Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Immunisation, Joint range of motion decreased, Localised infection, Off label use
Clinical narrative: Diabetic; Toes did not bend; Infected toe/ infected right big toe/infection under callus on toe; Patient received third dose COVID-19 Vaccine; Pain; Patient received third dose COVID-19 Vaccine; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3772691-00).   A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation; and adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, (citrate free) for psoriatic arthritis moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. Historical vaccines included BNT162b2 received by the patient on 01Feb2021 as dose 1, single and on 01Mar2021 as dose 2, single; both intramuscular at the age of 63 years old for COVID-19 immunisation. On an unspecified date, the patient experienced "toes did not bend" (also reported as joint range of motion decreased), diabetes (diabetic) and infected right big toe/infection under callus on toe. In 2021, the patient experienced pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The patient has not recovered from diabetes and infected toe; recovered from pain in 2021; while outcome of the remaining event (joint range of motion decreased) was unknown. Causality for BNT162b2: The reporter's causality for the events of TOES DID NOT BEND, DIABETIC, INFECTED RIGHT BIG TOE/INFECTION UNDER CALLUS ON TOE was not provided. The reporter's causality for the event of PAIN with BNT162b2 was reported as possible and not reported. Causality for adalimumab (HUMIRA): The reporter's causality for the events of TOES DID NOT BEND, DIABETIC, PAIN was not provided. The reporter's causality for the event of INFECTED RIGHT BIG TOE/INFECTION UNDER CALLUS ON TOE with adalimumab (HUMIRA) was a reasonable possibility.   The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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; 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.