Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: Vaccination site pain; Muscle spasm; Arthralgia; Pain in hand; Crohn's aggravated; Joint catching; Joint range of motion decreased; Weakness in extremity; This is a solicited report based on information received by Pfizer  (Mfr. Control No.: 21K-163-4113519-00). A contactable consumer (patient) reported that:   Solicited report by a consumer of a 73 year old female with events of non-serious vaccine related issue/sore arm following the covid vaccine, catching in right elbow did not open and close smoothly, weakness in right elbow, crohns flare, cheek muscle spasms, joint pain/pain in right wrist and pain in hand with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced vaccine related issue/sore arm following the covid vaccine, cheek muscle spasms, joint pain/pain in right wrist and pain in hand. 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. Pfizer covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01Mar2021, she received first dose covid-19 vaccine manufactured by Pfizer. On 31Mar2021, she received second dose covid-19 vaccine manufactured by Pfizer. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of vaccine related issue/sore arm following the covid vaccine, catching in right elbow did not open and close smoothly onset in May2021, catching in right elbow did not open and close smoothly onset in May2021, weakness in right elbow, crohns flare, cheek muscle spasms, joint pain/pain in right wrist and pain in hand was not provided. Change History: On 09Nov2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. the events of "vaccine related issue/sore arm following the covid vaccine", "catching in right elbow did not open and close smoothly", "weakness in right elbow" and "pain in hand" were added. The event of "joint pain" was amended to "joint pain/pain in right wrist".  The reporter's causality assessment for event Vaccination site pain with suspect vaccine BNT162B2 was provided as Possible as per reporter. The reporter's assessment of the causal relationship of the other events 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 available information the events of Crohn's disease, Vaccination site pain, Joint lock, Joint range of motion decreased, Muscular weakness, Muscle spasms, Arthralgia, Pain in extremity are assessed as possibly related to the suspect vaccine BNT162B2 based on plausible temporal association. ''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.