PMID- 27836437
OWN - NLM
STAT- MEDLINE
DCOM- 20171215
LR  - 20220318
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 34
IP  - 50
DP  - 2016 Dec 7
TI  - Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) 
      in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting 
      System (VAERS), June 1, 2012-December 31, 2015.
PG  - 6330-6334
LID - S0264-410X(16)30987-2 [pii]
LID - 10.1016/j.vaccine.2016.10.052 [doi]
AB  - BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) was first 
      recommended for use in adults aged ⩾19years with immunocompromising conditions in 
      June 2012. On August 2014, the Advisory Committee on Immunization Practices 
      (ACIP) recommended routine use of PCV13 among adults aged ⩾65years. METHODS: We 
      assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19years 
      reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to 
      December 2015. VAERS is a national spontaneous reporting system for monitoring 
      AEs following vaccination. Our assessment included automated data analysis, 
      clinical review of all serious reports and reports of special interest. We 
      conducted empirical Bayesian data mining to assess for disproportionate 
      reporting. RESULTS: VAERS received 2976 US PCV13 adult reports; 2103 (71%) of 
      these reports were from PCV13 administered alone. Fourteen percent were in 
      persons aged 19-64years and 86% were in persons aged ⩾65years. Injection site 
      erythema (28%), injection site pain (24%) and fever (22%) were the most frequent 
      AEs among persons aged 19-64years; injection site erythema (30%), erythema (20%) 
      and injection site swelling (18%) were the most frequent among persons aged 
      ⩾65years who were given the vaccine alone. The most frequently reported AEs among 
      non-death serious reports were injection site reactions and general malaise among 
      persons 19-64years old; injection site reactions, general malaise and 
      Guillain-Barre syndrome among those ⩾65years (Table 2). Data mining did not 
      detect disproportional reporting for any unexpected AE. CONCLUSIONS: The results 
      of this study were consistent with safety data from pre-licensure studies of 
      PCV13. We did not detect any new or unexpected AEs.
CI  - Published by Elsevier Ltd.
FAU - Haber, Penina
AU  - Haber P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
      Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, 
      United States. Electronic address: PHaber@cdc.gov.
FAU - Arana, Jorge
AU  - Arana J
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
      Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, 
      United States.
FAU - Pilishvili, Tamara
AU  - Pilishvili T
AD  - National Center for Immunization and Respiratory Diseases (NCIRD), Centers for 
      Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, 
      United States.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
      Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, 
      United States.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
      Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, 
      United States.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
      Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, 
      United States.
LA  - eng
PT  - Journal Article
DEP - 20161109
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (13-valent pneumococcal vaccine)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pneumococcal Vaccines/*adverse effects
MH  - Prevalence
MH  - *Product Surveillance, Postmarketing
MH  - United States/epidemiology
MH  - Young Adult
OTO - NOTNLM
OT  - 13-Valent pneumococcal conjugate vaccine (PCV13)
OT  - Post-licensure surveillance
OT  - Vaccine safety
EDAT- 2016/11/12 06:00
MHDA- 2017/12/16 06:00
CRDT- 2016/11/13 06:00
PHST- 2016/07/14 00:00 [received]
PHST- 2016/10/17 00:00 [revised]
PHST- 2016/10/19 00:00 [accepted]
PHST- 2016/11/12 06:00 [pubmed]
PHST- 2017/12/16 06:00 [medline]
PHST- 2016/11/13 06:00 [entrez]
AID - S0264-410X(16)30987-2 [pii]
AID - 10.1016/j.vaccine.2016.10.052 [doi]
PST - ppublish
SO  - Vaccine. 2016 Dec 7;34(50):6330-6334. doi: 10.1016/j.vaccine.2016.10.052. Epub 
      2016 Nov 9.