PMID- 38411838
OWN - NLM
STAT- MEDLINE
DCOM- 20240417
LR  - 20240418
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 47
IP  - 5
DP  - 2024 May
TI  - Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza 
      Vaccines in the Vaccine Adverse Event Reporting System (VAERS).
PG  - 487-493
LID - 10.1007/s40264-024-01406-8 [doi]
AB  - INTRODUCTION: Bivalent mRNA coronavirus disease 2019 (COVID-19) vaccines may be 
      simultaneously administered with other recommended vaccines, including seasonal 
      influenza vaccines. However, few studies have evaluated the safety of 
      co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines. 
      OBJECTIVE: The aim was to describe reports to the Vaccine Adverse Event Reporting 
      System (VAERS) after co-administration of bivalent mRNA COVID-19 and seasonal 
      influenza vaccines. METHODS: We searched the VAERS database for reports of 
      adverse events (AEs) following co-administration of bivalent mRNA COVID-19 and 
      seasonal influenza vaccines during the period of September 1, 2022-March 31, 
      2023. We assessed the characteristics of these reports and described the most 
      frequently reported AEs. Clinicians reviewed available medical records for 
      reports of serious AEs and adverse events of special interest (AESI). RESULTS: 
      During the period of 1 September 2022 through 31 March 2023, VAERS received 3689 
      reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal 
      influenza vaccines. The median age of vaccinees was 59 years (interquartile range 
      39, 70 years); 342 reports (9.3%) were classified as serious. The most common AEs 
      among non-serious reports were severe-acute-respiratory-syndrome-related 
      coronavirus (SARS-CoV-2) infection (785, 23.5%), cough (592, 17.7%), and fatigue 
      (568, 17.0%). The most common AEs among serious reports were Severe Acute 
      Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection (88, 25.7%), dyspnea 
      (81, 23.7%), and condition aggravated (55, 16.1%). DISCUSSION: Reports of AEs 
      following co-administration of bivalent mRNA COVID-19 and seasonal influenza 
      vaccines did not reveal any unusual or unexpected patterns of AEs. Increased 
      reporting of certain events (e.g., COVID-19) was expected due to Food and Drug 
      Administration (FDA) and Centers for Disease Control and Prevention (CDC) 
      reporting requirements. CDC and FDA will continue to monitor the safety of 
      co-administration of mRNA COVID-19 and seasonal influenza vaccines.
CI  - (c) 2024. This is a U.S. Government work and not under copyright protection in the 
      US; foreign copyright protection may apply.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA. pmoro@cdc.gov.
FAU - Ennulat, Carol
AU  - Ennulat C
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA.
FAU - Brown, Hannah
AU  - Brown H
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA.
FAU - Woody, Gina
AU  - Woody G
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA.
FAU - Zhang, Bicheng
AU  - Zhang B
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA.
FAU - Marquez, Paige
AU  - Marquez P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA.
FAU - Woo, Emily Jane
AU  - Woo EJ
AD  - Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 
      New Hampshire Ave, Silver Spring, MD, 20993, USA.
FAU - Su, John R
AU  - Su JR
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, 
      Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, 
      GA, 30329-4027, USA.
LA  - eng
PT  - Journal Article
DEP - 20240227
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Influenza Vaccines)
RN  - 0 (RNA, Messenger)
SB  - IM
MH  - Humans
MH  - Adverse Drug Reaction Reporting Systems
MH  - *COVID-19/prevention & control
MH  - COVID-19 Vaccines/adverse effects
MH  - *Influenza Vaccines/adverse effects
MH  - RNA, Messenger
MH  - SARS-CoV-2
MH  - United States
MH  - Adult
MH  - Middle Aged
MH  - Aged
EDAT- 2024/02/27 12:45
MHDA- 2024/04/17 06:42
CRDT- 2024/02/27 11:12
PHST- 2024/02/04 00:00 [accepted]
PHST- 2024/04/17 06:42 [medline]
PHST- 2024/02/27 12:45 [pubmed]
PHST- 2024/02/27 11:12 [entrez]
AID - 10.1007/s40264-024-01406-8 [pii]
AID - 10.1007/s40264-024-01406-8 [doi]
PST - ppublish
SO  - Drug Saf. 2024 May;47(5):487-493. doi: 10.1007/s40264-024-01406-8. Epub 2024 Feb 
      27.