Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: Vaccination site pain; Muscle spasm; Arthralgia/joint pain/pain in right wrist; pain in hand/vaccine related issue/sore arm following the Covid vaccine; Crohn's aggravated; Joint catching/catching in right elbow did not open and close smoothly; Joint range of motion decreased; Weakness in extremity/weakness in right elbow; 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 (AbbVie).  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), first regimen subcutaneous (Lot number: 1147299) at citrate free (1 in 10 d) and second regimen subcutaneous (Lot number: 1147299) at citrate free (1 in 7 d) for Moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Vaccination history included: Bnt162b2 (Dose 1, intramuscular, lot number unknown), administration date: 10Mar2021, when the patient was 73 years old, for Covid-19 immunization. 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"; JOINT LOCK (non-serious) with onset May2021, outcome "unknown", described as "Joint catching/catching in right elbow did not open and close smoothly"; 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/weakness in right elbow"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle spasm"; 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/vaccine related issue/sore arm following the Covid vaccine". The action taken for adalimumab was dosage increased.  The reporter considered "vaccination site pain" related to bnt162b2 and not provided for other events. The reporter's causality for the all events of adalimumab was not provided.  The reporter's assessment of the causal relationship of the events (except 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 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 limited information in the case  a possible causal association between the reported  events and the suspect drug BNT162B2 cannot be 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.