Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low-grade fever; This is a spontaneous report from a contactable consumer (parent) from a Pfizer sponsored program reporting for her son. This 1 of 2 reports with first dose details. A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Down Syndrome from an unknown date and unknown if ongoing. It was reported that patient had Down's Syndrome and special needs. The patient's concomitant medications were not reported.  The patient experienced low-grade fever and tired on an unspecified date. Reporter declined to provide physician name and contact information as well since caller did not reach out to the physician regarding patient experience and thought it was not necessary. Reporter stated that patient had experienced low-grade fever for several days after the first dose of the Pfizer BioNTech COVID-19 vaccine. Patient was also tired for 1 day but able to tolerate it well but was hard to tell because patient couldn't tell what exactly was happening to him.  In response, disclaimer was provided and 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 percent 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 "gt; 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."  Clinical outcome of the event low-grade fever was unknown.  Information on lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021857083 same patient, vaccine different dose, different AE.