Published: 22 June 2015
Revised: 3 March 2016

Safety Information

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Influenza vaccine and mild hypersensitivity reactions

22 June 2015

The Centre for Adverse Reactions Monitoring (CARM) has received an increased proportion of reports of hypersensitivity and local reactions with the seasonal influenza vaccination as compared with previous years (see Table). A similar situation has also been reported in Australia.

Hypersensitivity and local reactions reported to CARM include dyspnoea (shortness of breath), pruritus (itching), paraesthesias (tingling or burning of the skin) and injection site inflammation, redness and pain. In the majority of reports the events were considered to be mild. None of the cases reported have required hospitalisation or been life threatening.

Healthcare professionals and consumers are reminded that immunisation remains the best defence again the influenza virus.

Table: Percentage of reports with hypersensitivity events associated with seasonal trivalent influenza vaccines since 2011

Year	Hypersensitivity Reactions	Hypersensitivity Reports	Total Influenza Reports	Percentage of Hypersensitivity /Total Reports (%)
2011	79	53	209	23.4
2012	79	58	197	29.4
2013	146	101	292	34.6
2014	110	75	255	29.4
2015 (to 20th May)	76	53	144	36.8

Approximately 1.15 million doses have been distributed in New Zealand in 2015. Further information on the number of reports received by CARM and number of influenza vaccine doses distributed in previous years is available in Prescriber Update

Products Affected

The influenza vaccination is used for prophylaxis against specific strains of the influenza virus in adults and children older than six months of age (with the exception of Fluvax, which should not be used in children under five years of age).

Product name	Sponsor
Influenza Vaccine
Fluarix	GlaxoSmithKline (NZ) Ltd
Fluvax	bioCSL (NZ) Ltd
Influvac	BPG Products
Vaxigrip	sanofi-aventis

*There is a quadrivalent vaccine (FluQuadri) available; however no reactions have been reported to CARM to 20 May 2015.

Additional Information

The overall benefit-risk of harm balance of the influenza vaccination remains positive.

Advice on this vaccination and possible side effects can be found in the consumer medicine information (CMI) and data sheet.

CMI for influenza vaccine

Data sheet for influenza vaccine

Regulator Actions

Medsafe is continuing to monitor reports of adverse events to the seasonal influenza vaccination.

Summaries of reports of adverse events associated with influenza vaccines are published each year in Prescriber Update.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

How to report an adverse reaction

Medsafe cannot give advice about an individual's medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Update to Original Communication

Prescriber Update – Spontaneous Reports: Seasonal Influenza Vaccination 2015