(P-342) Adverse Events of the COVID-19 Vaccines Reported to the Vaccine Adverse Event Reporting System (VAERS), December 14, 2020 -january 22, 2021

Background: The U.S. Food and Drug Administration (FDA) issued the emergency use authorizations for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and the Moderna vaccine on December 18, 2020. As of January 22, 2021, a total of 24,104,647 doses of COVID-19 vaccines have been administered in the U.S. However, many consumers remain hesitant to receive the vaccines because of concerns about potentially serious side effects.

Objectives: To assess the frequency and type of adverse events (AEs) of COVID-19 vaccines reported in the Vaccine Adverse Event Reporting System (VAERS).

Methods: The FDA VAERS accepts reports of AEs and adverse reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. We assessed VAERS reports between December 14, 2020, and January 22, 2021, after the Pfizer-BioNTech COVID-19 vaccine approval. We conducted a descriptive analysis to examine the frequency and type of AEs of COVID-19 vaccines administered in the U.S.

Results: Between December 14, 2020, and January 22, 2021, a total of 8519 AEs of COVID-19 vaccines were reported, including 6936 (81.4%) cases of Pfizer-Biotech vaccine, 1580 (18.5%) cases of Moderna vaccine, and 3 cases with the missing manufacturer. Among reported AEs due to COVID-19 vaccines, 6441 (75.6%) were female and the mean age was 45 years old (ranging 1~104 years). There were 715 (8.4%) patients hospitalized, with the average length of hospitalization of 2.55 days (ranging 1~22 days). In addition, 270 (3.2%) individuals (mean age of 47) reported life-threatening events, and 18 visited emergency rooms after being vaccinated. The top ten reported AEs were: headache (21.0%), fatigue (15.6%), dizziness (15.0%), pyrexia (14.1%), chills (13.8%), pain (13.7%), nausea (13.6%), injection site pain (10.1%), pain in extremity (8.5%), and dyspnoea (7.2%). It was reported that 285 (3.3%) individuals died after they were administered the COVID-19 vaccines (among which 166 (58.2%) deaths received the Pfizer-Biotech vaccine), with a mean age of 76 (1-104). Among the 285 deaths, 160(56.1%) had type 2 diabetes, 126(44.2%) had heart diseases, 84(29.8%) had hypertension, 46(16.1%) had kidney disease, 44(15.4%) had dementia or Alzheimer's disease, 31(10.8%) had Chronic obstructive pulmonary disease(COPD), and 26(9.1%) was positive with the COVID-19 testing previously.

Conclusions: Based on existing VAERS reports, serious AEs of the Pfizer-BioNTech and Moderna COVID-19 vaccine were rare and tended to occur in individuals with underneath conditions. Our findings may guide current and upcoming COVID-19 vaccination.