Age: 1.42
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Urticaria
Clinical narrative: Extreme hives; facial paralysis; They diagnosed him with covid; loss of motor functions; confusion; pain; fever; fast heartbeat; heart palpitations; dizziness; vaccine location-Right buttocks; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Jan2022 (Batch/Lot number: unknown) at the age of 17 months as dose 1 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient had never had a cold. It was unknown if patient had COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines in four weeks. The following information was reported: URTICARIA (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "Extreme hives"; FACIAL PARALYSIS (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (21Jan2022), described as "facial paralysis"; COVID-19 (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "They diagnosed him with covid"; MOTOR DYSFUNCTION (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "loss of motor functions"; CONFUSIONAL STATE (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "confusion"; PAIN (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "pain"; PYREXIA (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "fever"; HEART RATE INCREASED (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "fast heartbeat"; PALPITATIONS (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "heart palpitations"; DIZZINESS (disability, life threatening) with onset 18Jan2022 03:30, outcome "recovered with sequelae" (2022), described as "dizziness"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 11Jan2022, outcome "unknown", described as "vaccine location-Right buttocks"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Jan2022, outcome "unknown", described as "Inappropriate age at vaccine administration". The patient underwent the following laboratory tests and procedures: heartbeat: (18Jan2022) fast. Therapeutic measures were not taken as a result of urticaria, facial paralysis, covid-19, motor dysfunction, confusional state, pain, pyrexia, heart rate increased, palpitations, dizziness. Clinical course: Extreme hives, fever, fast heartbeat, loss of motor functions, heart palpitations, facial paralysis that lasted for 3 days, confusion, dizziness, pain. Seemed to be lasting effects almost a month later. They diagnosed him with COVID but it was consistent with adverse reaction to vaccine.  The lot number for BNT162B2 was not provided and will be requested during follow up.