PMID- 35198503
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220224
IS  - 2319-9644 (Print)
IS  - 2279-042X (Electronic)
IS  - 2279-042X (Linking)
VI  - 10
IP  - 3
DP  - 2021 Jul-Sep
TI  - Summary of COVID-19 Vaccine-Related Reports in the Vaccine Adverse Event 
      Reporting System.
PG  - 107-113
LID - 10.4103/jrpp.jrpp_49_21 [doi]
AB  - Identification of the severe acute respiratory syndrome coronavirus 2 in humans 
      toward the end of 2019 triggered a rapid, intensive effort to develop a vaccine. 
      Among the first three COVID-19 vaccines granted emergency use authorization by 
      the U. S. Food and Drug Administration (FDA) were two mRNA vaccines, never used 
      on a large scale in humans, and one replication-incompetent human adenovirus 
      vector vaccine. Since the beginning of the vaccination efforts in December 2020, 
      almost 220,000 adverse events (AEs) have been reported through the Vaccine 
      Adverse Event Reporting System, a reporting platform administered jointly by the 
      FDA and the Centers for Disease Control to monitor vaccine-related AEs. We 
      queried this database twice (04/23/21 and 05/14/21) and identified the AE reports 
      with valid manufacturer-specific lot numbers (n = 76,336), a subset representing 
      33.54% of the total reported AEs. Using vaccine and demographic characteristics 
      at the time of each query date, a model was generated to predict significant AEs, 
      such as death. Our regression analysis revealed that the average age (IRR 1.08) 
      and the number of doses administered in an assisted living facility (IRR 1.01) 
      were significantly associated with the number of deaths observed in each lot, 
      whereas the proportion of remaining vaccine shelf-life (IRR 1.30) and the vaccine 
      manufacturer (IRR 1.09) were not. Studies such as this one are vital, as one of 
      the best answers to vaccine hesitancy is reliable data confirming that the 
      available COVID-19 vaccines are safe and not associated with a significantly 
      higher risk of AEs than vaccines for other conditions.
CI  - Copyright: (c) 2021 Journal of Research in Pharmacy Practice.
FAU - Ceacareanu, Alice C
AU  - Ceacareanu AC
AD  - Translational Biomedical Research Management Graduate Program, Hartwick College, 
      Oneonta, NY 13820, United States.
FAU - Wintrob, Zachary A P
AU  - Wintrob ZAP
AD  - Clinical Services, ROAKETIN Inc., Oneonta, NY 13820, United States.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20211225
PL  - India
TA  - J Res Pharm Pract
JT  - Journal of research in pharmacy practice
JID - 101614023
PMC - PMC8809454
OTO - NOTNLM
OT  - COVID-19
OT  - mRNA
OT  - safety
OT  - vaccine
OT  - vaccine adverse event reporting system
COIS- There are no conflicts of interest.
EDAT- 2022/02/25 06:00
MHDA- 2022/02/25 06:01
PMCR- 2021/12/25
CRDT- 2022/02/24 05:43
PHST- 2021/06/28 00:00 [received]
PHST- 2021/09/01 00:00 [accepted]
PHST- 2022/02/24 05:43 [entrez]
PHST- 2022/02/25 06:00 [pubmed]
PHST- 2022/02/25 06:01 [medline]
PHST- 2021/12/25 00:00 [pmc-release]
AID - JRPP-10-107 [pii]
AID - 10.4103/jrpp.jrpp_49_21 [doi]
PST - epublish
SO  - J Res Pharm Pract. 2021 Dec 25;10(3):107-113. doi: 10.4103/jrpp.jrpp_49_21. 
      eCollection 2021 Jul-Sep.