Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: Vaccination site pain/vaccine related issue/sore arm; cheek muscle spasms; Arthralgia/joint pain/pain in right wrist; Pain in hand; Crohn's aggravated; Joint catching; Joint range of motion decreased; Weakness in extremity; 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-163-4113519-00 regulatory authority.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1147299) at citrate free (1 in 10 day) and second regimen subcutaneous (Lot number: 1147299) at weekly (unk, weekly(citrate free (1 in 7 day))) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Intramuscular, vaccination site: arm), administration date: 10Mar2021, when the patient was 73 years old, for covid-19 immunisation, reaction(s): "vaccine related issue/sore arm", "cheek muscle spasms", "joint pain/pain in right wrist", "pain in hand". The following information was reported: CROHN'S DISEASE (medically significant) with onset Jul2021, outcome "unknown", described as "Crohn's aggravated"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain/vaccine related issue/sore arm"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "cheek muscle spasms"; ARTHRALGIA (non-serious), outcome "recovering", described as "Arthralgia/joint pain/pain in right wrist"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in hand"; JOINT LOCK (non-serious) with onset May2021, outcome "unknown", described as "Joint catching"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset May2021, outcome "unknown", described as "Joint range of motion decreased"; MUSCULAR WEAKNESS (non-serious) with onset May2021, outcome "unknown", described as "Weakness in extremity". The action taken for adalimumab was dosage increased.Additional information included: In May2021, the patient experienced catching in right elbow did not open and close smoothly and weakness in right elbow. In Jul2021, the patient experienced crohns flare. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "vaccination site pain" related to bnt162b2. The reporter's assessment of the causal relationship besides events of "vaccination site pain" with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based 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 product is evaluated as part of 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.