Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cataract, Condition aggravated, Diabetes mellitus
Clinical narrative: Condition aggravated/flare up, flare in hands; Back pain; Joint pain all over left arm; left arm  swelling; Cataract; Diabetic; Skin ulcer/ulcer on big toe; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4491516-00 (Company).  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: SKIN ULCER (medically significant) with onset 2021, outcome "recovered", described as "Skin ulcer/ulcer on big toe"; CATARACT (medically significant), outcome "recovering"; DIABETES MELLITUS (medically significant), outcome "recovering", described as "Diabetic"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Condition aggravated/flare up, flare in hands"; BACK PAIN (medically significant), outcome "recovered"; ARTHRALGIA (medically significant), outcome "recovered", described as "Joint pain all over left arm"; PERIPHERAL SWELLING (medically significant), outcome "recovered", described as "left arm swelling". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of skin ulcer. Clinical information: It was reported that on unknown dates, the patient experienced cataract, diabetic, flare up, flare in hands, back pain, joint pain all over left arm and left arm swelling. In 2021, the patient experienced ulcer on big toe. On unknown dates, back pain, joint pain all over left arm and left arm swelling resolved. PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect. In 2021, the patient had ulcer on big toe and had surgery. The outcome of surgery was recovered. Patient had back pain and went to pain management. Patient also had joint pain all over left arm and had swelling after last Covid booster shoot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "cataract", "diabetic", "skin ulcer/ulcer on big toe", "condition aggravated/flare up, flare in hands" and "back pain" 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 considered "joint pain all over left arm" and "left arm swelling" related to BNT162b2.  No follow-up attempts are Needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be totally excluded for the reported events of Cataract, Diabetes mellitus, Skin ulcer, Condition aggravated , Back pain, Arthralgia and Peripheral swelling. 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.