PMID- 37517652
OWN - NLM
STAT- MEDLINE
DCOM- 20231113
LR  - 20231115
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Linking)
VI  - 262
DP  - 2023 Nov
TI  - Postmarketing Safety Surveillance of a Hexavalent Vaccine in the Vaccine Adverse 
      Event Reporting System.
PG  - 113643
LID - S0022-3476(23)00506-1 [pii]
LID - 10.1016/j.jpeds.2023.113643 [doi]
AB  - We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and 
      acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus 
      influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. 
      Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were 
      serious. Most frequently reported AEs were fever (10.2%) and injection site 
      erythema (5.4%). AEs reported were consistent with findings from prelicensure 
      studies.
CI  - Published by Elsevier Inc.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver 
      Spring, MD. Electronic address: pmoro@cdc.gov.
FAU - Zhang, Bicheng
AU  - Zhang B
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver 
      Spring, MD.
FAU - Marquez, Paige
AU  - Marquez P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver 
      Spring, MD.
FAU - Reich, Jonathan
AU  - Reich J
AD  - Center for Biologics Evaluation and Research, Food and Drug Administration, 
      Silver Spring, MD.
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20230728
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Humans
MH  - *Diphtheria-Tetanus-Pertussis Vaccine/adverse effects
MH  - *Haemophilus Vaccines/adverse effects
MH  - Hepatitis B Vaccines/adverse effects
MH  - Poliovirus Vaccine, Inactivated/adverse effects
MH  - Vaccines, Combined/adverse effects
MH  - Vaccines, Conjugate
OTO - NOTNLM
OT  - epidemiology
OT  - hexavalent vaccine
OT  - surveillance
OT  - vaccine safety
COIS- Declaration of Competing Interest Funded by the Centers for Disease Control and 
      Prevention (CDC) and US Food and Drug Administration (FDA). The authors declare 
      no conflicts of interest.
EDAT- 2023/07/31 00:41
MHDA- 2023/11/13 06:42
CRDT- 2023/07/30 19:17
PHST- 2023/03/14 00:00 [received]
PHST- 2023/07/14 00:00 [revised]
PHST- 2023/07/25 00:00 [accepted]
PHST- 2023/11/13 06:42 [medline]
PHST- 2023/07/31 00:41 [pubmed]
PHST- 2023/07/30 19:17 [entrez]
AID - S0022-3476(23)00506-1 [pii]
AID - 10.1016/j.jpeds.2023.113643 [doi]
PST - ppublish
SO  - J Pediatr. 2023 Nov;262:113643. doi: 10.1016/j.jpeds.2023.113643. Epub 2023 Jul 
      28.