Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Flare Up of Uveitis; Hives; Swelling around the site; Itching; sick; white count was too low; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4157862.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 11Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from Mar2022 (Batch/Lot number: unknown) to Sep2022 at 40 mg (40 mg, every 2 weeks (40mg/0.4ml)) and second regimen since 28Sep2022 (ongoing) (Batch/Lot number: unknown) at 40 mg every 3 weeks, all subcutaneous for uveitis. The patient's relevant medical history included: "Uveitis" (unspecified if ongoing); "Tourette Syndrome", start date: 2017 (unspecified if ongoing), notes: Tourette Syndrome on and off; "Tobacco Use: no" (unspecified if ongoing), notes: Tobacco Use: no; "Alcohol Use: no" (unspecified if ongoing), notes: Alcohol Use: no. Concomitant medication(s) included: FOLIC ACID taken for uveitis; METHOTREXATE taken for uveitis. The following information was reported: UVEITIS (medically significant), outcome "not recovered", described as "Flare Up of Uveitis"; URTICARIA (non-serious), outcome "not recovered", described as "Hives"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "Swelling around the site"; PRURITUS (non-serious), outcome "not recovered", described as "Itching"; ILLNESS (non-serious), outcome "not recovered", described as "sick"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "recovering", described as "white count was too low". The patient underwent the following laboratory tests and procedures: White blood cell count: (12Sep2022) 3.000 10^9/L, notes: white count was too low. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of uveitis, urticaria, vaccination site swelling, pruritus, illness, white blood cell count decreased. Additional information:The patient has other concomitant therapy of multivitamins.The patient was treated with Benadryl, Claritin.Patient with no Alcohol Use and no Tobacco Use, No known allergies.The reporter's causality for the event(s) of Flare up uveitis after covid-19 vaccine pfizer with Adalimumab Solution for Injection was No Reasonable Possibility;The reporter's causality for the event(s) of Flare Up of Uveitis, Hives, Itching, Swelling around the site and sick with Adalimumab Solution for Injection was Not Provided;The reporter's causality for the event(s) of white count was too low with Adalimumab Solution for Injection was Reasonable Possibility;The reporter's causality for the event(s) of Flare Up of Uveitis, Hives, Itching, Swelling around the site, sick and white count was too low with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided;The reporter's causality for the event(s) of Flare up uveitis after covid-19 vaccine pfizer with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility;Agency's opinion was that the causality for the event(s) of Flare Up of Uveitis, Flare up uveitis after covid-19 vaccine pfizer, Hives, Itching, Swelling around the site, sick and white count was too low with Adalimumab Solution for Injection was Not Provided;Agency's opinion was that the causality for the event(s) of Flare Up of Uveitis, Flare up uveitis after covid-19 vaccine pfizer, Hives, Itching, Swelling around the site, sick and white count was too low with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided; Reporter's Alternative Etiology for Flare up uveitis after covid-19 vaccine pfizer with Adalimumab Solution for Injection: Pfizer covid-19 vaccine.  The reporter considered "flare up of uveitis" related to BNT162b2. The reporter's assessment of the causal relationship of "hives", "swelling around the site", "itching", "sick" and "white count was too low" with the suspect product(s) 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 possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccination site swelling is possibly related to the suspect product. All the other events are assessed as related to patient underlying medical conditions.