Age: 16.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Juvenile idiopathic arthritis, Pain, Pain assessment
Clinical narrative: pain; Polyarticular Juvenile idiopathic arthritis flare; Extreme Fatigue; FACILITATED COLLECT  This is a solicited report from a non-interventional study based on information received by Pfizer from a regulatory authority. (MFR Control No.: 21k-163-4117526-00). This report was received from a contactable consumer (patient) reporting for himself. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported) intramuscular on 11Aug2021 (at the age of 16-year-old) as dose 1, single for COVID-19 immunisation, and he started to receive adalimumab (HUMIRA), subcutaneous from unspecified date and ongoing for moderate to severe polyarticular juvenile idiopathic arthritis. The patient's medical history included moderate to severe polyarticular juvenile idiopathic arthritis from unspecified date and ongoing. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient's concomitant medications were not reported. On 29Aug2021, the patient experienced polyarticular juvenile idiopathic arthritis flare and extreme fatigue. In 2021, the extreme fatigue resolved. Patient mother reported patient has joint pain that increased from three to ten in his ankles and back. He was hospitalized for pain and flare. He was extremely tired with the flare and had fatigue for almost a month. The patient underwent lab tests and procedures which included pain scale (increased three to ten). The action taken in response to the events for adalimumab dose not changed. The outcome of the events was resolved on 2021 for extreme fatigue, unknown for pain and resolving for polyarticular juvenile idiopathic arthritis flare.   The reporter's assessment of causal relationship of the events with suspect drugs was not provided. The company assessment of causal relationship of the events with bnt162b2 was not provided, while with the suspect drug adalimumab was reported as no reasonable possibility for the events fatigue and polyarticular Juvenile idiopathic arthritis flare, and not reported for pain.  The reporter's assessment of the causal relationship of the events 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 are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events Juvenile idiopathic arthritis flare, Fatigue extreme,pain  and  the suspect drug "BNT162B2" cannot be completely 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.