Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Illness, Ligament sprain, Pain in extremity, Rheumatoid arthritis, Vaccination site mass
Clinical narrative: Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain; Dizziness; Loss of balance; Sickness; Vision decreased / Bilateral abnormal vision; Blurring of eyes; fatigue; bumps from the injector pen; Pain in extremity / ARM PAIN; This is a solicited report from non-Pfizer sponsored program received from a contactable physician based upon information received by Pfizer from company (21K-163-3820459-00). A 59-year-old adult make received the first dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not provided) as a single dose on 12Mar2021 (at 59-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, unspecified formulation) 40mg at an unspecified frequency from an unspecified date for arthritis. Relevant medical history included rheumatoid arthritis, inflammation, high blood pressure, red face, red skin, used cane for walking because he could not walk (before adalimumab), and a loss of hearing in the left ear (one month prior to starting adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included sulfasalazine for inflammation; lisinopril for high blood pressure; and another [unspecified] medication for inflammation. The patient previously received treatment for inflammation with steroids which were not good enough. On an unspecified date in Mar2021, after receiving the vaccine, the patient developed arm pain, it made him tired, he had dizziness, fatigue almost every time, and a loss of balance. The patient had bumps from the injector pen/ Injection site papule, Pain in joint involving hand, bruising, sprain, and sickness. On an unspecified date in Apr2021 the patent experienced bilateral abnormal vision/vision decreased and blurring of eyes.  On 09Apr2021, patient received second dose BNT162b2 (solution for injection; Lot EL3302 expiry information not provided) as a single dose. The action taken with adalimumab was unknown. The outcome of the event Sickness was recovered on an unspecified date. The outcome of the events bilateral abnormal vision/vision decreased, blurring of eyes, and fatigue, was not recovered. The outcome of the events pain in extremity / arm pain, bruising, sprain, dizziness, loss of balance, was recovering. The outcome of the events Pain in joint involving hand, Injection site papule, and bumps from the injector pen was unknown.   The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 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 possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of subject product,  BNT162B2 vaccine cannot be excluded for the reported events of  Injection site papule, Pain in joint involving hand, bruising, dizziness, loss of balance, fatigue and sickness, based on temporal relationship.   Based on the information provided by the reporter, it appears unlikely that the subject product contributed to the RA flare and other reported events, which likely represent intercurrent medical conditions. There is very limited information provided in this report.   This case will be reassessed upon receipt of follow-up information.  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.