Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Intraocular pressure increased, Intraocular pressure test, Myalgia, Nausea
Clinical narrative: shadow of a cataract on both eyes and it is worse on the left eye; now injecting with pre-filled pens /does feel a little discomfort; when she was injecting with pre-filled syrmges they would leave a rash on her for at least three days; sinus polyps; has arthritis to her thumb; osteoarthritis; some muscle pain; she believes her eyesight has worsened since being on Dupixent; she also has red eyelids; her blood pressure has improved and her M D lowered her blood pressure medication. It also helped her nasal polyps as well with no reported adverse event; some joint pain; eye pressure is increased characterized by her right eye pressure went from 19 to 22; a little bit of liquid that came out onto her leg after she pulled the needle out; a little bit of liquid that came out onto her leg after she pulled the needle out; Dry eye; Nauseous; tired; sore arm; reddening around eye area; redness around the injection site; This is a solicited report received from a Consumer or other non HCP from License Party, Program ID: Unknown. Other Case identifier(s): 2021SA042472 (Sanofi), AE-015803 (BioNTech).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in arm for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 2020) at 600 mg (600 mg once) and second regimen since 2020 (ongoing)) at 300 mg cyclic (followed by maintenance 300 mg every other week), all subcutaneous for asthma; dupilumab (DUPIXENT), first regimen since 01Oct2020) at 600 mg (600 mg once) and second regimen since Oct2020) at 300 mg cyclic (followed by maintenance 300 mg every other week), all subcutaneous for asthma. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing); "Borderline glaucoma", start date: 2006 (ongoing); "Nasal polyps" (ongoing); "Myopia" (ongoing); "nebulizers" (unspecified if ongoing); "Cataract" (unspecified if ongoing). Concomitant medication(s) included: MOMETASONE; SODIUM CHLORIDE; PREDNISONE. The following information was reported: OCULAR HYPERAEMIA (non-serious) with onset Jan2021, outcome "unknown", described as "reddening around eye area"; INJECTION SITE ERYTHEMA (non-serious) with onset Jan2021, outcome "recovered", described as "redness around the injection site"; VACCINATION SITE PAIN (non-serious) with onset Jan2021, 3 months 25 days after the suspect product(s) administration, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset 29Jan2021, outcome "unknown", described as "Nauseous"; FATIGUE (non-serious) with onset 29Jan2021, outcome "unknown", described as "tired"; DRY EYE (non-serious) with onset Jun2021, outcome "recovering"; CATARACT (medically significant), outcome "not recovered", described as "shadow of a cataract on both eyes and it is worse on the left eye"; INJECTION SITE DISCOMFORT (non-serious), outcome "recovering", described as "now injecting with pre-filled pens /does feel a little discomfort"; INJECTION SITE RASH (non-serious), outcome "recovering", described as "when she was injecting with pre-filled syrmges they would leave a rash on her for at least three days"; INTRAOCULAR PRESSURE INCREASED (non-serious), outcome "unknown", described as "eye pressure is increased characterized by her right eye pressure went from 19 to 22"; SINUS POLYP (non-serious), outcome "not recovered", described as "sinus polyps"; ARTHRITIS (non-serious), outcome "unknown", described as "has arthritis to her thumb"; OSTEOARTHRITIS (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "some muscle pain"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "she believes her eyesight has worsened since being on Dupixent"; ERYTHEMA OF EYELID (non-serious), outcome "unknown", described as "she also has red eyelids"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "her blood pressure has improved and her M D lowered her blood pressure medication. It also helped her nasal polyps as well with no reported adverse event"; ARTHRALGIA (non-serious), outcome "unknown", described as "some joint pain"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), outcome "unknown" and all described as "a little bit of liquid that came out onto her leg after she pulled the needle out". The patient underwent the following laboratory tests and procedures: Intraocular pressure test: (unspecified date) increased; (2020) went from 19 to 22; (2020) went from 20 to 28. The action taken for dupilumab was dosage not changed; for dupilumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of dry eye. Clinical course details were as follows: Based on the additional information was received on 24 Mar2021 from patient: overall reporter causality updated to related. pre-filled pens /does feel a little discomfort, when she was injecting with This case involves a 75 years old female patient who had shadow of a cataract on both eyes and it is worse on the left eye, now injecting with pre-filled syringes they would leave a rash on her for at least three days, redness around the injection site, eye pressure is increased characterized by her right eye pressure went from 19 to 22, sore arm, chilis, low grade fever, nausea/nauseous, tiredness/tired, sinus polyps, has arthritis to her thumb, osteoarthritis, she believes her eyesight has worsened since being on dupixent, reddening around eye area, she also has ted eyelids, dry eyes and her blood pressure has improved while she was treated with dupilumab [Dupixent] delivered via dupilumab pre-filled syringe and dupilumab single dose pre-filled pen and Covid-19 vaccine and her and lowered her blood pressure medication, it also helped her nasal polyps as well with no reported adverse event directly linked with Therapeutic response unexpected. The patient's past medical history included Blood pressure abnormal. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Borderline glaucoma in 2006, Nasal polyps, Myopia and Cataract. Concomitant medications included Prednisone; Sodium chloride; and Mometasone. On 01Oct2020, the patient started taking dupilumab solution for injection PFS (pre-filled syringe) (strength: 300 mg) at a dose of 600 mg once subcutaneously followed by maintenance 300 mg every other week (with an unknown batch number and expiry date) for moderate persistent asthma. Information on batch number was requested. On an unknown date patient switched from syringe to pen at a dose of 600 mg once subcutaneously Followed by maintenance 300 mg every other week (with an unknown batch number and expiry date) for moderate persistent asthma. First time product used: No. Since starting Dupixent (on an unknown date in 2020), the patient experienced that her eye pressure was increased characterized by her right eye pressure went from 19 to 22, her left eye pressure went from 20 to 28 (intraocular pressure increased), and her doctor felt her dupilumab was beneficial to her. Since an unknown date (latency; unknown) (with unknown batch number and expiry date) the patient experienced that her blood pressure has improved and her MD (medical doctor) lowered her blood pressure medication and it also helped her nasal polyps as well (therapeutic response unexpected)- (latency: unknown) (with unknown batch number and expiry date). She was no longer using nasal sprays, nebulizers, sodium chloride, emergency inhalers or prednisone, the does not have to sleep in a recliner any more and she still uses her maintenance inhaler. For 3 to 5 days (in Jan2021), the patient had redness around the injection site (injection site erythema, latency: 3 months approximately) (with unknown batch number and expiry date) and the reported that this wis the only side effect she had from Dupixent. Now, she believed her asthma was better because she can breathe through her nostrils, no mucus, and no drainage from sinuses going into the lungs. On unknown date (latency; unknown) (with unknown batch number and expiry date), the patient had a shadow of a cataract on both eyes and it is worse on the left eye (cataract); and she is nearsighted and does not need reading glasses. On 26Jan2021, the patient had started taking COVID-19 vaccine (strength, formulation, dose, route, batch number and expiry date: unknown), and her only side effect was a sore arm (Vaccination site pain, onset: Jan2021, latency: 3 months 25 days following Dupilumab and unknown latency following covid-19 vaccine). After Administration, she became nauseous (nausea) and tired (fatigue) (onset: 29Jan2021, latency: 3 months 28 days following Dupilumab and 3 days latency following covid-19 vaccine) (with unknown batch number and expiry date). Further on 16Feb2021 the patient had took the second dose of Covid-19 (strength, formulation, dose, route). On 16Feb2021 (with unknown batch number and expiry date) later that evening she had chills, low-grade fever (pyrexia) (latency; unknown), nausea, and tiredness, No other information was available at the time of the report. Upon follow up, patient reported redness around the injection site after previous injections. She stated it cleared up after a few days. Patient stated after she gave injection with pen, there was a little bit of liquid that came out onto her leg after she pulled the needle out. She was not sure if she did something wrong of there was something wrong with the pen itself. Upon follow up, it was reported that when she was using the syringe of Dupixent, during Oct, Feb, she would get red for 3 days around the injection site (injection site erythema) unknown onset date and latency) (with unknown batch number and expiry date). Redness has stopped now that she has used the Pen. Patient call also stated that she has sinus polyps (unknown onset date and latency) (with unknown batch number and expiry date). Upon next follow up, the patient reported that she had a terrible time with syringe so the switched from syringe to pen because she has arthritis to her thumb (arthritis) (unknown latency) (with unknown batch number and expiry date). At the time of the report, the Dupixent is continued. Patient diagnosed with dry eyes in Jun2021. Dry eye diagnosis is being treated with Refresh eye drops. Patient's eye doctor told her Dupixent wat the cause of het dry eyes and suggested that she ask her prescribing healthcare provider to reduce the dose from 300mg every two weeks to 200mg every two weeks. The nurse referred the patient to her prescribing healthcare provider regarding the next step. She said she has an appointment with the prescribing healthcare provide on 05Jul2022. At the time of the report, it is unknown if Dupixent is continued, discontinued, of on hold. On an unknown date Patient states they have dry eyes (dry eye) (onset Jun2021) (8 months approximately latency) (with unknown batch number and expiry date) following first dose intake of Dupixent and months following first dose of covid-19 and reddening around the eye arca (Ocular hypomania) (unknow latency) (with unknown batch number and expiry date) while on Dupixent. Upon follow up: Patient has reported that she has been on Dupixent for 2 years, and she said she can really tell a difference with her 'polyps' and asthma. The consumer said that the Dupixent in improved her symptoms and stated that she can breathe through her nose since she got her first injection. The consumer reported that she has to take her mometasone once a day, which has decreased from twice a day to help with symptoms. The consumer stated that the believes her eyesight has worsened since being on Dupixent (Visual impairment), and the also has ted eyelids (erythema of eyelid) (onset date and latency unknown) (with unknown batch number and expiry date) and dry eyes, and she never had dry eyes prior to staring Dupixent therapy. The consumer stated that prior to Dupixent, she had a shadow of a cataract, and she stated that her left eye may be a candidate for cataract surgery. No treatment reported for the consumer's eyesight has worsened. The consumer sees her provider next week about the cataract. Unknown if both the consumer eyesight has worsened, and cataracts are ongoing or resolved. The consumer stated that het eye conditions could be due to old age as well. The consumer's prescribing provider is aware of her dry eyes since starting Dupixent. Patient stated that she believes the Dupixent is what is causing her dry eyes but her medical provider did prescriber refresh tears and those are helping. Patient advised that when she was injecting with pro-filled syringes they would leave a rash on her for at least three days (injection site rash) (onset date and latency: unknown) (with unknown batch number and expiry date). Patient was now injecting with pre-filled pens and they would leave no rash but she does feel a little discomfort (injection site discomfort) (onset date and latency: unknown) (with unknown batch number and expiry date). No further information reported. On an unknown date (Latency: unknow) (with unknown batch number and expiry date] Patient reports dry eyes (previously reported) and some muscle/joint pain (myalgia (arthralgia). She also mentioned she has osteoarthritis so it could be that. No further information was provided. Action taken: unknown for erythema of eyelid and Visual impairment; no action taken for rest of the events with respect to dupilumab. Not applicable for all events with respect to Covid vaccine. Corrective treatment: The patient was treated with Povidone (refresh[povidone ]) and Carmellose sodium (refresh tears) for Dry eye, she will check her eye pressure in 3 months and if her eye pressure is still elevated, the doctor will put her on another eye drop, not reported for others. Reporter causality: related for pain in am, nausea, fatigue, chills and pyrexia for COVID vaccine, not related for pain in arm, nausea, fatigue, chills and pyrexia, and not reported for rest of the events with dupilumab pre-filled syringe; filled for injection site erythema, un assessable for  Ocular hyperamia; osteoarthritis via both the suspects, not reported for rest of the events for dupilumab single dose pre-filled pen. Other Company Sanofi causality: reportable for injection site erythema & injection site rash, injection site discomfort; not reportable for rest of the events for both the dupilumab single dose pre-filled pen and dupilumab pre-fille syringe.   The reporter considered "sore arm", "nauseous" and "tired" related to BNT162b2. The reporter's assessment of the causal relationship of "shadow of a cataract on both eyes and it is worse on the left eye", "now injecting with pre-filled pens /does feel a little discomfort", "when she was injecting with pre-filled syrmges they would leave a rash on her for at least three days", "redness around the injection site", "eye pressure is increased characterized by her right eye pressure went from 19 to 22", "sinus polyps", "has arthritis to her thumb", "osteoarthritis", "some muscle pain", "she believes her eyesight has worsened since being on dupixent", "reddening around eye area", "she also has red eyelids", "her blood pressure has improved and her m d lowered her blood pressure medication. it also helped her nasal polyps as well with no reported adverse event", "some joint pain" and "dry eye" with the suspect product(s) BNT162b2 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.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 is under agreement with BIONTECH SE.; Sender's Comments: Based on known drug safety profile and close temporal association the events vaccination site pain, nausea and fatigue are assessed as related to the suspect drug  BNT162b2. The other events Cataract, Injection site discomfort, Injection site rash, Injection site erythema, Intraocular pressure increased , Sinus polyp, Arthritis, Osteoarthritis, Myalgia , Visual impairment , Ocular hyperaemia, Erythema of eyelid , Dry eye , Arthralgia, Therapeutic response unexpected, are assessed as unrelated to the suspect drug BNT162b2 and could be related to underlying condition and due to use of dupilumab medication. ,Linked Report(s) : US-PFIZER INC-202400265438 same reporter/patient, different dose/event;