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Original Investigation |

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

Melissa S. Stockwell, MD, MPH1,2,3; Karen Broder, MD4; Philip LaRussa, MD1; Paige Lewis, MSPH4; Nadira Fernandez, MD1; Devindra Sharma, MSN, MPH4; Angela Barrett1; Jose Sosa, MD1; Claudia Vellozzi, MD, MPH4
[+] 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.
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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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Figure 1.
Study Flow Diagram

In patients receiving TIV-1, 68% of TIV-1 doses are the first influenza dose the patient received in the 2011-2012 season but not necessarily the first dose that patient ever received. In patients receiving TIV1- and PCV13, 96% of TIV-1 and PVC13 doses are the first influenza dose the patient ever received. In patients receiving PCV13, 0.9% were receiving their first dose, 2.7% their second dose, 16.4% their third dose, and 80.0% their fourth dose. In patients receiving TIV and PVC13, 0.9% were receiving their first dose of PCV13, 5.7% their second dose, 65.6% their third dose, and 35.8% at least their fourth dose. In patients receiving TIV-1 and PCV13, 1.3% were receiving their first dose of PCV13, 6.4% their second dose, 81.5% their third dose, and 10.8% their fourth dose. In patients receiving TIV-2 and PCV13, 0% were receiving their first dose, 3.6% their second dose, 20.0% their third dose, and 76.3% at least their fourth dose. PCV13 indicates 13-valent pneumococcal conjugate vaccine; TIV, trivalent inactivated influenza vaccine; TIV-1, first influenza dose that season; and TIV-2, second influenza dose that season.

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Figure 2.
Response Rates to Text Messages Monitoring for Fever on Day 0 Through Day 7

A, Response rates to all messages regardless of delivery status. B, Response rates only to messages with confirmed delivery.

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Submit a Comment
Using SMS techology may enhance vaccine safety monitoring efforts
Posted on March 5, 2014
Paul Effler, MD, MPH
WA Department of Heath/University of Western Australia
Conflict of Interest: None Declared
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.
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