Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Product use in unapproved indication
Clinical narrative: Pneumonia; heart failure/passed away a week ago due to congestive heart failure; was hospitalized with difficulty in breathing; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024SA146768 (Sanofi).  An 88-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 28Dec2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 88 years for immunisation; dupilumab (DUPIXENT), on 09Dec2021 as 600 mg (Lot number: 3F347A, Expiration Date: 31Dec2025) and in 2022 as 300 mg (Lot number: 3F347A, Expiration Date: 31Dec2025), all subcutaneous for dermatitis, dermatitis atopic, asthma. The patient's relevant medical history included: "Unspecified Urinary Incontinence" (unspecified if ongoing); "Cough" (unspecified if ongoing); "Chronic Kidney Disease Stage 3b/Chronic kidney disease stage G3b" (unspecified if ongoing); "Pruritus Unspecified" (unspecified if ongoing); "Chr Obstructive Pulmonary Dis Unsp" (unspecified if ongoing); "Emphysema Unspecified" (unspecified if ongoing); "Centrilobular Emphysema" (unspecified if ongoing); "Other Seasonal Allergic Rhinitis" (unspecified if ongoing); "Essential Primary Hypertension" (unspecified if ongoing); "Essential Primary Hypertension" (unspecified if ongoing); "Hyperlipidemia Unspecified" (unspecified if ongoing); "Type 2 Diabetes Mellitus Without Complications" (unspecified if ongoing); "Hypothyroidism Unspecified" (unspecified if ongoing); "Neoplasm of uncertain behavior of skin" (unspecified if ongoing); "Allergic contact dermatitis" (unspecified if ongoing); "Atopic dermatitis" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Stent placement" (unspecified if ongoing); "Skin Breakout" (unspecified if ongoing). Concomitant medication(s) included: TOLTERODINE TARTRATE; SPIRIVA RESPIMAT; MONTELUKAST SODIUM; NIFEDIPINE; ROSUVASTATIN; METOPROLOL; BUDESONIDE; POTASSIUM; TRIAMCINOLONE taken for rash. Past drug history included: Codeine, reaction(s): "Drug Allergies: Codeine"; Durlaza, reaction(s): "Drug allergies: Durlaza"; Aspirin, reaction(s): "Drug allergies: Aspirin". The following information was reported: DYSPNOEA (hospitalization) with onset Dec2023, outcome "unknown", described as "was hospitalized with difficulty in breathing"; CARDIAC FAILURE CONGESTIVE (death, hospitalization, medically significant) with onset 14May2024, outcome "fatal", described as "heart failure/passed away a week ago due to congestive heart failure"; PNEUMONIA (death, hospitalization, medically significant), outcome "fatal". The patient was hospitalized for cardiac failure congestive, pneumonia, dyspnoea (discharge date: 04Jan2024). The patient underwent the following laboratory tests and procedures: Angiogram: heart function of 30%; Echocardiogram: No history of cardiac failure as per past, notes: No history of cardiac failure as per past echocardiograms. Therapeutic measures were taken as a result of cardiac failure congestive, pneumonia. The patient date of death was May2024. Reported cause of death: "heart failure/passed away a week ago due to congestive heart failure", "Pneumonia". It was not reported if an autopsy was performed.  Additional information: This case involves an 88 year old female patient who had pneumonia and moved to hospice after a fall, taking Dupixent in indication dermatitis who had no reported adverse event directly linked to this product use in unapproved indication and heart failure/passed away a week ago due to congestive heart failure while being treated via Dupixent single-dose prefilled pen. On 09Dec2021, the patient started taking dupilumab solution for injection (150mg/ ml) at a loading dose of 600 mg, followed by maintenance dose of 300 mg QOW since an unknown date in 2022 subcutaneous for dermatitis (product use to unapproved Indication) (same day latency) (3F347A and expiry date on 31Dec2025), Other atopic dermatitis and Unspecified asthma uncomplicated delivered via Dupixent single dose pre-filled pen. The patient was last seen in clinic on 09Nov2023 and was doing good. No issues with Dupixent and her skin was cleat. On 28Dec2023, the patient started taking RSV VACCINE with unknown dose, frequency, route, strength, formulation for prophylactic vaccination. The patient had RSV (Respiratory Syncytial Virus) shot on 28Dec2023 and 14 hours later she was hospitalized with difficulty in breathing (dyspnoea) (onset date: Dec2023 and latency approximately 2 years with Dupixent) where she was diagnosed with Pneumonia and congestive heart failure. She was discharged home from Hospital on 04Jan2024 on 11 liters of oxygen and Lasix. The reporter does not know what treatment was given in the hospital. Four days before she passed, the patient fell down from her bed and was taken to ER (emergency room). She stated that her bed side bars were left open during shift change and during that time she fell from her bed and moved to hospice after a fail care. She had bruise on her face and cheek (contusion) with no broken bones and was sent back to home from ER. Dupixent helped the patient tremendously and her skin was clear from head to toe. No history of cardiac failure as per past echocardiograms. The patient's daughter stated that the patient passed away a week ago (May2024) due to congestive heart failure. Patient received the last dose of dupilumab on an unknown date May2024. Corrective treatment: Oxygen and Lasix was used as corrective treatment was received for Cardiac failure congestive.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events cardiac failure congestive, pneumonia, and dyspnoea are conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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: heart failure/passed away a week ago due to congestive heart failure; Pneumonia