Risk of Fever After Pediatric Trivalent Inactivated Influenza Vaccine and 13-Valent Pneumococcal Conjugate Vaccine | Clinical Pharmacy and Pharmacology | JAMA Pediatrics | JAMA Network
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1.
Broder  KR, Martin  DB, Vellozzi  C.  In the heat of a signal: responding to a vaccine safety signal for febrile seizures after 2010-11 influenza vaccine in young children, United States.  Vaccine. 2012;30(11):2032-2034.PubMedGoogle ScholarCrossref
2.
Tse  A, Tseng  HF, Greene  SK, Vellozzi  C, Lee  GM; VSD Rapid Cycle Analysis Influenza Working Group.  Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011.  Vaccine. 2012;30(11):2024-2031.PubMedGoogle ScholarCrossref
3.
Subcommittee on Febrile Seizures; American Academy of Pediatrics.  Neurodiagnostic evaluation of the child with a simple febrile seizure.  Pediatrics. 2011;127(2):389-394.PubMedGoogle ScholarCrossref
4.
Sullivan  JE, Farrar  HC; Section on Clinical Pharmacology and Therapeutics; Committee on Drugs.  Fever and antipyretic use in children.  Pediatrics. 2011;127(3):580-587.PubMedGoogle ScholarCrossref
5.
Fiore  AE, Uyeki  TM, Broder  K,  et al; Centers for Disease Control and Prevention (CDC).  Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010.  MMWR Recomm Rep. 2010;59(RR-8):1-62.PubMedGoogle Scholar
6.
Centers for Disease Control and Prevention (CDC).  Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011.  MMWR Morb Mortal Wkly Rep. 2011;60(33):1128-1132.PubMedGoogle Scholar
7.
Brenner  J. Pew Internet: Mobile, Pew Internet and American Life Project, Pew Research Center, 2013. http://pewinternet.org/Commentary/2012/February/Pew-Internet-Mobile.aspx. Accessed July 17, 2013.
8.
Zichuhr  K, Smith  A.  Digital differences. Pew Internet & American Life Project. http://www.pewinternet.org/~/media//Files/Reports/2012/PIP_Digital_differences_041312.pdf. Accessed July 17, 2013.
9.
Stockwell  M, Andres  R, Fernandez  N, Vargas  C, Lara  M.  FluNet: Real-time influenza vaccine surveillance. Poster presented at: Infectious Disease Society of America Annual Conference; October 20-23, 2011; Boston, MA; and mHealth Summit; December 5-7, 2011; National Harbor, MD.
10.
Baron  S, Goutard  F, Nguon  K, Tarantola  A.  Use of a text message-based pharmacovigilance tool in Cambodia: pilot study.  J Med Internet Res. 2013;15(4):e68.PubMedGoogle ScholarCrossref
11.
Stockwell  MS, Kharbanda  EO, Martinez  RA, Vargas  CY, Vawdrey  DK, Camargo  S.  Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial.  JAMA. 2012;307(16):1702-1708.PubMedGoogle ScholarCrossref
12.
Stockwell  MS, Kharbanda  EO, Martinez  RA,  et al.  Text4Health: impact of text message reminder-recalls for pediatric and adolescent immunizations.  Am J Public Health. 2012;102(2):e15-e21.PubMedGoogle ScholarCrossref
13.
Kharbanda  EO, Stockwell  MS, Fox  HW, Andres  R, Lara  M, Rickert  VI.  Text message reminders to promote human papillomavirus vaccination.  Vaccine. 2011;29(14):2537-2541.PubMedGoogle ScholarCrossref
14.
Greenes  DS, Fleisher  GR.  Accuracy of a noninvasive temporal artery thermometer for use in infants.  Arch Pediatr Adolesc Med. 2001;155(3):376-381.PubMedGoogle ScholarCrossref
17.
Van Buynder  PG, Frosst  G, Van Buynder  JL,  et al.  Increased reactions to pediatric influenza vaccination following concomitant pneumococcal vaccination.  Influenza Other Respi Viruses. 2013;7(2):184-190.PubMedGoogle ScholarCrossref
18.
Nuorti  JP, Whitney  CG; Centers for Disease Control and Prevention (CDC).  Prevention of pneumococcal disease among infants and children: use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP).  MMWR Recomm Rep. 2010;59(RR-11):1-18.PubMedGoogle Scholar
19.
Centers for Disease Control and Prevention (CDC).  Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2012-13 influenza season.  MMWR Morb Mortal Wkly Rep. 2012;61(32):613-618.PubMedGoogle Scholar
20.
Centers for Disease Control and Prevention.  Flu vaccination coverage, United States, 2011-12 Influenza Season.http://www.cdc.gov/flu/professionals/vaccination/coverage_1112estimates.htm. Accessed July 18, 2013.
21.
Vaccine information statements. http://www.cdc.gov/vaccines/pubs/vis/. Accessed July 18, 2013.
22.
Berg  AT, Shinnar  S, Shapiro  ED, Salomon  ME, Crain  EF, Hauser  WA.  Risk factors for a first febrile seizure: a matched case-control study.  Epilepsia. 1995;36(4):334-341.PubMedGoogle ScholarCrossref
23.
Barberà-Cremades  M, Baroja-Mazo  A, Gomez  AI, Machado  F, Di Virgilio  F, Pelegrín  P.  P2X7 receptor-stimulation causes fever via PGE2 and IL-1β release.  FASEB J. 2012;26(7):2951-2962.PubMedGoogle ScholarCrossref
24.
Virta  M, Hurme  M, Helminen  M.  Increased plasma levels of pro- and anti-inflammatory cytokines in patients with febrile seizures.  Epilepsia. 2002;43(8):920-923.PubMedGoogle ScholarCrossref
25.
Choi  J, Min  HJ, Shin  JS.  Increased levels of HMGB1 and pro-inflammatory cytokines in children with febrile seizures.  J Neuroinflammation. 2011;8:135.PubMedGoogle ScholarCrossref
26.
Ishizaki  Y, Kira  R, Fukuda  M,  et al.  Interleukin-10 is associated with resistance to febrile seizures: genetic association and experimental animal studies.  Epilepsia. 2009;50(4):761-767.PubMedGoogle ScholarCrossref
27.
Salmon  DA, Pavia  A, Gellin  B.  Editors’ introduction: vaccine safety throughout the product life cycle.  Pediatrics. 2011;127(suppl 1):S1-S4.PubMedGoogle ScholarCrossref
28.
Varricchio  F, Iskander  J, Destefano  F,  et al.  Understanding vaccine safety information from the Vaccine Adverse Event Reporting System.  Pediatr Infect Dis J. 2004;23(4):287-294.PubMedGoogle ScholarCrossref
29.
Baggs  J, Gee  J, Lewis  E,  et al.  The Vaccine Safety Datalink: a model for monitoring immunization safety.  Pediatrics. 2011;127(suppl 1):S45-S53.PubMedGoogle ScholarCrossref
30.
Blumberg  SJ, Luke  JV.  Reevaluating the need for concern regarding noncoverage bias in landline surveys.  Am J Public Health. 2009;99(10):1806-1810.PubMedGoogle ScholarCrossref
31.
Fox  S. Mobile health 2010. Pew Internet and American Life Project, 19 October 2010. http://www.pewinternet.org/~/media//Files/Reports/2010/PIP_Mobile_Health_2010.pdf. Accessed July 17, 2013.
32.
Smith  A.  Mobile access 2010. Pew Internet and American Life Project, 7 July 2010. http://www.pewinternet.org/~/media//Files/Reports/2010/PIP_Mobile_Access_2010.pdf. Accessed July 17, 2013.
33.
US Department of Health and Human Services (HHS) Text4Health Task Force.  Health text messaging recommendations to the Secretary.http://www.hhs.gov/open/initiatives/mhealth/recommendations.html. Accessed July 18, 2013.
34.
Petousis-Harris  H, Poole  T, Turner  N, Reynolds  G.  Febrile events including convulsions following the administration of four brands of 2010 and 2011 inactivated seasonal influenza vaccine in NZ infants and children: the importance of routine active safety surveillance.  Vaccine. 2012;30(33):4945-4952.PubMedGoogle ScholarCrossref
35.
Prymula  R, Siegrist  CA, Chlibek  R,  et al.  Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials.  Lancet. 2009;374(9698):1339-1350.PubMedGoogle ScholarCrossref
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    1 Comment for this article
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    Using SMS techology may enhance vaccine safety monitoring efforts
    Paul Effler, MD, MPH | WA Department of Heath/University of Western Australia
    This is an interesting article and we absolutely agree that 'SMS text messaging could be an important additional component to the current US vaccine safety monitoring efforts'. In Australia we have demonstrated the potential impact of this approach in two different settings. The first report, published in 2013, describes the Western Australia Department of Health’s efforts to use SMS to monitor the safety of AEFI following influenza vaccine in pregnant women [“Using SMS technology to verify the safety of seasonal trivalent influenza vaccine for pregnant women in real time” Annette K Regan, Christopher C Blyth and Paul V Effler. Med J Aust 2013; 199 (11): 744-746.doi: 10.5694/mja13.10712.] A second report details using text messages to routinely follow-up with adult and pediatric vaccinees in the general practice setting. This article ““Using automated text messages to monitor adverse events following immunisation in general practice” has been accepted and is currently allocated to the 21 April issue of the Medical Journal of Australia. Again, great work by Dr. Stockwell and her team for demonstrating the feasibility of using SMS to monitor AEFI - and even conduct hypothesis driven research – in the US environment.
    CONFLICT OF INTEREST: None Reported
    READ MORE
    Original Investigation
    March 2014

    Risk of Fever After Pediatric Trivalent Inactivated Influenza Vaccine and 13-Valent Pneumococcal Conjugate Vaccine

    Author Affiliations
    • 1Department of Pediatrics, Columbia University, New York, New York
    • 2Department of Population and Family Health, Mailman School of Public Health, Columbia University, New York, New York
    • 3NewYork–Presbyterian Hospital, New York,
    • 4Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia
    JAMA Pediatr. 2014;168(3):211-219. doi:10.1001/jamapediatrics.2013.4469
    Abstract

    Importance  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.

    Design, Setting, and Participants  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.

    Exposures  Receipt of TIV and/or PCV13.

    Main Outcome(s) and Measure(s)  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 and Relevance  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.

    Trial Registration  clinicaltrials.gov Identifier: NCT01467934

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