Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children

Muhammad, Riyadh D.; Haber, Penina; Broder, Karen R.; Leroy, Zanie; Ball, Robert; Braun, M. Miles; Davis, Robert L.; McMahon, Ann

doi:10.1097/inf.0b013e3181ff9795

Cited by 13 publications

(4 citation statements)

References 43 publications

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“…During the 1990–2006 and 2008–2009 influenza seasons, Muhammad et al. 24 investigated possible new or unexpected AEs following TIV administration to children aged 2 to 17 years and 5 to 17 years, respectively. From 1990 to 2006, 2,054 cases of vaccine AEs were reported, peaking in the 2003–2004 influenza season, whereas 506 were reported in 2008–2009.…”

Section: Vaccine Types and Production Methodsmentioning

confidence: 99%

Influenza vaccines: Evaluation of the safety profile

Trombetta

Gianchecchi

Montomoli

2018

Human Vaccines & Immunotherapeutics

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The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated.Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines. Both display a good safety profile in adults and children. However, they can cause adverse events and/or rare adverse events, some of which are more prevalent in children, while others with a higher prevalence in adults.The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods.

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Section: Vaccine Types and Production Methodsmentioning

confidence: 99%

Influenza vaccines: Evaluation of the safety profile

Trombetta

Gianchecchi

Montomoli

2018

Human Vaccines & Immunotherapeutics

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“…Another VAERS review focusing on influenza vaccination in children from 1990 to 2006 found 201 reports of vaccination errors; 94% did not report any AHE [20].…”

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confidence: 99%

Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013

Hibbs

Moro

Lewis

et al. 2015

Vaccine

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“…Several studies have described immunization errors using passive surveillance data in the Vaccine Adverse Event Reporting System (VAERS), but none of these publications investigated immunization errors as a causative factor for fatal outcomes [7][8][9][10][11]. A study by Hibbs et al thoroughly discusses immunization errors reported to VAERS, but no details were provided on the number or causes of fatal outcomes [12].…”

Section: Introductionmentioning

confidence: 99%

Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series

Hoeve

Gadroen

Kwa

et al. 2020

Vaccine

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Background: Serious adverse reactions after immunization are rare but do occur. In very rare instances, cases with fatal outcome have been reported. These reports can have a huge impact and even more so when due to an immunization error. The aim of this study is to systematically review immunization errors with fatal outcomes in EudraVigilance. Methods: This was a case-series analysis of Individual Case Safety Reports (ICSRs) reporting immunization errors and a fatal outcome. To determine the level of certainty of a causal association between the immunization errors and fatal outcomes two independent reviewers assessed all ICSRs using the WHO tool ''Causality assessment of an Adverse Event Following Immunization (AEFI)". In accordance with the tool, the ICSRs were classified as consistent, indeterminate, inconsistent/coincidental, or unclassifiable. In addition, we estimated the contribution of reported errors to the fatal outcomes as large, moderate, small, none, or unclassifiable using a classification developed for this study. Results: A total of 154 ICSRs met the inclusion criteria. Vaccines reported most frequently were pneumococcal (33), rabies (27) and influenza vaccines (24). Most frequently reported errors were noncompliance with recommended schedules of immunization (63). The most frequently reported vaccine-error combination was rabies vaccines and non-compliance with a recommended schedule of immunization (23). Twelve cases were classified as consistent with causal association and had a large error contribution. These cases concerned a cluster of six cases reporting incorrect handling of multidose vials containing measles vaccine and six cases reporting administration of live-attenuated vaccines to immunocompromised patients. Discussion: In this study, we showed that fatal outcomes following immunization errors are very rare. Four key issues were the importance of: (1) quality control of multi-dose vaccines, (2) screening patients for immunocompromising factors, (3) education on the importance of adherence, and (4) measures to improve distinction between vaccines and medicines.

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Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children

Abstract: In this analysis, we found no unexpected AEs. Our review of medication error and GBS reports suggests that ongoing monitoring in these areas is appropriate.

Cited by 13 publications

References 43 publications

Influenza vaccines: Evaluation of the safety profile

Influenza vaccines: Evaluation of the safety profile

Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013

Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series

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