A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging

Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.

Abstract

Background: Using text messaging for vaccine safety monitoring, particularly for non-medically attended events, would be valuable for pandemic influenza and emergency vaccination program preparedness. We assessed the feasibility and acceptability of text messaging to evaluate fever and wheezing post-influenza vaccination in a prospective, observational, multi-site pediatric study.

Methods: Children aged 2-11 years old, with an emphasis on children with asthma, were recruited during the 2014-2015 influenza season from three community-based clinics in New York City, and during the 2014-2015 and 2015-2016 seasons from a private practice in Fall River, Massachusetts. Parents of enrolled children receiving quadrivalent live attenuated (LAIV4) or inactivated influenza vaccine (IIV4) replied to text messages assessing respiratory symptoms (day 3 and 7, then weekly through day 42), and temperature on the night of vaccination and the next seven nights (day 0-7). Missing data were collected via diary (day 0-7 only) and phone. Phone confirmation was obtained for both presence and absence of respiratory symptoms. Reporting rates, fever (T≥100.4 °F) frequency, proportion of wheezing and/or chest tightness reports captured via text message versus all sources (text, phone, diary, electronic health record) and parental satisfaction were assessed.

Results: Across both seasons, 266 children were analyzed; 49.2% with asthma. Parental text message response rates were high (>70%) across sites. Overall, fever frequency was low (day 0-2: 4.1% [95% confidence interval (CI) 2.3-7.4%]; d3-7: 6.7% [95% CI 4.1-10.8%]). A third (39.2%) of parents reported a respiratory problem in their child, primarily cough. Most (88.2%) of the 52 wheezing and/or chest tightness reports were by text message. Most (88.1%) participants preferred text messaging over paper reporting.

Conclusions: Text messaging can provide information about pediatric post-vaccination fever and wheezing and was viewed positively by parents. It could be a helpful tool for rapid vaccine safety monitoring during a pandemic or other emergency vaccination program.

Trial registration: clinicaltrials.gov Identifier: NCT02295007.

Keywords: Asthma; Influenza; Influenza vaccination; SMS; Text message; Vaccination; Vaccine safety; Wheeze.

Publication types

  • Observational Study

MeSH terms

  • Child
  • Child, Preschool
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Feasibility Studies
  • Female
  • Fever / chemically induced
  • Fever / epidemiology*
  • Humans
  • Influenza Vaccines / administration & dosage*
  • Influenza Vaccines / adverse effects*
  • Male
  • Massachusetts / epidemiology
  • New York City / epidemiology
  • Prospective Studies
  • Respiratory Sounds*
  • Text Messaging / statistics & numerical data*

Substances

  • Influenza Vaccines

Associated data

  • ClinicalTrials.gov/NCT02295007