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. 2017 Jun 3;9(3):164–176. doi: 10.1093/inthealth/ihx019

Table 1.

The features of the papers identified from 2000 to September 2016 in literature review to have active contact with participant after vaccination for surveillance of AEFI (n=23)

Year Published n Data on all vaccinated. Reactions and non-reactions Cohort & age Contact participant method Response to surveillance rates When surveillance occurred post- vaccination Vaccine Strengths Weaknesses Finding Author Country
2005 Two sites n=715 & n=822 Yes Active adult military personnel Web or telephone 66% & 86% For 28 days after vaccination Smallpox vaccine

  • Novel web-based reporting system.

  • Assessment of user experience

  • Predicted utility of web reporting.

  • Participants educated thus limited generalisability

  • Number declined to participate not collected.

 Electronic monitoring acceptable Olmsted38,42 US
2007 406 Yes Infants at 4 clinics Pink diary card & clinic interview & medical records 91% completed the study Diary card collected 4 weeks after final vaccination DTPaHBVHiBx3

  • Provide data where no country wide AEFI data available.

  • Able to conduct prospective study in resource poor environment.

 Small sample n=406. Descriptive Agreement with other studies Dodoo21 Ghana
2009 n=8700 in study group. n=4130 control Yes Children <3 years in 6 cities Postcards 44% returned postcards (study group) 32% returned postcards(control group) 2 weeks after vaccine Oral polio vaccine Comparison group Unable to evaluate parental assessment Mild diarrhoea in OPV group Sugawara57 Japan
2010 95 244 Yes Children >4 years and adults from 245 schools Diary cards and telephone interview 31.2% by diary card. (20% Sample of persons not returned card telephoned) Diary card complete days 1, 2, 3 & 7 after vaccination 2009 Pandemic H1N1

  • Large sample n=95 244.

  • Higher AEFI rates in children than adults consistent with pre-licensure data.

 Convenience sample limited to school students and family Pandemic influenza vaccine had similar safety profile to seasonal vaccine Wu25 China
2011

  • n=9000 (non-adjuvanted H1N1)

  • n=19 000 (adjuvanted H1N1)

 Yes Children and adults Computer assisted telephone interview Not reported – CATI survey has data for 100% Not reported 2009 Pandemic influenza adjuvanted and non-adjuvanted

  • Large sample n=9000 & n=19 000

  • Comparison groups of adjuvanted and non-adjuvanted vaccine.

  • Two groups different populations, cannot compare

  • Described as ad hoc active surveillance

 Safety demonstrated Choe26 Korea
2011 3569 Yes Adults >60 years at risk of influenza and staff Email with web questionnaire 5% lost to follow up for first email survey 1 week after 1st vaccine and approximatly 1 week after 2nd vaccine. Third questionnaire 3 months after first questionnaire. 2009 Pandemic vaccine

  • Large numbers of general practices – 989 approached 117 participated

  • Three surveys so could follow time course of AEFIs and find late AEFI.

  • Possible selection bias

  • No denominator data for invited participants.

 One third reported AEFI Harmark23 Netherlands
2011 2590 & 702 Yes Infants Diary cards for 30 days after each dose and telephone call 6 mths after final dose 96% completed study. Details of withdrawals provided Diary card for 4 days after each dose AND telephone call 6 months after last study vaccine DTPa-IPV/HiB × 4 plus Hep B × 3 and Rotarix Vs DTPa-HBV-IPV/HiB × 2 and DTPa-HPV-IPV/HiB × 1 plus Hep B × 2 and Rotarix

  • Compare two combination vaccines and two schedules

  • Concurrent vaccine Rotavirus vaccine constant.

  • Descriptive.

  • Response rates not reported.

 Demonstrated safety of combination vaccines Lim24 Singapore
2013 906 Yes Persons >60 years Email and telephone 84.7% interviewed Interview 14 days after vaccine Yellow fever vaccine

  • Study response to concerns

  • Mild and moderate AEFI same rates as clinical trials.

 Wide range of interval from vaccination to interview (6 to 155 days) Pre-immunisation screening for YF vaccine in >60-year-olds Miyaji18 Brazil
2013 184 Yes Adults >18 years SMS 71.9% replied. 54.9% immediate SMS reply & 16.8% SMS response after additional prompts 48 hours after vaccine All/any

  • Software generated responses to participant SMS reply

  • First in country AEFI system. High response rate.

  • No denominator

  • Small size

 Proof of concept Baron17 Cambodia
2014 9798 Yes Children Self-administered questionnaire & diary card & MO visit and interview if report symptoms 96.2% completed questionnaire & diary cards Diary card for 2 weeks Mouse-brain derived Japanese Encephalitis vaccine

  • Investigate safety concerns from passive system

  • Sample size calculation

  • Diary cards delivered and explained & later picked up and confirmed

  • Instruction on axillary temperature

  • Causality assessment

 Authors report some incompleteness of self-assessment AEFI incident rate several-fold higher than National passive surveillance rate De Alwis20 Sri Lanka
2014 3281 & ongoing Yes All Automated SMS tool 72.6% responded by SMS. >80% responded within 24 h Automated SMS 3 days after vaccination All

  • System developed integrated with general practice software completely automating active surveillance

  • All surveillance for all vaccines

  • Continuous active AEFI surveillance

  • Serious AEFI follow-up by own GP/practice

 AEFI linked to vaccine by timing not causally linked Complete & automated active AEFI surveillance system. Real time and rapid signal detection. Leeb28 & second study same system by Westphall27 Australia
2014 477 Yes Children 6 months to <10 years Automated email or SMS with link to web-survey 57% & 61% response to online survey Day 3 and day 42 after vaccination Inactivated Influenza Vaccine

  • Web-based system developed to manage active surveillance

  • Compare brands

  • General practice and public clinics.

  • Small study

  • Manual entry of patient data by clinician thereafter automated.

 Online system automated. Data quickly to public health authorities for rapid analysis. Cashman30 Australia
2014 1230 Yes Children 6 months to 18 years Email contact with online survey 72% online plus 11% by phone Day 8 after vaccination Trivalent influenza vaccine and live attenuated intranasal vaccine

  • Comparison of vaccines

  • High response rate

  • Real time.

 Number of people approached but declined not recorded AEFI rates lower than clinical trials and close to the rates for national passive surveillance Bettinger37 Canada
2014 3,173 Yes Pregnant women SMS with telephone survey for those with reporting symptoms 83.6% replied to SMS Day 7 after vaccination Trivalent Influenza Vaccine

  • Under-investigated specific target population

  • Comparison of SMS contact and telephone contact

  • Economic analysis.

  • High response rate.

 May not be representative study group Mobile phone enabled efficient timely surveillance Regan29 Australia
2014 1422 Yes Infants Diary card and telephone call 1 month after each dose Not reported Diary card for 3 days and telephone call 1 month after each dose DTwP and DTaP

  • 5 year study

  • Control for injection technique, used two trained immunisers only.

 Too small to detect rare events DTaP less reactions than DTwP in infants Korkmaz22 Turkey
2014 530 Yes Infants SMS prompt for temperature SMS reply from parents for 7 days 95.1% day 1 decreasing daily to 79.6% day 7 Nightly for 7 days after vaccination TIV and PCV 13 compared to TIV or PCV13

  • Comparison of single vaccines and concomitant vaccines

  • Thermometer supplied so temperatures measured.

 Single symptom New finding of increased risk of fever with these concomitant vaccines TIV & PCV Stockwell36 USA
2015 1086 pregnant & 314 non-pregnant Yes Pregnant women SMS 86% replied by SMS Day 7 after vaccination Influenza vaccine Comparison group Potential reporting bias Influenza vaccine AEFI similar in pregnant and non-pregnant women Regan34 Australia
2015 22 080 Yes Health care workers Email with link to online survey 68.7% Day 8 after vaccination Influenza vaccine

  • Internally recruited controls

  • Ongoing annually

  • Annual data available on web

  • Large study

 HCW not representative of community for AEFI or Web survey completion Rapid evaluation in light of safety signal Bettinger32 Canada
2015 3340 Yes Children SMS and email 75% participation Day 3 after vaccination Trivalent Influenza Vaccine

  • Creation of system.

  • Real time feedback.

 Interpret parental reports with care National system. Rapid real time feedback to inform program rollout Pillsbury31 Australia
2015 236 study group & 235 controls No Children Telephone call from investigators. Response by ‘beep’ phone call not picked up Unknown Surveillance for 30 days after vaccination Routine childhood EPI vaccines

  • Cost to participants decreased by response of unanswered telephone call

  • Randomised control trial.

 Mostly urban not rural participants Telephone ‘beep’ increases community based AEFI reporting Tsafack19 Cameroon
2016 76 Yes Adult hospital staff and family App 63% downloaded app. 50% completed all surveys Day 8 and day 30 after vaccination Influenza vaccine App developed

  • Usability data only on successful suers of the app

  • Usability data only from successful users of the app. Is unknown if acceptable to larger population.

 Proof of concept that app to demonstrate technology is functional Wilson39 Canada
2016 5155 Yes Pregnant women SMS 84.3% replied by SMS Day 7 after vaccination TIV and dTpa

  • High response rate

  • Review of both antenatal vaccines.

 AEFI data collection by SMS differs to other methods – further investigation required Safety data supports antenatal vaccination Regan35 Australia
2016 987 Yes University students and staff Email with link to online survey 33% 8–10 days after each dose Meningococcal B vaccine - 4CMenB Support of emergency vaccine programme Emergency response so full methodology previously developed unable to be employed Medically attended events more frequent than in clinical trial data but local reactions consistent with previously reported Langley33 Canada