PMID- 37133747
OWN - NLM
STAT- MEDLINE
DCOM- 20230508
LR  - 20230513
IS  - 1744-8395 (Electronic)
IS  - 1476-0584 (Linking)
VI  - 22
IP  - 1
DP  - 2023 Jan-Dec
TI  - Safety outcomes associated with the moderna COVID-19 vaccine (mRNA-1273): a 
      literature review.
PG  - 393-409
LID - 10.1080/14760584.2023.2209177 [doi]
AB  - INTRODUCTION: Current safety data from Phase 3 clinical trials have concluded 
      that apart from transient local and systemic reactions, no safety concerns were 
      identified for the Moderna COVID-19 vaccine (mRNA-1273). However, Phase 3 studies 
      are insufficient to detect rare adverse events (AEs). A literature search of the 
      two major electronic databases, Embase and PubMed, was performed to enable the 
      identification and characterization of all relevant articles from December 2020 
      to November 2022. AREAS COVERED: This narrative review summarizes the key safety 
      outcomes associated with the mRNA-1273 vaccine to inform healthcare decisions and 
      increase public awareness of mRNA-1273 vaccine safety. The primary adverse events 
      (AEs) reported within a diverse population, receiving the mRNA-1273 vaccine, 
      were; localized injection site pain, fatigue, headache, myalgia, and chills. In 
      addition, the mRNA-1273 vaccine was also associated with; less than a 1-day 
      change in the menstrual cycle, a 10-fold higher risk of myocarditis and 
      pericarditis within young males aged 18-29 years and increased levels of 
      anti-polyethylene glycol (PEG) antibodies. EXPERT OPINION: The transient nature 
      of commonly observed AEs and the rare occurrence of severe events within 
      mRNA-1273 recipients show no significant safety concerns which should prevent 
      vaccination. However, large-scale epidemiological studies with longer follow-up 
      periods are required to surveillance rare safety outcomes.
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
PT  - Review
PL  - England
TA  - Expert Rev Vaccines
JT  - Expert review of vaccines
JID - 101155475
RN  - EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273)
SB  - IM
MH  - Male
MH  - Female
MH  - Humans
MH  - *2019-nCoV Vaccine mRNA-1273
MH  - *COVID-19/prevention & control
MH  - Databases, Factual
MH  - Fatigue
MH  - Headache
OTO - NOTNLM
OT  - COVID-19
OT  - SARS-CoV-2
OT  - mRNA-1273
OT  - moderna
OT  - safety
EDAT- 2023/05/03 12:42
MHDA- 2023/05/08 10:17
CRDT- 2023/05/03 11:14
PHST- 2023/05/08 10:17 [medline]
PHST- 2023/05/03 12:42 [pubmed]
PHST- 2023/05/03 11:14 [entrez]
AID - 10.1080/14760584.2023.2209177 [doi]
PST - ppublish
SO  - Expert Rev Vaccines. 2023 Jan-Dec;22(1):393-409. doi: 
      10.1080/14760584.2023.2209177.