Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test positive, Uveitis
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Exposure to COVID-19; Uveitis flare up; 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): 22K-163-4227697-00.  A 16 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for juvenile idiopathic arthritis. Family history included: "COVID" (unspecified if ongoing), notes: Patient brother had Covid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 virus test positive"; EXPOSURE TO SARS-COV-2 (medically significant), outcome "unknown", described as "Exposure to COVID-19"; UVEITIS (medically significant), outcome "recovering", described as "Uveitis flare up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. Clinical course: Solicited report by a consumer of an adolescent female with events of non-serious patient brother had covid then patient was tested positive and uveitis flare up with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced patient brother had covid then patient was tested positive and uveitis flare up. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. She received first dose COVID-19 vaccine manufactured by Pfizer/Biontech. Causality for HUMIRA (ADALIMUMAB):  The reporter's causality for the event of patient brother had covid then patient was tested positive unknown onset was not provided/reported. The reporter's causality for the events of patient brother had covid then patient was tested positive unknown onset and uveitis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect products 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.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19, Drug ineffective, Exposure to SARS-COV-2, Uveitis. 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