title: Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine.
abstract: OBJECTIVE
  An observational study found an increased risk of febrile seizure on the day of or 1 day after vaccination (days 0-1) with trivalent inactivated influenza vaccine (TIV) in the 2010-2011 season; risk was highest with simultaneous vaccination with TIV and 13-valent pneumococcal vaccine (PCV13) in children who were 6 to 23 months old. Text messaging is a novel method for surveillance of adverse events after immunization that has not been used for hypothesis-driven vaccine safety research.
  
  
  OBJECTIVE
  To prospectively evaluate whether children receiving TIV and PCV13 simultaneously had higher rates of fever on days 0 to 1 than those receiving either product without the other.
  
  
  METHODS
  Prospective observational cohort study of parents of children 6 to 23 months old recruited from 3 medical center-affiliated clinics in New York City from November 1, 2011, through April 5, 2012. A total of 530 of 614 eligible participants (86.3%) were enrolled. Parents were texted on the night of vaccination (day 0) and the 7 subsequent nights (days 1-7) to report their child's temperature. We used log-binomial regression to calculate adjusted relative risks (aRRs) and excess risk for fever on days 0 to 1, adjusted for age group, past influenza vaccination and simultaneous receipt of selected inactivated vaccines.
  
  
  METHODS
  Receipt of TIV and/or PCV13.
  
  
  METHODS
  Temperature of 38°C or higher on days 0 to 1 after vaccination.
  
  
  RESULTS
  On days 0 to 1, children receiving TIV and PCV13 simultaneously had higher rates (37.6%) of fever (temperature ≥38°C) than those receiving TIV (7.5%; aRR, 2.69; 95% CI, 1.30-5.60) or PCV13 (9.5%; aRR, 2.67; 95% CI, 1.25-5.66). The excess risk of fever after TIV and PCV13 was 20 and 23 per 100 vaccinations compared with TIV without PCV13 and PCV13 without TIV, respectively. Fever rates for days 2 to 7 were similar across groups. For days 0 to 1, 74.8% of the text messages were confirmed delivered; for another 9.0%, delivery status was unknown. Response rates were 95.1% and 90.9% for days 0 and 1 for confirmed delivered messages, respectively.
  
  
  CONCLUSIONS
  Simultaneous TIV and PCV13 administration was associated with higher transient increased fever risk than administration of either vaccine without the other product. Text messaging to prospectively assess a specific vaccine adverse event has potential for enhancing prelicensure and postlicensure monitoring of adverse events after immunization and deserves further study.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01467934.
authors.affiliation: Department of Pediatrics, Columbia University, New York, New York2Department of Population and Family Health, Mailman School of Public Health, Columbia University, New York, New York3NewYork-Presbyterian Hospital, New York.
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Stockwell
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Karen
authors.initials: K
authors.lastname: Broder
authors.affiliation: Department of Pediatrics, Columbia University, New York, New York.
authors.forename: Philip
authors.initials: P
authors.lastname: LaRussa
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Paige
authors.initials: P
authors.lastname: Lewis
authors.affiliation: Department of Pediatrics, Columbia University, New York, New York.
authors.forename: Nadira
authors.initials: N
authors.lastname: Fernandez
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Devindra
authors.initials: D
authors.lastname: Sharma
authors.affiliation: Department of Pediatrics, Columbia University, New York, New York.
authors.forename: Angela
authors.initials: A
authors.lastname: Barrett
authors.affiliation: Department of Pediatrics, Columbia University, New York, New York.
authors.forename: Jose
authors.initials: J
authors.lastname: Sosa
authors.affiliation: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Claudia
authors.initials: C
authors.lastname: Vellozzi
mesh_terms: D005260:Female; D005334:Fever / Q000139:chemically induced*; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D009519:New York City / Q000453:epidemiology; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D011930:Reaction Time; D012307:Risk Factors; D060145:Text Messaging; D016896:Treatment Outcome
chemical_list: C538862:13-valent pneumococcal vaccine; D007252:Influenza Vaccines; D022242:Pneumococcal Vaccines