non HCP from License Party, Program ID: NOT AVAILABLE. Other Case identifier(s): 2021SA054848 (BioNTech SE). A 65-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 15Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 05Aug2019) at 600 mg 1x/day and second regimen since 19Aug2019) at 300 mg (300 mg, every other week (maintenance dose)), all subcutaneous for dermatitis atopic, asthma. The patient's relevant medical history included: "loses her speech" (unspecified if ongoing); "body becomes numb" (unspecified if ongoing); "mimic a stroke" (unspecified if ongoing); "Aphasia" (unspecified if ongoing); "Hypoaesthesia" (unspecified if ongoing); "migraine" (ongoing), notes: since her 40s.; "post-traumatic stress disorder not dementia," (unspecified if ongoing); "allergic asthma" (ongoing); "Forgetfulness" (unspecified if ongoing); "hospital", start date: Feb2021 (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE; SYMBICORT; PREDNISONE. The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "fever (pyrexia)"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown"; MIGRAINE (non-serious) with onset 11May2022, outcome "recovering"; CATARACT (hospitalization, medically significant) with onset 01May2025, outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "Patient's autoimmune system has never been correct"; ASTHMA (non-serious), outcome "not recovered", described as "asthmatic flare up"; COUGH (non-serious), outcome "not recovered"; PANIC ATTACK (non-serious), outcome "not recovered"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; DYSPNOEA EXERTIONAL (non-serious), outcome "not recovered", described as "shortness of breath upon exertion"; APHONIA (non-serious), outcome "unknown", described as "loses her voice"; SENSITIVITY TO WEATHER CHANGE (non-serious), outcome "unknown", described as "weather changes will affect her voice"; DYSPHONIA (non-serious), outcome "recovering", described as "voice is noted to be hoarse and raspy". The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of cataract. The reporter's assessment of the causal relationship of "cataract", "patient's autoimmune system has never been correct", "asthmatic flare up", "cough", "panic attack", "confusion", "fever (pyrexia)", "chills", "shortness of breath upon exertion", "nausea", "loses her voice", "weather changes will affect her voice", "voice is noted to be hoarse and raspy" and "migraine" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: The patient's past medical history included sometimes loses her speech and her body becomes numb and that they could mimic a stroke, Aphasia and Hypoaesthesia. At the time of the event, the patient had ongoing very bad migraine since her 40s. describes her migraine episodes as being debilitating, had post-traumatic stress disorder not dementia, allergic asthma and forgetfulness. Concomitant medications included budesonide, formoterol fumarate (Symbicort), prednisone. On 05Aug2019, the patient took Dupixent (Dupilumab) (strength:150mg/ml) at a dose of 600 mg(milligram) 1x/day, followed by since 19Aug2019 with maintenance dose of 300 mg QOW (every other week) via subcutaneous route (with an unknown form, batch number and expiry date) for atopic Dermatitis, Asthma via prefilled syringe. On 15Apr2021, the patient started taking covid-19 vaccine (with an unknown formulation, strength, dosage, route, frequency, batch number, and expiry date) for COVID-19 immunization. On an unknown date in Feb2021 patient was in the hospital and that she was not called to schedule (hospitalization), latency: (1 year 5 months approximately) following the first dose intake of dupilumab. On an unknown date in Apr2021 the patient developed fever (pyrexia), chills, and nausea, latency(1 year 7 months approximately) following the first dose intake of dupilumab. The patient was in bed for 3 days due to fever, chills, and nausea. Patient reported having an asthmatic flare up (asthma) and stated that every year around this time her cough gets worse (cough) (onset date and latency: unknown) following the first dose intake of dupilumab due to the weather and seasons changing. On an unknown date, patient had a panic attack (panic attack) (unknown latency) right after she took Dupixent she noticed she was more confused. On an unknown date, confusion was much worse (confusional state) (condition aggravated) (unknown latency) following the first dose intake of dupilumab. Upon follow-up it was stating that Dupixent keeps the consumer stable. However, the consumer loses her voice slightly close to the time where she would take her next injection (aphonia) (unknown latency and onset) following the first dose intake of dupilumab. On an unknown date, patient's voice is noted to be hoarse and raspy(dysphonia) (unknown latency) and states that he weather changes will affect her voice ( sensitivity to weather change) (unknown latency) following the first dose intake of dupilumab. It was reported on follow-up "is having migraine headaches since yesterday; she does states that she has a history of migraines that had been intermittent since before starting Dupixent; patient's voice is noted to be hoarse and raspy; states that he weather changes would affect her voice; that was her case today and was a common thing with Asthma; In inquiring about what device she uses, she does say that she uses syringe, but she did mention previously at one point that she tried the auto-injecting pen, and at which point, she was saying that it was difficult to control the device more than the syringe offers better control than the pen; Currently the patient was using syringe and was planning to proceeding over with the prefilled syringe; She had attempted a pen previously, and didn't like how it was functional to her; said that the syringe was easier for her to control; so there's some lack of control with the pen versus the prefilled syringe. Patient's last dose was taken on 15Apr2022". On 11May2022, latency: 2 years 9 months 6 days, patient stated she has had a severe migraine. On an unknown date, the patient took Dupilumab Solution for injection (strength: 300 mg) at a dose of 300 mg QOW subcutaneous for Dermatitis atopic and Asthma. Patient reported that she was recently in the hospital. On 01May2025, she recently had cataract surgery (cataract) (latency: 5 years 8 months 27) (unknown batch number and expiry date). She informed that she had really bad attacks. She expressed being harsh with her voice.Information regarding batch number and expiration date corresponding to the one at the time of event occurrence was requested. No lab data was provided. Action taken: Unknown for cataract and o action taken for all the other events with pre-filled syringe and no action taken for cataract and unknown for all the other event with pre-filled pen. Corrective: cataract surgery for the event cataract and not reported for all the other events. Outcome: Not recovered/not resolved for the events panic attack, confusional state, autoimmune disorder, aphonia, condition aggravated and dyspnoea exertional), recovering for migraine, Dysphonia, cataract and unknown for rest of the events. Reporter causality: Unassessable for hospitalization and not related for events pyrexia, chills, nausea, asthma, cough, migraine and not reported for rest all events Company causality: Not reportable for all the events. Seriousness Criteria: Medically significant for the event autoimmune disorder, cataract and hospitalized for the event (hospitalization), cataract. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on known disease pathophysiology, and limited information available, the events are assessed as not related to COVID-19 Vaccine, and more likely due to underlying medical conditions.
Allergic asthma; Migraine (since her 40s.)
Medical History/Concurrent Conditions: Aphasia; Forgetfulness; Hospitalisation; Hypoaesthesia; Numbness; Post-traumatic stress disorder; Speech loss; Stroke mimic
BUDESONIDE; SYMBICORT; PREDNISONE; DUPIXENT