Continuous active surveillance of adverse events following immunisation using SMS technology.

On-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner. SmartVax is a vaccine safety monitoring tool that uses automated data extraction from existing practice management software and short message service (SMS) technology to follow-up vaccinees in real-time. We report on childhood vaccine safety surveillance using SmartVax at a medical practice in Perth, Western Australia. Parents of all children under age five years who were vaccinated according to the Australian National Immunisation Schedule between November 2011 and June 2015 were sent an SMS three days post administration to enquire whether the child had experienced a suspected vaccine reaction. Affirmative replies triggered a follow-up SMS requesting details of the reaction(s) via a link to a survey that could be completed using a smartphone or the web. Rates of reported AEFI including fever, headache, fatigue, rash, vomiting, diarrhoea, rigours, seizures, and local reactions were calculated by vaccination time point. Overall, 239 (8.2%; 95% CI 7.2-9.2%) possible vaccine reactions were reported for 2897 vaccination visits over the 44 month time period. The proportion of children experiencing a possible AEFI, mostly local reactions, was significantly greater following administration of diphtheria-tetanus-pertussis-poliomyelitis vaccine at 4 years of age (77/441; 17.5%; 95% CI 13.9-21.0%) compared to the vaccinations given at 2-18 months (p<0.001). Across all time points, local reactions and fatigue were the most frequently reported AEFI. Automated SMS-based reporting can facilitate sustainable, real-time, monitoring of adverse reactions and contribute to early identification of potential vaccine safety issues.

Westphal DW ，Williams SA ，Leeb A ，Effler PV ... -  《-》

Active SMS-based influenza vaccine safety surveillance in Australian children.

Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6-71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands. Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually.

Pillsbury A ，Quinn H ，Cashman P ，Leeb A ，Macartney K ，AusVaxSafety consortium ... -  《-》

Using automated text messages to monitor adverse events following immunisation in general practice.

Leeb A ，Regan AK ，Peters IJ ，Leeb C ，Leeb G ，Effler PV ... -  《-》

Active SMS-based surveillance of adverse events following immunisation with influenza and pertussis-containing vaccines in Australian pregnant women using AusVaxSafety.

Maternal immunisation is important to protect both mother and baby, but safety concerns can lead to low uptake. AusVaxSafety participant-based surveillance actively monitors adverse events following immunisation (AEFI) in Australia. We aimed to analyse AEFI in the days following vaccination with seasonal inactivated influenza vaccine (IIV) and/or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa) in pregnant women in Australia. De-identified AEFI reports were solicited from vaccine recipients via automated SMS survey (using SmartVax software) following routine vaccination with IIV and/or dTpa at 219 national sentinel surveillance sites from 2015 to 2018. AEFI rates were compared by vaccine group (IIV alone, dTpa alone, or IIV and dTpa together), vaccine brand, trimester (IIV only) and vaccination period (April to August 2016-2018; IIV only). Women who had two vaccination encounters during surveillance were identified and AEFI rates compared for each dose. Among 13,758 participants, overall AEFI rates were lower following IIV (4.9%) than dTpa (6.4%) or IIV and dTpa given concomitantly (7.4%). The AEFI profile was similar for both vaccines, with injection site reactions, tiredness, and headache most commonly reported. Injection site pain and swelling/redness were significantly more common in women who received dTpa than IIV. Reports of medical attendance following immunisation were similar (0.3%) for each vaccine group. AEFI rates did not differ by IIV brand (FluQuadri®, Fluarix® Tetra), dTpa brand (Boostrix®, Adacel®), or by trimester. Among women with sequential dTpa vaccinations, 6.0% (7/116) had an AEFI following their second dTpa dose. Self-reported AEFI rates did not differ by trimester (IIV), or by vaccine brand (IIV or dTpa). Concomitant influenza and pertussis vaccination was associated with more frequent, but low rates of minor, expected AEFI. These real world 'citizen science-based' data provide further reassuring evidence of the safety of maternal vaccination.

Glover C ，Crawford N ，Leeb A ，Wood N ，Macartney K ... -  《-》

Annual report: Surveillance of adverse events following immunisation in Australia, 2005.

Lawrence G ，Boyd I ，McIntyre P ，Isaacs D ... -  《-》