PMID- 31155414
OWN - NLM
STAT- MEDLINE
DCOM- 20200908
LR  - 20231027
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 37
IP  - 28
DP  - 2019 Jun 19
TI  - Is there any harm in administering extra-doses of vaccine to a person? Excess 
      doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 
      2007-2017.
PG  - 3730-3734
LID - S0264-410X(19)30576-6 [pii]
LID - 10.1016/j.vaccine.2019.04.088 [doi]
AB  - BACKGROUND: The administration of an extra dose of a vaccine may occur due to a 
      programmatic error (e.g., vaccination error) when there is need to provide one of 
      the antigens of a combination vaccine not readily available as a single antigen, 
      or when there is need to provide immunization in a person with uncertain 
      vaccination histories (e.g., refugees). There is little data available on the 
      safety of an extra dose of vaccine. OBJECTIVE: To assess for the presence of 
      adverse events (AEs) most commonly reported following the administration of 
      excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS). 
      METHODS: We searched VAERS for US reports where an excess dose of vaccine was 
      administered to a person received from 1/1/2007 through 1/26/2018. We reviewed 
      medical records for all serious reports and a random sample of non-serious 
      reports. The most common AEs among reports of excess dose of vaccine administered 
      were compared with the corresponding AEs for all vaccines reported to VAERS 
      during the same period. RESULTS: Out of 366,815 total VAERS reports received, 
      5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did 
      not describe an adverse health event (AHE). The most common vaccines reported 
      were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A 
      (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only 
      AHEs were reported, the most common were pyrexia (12.8%), injection site erythema 
      (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs 
      among these reports was comparable to all reports submitted to VAERS during the 
      same study period. CONCLUSION: More than three-fourths of reports of an excess 
      dose of vaccine did not describe an AHE. Among reports where an AHE event was 
      reported, we did not observe any unexpected conditions or clustering of AEs.
CI  - Published by Elsevier Ltd.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control 
      and Prevention, USA. Electronic address: pmoro@cdc.gov.
FAU - Arana, Jorge
AU  - Arana J
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control 
      and Prevention, USA.
FAU - Marquez, Paige L
AU  - Marquez PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control 
      and Prevention, USA.
FAU - Ng, Carmen
AU  - Ng C
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control 
      and Prevention, USA.
FAU - Barash, Faith
AU  - Barash F
AD  - Center for Biologics Evaluation and Research (CBER), Food and Drug Administration 
      (FDA), USA.
FAU - Hibbs, Beth F
AU  - Hibbs BF
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control 
      and Prevention, USA.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control 
      and Prevention, USA.
LA  - eng
GR  - CC999999/ImCDC/Intramural CDC HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20190530
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Drug Overdose/*immunology
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Middle Aged
MH  - United States
MH  - Vaccination/*adverse effects
MH  - Vaccines/*administration & dosage/*adverse effects
MH  - Young Adult
PMC - PMC6925972
MID - NIHMS1061332
OTO - NOTNLM
OT  - Adverse event
OT  - Epidemiology
OT  - Excess dose
OT  - Extra dose
OT  - Surveillance
OT  - Vaccination errors
OT  - Vaccine safety
COIS- Declaration of interest The authors declare that there are no conflict of 
      interest.
EDAT- 2019/06/04 06:00
MHDA- 2020/09/09 06:00
PMCR- 2019/12/22
CRDT- 2019/06/04 06:00
PHST- 2019/01/23 00:00 [received]
PHST- 2019/04/12 00:00 [revised]
PHST- 2019/04/16 00:00 [accepted]
PHST- 2019/06/04 06:00 [pubmed]
PHST- 2020/09/09 06:00 [medline]
PHST- 2019/06/04 06:00 [entrez]
PHST- 2019/12/22 00:00 [pmc-release]
AID - S0264-410X(19)30576-6 [pii]
AID - 10.1016/j.vaccine.2019.04.088 [doi]
PST - ppublish
SO  - Vaccine. 2019 Jun 19;37(28):3730-3734. doi: 10.1016/j.vaccine.2019.04.088. Epub 
      2019 May 30.