PMID- 27013434
OWN - NLM
STAT- MEDLINE
DCOM- 20161017
LR  - 20220410
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 34
IP  - 20
DP  - 2016 Apr 29
TI  - Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular 
      pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting 
      System (VAERS), 2011-2015.
PG  - 2349-53
LID - S0264-410X(16)30032-9 [pii]
LID - 10.1016/j.vaccine.2016.03.049 [doi]
AB  - BACKGROUND: In October 2011, the Advisory Committee on Immunization Practices 
      (ACIP) issued updated recommendations that all pregnant women routinely receive a 
      dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) 
      vaccine. OBJECTIVES: We characterized reports to the Vaccine Adverse Event 
      Reporting System (VAERS) in pregnant women who received Tdap after this updated 
      recommendation (2011-2015) and compared the pattern of adverse events (AEs) with 
      the period before the updated recommendation (2005-2010). METHODS: We searched 
      the VAERS database for reports of AEs in pregnant women who received Tdap vaccine 
      after the routine recommendation (11/01/2011-6/30/2015) and compared it to 
      published data before the routine Tdap recommendation (01/01/2005-06/30/2010). We 
      conducted clinical review of reports and available medical records. The clinical 
      pattern of reports in the post-recommendation period was compared with the 
      pattern before the routine Tdap recommendation. RESULTS: We found 392 reports of 
      Tdap vaccination after the routine recommendation. One neonatal death but no 
      maternal deaths were reported. No maternal or neonatal deaths were reported 
      before the recommendation. We observed an increase in proportion of reports for 
      stillbirths (1.5-2.8%) and injection site reactions/arm pain (4.5-11.9%) after 
      the recommendation compared to the period before the routine recommendation for 
      Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion 
      (16.7-1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) 
      occurred during the third trimester compared to 4% before the 2011 Tdap 
      recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did 
      not report an AE. One medical facility accounted for 27% of all submitted 
      reports. CONCLUSIONS: No new or unexpected vaccine AEs were noted among pregnant 
      women who received Tdap after routine recommendations for maternal Tdap 
      vaccination. Changes in reporting patterns would be expected, given the broader 
      use of Tdap in pregnant women in the third trimester.
CI  - Published by Elsevier Ltd.
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), <add>1600 Clifton Road, MS D26</add>, 
      Atlanta, GA 30333, USA. Electronic address: pmoro@cdc.gov.
FAU - Cragan, Janet
AU  - Cragan J
AD  - Birth Defects Branch, Division of Birth Defects and Developmental Disabilities, 
      National Center on Birth Defects and Developmental Disabilities (NCBDDD), CDC, 
      Atlanta, GA 30333, USA.
FAU - Tepper, Naomi
AU  - Tepper N
AD  - Women's Health and Fertility Branch, Division of Reproductive Health, National 
      Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), CDC, 
      Atlanta, GA 30333, USA.
FAU - Zheteyeva, Yenlik
AU  - Zheteyeva Y
AD  - Community Interventions for Infection Control Unit, Division of Global Migration 
      and Quarantine, CDC, Atlanta, GA 30333, USA.
FAU - Museru, Oidda
AU  - Museru O
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), <add>1600 Clifton Road, MS D26</add>, 
      Atlanta, GA 30333, USA.
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), <add>1600 Clifton Road, MS D26</add>, 
      Atlanta, GA 30333, USA.
FAU - Broder, Karen
AU  - Broder K
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), <add>1600 Clifton Road, MS D26</add>, 
      Atlanta, GA 30333, USA.
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
PT  - Journal Article
DEP - 20160322
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Advisory Committees
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage/*adverse 
      effects
MH  - Female
MH  - Humans
MH  - Pregnancy
MH  - United States
MH  - Young Adult
PMC - PMC6500453
MID - NIHMS1025238
OTO - NOTNLM
OT  - Adverse events
OT  - Epidemiology
OT  - Pregnancy
OT  - Surveillance
OT  - Tdap
OT  - Vaccine safety
COIS- Disclosure: None of the authors have a conflict of interest
EDAT- 2016/03/26 06:00
MHDA- 2016/10/19 06:00
PMCR- 2019/05/04
CRDT- 2016/03/26 06:00
PHST- 2016/01/14 00:00 [received]
PHST- 2016/03/11 00:00 [revised]
PHST- 2016/03/15 00:00 [accepted]
PHST- 2016/03/26 06:00 [entrez]
PHST- 2016/03/26 06:00 [pubmed]
PHST- 2016/10/19 06:00 [medline]
PHST- 2019/05/04 00:00 [pmc-release]
AID - S0264-410X(16)30032-9 [pii]
AID - 10.1016/j.vaccine.2016.03.049 [doi]
PST - ppublish
SO  - Vaccine. 2016 Apr 29;34(20):2349-53. doi: 10.1016/j.vaccine.2016.03.049. Epub 
      2016 Mar 22.