Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
pemphigoid/severe bullous pemphigoid; Skin ulcer; Peripheral swelling (swollen feet and leg); Blister; Rash pruritic (itchy spots on body); Skin lesion; Blood pressure inadequately controlled; Condition aggravated; Red blood cell count decreased; Haemoglobin decreased; Haematocrit decreased; Passed away; This is a solicited report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): AE-019124 (BioNTech). Initial information received on 02Apr2024 regarding a solicited valid serious case received from patient's grandson in the scope of patient support program Study Title. This case involves an 84 years old male patient who had severe bullous pemphigoid in patient's legs, blisters. itchy spots on body, worse, more lessions, bp is not controlled and refractory. rash Red blood cell count mildy decreasd, hemoglobin and hematocrit count mildly decreased and passed away while being treated with Duplimab (Dupixen) delivered via dupilumab single dose pre filled pen and COVID-19 vaccine. The patient's pest medical history included Squamous cell carcinoma, Hernia and Atrial fibrillation. The patient's pest medical treatment(s), vaccination (s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus and Hypertension and treated with atorvastatin, metprolol, metformin and Eliquis, Eczema and patient vas legally blind since several years. Social History of Single Question Alcohol Screening: 0 days. EIOH (Early Intraoperative Hypotension): none. Smoking status Nover smoker. Pneumonia vaccination or previously received Healthcare Proxy: No and Living Will: Yes patient had no known allergies. Alert: Premedication prior to procedures, no cough or shortness of breath. Concomitant medications included Nicotinic acid (Niacin); Ketoconazole (Ketoconazole); Pantoprazole (Pantoprazole); Propionic acid (Propionic acid); Apixaban (Eliquis); Triamcinolone (Triamcinolone); Hydrocortisone (Hydrocortisone); Metoprolol succinate (Metoprolol succinate); Methotrexate (Methotrexate); Atorvastatin calcium (Atorvastatin) for Hypertension; Naproxen (Naproxen) for Pain; Furosemide (Lasix); Sulfadiazine silver (Silvadene); Pantoprazole sodium sesquihydrate (Protonix); Metformin hydrochloride (Metformin) for Diabetes mellitus; Amoxicillin trihydrate, Clavulanate potassium (Augmentin); Mupirocin (Mupirocin); and Clobetasol (Clobetasol).On 19Aug2022, the patient started taking Dupilumab Solution for injection (Strength: 300mg/2ml) at a loading dose of 600 mg 1x as loading dose followed by 300 mg QOW (every other week) since 2022 subcutaneously delivered via dupilumab single dose prefilled pen for Atopic dermatitis, Unspecified/ atopic dermatitis. On 02Oct2024, patient had a shot of COVID-19 vaccine (with unknown dose, strength, route, formulation, frequency) for prophylactic vaccination. On an unknown date (latency: unknown) (with unknown batch number and expiry date) patient grandson stated since his grandfather started taking Dupixent he had periodic incidents of going suddenly blind in his left Eye and believes may be directly associated with taking Dupixent. Patients last incident of going blind in left eye suddenly took place on 24Dec2023. The granddaughter of patient stated that her grandfather has recently been going blind in his left eye, temporary and it periodically, it only began since he began taking the injection, he did not experience going blind in his left eye prior to taking Dupixent. At the time of the report, Dupixent is continued. Upon follow up On an unknown date in Jan2025 (Latency: 2 years 5 months) Doctor recommended patient to go to ER (emergency room) due to swollen legs (Peripheral swelling) and ulcers (Skin ulcer) and was then admitted to hospital from 07Jan2025 and 09Jan2025. Blood tests 07Jan2025, 08Jan2025 and 09Jan2025: CMP (comprehensive metabolic panel) mostly within normal range; CBC (complete blood count) mostly within normal range; except mildly decreased RBC and hemoglobin and hematocrit value was mildly decreased (Red blood cell count decreased)(Haemoglobin decreased)(Hematocrit decreased) (Latency: 2 years 5 months)(with unknown batch number and expiry date) Reportedly On an unknown date (Latency: unknown), patient's BP (blood pressure) was not controlled and refractory (Blood pressure inadequately controlled). Since Apr2024, patient could not taper oral prednisone below 30 mg qd (once daily) still new rash (Rash) and blisters (Blister)(onset and latency unknown) (with unknown batch number and expiry date). Reportedly On an unknown date (Latency: unknown) patient had itchy spots on body, worse, more lesions (skin lesion)(condition aggravated), (rash pruritic)(unknown batch number and expiry date). Upon follow-up, patient daughter stated that patient had passed away (death) (Onset: 09Feb2025) (Latency: 2 years 5 months 21 days) (unknown batch number and expiry date). It was unknown if an autopsy was done. Unknown cause of death. Upon follow-up medical assistant (MA), were not aware that the patient had died, no mention in the patient's chart, therefor they did not know cause of death, have any death details, and did not know if an autopsy was performed. They did not feel Dupixent was related to the death. His last office visit was on 17Jan2025, no mention of his atopic dermatitis but he was continued on Dupixent at that time. The MA stated there were events mentioned during the last office visit including severe bullous pemphigoid in his legs (pemphigoid) (onset, latency: unknown) (unknown batch number and expiry date) with an emergency room visit, he was on methotrexate for unknown reason and was on prednisone since Apr2024 for bullous pemphigoid. Information regarding batch number and expiry date corresponding to the one at time of event occurrence was requested. Relevant laboratory test results included: Full blood count - On 07Jan2025: [with in normal range]; on 08Jan2025: [with in normal range]; on 09Jan2025: [with in normal range] Haematocrit - On 07Jan2025: [mildly decreased]; on 08Jan2025: [mildly decreased]; on 09Jan2025: [mildly decreased] Haemoglobin - On 07Jan2025: [mildly decreased]; on 08-Jan-2025: [mildly decreased]; on 09Jan2025: [mildly decreased] Metabolic function test - On 07Jan2025: [with in normal range]; on 08Jan2025: [with in normal range]; on 09Jan2025: [with in normal range] Red blood cell count - On 07Jan2025: [mildly decreased]; on 08Jan2025: [mildly decreased]; on 09Jan2025: [mildly decreased]. Action Taken with dupilumab: No action taken for the event pemphigoid; Not applicable for death and unknown for rest all the events. Action Taken with COVID-19 vaccine: Not applicable for all events. Corrective treatment: The patient was treated with Doxycycline (Doxycycline), Furosemide (Furosemide) and Prednisone (Prednisone) for Pemphigoid and not reported for rest of the events. Outcome: Fatal for death and unknown for all the events. Reporter Causality with dupilumab: not related for the event death and not reported for all other events. Reporter Causality with COVID-19 vaccine: Not reported for all events. Company Causality with dupilumab: Not Reportable for all the events. Company Causality with COVID-19 vaccine: Not reportable for all events. Seriousness Criteria: The event death, pemphigoid along with symptoms was assessed as medically significant and death for the event death. Patient was hospitalized for the event pemphigoid and symptoms. Additional information was received on 03Apr2024 from granddaughter of the patient: Event blindness transient verbatim was updated. loading dose was added. Therapy start date was added. Clinical course was added. Narrative was updated. Additional information was received on 10Apr2025 from patient's daughter: event death, concomitant medications, strength were added and text amended accordingly. Additional information was received on 15Apr2025 from Medical assistant. New event of pemphigoid was added. Concomitant medication was added. Text amended accordingly. Additional information was received on 15Apr2025 from physician. new event Blister, Rash pruritic, Rash, Skin lesion, condition aggravated, Red blood cell count decreased, Haemoglobin decreased, Hematocrit decreased and Blood pressure inadequately controlled was added. Concomitants, medical history, treatment drugs were added. Event of blindness transient was deleted. Text amended. COMIRNATY (2024-2025 FORMULA) is under agreement with BIONTECH SE.; Sender's Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results is received. There is no reasonable possibility that the events pemphigoid, skin ulcer, blister, skin lesions aggravated were related to Comirnaty (2024-2025 Formula). These are more likely associated with the history of squamous cell carcinoma. There is no reasonable possibility that the events peripheral swelling, red blood cell decreased, hemoglobin decreased, and hematocrit decreased were related to Comirnaty (2024-2025 Formula). These are more likely intercurrent conditions. The events blood pressure inadequately controlled is more likely associated with the history of atrial fibrillation. There is a reasonable possibility that the event rash is related to Comirnaty (2024-2025) based on known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death
Diabetes mellitus; Hypertension
Medical History/Concurrent Conditions: Atrial fibrillation; Hernia; Pain; Squamous cell carcinoma
NIACIN; KETOCONAZOLE; PANTOPRAZOLE; PROPIONIC ACID; ELIQUIS; TRIAMCINOLONE; HYDROCORTISONE; METOPROLOL SUCCINATE; METHOTREXATE; ATORVASTATIN; NAPROXEN; LASIX [FUROSEMIDE]; SILVADENE; PROTONIX [OMEPRAZOLE]; METFORMIN; AUGMENTIN [AMOXICILLIN
Test Name: blood pressure; Result Unstructured Data: Test Result:Unknown results; Comments: not controlled and refractory; Test Date: 20250107; Test Name: Blood tests; Result Unstructured Data: Test Result:With in normal range; Comments: CMP (comprehensive metabolic panel) mostly within normal range ; CBC (complete blood count) mostly within normal range; Test Date: 20250108; Test Name: Blood tests; Result Unstructured Data: Test Result:with in normal range; Comments: CMP (comprehensive metabolic panel) mostly within normal range ; CBC (complete blood count) mostly within normal range; Test Date: 20250109; Test Name: Blood tests; Result Unstructured Data: Test Result:with in normal range; Comments: CMP (comprehensive metabolic panel) mostly within normal range ; CBC (complete blood count) mostly within normal range; Test Date: 20250107; Test Name: Hematocrit; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250108; Test Name: Hematocrit; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250109; Test Name: Hematocrit; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250107; Test Name: Haemoglobin; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250108; Test Name: Haemoglobin; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250109; Test Name: Haemoglobin; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250107; Test Name: Metabolic function test; Result Unstructured Data: Test Result:with in normal range; Test Date: 20250108; Test Name: Metabolic function test; Result Unstructured Data: Test Result:with in normal range; Test Date: 20250109; Test Name: Metabolic function test; Result Unstructured Data: Test Result:with in normal range; Test Date: 20250107; Test Name: Red blood cell count; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250108; Test Name: Red blood cell count; Result Unstructured Data: Test Result:mildly decreased; Test Date: 20250109; Test Name: Red blood cell count; Result Unstructured Data: Test Result:mildly decreased