Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Blood test, Cataract, Electrocardiogram, Eye disorder
Clinical narrative: Eye issues; atrial flutter; Heart beat of 169 beats per minute; worsened cataracts/cataract in both eyes; Toxoplasmosis; This is a solicited report received from a Consumer or other non HCP and an Other HCP.  A 61-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since May2021 (ongoing) (Lot number: 1166768) at 40 mg (40 mg, every 2 weeks), subcutaneous for uveitis. The patient's relevant medical history included: "ulcerative colitis", start date: 1980 (unspecified if ongoing); "Small cataracts", start date: 2020 (unspecified if ongoing); "uveitis in left eye", start date: 2021 (unspecified if ongoing); "Left eye pain" (unspecified if ongoing); "Non-tobacco user" (unspecified if ongoing); "bad vision/vision change" (unspecified if ongoing); "eye problems" (unspecified if ongoing); "Visbiome probiotic Supplement" (unspecified if ongoing); "Potassium supplementation" (unspecified if ongoing); "Allergy prophylaxis" (unspecified if ongoing); "Prevents itching Prevention" (unspecified if ongoing); "Thyroid disorder" (unspecified if ongoing); "Restless Legs Syndrome" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Zinc Supplement" (unspecified if ongoing); "Folate supplementation" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "calcium Supplement" (unspecified if ongoing); "Cardiac disorder prophylaxis" (unspecified if ongoing); "Amino acid supplementation" (unspecified if ongoing). Concomitant medication(s) included: VISBIOME taken for probiotic therapy; POTASSIUM taken for mineral supplementation; CLARITIN [GLICLAZIDE] taken for allergy prophylaxis, pruritus; SYNTHROID taken for thyroid disorder; PRAMIPEXOLE [PRAMIPEXOLE DIHYDROCHLORIDE] taken for restless legs syndrome; PREDNISONE ACETATE taken for steroid therapy; EZETIMIBE taken for blood cholesterol increased; ZINC OXIDE taken for mineral supplementation; FOLIC ACID taken for vitamin supplementation; NAPROXEN SODIUM taken for arthritis; CALCIUM LACTATE taken for mineral supplementation; METHOTREXATE SODIUM; BABY ASPIRIN taken for cardiovascular event prophylaxis; LYSINE HYDROCHLORIDE taken for nutritional supplementation. The patient had other concomitant therapy of multivitamin.  The following information was reported: TOXOPLASMOSIS (non-serious) with onset Aug2021, outcome "unknown"; CATARACT (medically significant) with onset 2022, outcome "recovered" (09Jan2023), described as "worsened cataracts/cataract in both eyes"; HEART RATE ABNORMAL (non-serious) with onset 19Dec2022, outcome "recovered" (26Jan2023), described as "Heart beat of 169 beats per minute"; ATRIAL FLUTTER (medically significant) with onset 19Dec2022, outcome "recovered" (26Jan2023); EYE DISORDER (non-serious), outcome "unknown", described as "Eye issues". It was reported that the patient had a Uveitis on right eye for more than ten years ago and had a Uveitis in the left eye before taking Humira and was the reason why she was taking Humira. Uveitis was not getting better during Humira therapy but was the same. The patient took almost two years of taking the HUMIRA and additional medicines such as steroids, antivirals to clear up the addition eye problem and toxoplasmosis. She had toxoplasmosis either earlier or at around Aug2021 or Sep2021 but she had no idea when it exactly started but she knew when it was detected. It was cleared up and she continued to take the HUMIRA to keep the uveitis under control. She had a cataract on both eyes which was due to taking unspecified steroid shots in both eyes. She was taking unspecified steroid shots for both of her eyes for two and a half years. The cataract and cataract removal were a direct result of all the steroids that she had to take to help clear up the toxoplasmosis. Steroids made cataracts grow quickly so once her treatment was done the physician removed the resulting cataracts. So, the unspecified steroids were considered as co suspect. On 30Dec2022, she underwent a cataract removal on her left eye and then on 09Jan2023 she underwent a cataract removal on her right eye to resolve the cataracts. None of these things were caused from the HUMIRA. She experienced atrial flutter and due to it on 26Jan2023 she underwent an outpatient heart ablation. Her physician put her on blood thinner and other medicines and just did a heart ablation a couple days ago and everything seems good so far. The physician said that could be a result of the COVID vaccinations she took, but the cause was unknown for sure as her heart was otherwise healthy. It was never suggested or believed the HUMIRA had anything to do with it. The physician said as people get older they just sometimes developed things like atrial fibrillation or atrial flutter. As per her no one believed that any of the issues which she had, were a result from or a side effect from the HUMIRA. Other lot numbers for the HUMIRA injections were 1168551 and 1207441. The patient underwent the following laboratory tests and procedures: Blood test: (2021) Toxoplasmosis; Electrocardiogram: (19Dec2022) atrial flutter; Heart rate: (19Dec2022) 169 beats per minute; Ophthalmological examination: (unspecified date) worsened cataracts; Toxoplasma serology: (unspecified date) Positive. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of atrial flutter, cataract, heart rate abnormal, eye disorder, toxoplasmosis. The patient was treated with Valtrex. Causalities provided as follow: The reporter's causality for the event(s) of Atrial Flutter and Heart beat of 169 beats per minute with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Atrial Flutter, Eye issues, Heart beat of 169 beats per minute, Toxoplasmosis and worsened cataracts/cataract in both eyes with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of Eye issues, Toxoplasmosis and worsened cataracts/cataract in both eyes with Adalimumab Solution for Injection was No Reasonable Possibility. AbbVie's opinion was that the causality for the event(s) of Atrial Flutter, Eye issues, Heart beat of 169 beats per minute, Toxoplasmosis and worsened cataracts/cataract in both eyes with Adalimumab Solution for Injection was No Reasonable Possibility. AbbVie's Alternative Etiology for worsened cataracts/cataract in both eyes with Adalimumab Solution for Injection: More likely related to complication of underlying panuveitis in this aged patient confounded by long use of steroids. AbbVie's Alternative Etiology for Atrial Flutter with Adalimumab Solution for Injection: Most likely related to increased risk from underlying Ulcerative colitis in an aged overweight patient possibly confounded by COVID vaccine and co-existing Hypercholesterolemia (suggested from concomittant medication). AbbVie's Alternative Etiology for Eye issues with Adalimumab Solution for Injection: More likely related to complication of underlying pan uveitis and cataract in this aged patient confounded by long use of steroids, with concurrent toxoplasmosis. AbbVie's Alternative Etiology for Toxoplasmosis with Adalimumab Solution for Injection: Most likely related to incidental infection due to contaminated food/water in this patient with underlying Panuveitis. AbbVie's Alternative Etiology for Heart beat of 169 beats per minute with Adalimumab Solution for Injection: Most likely related to concurrent atrial flutter.  The reporter's assessment of the causal relationship of "atrial flutter", "worsened cataracts/cataract in both eyes", "heart beat of 169 beats per minute", "eye issues" and "toxoplasmosis" 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.; Sender's Comments: Based on the available information, there is not a reasonable possibility that the events atrial flutter, cataract, heartbeat of 169 beats per minute, eye disorder and toxoplasmosis were related to the suspect drug BNT162b2 (BNT162B2 NOS) therapy considering the product safety profile. The events could most likely be due to patient underlying contributory factors including the relevant medical history and use of co-suspect and other concomitant medications. This case will be reassessed upon receipt of additional information.