PMID- 37376508
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230701
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 11
IP  - 6
DP  - 2023 Jun 19
TI  - Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and 
      Meta-Analysis.
LID - 10.3390/vaccines11061118 [doi]
LID - 1118
AB  - With the mass vaccination program for COVID-19 mRNA vaccines, there has been 
      sufficient real-world study (RWS) on the topic to summarize their safety in the 
      total population and in immunocompromised (IC) patients who were excluded from 
      phase 3 clinical trials. We conducted a systematic review and meta-analysis to 
      evaluate the safety of COVID-19 mRNA vaccines, with a total of 5,132,799 subjects 
      from 122 articles. In the case of the total population vaccinated with first, 
      second, and third doses, the pooled incidence of any adverse events (AEs) was 
      62.20%, 70.39%, and 58.60%; that of any local AEs was 52.03%, 47.99%, and 65.00%; 
      that of any systemic AEs was 29.07%, 47.86%, and 32.71%. Among the 
      immunocompromised patients, the pooled odds ratio of any AEs, any local AEs, and 
      systemic AEs were slightly lower than or similar to those of the healthy controls 
      at 0.60 (95% CI: 0.33-1.11), 0.19 (95% CI: 0.10-0.37), and 0.36 (95% CI: 
      0.25-0.54), with pooled incidences of 51.95%, 38.82%, and 31.00%, respectively. 
      The spectrum of AEs associated with the vaccines was broad, but most AEs were 
      transient, self-limiting, and mild to moderate. Moreover, younger adults, women, 
      and people with prior SARS-CoV-2 infection were more likely to experience AEs.
FAU - Xu, Wanqian
AU  - Xu W
AD  - School of Public Health, The Second Hospital of Nanjing, Nanjing Medical 
      University, Nanjing 211166, China.
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
FAU - Ren, Weigang
AU  - Ren W
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
AD  - Department of Infectious Diseases, The Second Hospital of Nanjing, Nanjing 
      University of Chinese Medicine, Nanjing 210003, China.
FAU - Wu, Tongxin
AU  - Wu T
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
AD  - Department of Infectious Diseases, The Second Hospital of Nanjing, Nanjing 
      University of Chinese Medicine, Nanjing 210003, China.
FAU - Wang, Qin
AU  - Wang Q
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
AD  - Department of Infectious Diseases, The Second Hospital of Nanjing, Nanjing 
      University of Chinese Medicine, Nanjing 210003, China.
FAU - Luo, Mi
AU  - Luo M
AD  - School of Public Health, The Second Hospital of Nanjing, Nanjing Medical 
      University, Nanjing 211166, China.
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
FAU - Yi, Yongxiang
AU  - Yi Y
AD  - School of Public Health, The Second Hospital of Nanjing, Nanjing Medical 
      University, Nanjing 211166, China.
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
AD  - Department of Infectious Diseases, The Second Hospital of Nanjing, Nanjing 
      University of Chinese Medicine, Nanjing 210003, China.
FAU - Li, Junwei
AU  - Li J
AD  - The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
AD  - Department of Infectious Diseases, The Second Hospital of Nanjing, Nanjing 
      University of Chinese Medicine, Nanjing 210003, China.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230619
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC10301865
OTO - NOTNLM
OT  - COVID-19
OT  - SARS-CoV-2
OT  - mRNA vaccines
OT  - meta-analysis
OT  - observational study
OT  - safety
COIS- All authors declare no conflict of interest.
EDAT- 2023/06/28 06:42
MHDA- 2023/06/28 06:43
PMCR- 2023/06/19
CRDT- 2023/06/28 01:39
PHST- 2023/04/07 00:00 [received]
PHST- 2023/06/13 00:00 [revised]
PHST- 2023/06/14 00:00 [accepted]
PHST- 2023/06/28 06:43 [medline]
PHST- 2023/06/28 06:42 [pubmed]
PHST- 2023/06/28 01:39 [entrez]
PHST- 2023/06/19 00:00 [pmc-release]
AID - vaccines11061118 [pii]
AID - vaccines-11-01118 [pii]
AID - 10.3390/vaccines11061118 [doi]
PST - epublish
SO  - Vaccines (Basel). 2023 Jun 19;11(6):1118. doi: 10.3390/vaccines11061118.