Influenza vaccine safety

Adverse reactions following vaccination

Risks of an adverse event following influenza vaccination are far less common than complications related to influenza itself, and the adverse events are generally localized and mild. Adverse reactions are more common in children not previously exposed to the vaccine or virus than in adults. The benefits of vaccination substantially outweigh the risks. 

Table 2: Comparison of risks associated with influenza disease and inactivated seasonal influenza vaccination

Risks associated with seasonal influenza infection

Risks associated with inactivated seasonal influenza vaccination*

Common symptoms

  • Fever, sore throat, runny nose, dry cough, fatigue, headache, and muscle ache
  • Croup and bronchiolitis common in children

Common adverse event (<1/100)

  • Soreness/pain, redness and/or swelling around the injection site
  • Short-term fever (1–2 days), may be high (>39.0 C°) in children
  • Short-term fatigue (1–2 days)
  • Muscle ache (1–2 days)

Possible complications

  • Bacterial pneumonia
  • Ear infection
  • Sinus infection
  • Myocarditis
  • Pericarditis
  • Worsening of chronic medical condition present before influenza illness (e.g. congestive heart failure)
  • Precipitation of severe cardiovascular or cerebrovascular event

Rare adverse event (<1/1000)

  • Urticaria
  • Febrile convulsions in children

Rare complications

  • Septicaemia
  • Encephalopathy
  • Guillain-Barré syndrome**
  • Death

Very rare adverse event (<1/10.000)

  • Anaphylaxis
  • Paresthesia

*Reported risks refer to inactivated influenza vaccines commonly used in organised immunisation programmes in the European Union. For details see Summary of Product Characteristics for each vaccine available on national regulatory agency websites.

**Julia Stowe, Nick Andrews, Lesley Wise, Elizabeth Miller Investigation of the Temporal Association of Guillain-Barré Syndrome With Influenza Vaccine and Influenza-like Illness Using the United Kingdom General Practice Research Database, American Journal of Epidemiology, Volume 169, Issue 3, 1 February 2009, Pages 382–388 /C Vellozzi, D Burwen, A Dobardzic, R Ball, K Walton, P Haber Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring, Vaccine, 27 (2009), pp. 2114-2120

News

Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2

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Update on narcolepsy cases associated with Pandemrix vaccination in 2009 in the Netherlands

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No Serological Evidence of Influenza A H1N1pdm09 Virus Infection as a Contributing Factor in Childhood Narcolepsy after Pandemrix™ Vaccination Campaign in Finland

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New Swedish Registry study confirms increased risk of narcolepsy in children and adolescents after vaccination with Pandemrix

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Association of receipt of Pandemrix™ and narcolepsy in children and adolescents in the UK (England)

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Peer-Reviewed Publication

The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

2013

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Narcolepsy and Pandemrix Vaccine – an association in adults as well as children

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Publication

Technical report In Brief: Narcolepsy in association with pandemic influenza vaccination

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Publication

Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation

technical report -

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New ECDC technical report on “Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation”

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Report on the association between the 2009 pandemic vaccine (Pandemrix®) and narcolepsy – Republic of Ireland

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Association of childhood narcolepsy and cataplexy and receipt of a pandemic influenza vaccine in Finland in 2009-10 – First papers in a peer review journal

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Event

Training workshop on vaccine safety for Member States, building on the experience obtained in the ECDC vaccine safety project VAESCO

23 Feb 2012 - 24 Feb 2012
Stockholm, Sweden

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Recommendation by the European Medicines Agency concerning Pandemrix vaccination and reports of narcolepsy in children and adolescents

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EMA's Committee for Medicinal Products for Human Use (CHMP) issues opinion on narcolepsy and vaccination with Pandemrix®

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Case inventory study from Sweden concerning association of Pandemrix vaccination and reports of narcolepsy with cataplexy in children and adolescents

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The real issues in vaccine safety

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European Medicines Agency (EMA) 2009 Influenza Pandemic Evaluation

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Narcolepsy following pandemic influenza A H1N1 2009 vaccination - ECDC update: the European Medicines Agency interim measures for Pandemrix

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Swedish MPA publishes interim results of a cohort study assessing the risk of narcolepsy after vaccination with Pandemic influenza vaccine Pandemrix®

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Reports of cases of narcolepsy and cataplexy in children and adolescents in Finland, Iceland, and Sweden

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ECDC – VAESCO investigation into narcolepsy

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Safety experience of influenza vaccination in pregnant women in the US over a 20-year period

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Update of the EMA European Pharmacovigilance Report

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Three 2009 Pandemic Vaccines now on the way to being licensed for use outside the Pandemic

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Vaccine Safety - Update of the EMA’s European Pharmacovigilance Report

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Vaccine Safety - US Department of Health and Human Services publishes 2009 pandemic influenza A(H1N1) vaccine safety risk assessment

ECDC comment -

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Ninth Update of EMA Pharmacovigilance Report, 3 Feb 2010

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Background rates of disease useful for assessment of pandemic vaccine safety

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Event

Understanding the association between narcolepsy and one of the 2009 adjuvanted influenza A (H1N1) vaccines

23 Oct 2015
Geneva, Switzerland

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