Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Feeling hot, Inappropriate schedule of product administration, Mass, Respiratory tract congestion
Clinical narrative: cataract surgery; having floaters; experiencing issues with her vision; weight gain; she begins wheezing; joint pain; having a bad cough; trouble breathing after doing a lot of activity; getting hot; multiple CT scans which found lumps; lightheadedness; congestion; one day late in giving Dupixent with no reported adverse event; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017301 (BioNTech), 2024SA265479 (Sanofi).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; dupilumab (DUPIXENT), as 200mg/1.14ml, dose of 200 mg qo w (every other week)) subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "cataract surgery"; VITREOUS FLOATERS (non-serious), outcome "unknown", described as "having floaters"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "experiencing issues with her vision"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "weight gain"; WHEEZING (non-serious), outcome "unknown", described as "she begins wheezing"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; COUGH (non-serious), outcome "unknown", described as "having a bad cough"; DYSPNOEA EXERTIONAL (non-serious), outcome "unknown", described as "trouble breathing after doing a lot of activity"; FEELING HOT (non-serious), outcome "unknown", described as "getting hot"; MASS (non-serious), outcome "unknown", described as "multiple CT scans which found lumps"; DIZZINESS (non-serious), outcome "unknown", described as "lightheadedness"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "congestion"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "one day late in giving Dupixent with no reported adverse event". The patient underwent the following laboratory tests and procedures: Computerised tomogram: which found lumps; Weight: gain. The action taken for dupilumab was unknown. Clinical course: Patient reported she had weight gain, joint pain, having a bad cough, trouble breathing after doing a lot of activity, getting hot, she begins wheezing, experiencing issues with her vision, having floaters and multiple CT (Computerized tomogram) scans which found lumps, lightheadedness and congestion while being treated with Dupilumab delivered via prefilled syringe and Covid-19 Vaccine. The patient reported that she was one day late in giving Dupixent with no adverse event reported directly linked to this inappropriate schedule of product administration. Patient reported "weight gain, joint pain, missed dose. The patient reported that she was one day late in giving Dupixent due to not knowing the process for obtaining her medication. Patient reported having a bad cough that has persisted ever since receiving her last Covid vaccine. She reported only have limitations and trouble breathing after doing a lot of activity or getting "hot", then she begins wheezing and had to use her rescue inhaler. Patient reported that overall, her exacerbations have improved since starting the medication. Patient reported one missed dose in October, when the shipment was late. Patient reported experiencing issues with her vision and having 'floaters". She reported being in contact with her optometrist and getting cataract surgery. Patient reported having the cough and getting multiple CT (computerized tomogram) scans which found lumps. Patient reported attending several appointments with her pulmonologist." Therapeutic measures were taken as a result of cataract, wheezing, dyspnoea exertional, feeling hot.  Batch/lot number is not provided, and it cannot be obtained.  BNT162B2 is under agreement with BIONTECH SE.