scholarly journals Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

2014 ◽  
Vol 11 (1) ◽  
pp. 91-94 ◽  
Author(s):  
Cristiano Alicino ◽  
Caterina Merlano ◽  
Simona Zappettini ◽  
Sergio Schiaffino ◽  
Giovanni Della Luna ◽  
...  
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Routine Surveillance

Vaccine Safety and Surveillance for Adverse Events Following Immunization (AEFI) in India

2017 ◽  
Vol 85 (2) ◽  
pp. 139-148 ◽  
Author(s):  
Jyoti Joshi ◽  
Manoja Kumar Das ◽  
Deepak Polpakara ◽  
Satinder Aneja ◽  
Mahesh Agarwal ◽  
...  
Keyword(s):  
Adverse Events ◽  
Vaccine Safety

scholarly journals Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 243 ◽  
Author(s):  
Jacob Puliyel ◽  
Pathik Naik
Keyword(s):  
Heart Disease ◽  
Adverse Events ◽  
Vaccine Safety ◽  
World Health Organisation ◽  
Epidemiological Studies ◽  
World Health ◽  
Causal Association ◽  
Risk Of Death ◽  
Post Marketing Surveillance ◽  
Definition Of

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design

2014 ◽  
Vol 56 (3) ◽  
pp. 513-525 ◽  
Author(s):  
Stanley Xu ◽  
Sophia Newcomer ◽  
Jennifer Nelson ◽  
Lei Qian ◽  
David McClure ◽  
...  
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Safety Studies

Feasibility of telemonitoring for active surveillance of influenza vaccine safety in the primary care setting in the Netherlands

2009 ◽  
Vol 15 (7) ◽  
pp. 362-367 ◽  
Author(s):  
Hubertus JM Vrijhoef ◽  
Joyce JM Janssen ◽  
Michael E Greenberg
Keyword(s):  
Primary Care ◽  
The Netherlands ◽  
Adverse Events ◽  
Care Setting ◽  
Primary Care Setting ◽  
Vaccine Safety ◽  
Incidence Rates ◽  
Paid Work ◽  
Hospital Emergency ◽  
Home Telemonitoring

We examined the feasibility of a commercial home telemonitoring system for monitoring adverse events related to vaccination and influenza-like illness (ILI) signs and outcomes in the primary care setting in the Netherlands. A prospective cohort of people eligible for influenza vaccination was monitored daily between mid-October 2007 and mid-March 2008. Adults from five primary care centres were invited to participate. A total of 245 people participated (response rate 75%). Their mean age was 61 years (SD = 15), 50% were female and 60% had a chronic disease. Most (73%) had no problems with installation of the system and 67% finished all sets of monitoring dialogues. The reported incidence of adverse events in the first week after vaccination was 8–38%. The reported incidence rates of ILI symptoms varied and were higher than reference data. A total of 39% of individuals consulted their general practitioner, 7% the hospital emergency department, 6% were hospitalized and 27% used medication. Of those in paid work, one-third reported absence of work due to ILI. Home telemonitoring appears to be feasible for monitoring vaccine adverse events and ILI symptoms and outcomes.

scholarly journals Vaccine hesitancy: evidence from an adverse events following immunization database, and the role of cognitive biases

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hossein Azarpanah ◽  
Mohsen Farhadloo ◽  
Rustam Vahidov ◽  
Louise Pilote
Keyword(s):  
Decision Making ◽  
Adverse Events ◽  
Cognitive Biases ◽  
Vaccine Safety ◽  
Vaccine Hesitancy ◽  
Decision Making Process ◽  
Evidence Based ◽  
Vaccine Acceptance ◽  
Vaccination Decision ◽  
Vaccine Information

Abstract Background Vaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading role. Moreover, cognitive biases are critical in connecting such concerns to vaccine hesitancy behaviors, but their role has not been comprehensively studied. In this study, our first objective is to address concerns regarding vaccine AEs to increase vaccine acceptance. Our second objective is to identify the potential cognitive biases connecting vaccine hesitancy concerns to vaccine-hesitant behaviors and identify the mechanism they get triggered in the vaccine decision-making process. Methods First, to mitigate concerns regarding AEs, we quantitatively analyzed the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2011 to 2018 and provided evidence regarding the non-severity of the AEs that can be used as a communicable summary to increase vaccine acceptance. Second, we focused on the vaccination decision-making process. We reviewed cognitive biases and vaccine hesitancy literature to identify the most potential cognitive biases that affect vaccine hesitancy and categorized them adopting the Precaution Adoption Process Model (PAPM). Results Our results show that the top frequent AEs are expected mild reactions like injection site erythema (4.29%), pyrexia (3.66%), and injection site swelling (3.21%). 94.5% of the reports are not serious and the average population-based serious reporting rate over the 8 years was 25.3 reports per 1 million population. We also identified 15 potential cognitive biases that might affect people’s vaccination decision-making and nudge them toward vaccine hesitancy. We categorized these biases based on the factors that trigger them and discussed how they contribute to vaccine hesitancy. Conclusions This paper provided an evidence-based communicable summary of VAERS. As the most trusted sources of vaccine information, health practitioners can use this summary to provide evidence-based vaccine information to vaccine decision-makers (patients/parents) and mitigate concerns over vaccine safety and AEs. In addition, we identified 15 potential cognitive biases that might affect the vaccination decision-making process and nudge people toward vaccine hesitancy. Any plan, intervention, and message to increase vaccination uptake should be modified to decrease the effect of these potential cognitive biases.

scholarly journals Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Qiao Liu ◽  
Chenyuan Qin ◽  
Min Liu ◽  
Jue Liu
Keyword(s):  
Adverse Events ◽  
Incidence Rate ◽  
Real World ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Immune Surveillance ◽  
Herd Immunity ◽  
Vaccine Safety ◽  
Vaccine Effectiveness ◽  
Alpha Variant

Abstract Background To date, coronavirus disease 2019 (COVID-19) becomes increasingly fierce due to the emergence of variants. Rapid herd immunity through vaccination is needed to block the mutation and prevent the emergence of variants that can completely escape the immune surveillance. We aimed to systematically evaluate the effectiveness and safety of COVID-19 vaccines in the real world and to establish a reliable evidence-based basis for the actual protective effect of the COVID-19 vaccines, especially in the ensuing waves of infections dominated by variants. Methods We searched PubMed, Embase and Web of Science from inception to July 22, 2021. Observational studies that examined the effectiveness and safety of SARS-CoV-2 vaccines among people vaccinated were included. Random-effects or fixed-effects models were used to estimate the pooled vaccine effectiveness (VE) and incidence rate of adverse events after vaccination, and their 95% confidence intervals (CI). Results A total of 58 studies (32 studies for vaccine effectiveness and 26 studies for vaccine safety) were included. A single dose of vaccines was 41% (95% CI: 28–54%) effective at preventing SARS-CoV-2 infections, 52% (31–73%) for symptomatic COVID-19, 66% (50–81%) for hospitalization, 45% (42–49%) for Intensive Care Unit (ICU) admissions, and 53% (15–91%) for COVID-19-related death; and two doses were 85% (81–89%) effective at preventing SARS-CoV-2 infections, 97% (97–98%) for symptomatic COVID-19, 93% (89–96%) for hospitalization, 96% (93–98%) for ICU admissions, and 95% (92–98%) effective for COVID-19-related death, respectively. The pooled VE was 85% (80–91%) for the prevention of Alpha variant of SARS-CoV-2 infections, 75% (71–79%) for the Beta variant, 54% (35–74%) for the Gamma variant, and 74% (62–85%) for the Delta variant. The overall pooled incidence rate was 1.5% (1.4–1.6%) for adverse events, 0.4 (0.2–0.5) per 10 000 for severe adverse events, and 0.1 (0.1–0.2) per 10 000 for death after vaccination. Conclusions SARS-CoV-2 vaccines have reassuring safety and could effectively reduce the death, severe cases, symptomatic cases, and infections resulting from SARS-CoV-2 across the world. In the context of global pandemic and the continuous emergence of SARS-CoV-2 variants, accelerating vaccination and improving vaccination coverage is still the most important and urgent matter, and it is also the final means to end the pandemic. Graphical Abstract

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 Spontaneous adverse event reporting by COVID-19 vaccinated healthcare professionals through an electronic form implemented by the hospital pharmacy

2021 ◽  
Author(s):  
João Cruz ◽  
Cristina Carvalho ◽  
Paula Silva ◽  
Leila Costa ◽  
Raquel Simões ◽  
...  
Keyword(s):  
Adverse Events ◽  
Hospital Pharmacy ◽  
Healthcare Professionals ◽  
Pathological Condition ◽  
Vaccine Safety ◽  
Adverse Event Reporting ◽  
Gastrointestinal Disorders ◽  
Answer Option ◽  
Spontaneous Adverse Event ◽  
Pharmacovigilance Plan

Aim Implementation of a web-form based pharmacovigilance plan for the spontaneous notification of adverse events to the Comirnaty® COVID-19 vaccine during its administration to hospital healthcare professionals. Methods An electronic pharmacovigilance form was developed containing 8 pre-defined event options, an open answer option for the description of other events and/or symptoms, and a question about the overall intensity of symptoms. The adverse events reports were standardised according to physiological and pathological condition. Results A total of 4119 adverse events notifications were obtained with a 45% rate of electronic notification. The most clinically relevant events reported were: tachycardia (n=19), dyspnoea (n=7), chest pain (n=6), facial/labial oedema (n=6), lipothymia (n=5), bronchospasm (n=2), herpetic infection (n=2), vasculitis (n=2), arrhythmia (n=1), difficult to control arterial hypertension (n=1), gastritis (n=1) and spontaneous abortion (n=1). Regarding the intensity of symptoms (n=2928), 70.0% were reported as mild, 25.8% as moderate and 4.27% as severe, with higher intensity in the 2nd dose compared to 1st dose. The highest frequency of severe events were reported in the groups from 40 to 59 years in both vaccination periods. During the vaccination process, no hospitalisations and no deaths were notified and/or recorded. Conclusion In this real world study, comparing with Comirnaty clinical trials program, it was observed a higher frequency of adenomegaly and gastrointestinal disorders. Noteworthy, the notification of a case of miscarriage. The use of hospital pharmacy pharmacovigilance electronic forms, seemed to be relevant to notification adherence and to obtain a greater and faster knowledge of COVID-19 vaccine safety profile.

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.

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