Number of COVID vaccine injuries reported to VAERS surpasses 50,000, CDC data show
Data released today by the Centers for Disease Control and Prevention (CDC) on the number of injuries and deaths reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID vaccines revealed steadily rising numbers, but no new trends. VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Every Friday, VAERS makes public all vaccine injury reports received to the system as of Friday of the previous week. Today’s data show that between Dec. 14, 2020, and March 26, a total of 50,861 total adverse events were reported to VAERS, including 2,249 deaths an increase of 199 over the previous seven days and 7,726 serious injuries, up 631 over the same time period.
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After having dealt with the issue when software may be considered a medical device according to its
intended purpose (in part 2) and the implications of the new
risk classification regime (in part 3), in this part 4 of our series on Software as a Medical Device in Europe, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“
MDR”).
INTRODUCTION: A NEW LIFE CYCLE-FOCUSED APPROACH
MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can obtain the CE marking, the MDR deploys a product life cycle-focused approach, aiming to establish responsibilities of medical device companies throughout the life cycle of the product. While not all requirements are new, to ensure conformity of the MDSW with the MDR, detailed and partly enhanced requirements concerning quality management, risk management, clini
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