Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: a little bit higher fever; was also tired; This is a spontaneous report from a Pfizer sponsored program. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included trisomy 21 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a little bit higher fever, was also tired. Caller mentioned that her son, (14 years old) who has "Down's Syndrome and special needs, had low-grade fever for several days after the first dose of the Pfizer BioNTech COVID-19 vaccine and a little bit higher fever on the second dose". "Son was also tired for 1 day but able to tolerate it well but was hard to tell because son can't tell what exactly is happening to him. Response: Disclaimer provided. Spoke from attached document. "The emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine has been expanded to include individuals 12 to 15 years of age. The dose in 12 to 15 years of age is the same dose as currently available for adults (30 mcg per 0.3 mL dose as a series of two doses). The Pfizer-BioNTech COVID-19 Vaccine is currently only available and recommended as a 30 mcg dose (2 doses; 3 weeks apart) for individuals 12 years of age and older. Topline results showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and the vaccine was also generally well-tolerated. These individuals will continue to be monitored for an additional two years after their second dose. Pfizer and BioNTech started a Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in children aged 5 to 11 years. This is part of the Phase 1/2/3 dose-escalation study in healthy children 6 months to 11 years was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:  5 to 11 years or 2 to 5 years or   6 months to 2 years.  Phase 1 is the open-label dose-finding portion of the study to evaluate safety, tolerability, and immunogenicity of Pfizer-BioNTech COVID-19 vaccine on a 2-dose (separated by approximately 21 days) schedule in up to 3 age groups.The "> 5 years to & lt;12 years of age" cohort will be randomized to receive one of three doses: 10 mcg, 20 mcg, or 30 mcg. After analysis of the Phase 1 results, one dose for this cohort will likely move forward into Phase 2-3 study. Phase 2/3 will evaluate the safety, tolerability, and immunogenicity in each age group at the selected dose level from Phase 1. Pfizer does not suggest or recommend the use of the Pfizer-BioNTech COVID-19 vaccine in any manner other than as described in the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full Prescribing Information. Outcome of the events was unknown.   Information on the lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021857082 same patient, vaccine different dose, different AE.