PMID- 27410239
OWN - NLM
STAT- MEDLINE
DCOM- 20170614
LR  - 20240327
IS  - 1935-2735 (Electronic)
IS  - 1935-2727 (Print)
IS  - 1935-2727 (Linking)
VI  - 10
IP  - 7
DP  - 2016 Jul
TI  - Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the 
      Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.
PG  - e0004846
LID - 10.1371/journal.pntd.0004846 [doi]
LID - e0004846
AB  - BACKGROUND: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi 
      Pasteur), was licensed for use in the United States. OBJECTIVE: To assess adverse 
      events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System 
      (VAERS), a spontaneous reporting surveillance system. METHODS: We searched VAERS 
      for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 
      2015. Medical records were requested for reports classified as serious (death, 
      hospitalization, prolonged hospitalization, disability, 
      life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre 
      syndrome (GBS). Physicians reviewed available information and assigned a primary 
      clinical category to each report using MedDRA system organ classes. Empirical 
      Bayesian (EB) data mining was used to identify disproportional AE reporting after 
      HDCV. RESULTS: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. 
      Among all reports, the three most common AEs included pyrexia (18.2%), headache 
      (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be 
      unrelated to vaccination. CONCLUSIONS: This 25-year review of VAERS did not 
      identify new or unexpected AEs after HDCV. The vast majority of AEs were 
      non-serious. Injection site reactions, hypersensitivity reactions, and 
      non-specific constitutional symptoms were most frequently reported, similar to 
      findings in pre-licensure studies.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), 
      National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers 
      for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of 
      America.
FAU - Woo, Emily Jane
AU  - Woo EJ
AD  - Center for Biologics Evaluation and Research, Food and Drug Administration, 
      Silver Spring, Maryland, United States of America.
FAU - Paul, Wendy
AU  - Paul W
AD  - Center for Biologics Evaluation and Research, Food and Drug Administration, 
      Silver Spring, Maryland, United States of America.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), 
      National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers 
      for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of 
      America.
FAU - Petersen, Brett W
AU  - Petersen BW
AD  - Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, 
      NCZEID, CDC, Atlanta, Georgia, United States of America.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), 
      National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers 
      for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of 
      America.
LA  - eng
PT  - Journal Article
DEP - 20160713
PL  - United States
TA  - PLoS Negl Trop Dis
JT  - PLoS neglected tropical diseases
JID - 101291488
RN  - 0 (Rabies Vaccines)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Cell Culture Techniques/methods
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - Product Surveillance, Postmarketing/*statistics & numerical data
MH  - Rabies Vaccines/*adverse effects
MH  - United States/epidemiology
PMC - PMC4943633
COIS- The authors have declared that no competing interests exist.
EDAT- 2016/07/15 06:00
MHDA- 2017/06/15 06:00
PMCR- 2016/07/13
CRDT- 2016/07/14 06:00
PHST- 2016/03/15 00:00 [received]
PHST- 2016/06/22 00:00 [accepted]
PHST- 2016/07/14 06:00 [entrez]
PHST- 2016/07/15 06:00 [pubmed]
PHST- 2017/06/15 06:00 [medline]
PHST- 2016/07/13 00:00 [pmc-release]
AID - PNTD-D-16-00472 [pii]
AID - 10.1371/journal.pntd.0004846 [doi]
PST - epublish
SO  - PLoS Negl Trop Dis. 2016 Jul 13;10(7):e0004846. doi: 
      10.1371/journal.pntd.0004846. eCollection 2016 Jul.