scholarly journals Surveillance of adverse events following immunisation in Australia annual report, 2019

2021 ◽  
Vol 45 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Clinical Findings ◽  
Reporting Rate ◽  
Influenza Vaccines ◽  
Causal Association ◽  
Site Reaction ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.

scholarly journals Surveillance of adverse events following immunisation in Australia: annual report, 2018

2020 ◽  
Vol 44 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
Program Schedule ◽  
National Immunisation Program ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.

Surveillance of adverse events following immunisation in Australia annual report, 2017

2019 ◽  
Vol 43 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Rona Hiam ◽  
Nicholas Wood ◽  
...  
Keyword(s):  
Adverse Events ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
National Immunisation Program ◽  
Conjugate Vaccination ◽  
Reporting Rates ◽  
To Receive

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.

scholarly journals Surveillance for Adverse Events following Immunization from 2008 to 2011 in Zhejiang Province, China

2012 ◽  
Vol 20 (2) ◽  
pp. 211-217 ◽  
Author(s):  
Yu Hu ◽  
Qian Li ◽  
Luoya Lin ◽  
Enfu Chen ◽  
Yaping Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Injection Site Reaction ◽  
Influenza Virus Vaccine ◽  
H1n1 Influenza ◽  
Reporting Rate ◽  
Zhejiang Province ◽  
The Individual ◽  
Zhejiang Provincial ◽  
Two Peaks ◽  
Reporting Rates

ABSTRACTThis study summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the National AEFI Surveillance System (NASS) in Zhejiang province and describes reporting trends from 2008 to 2011. AEFI reporting rates were calculated using denominator data from the Individual Immunization Information System and the Zhejiang provincial Bureau of Statistics. A total of 6,265 AEFI records were reported; the overall reporting rate was 9.2 per 100,000 doses. There were two peaks of reporting rates, which were associated mainly with the introduction of the pandemic H1N1 influenza virus vaccine (pH1N1) in 2009 and the measles-mumps vaccine (MM) campaign in 2010. The majority of the AEFI described nonserious events. Fifteen deaths were recorded, but only one was possibly related to immunization. The most frequently reported reactions were fever and injection site reaction. Vaccines distributed in Zhejiang province have proven to be generally safe. The data on AEFI surveillance provide a reference point for ongoing reporting of trends and illustrate the value of the NASS database as a surveillance tool for monitoring of AEFI.

scholarly journals Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia

2017 ◽  
Vol 22 (20) ◽  
Author(s):  
Hazel J Clothier ◽  
Nigel Crawford ◽  
Melissa A Russell ◽  
Jim P Buttery
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Influenza Vaccine ◽  
Allergic Reaction ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Clinical Severity ◽  
Influenza Vaccines ◽  
Seasonal Influenza Vaccine ◽  
Initial Investigation

Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC’s initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand. The initial investigation showed an increased proportion of allergy-related AEFI compared with 2014 (25% vs 12%), predominantly in adults, with insufficient clinical severity to alter the programme risk-benefit. While overall TIV AEFI RR in 2015 was similar to previous years (RR: 1.07, 95% confidence interval (CI): 0.88–1.29), we identified a near-doubling RR for allergy-related AEFI in 2015 (RR: 1.78, 95% CI: 1.14­– 2.80) from 2011 to 2014 with no difference by vaccine brand or severity increase identified. This increase in generalised allergy-related AEFI, across all used vaccine brands, supports evidence of variable reactogenicity arising from influenza vaccine strain variations. This investigation underlines the importance of effective seasonal influenza vaccine pharmacovigilance.

scholarly journals Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

2015 ◽  
Vol 20 (43) ◽  
Author(s):  
Alexis Pillsbury ◽  
Patrick Cashman ◽  
Alan Leeb ◽  
Annette Regan ◽  
Darren Westphal ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Real Time ◽  
Surveillance System ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Influenza Vaccines ◽  
Safety Surveillance ◽  
Medical Attendance

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.

scholarly journals Assessing safety of Ontario’s publicly funded MMR and MMRV immunization programs, 2012 to 2016

2019 ◽  
Vol 25 (6) ◽  
pp. 358-364
Author(s):  
Chi Yon Seo ◽  
Mohammed Rashid ◽  
Tara Harris ◽  
Jody Stapleton ◽  
Shelley L Deeks
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Public Confidence ◽  
Publicly Funded ◽  
Systemic Reactions ◽  
Event Category ◽  
Reporting Rates ◽  
Surveillance Database ◽  
Routine Immunization Schedule

Abstract Background The combined measles, mumps, rubella (MMR) and measles, mumps, rubella, and varicella (MMRV) vaccines are part of Ontario’s routine immunization schedule. Objective To assess adverse events following immunization (AEFIs) reported in Ontario following administration of MMR and MMRV vaccines between 2012 and 2016. Methods Reports of AEFIs were extracted from the provincial surveillance database on May 9, 2017. Events were grouped by provincial surveillance definitions. Reporting rates were calculated using provincial population estimates or net doses distributed as the denominator. A serious AEFI is defined as an AEFI that resulted in an in-patient hospitalization or death. Results Overall, 289 AEFIs were reported following administration of MMR (n=246) or MMRV (n=43) vaccines, for annualized reporting rates of 16.6 and 8.8 reports per 100,000 distributed doses, respectively. The highest age-specific reporting rate was in children aged 1 to 3 years for MMR (7.7 per 100,000 population) and children aged 4 to 9 years for MMRV (0.8 per 100,000 population). Systemic reactions were the most frequently reported event category, while rash was the most frequently reported event for both vaccines. There were 22 serious AEFIs, 19 following MMR and 3 following MMRV (1.3 and 0.6 per 100,000 doses distributed, respectively). Conclusions Our assessment found a low reporting rate of adverse events following MMR and MMRV vaccines in Ontario. No safety concerns were identified. Our findings are consistent with the safety profiles of these vaccines. Continued monitoring of vaccine safety is necessary to maintain timely detection of unusual postvaccine events and public confidence in vaccine safety.

Open-label, phase I study evaluating feasibility and safety of subcutaneous IMP321 (LAG-3Ig fusion protein, eftilagimod alpha) combined with avelumab in advanced stage solid tumor entities: Results from stratum D of the INSIGHT platform trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3099-3099
Author(s):  
Thorsten Oliver Goetze ◽  
Daniel Wilhelm Mueller ◽  
Mohammad-Reza Rafiyan ◽  
Dragan Kiselicki ◽  
Regina Eickhoff ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Events ◽  
Phase I ◽  
Injection Site Reaction ◽  
Kidney Injury ◽  
Advanced Stage ◽  
Site Reaction ◽  
Grade 5 ◽  
Common Grade ◽  
Grade 3

3099 Background: Stratum D of the INSIGHT study investigates the feasibility and safety of s.c. application of IMP321 (eftilagimod alpha) combined with the PD-L1 inhibitor avelumab in advanced stage solid tumors. The MHC class II agonist IMP321 activates antigen-presenting cells followed by CD8 T-cell activation. The addition of avelumab aims at enhancing activity by combining IMP321’s activating effects on immune cells with the release of immune inhibitory effects caused by interruption of the PD-1/PD-L1 axis. Methods: This investigator-initiated phase I trial consists of four strata: intratumoral (A) or intraperitoneal IMP321 (B); s.c. IMP321 with SOC (C) or with PD-L1 inhibition (D). This abstract focuses on Stratum D. Patients (pts) receive 800mg avelumab i.v. q2w along with s.c. IMP321 injections (6mg IMP321 in cohort 1 and 30mg IMP321 in cohort 2). 12 pts are planned in stratum D : 6 pts in cohort 1 and 6 pts in cohort 2. Primary endpoint is safety. Results: So far, 8 pts have been enrolled (6 in cohort 1 and 2 in cohort 2). In 6 pts (cohort 1) treated for different tumor indications (gastric, gallbladder, colon cancer, pleural mesothelioma), no dose limiting toxicities occurred. 3 serious adverse events (SAEs) (1 acute kidney injury grade 5 in 1 pt, 2 preileus grade 3 in 1 pt) were reported, none of them was related to any of the study drugs. In total, 34 adverse events (AEs; grade 1-2, 21; grade 3, 12; no grade 4; grade 5, 1) have been documented in 5 pts. Most common grade 1-2 AEs were pain, nausea, and injection site reaction in 50%, 33%, and 17% of the pts. Most common grade 3 AEs were nausea/vomiting, preileus/ileus, and ascites in 33%, 33%, and 17% of the pts. One AE grade 5 (acute kidney injury) was reported. 4 AEs grade 1-2 were possibly or definitely related to IMP321 (injection site reaction 2x; fever; lipohypertrophy), 6 AEs grade 1-2 were possibly or definitely related to avelumab (nausea 2x; chills; fever; dyspnea; lipohypertrophy). All AEs grade 3-5 were unrelated to any of the study drugs. Of the 8 pts enrolled so far, 4 had disease progression (acc. to RECIST 1.1), 1 partial response, 1 stable disease with some extent of tumor shrinkage, and 2 have not had tumor assessment yet. Conclusions: Combination treatment with avelumab 800mg and IMP321 6mg is safe and well tolerated. Cohort 2 will be presented at the meeting. Clinical trial information: NCT03252938 .

scholarly journals Crowdsourcing sugammadex adverse event rates using an in-app survey: feasibility assessment from an observational study

2018 ◽  
Vol 9 (7) ◽  
pp. 331-342 ◽  
Author(s):  
Craig S. Jabaley ◽  
Francis A. Wolf ◽  
Grant C. Lynde ◽  
Vikas N. O’Reilly-Shah
Keyword(s):  
Adverse Events ◽  
Mobile Applications ◽  
Global Assessment ◽  
Adverse Drug Reaction Reporting ◽  
Clinical Decision ◽  
Reporting Rate ◽  
Feasibility Assessment ◽  
Anesthesia Providers ◽  
Event Rates ◽  
Reporting Rates

Background: Mobile applications (apps) have become a ubiquitous source of clinical decision support. We sought to ascertain the feasibility of using an app platform to obtain a crowdsourced measure of adverse drug reaction reporting rates associated with sugammadex administration and compare it with traditionally-derived estimates. Methods: Using the widely-distributed anesthesia calculator app, ‘Anesthesiologist’, we surveyed anesthesia providers regarding their experience with adverse drug reactions associated with sugammadex administration. Results: Data were analyzed from 2770 participants in 119 countries responding between March 2016 and May 2017, who were estimated to have administered between 1.6–2.9 million doses (588–1040 administrations per participant). A low and high-end reporting rate of adverse events was estimated based on respondents’ reported frequency and duration of sugammadex use. The estimated reporting rate of anaphylaxis due to sugammadex was 0.0055–0.098%, similar in range to previously published estimates. Conclusions: Use of an in-app survey facilitated a global assessment of anesthesia providers and could have useful applications in monitoring adverse events and estimating their rates. Further work is needed to validate this approach for other medications and clinical domains.

scholarly journals Acute Kidney Injury and Bisphosphonate Use in Cancer: A Report From the Research on Adverse Drug Events and Reports (RADAR) Project

2013 ◽  
Vol 9 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Beatrice J. Edwards ◽  
Sarah Usmani ◽  
Dennis W. Raisch ◽  
June M. McKoy ◽  
Athena T. Samaras ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Events ◽  
Adverse Drug Events ◽  
Reporting System ◽  
Kidney Injury ◽  
Clinical Findings ◽  
Unexpected Finding ◽  
Safety Signal ◽  
Causal Association ◽  
Significant Safety

Analysis of bisphosphonate-associated acute kidney injury reports for cancer cases within FDA's Adverse Events and Reporting System failed to demonstrate a significant safety signal, an unexpected finding given prior preclinical and clinical findings that suggested a causal association between BPs and AKI.

scholarly journals Az új, csökkentett dózisú, hazai gyártású influenzavakcina (FluArt) forgalomba hozatalát követő első szezonjának biztonságossági vizsgálata

2017 ◽  
Vol 158 (49) ◽  
pp. 1953-1959
Author(s):  
Péter Vajó ◽  
Orsolya Gyurján ◽  
Ágnes Mira Szabó ◽  
László Kalabay ◽  
Zoltán Vajó ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Safety Data ◽  
Influenza Vaccines ◽  
European Medicines Agency ◽  
Fisher Exact Test ◽  
Exact Test ◽  
Reduced Dose ◽  
Safety Surveillance ◽  
Dose Vaccine

Abstract: Introduction: The currently licensed seasonal influenza vaccines contain split, subunit or whole virions, typically in amounts of 15 µg hemagglutinin per virus strain for adult and up to 60 µg in elderly patients. Aim: The present study reports safety data of the newly licensed, reduced dose vaccine with 6 µg of hemagglutinin per strain produced by Fluart (Hungary) after its first season on the market. The main objective of enhanced safety surveillance was to detect a potential increase in reactogenicity and allergic events that is intrinsic to the product in near real-time in the earliest vaccinated cohorts. Method: The study methods were based on the Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU by the European Medicines Agency. Statistics: We used the Fisher exact test with 95% confidence intervals. Results: We studied 587 patients and detected a total 24 adverse events, all of which have already been known during the licensing studies of the present vaccine. The frequencies of the adverse events were not different from what had been seen with the previously licensed 15 µg vaccine. Conclusions: Based on the results, the authors conclude that the new, reduced dose vaccine FluArt is safe and tolerable. Orv Hetil. 2017; 158(49): 1953–1959.

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