PMID- 37723099
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231103
IS  - 1744-8395 (Electronic)
IS  - 1476-0584 (Linking)
VI  - 22
IP  - 1
DP  - 2023 Jan-Dec
TI  - Analysis of the adverse events following the mRNA-1273 COVID-19 vaccine.
PG  - 801-812
LID - 10.1080/14760584.2023.2260477 [doi]
AB  - OBJECTIVE: This study aims to characterize the adverse events (AEs) following the 
      administration of the mRNA-1273 COVID-19 vaccine from the Vaccine Adverse Event 
      Reporting System (VAERS) data. METHODS: In this case/non-case analysis, reports 
      between 1 January 2021, and 27 October 2022, were extracted from VAERS. AEs were 
      defined as preferred terms (PTs) by Medical Dictionary for Regulatory Activities 
      (MedDRA) terminology. Disproportionality analyses were conducted to calculate the 
      reporting odds and proportional reporting ratios. The Bayesian approach was used 
      to calculate information component (IC) values and Empirical Bayesian Geometric 
      Mean scores for all the AEs detected. RESULTS: 186 MedDRA PTs compromising 
      702,495 AEs associated with the mRNA-1273 vaccine were identified. Three 
      statistically significant signals were identified for general and systemic AEs, 
      administration site conditions, and product issues. Cardiac disorders were rarely 
      reported, the most common being; 489 reports for 'myocarditis' (19.44%), 475 for 
      'acute myocardial infarction' (18.88%), 457 for 'myocardial infarction' (18.16%), 
      290 for 'bradycardia' (11.53%) and 281 for 'pericarditis' (11.17%). CONCLUSIONS: 
      The most frequently identified AEs following mRNA-1273 vaccination agree with 
      those listed within the Summary of Product Characteristics. In addition, 
      disproportionality analysis did not find any statistically significant signals 
      for myocarditis or pericarditis.
FAU - Shabu, Angel
AU  - Shabu A
AD  - Department of Life Sciences, University of Bath, Bath, UK.
FAU - Nishtala, Prasad S
AU  - Nishtala PS
AD  - Department of Life Sciences, University of Bath, Bath, UK.
AD  - Centre for Therapeutic Innovation, University of Bath, Bath, UK.
LA  - eng
PT  - Journal Article
DEP - 20230925
PL  - England
TA  - Expert Rev Vaccines
JT  - Expert review of vaccines
JID - 101155475
RN  - EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273)
SB  - IM
MH  - Humans
MH  - United States
MH  - 2019-nCoV Vaccine mRNA-1273
MH  - Adverse Drug Reaction Reporting Systems
MH  - Bayes Theorem
MH  - *COVID-19/prevention & control
MH  - *Myocardial Infarction
OTO - NOTNLM
OT  - Adverse events (AEs)
OT  - COVID-19
OT  - SARS-CoV-2
OT  - mRNA-1273
OT  - moderna
EDAT- 2023/09/19 00:43
MHDA- 2023/09/19 00:44
CRDT- 2023/09/18 22:23
PHST- 2023/09/19 00:44 [medline]
PHST- 2023/09/19 00:43 [pubmed]
PHST- 2023/09/18 22:23 [entrez]
AID - 10.1080/14760584.2023.2260477 [doi]
PST - ppublish
SO  - Expert Rev Vaccines. 2023 Jan-Dec;22(1):801-812. doi: 
      10.1080/14760584.2023.2260477. Epub 2023 Sep 25.