Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Off label use, Product use issue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Pain, itching, redness, hives. All located within 2.5' diameter of injection site; Pain, itching, redness, hives. All located within 2.5' diameter of injection site; Pain, itching, redness, hives. All located within 2.5' diameter of injection site; Pain, itching, redness, hives. All located within 2.5' diameter of injection site/ Hives at injection site; Other vaccine (Flulaval / flu shot) same date vaccine date 16Nov2021; Other vaccine (Flulaval / flu shot) same date vaccine date 16Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer and Physician).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 16:30 (Lot number: Fk5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: 3P3TY) as dose 4, single. Relevant medical history included: "ADHD" (ongoing); "Abdominal pain" (ongoing). Concomitant medication(s) included: CONCERTA; METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing); METADATE taken for attention deficit hyperactivity disorder, start date: 14Oct2021 (ongoing); METHYLPHENIDATE CD taken for attention deficit hyperactivity disorder, start date: 14Oct2021 (ongoing). Vaccination history included: Flulaval (Number of previous doses: 3). The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 17Nov2021 18:30, outcome "recovered" (Nov2021) and all described as "Pain, itching, redness, hives. All located within 2.5' diameter of injection site"; VACCINATION SITE URTICARIA (non-serious) with onset 16Nov2021 19:00, outcome "recovered" (18Nov2021), described as "Pain, itching, redness, hives. All located within 2.5' diameter of injection site/ Hives at injection site"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "Other vaccine (Flulaval / flu shot) same date vaccine date 16Nov2021". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pruritus, vaccination site erythema, vaccination site urticaria. Additional Information: FLULAVAL Manufacturer reported as Glaxo. Patient had no known allergies. Consumer reported a concomitant medication as methylphenidate (METADATE) 10mg however physician reported concomitant methylphenidate CD 10 mg. Consumer reported patient had no other vaccines in four weeks. Patient did not have COVID prior vaccination and was not COVID tested post vaccination. Vaccination was done at doctor's office/urgent care. The pain, itching, redness, hives all located within 2.5" diameter of injection site began approximately 26 hours after injection. Physician also described event as hive at injection site. Consumer assessed the events as not serious and indicated the events were not life-threatening or disabling/incapacitating, and did not cause/prolong hospitalization. Physician also assessed the events as not serious. No relevant tests were done. Treatment included ice and acetaminophen (TYLENOL). Physician commented was local site reaction mild. Would pre-treat with antihistamine prior to second dose.  Physician considered the Pfizer product BNT162B2 had a casual effect to the adverse events.  No follow-up attempts are possible. No further information is expected.