Report prepared by Pfizer worldwide safety THROUGH 28-FEB-2021

… Pfizer’s safety database contains cases of AEs reported spontaneously to Pfizer

… Reports are submitted voluntarily, and the magnitude of underreporting is unknown

… Due to the large numbers of spontaneous adverse event reports received for the product

… Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports

… on 01 December 2020 through 28 February 2021

… there was a total of 42,086 case reports

… containing 158,893 events

… Recovered with sequelae 520

… Not recovered at the time of report 11361

… Fatal 1223

… Nervous system disorders (25,957)

… Safety concerns – Important potential risks: Vaccine-Associated Enhanced Disease (VAED), Including Vaccine-associated Enhanced Respiratory Disease (VAERD)

… Safety concerns – Missing information: Use in Pregnancy and lactation. Use in Paediatric Individuals <12 Years of Age. Vaccine Effectiveness

… Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23)

… premature birth with neonatal death

… Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2

 

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