FDA is aware of reports of an anaphylactic reaction in a #COVID19 vaccine recipient. The agency will continue to work with CDC and Pfizer to better understand what occurred. fda.gov/covid19vaccines
FDA takes seriously reports of any adverse events and requires Pfizer and vaccination providers to report the following serious adverse events, among other things, to the Vaccine Adverse Event Reporting System.
Importantly, fact sheets that provide important information, including dosing instructions, & information about the benefits & risks of the Pfizer-BioNTech COVID-19 Vaccine, are required to be made available to vaccination providers and vaccine recipients. go.usa.gov/xAYge
The vaccination provider fact sheet notes: severe allergic reactions have been reported following vaccination & appropriate medical treatment used to manage immediate allergic reactions must be immediately available for administration in event of any acute anaphylactic reaction.
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