Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Hypoaesthesia, Ocular hyperaemia, Procedural pain, Tremor
Clinical narrative: Postoperative pain; Cloudy vision; Numbness in hand; Eyes red; Vision peripheral defective; Tremor of hands; cataract aggravated; Vaccination site nodule; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3912938-00.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1 , single (Batch/Lot number: unknown) and on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as 40 mg (Batch/Lot number: unknown) and in 2013 as citrate free (Batch/Lot number: unknown), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 2021, outcome "not recovered"; CATARACT (medically significant), outcome "not recovered", described as "cataract aggravated"; PROCEDURAL PAIN (non-serious), outcome "not recovered", described as "Postoperative pain"; VISION BLURRED (non-serious), outcome "not recovered", described as "Cloudy vision"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in hand"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "Eyes red"; VISUAL FIELD DEFECT (non-serious), outcome "not recovered", described as "Vision peripheral defective"; TREMOR (non-serious), outcome "not recovered", described as "Tremor of hands". The action taken for adalimumab was unknown. It was reported that solicited report by a consumer of a 59-year-old female with events of cataract gotten worse/had cataracts removed boths eyes are cloudy and achy and non-serious knot in arm of injection after second dose of covid vaccination, cataract gotten worse / had cataracts removed boths eyes are cloudy and achy, numbness in the hands, eyes red, sees a line on the perhical vision pd vision a black  line and slight tremor in left hand/hands shaking/jittery/trembles when reaches arms out with HUMIRA 40MG/0.4ML (ADALIMUMAB). On unknown dates, the patient experienced cataract gotten worse / had cataracts removed boths eyes are cloudy and achy, numbness in the hands, eyes red, sees a line on the perhical vision pd vision a black line and slight tremor in left hand/hands shaking/jittery/trembles when reaches arms out. In 2021, the patient experienced knot in arm of injection after second dose of covid vaccination. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had cataract which have gotten worse, she stated her eyesight was hazy and cloudy vision. She trembles when reaches her arms out, she had slight tremor in left hand. When she got her second dose of Covid vaccination she had a knot in the arm of the injection. She had cataract removed her both eyes were cloudy and achy and red. She saw a line on the peripheral vision PD vision a black line. Physician told her to wait for a month to heal. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 12Mar2021, she received first dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 02Apr2021, she received second dose COVID-19 Vaccine manufactured by Pfizer/BioNtech.  The reporter's assessment of the causal relationship of "cataract aggravated", "vaccination site nodule", "postoperative pain", "cloudy vision", "numbness in hand", "eyes red", "vision peripheral defective" and "tremor of hands" 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. The reporter's assessment of the causal relationship of "cataract aggravated", "vaccination site nodule", "postoperative pain", "cloudy vision", "numbness in hand", "eyes red", "vision peripheral defective" and "tremor of hands" with the suspect product(s) adalimumab (HUMIRA) was No reasonable possibility at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.