Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Fatigue, Joint noise, Pain in extremity, Vaccination site pain
Clinical narrative: cataract; She had some thumb pain; sore arm; Fatigue; She had some thumb pain and clicks; Vaccination site pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4201125-00.  A 84 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 84 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CATARACT (medically significant) with onset 2021, outcome "not recovered", described as "cataract"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "She had some thumb pain"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "recovered" (2021), described as "sore arm"; FATIGUE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; JOINT NOISE (medically significant) with onset 2021, outcome "not recovered", described as "She had some thumb pain and clicks"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain". The action taken for adalimumab was unknown. The patient had cataract and was scheduled for cataract surgery. She stated that the Covid vaccine caused her sore arm and fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of cataract, vaccination site pain, covid vaccine caused sore arm and fatigue onset in 2021, covid vaccine caused sore arm and fatigue onset in 2021, thumb pain and clicks unknown onset and thumb pain and clicks unknown onset was not provided. opinion is that there is no reasonable possibility that the events of cataract, vaccination site pain, covid vaccine caused sore arm and fatigue onset in 2021, COVID VACCINE caused sore arm and fatigue onset in 2021, thumb pain and clicks unknown onset and thumb pain and clicks unknown onset are related to HUMIRA (ADALIMUMAB).  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's assessment of the causal relationship of the events cataract, vaccination site pain, covid vaccine caused sore arm and fatigue, thumb pain and clicks with the suspect product 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 plausible temporal relation, the association between the events of cataract, pain in thumb, pain in arm, fatigue, joint noise and vaccination site pain and the suspect product of BNT162B2 cannot be completely ruled out. 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.