Vaccinations

– Scottish Parliament written question – answered at on 4 November 2010.

Alert me about debates like this

Photo of Richard Simpson Richard Simpson Labour

Question S3W-36946

To ask the Scottish Executive, further to the answer to question S3W-35200 by Nicola Sturgeon on 3 August 2010, what side effects were recorded in the 77 reports considered serious by the reporter.

Photo of Nicola Sturgeon Nicola Sturgeon Scottish National Party

As of 2 September 2010, the Medicines and Healthcare Products Regulatory Agency (MHRA) has received a total of 75 reports of suspected adverse reactions (ADRs) associated with the use of HPV vaccine (including Cervarix and brand unspecified reports) from Scotland, covering 106 adverse reactions, which were considered serious by the reporter. These events are listed in the following table below as provided by MHRA. The total number of cases considered serious has decreased from 77 to 75, since two cases were identified as duplicate reports; these have therefore been discounted from the data.

The number and nature of suspected ADRs received so far is very much in line with what the MHRA expected to receive at this time and no serious new risks have been identified. Following administration of at least 4 million doses across the UK since September 2008, the balance of risks and benefits of Cervarix remains positive.

It is important to note that such reports do not necessarily mean that the events described were caused by the vaccine. Reporters are encouraged to report suspected ADRs i.e. the reporter does not have to be sure that the vaccine caused the reaction – a mere suspicion will suffice. Therefore, reports submitted to MHRA may be adverse reactions to the vaccine, they may be related to the process of vaccination rather than to the vaccine itself (e.g. nervousness or anxiety about needles or vaccination); or they may be purely coincidental events that would have occurred anyway in the absence of vaccination (e.g. events due to underlying medical conditions). These events are therefore not a summary of known or proven adverse reactions to the vaccines and must not be interpreted and used as such.

A list of the recognised side effects is provided in the product information for healthcare professionals (Summary of Product Characteristics) and patients (Patient Information Leaflet) which is available to view at www.medicines.org.uk.

CCCCCC" cellpadding="2" cellspacing="0" width="100%">
Reaction (SOC)Reaction (PT)Number of ReportsNumber of Fatal Reports
Congenital, Familial and Genetic Disorders Cerebral Palsy10
Eye Disorders Photophobia 30
Gastrointestinal Disorders Nausea 30
General Disorders and Administration Site ConditionsChest Discomfort60
Chills10
Condition Aggravated 10
Feeling Hot30
Feeling Of Body Temperature Change10
Malaise30
Pyrexia40
Immune System Disorders Anaphylactic Shock 10
Type I Hypersensitivity10
Infections And Infestations Herpes Zoster10
Investigations Cell Marker Increased10
Metabolism And Nutrition Disorders Decreased Appetite30
Musculoskeletal And Connective Tissue Disorders Arthralgia10
Arthritis10
Muscular Weakness10
Neck Pain30
Pain In Extremity40
Nervous System Disorders Convulsion 20
Dysgeusia20
Dyskinesia10
Grand Mal Convulsion20
Headache60
Hypertonia 10
Hypoaesthesia 20
Lethargy30
Loss Of Consciousness30
Migraine10
Paraesthesia10
Sensory Loss20
Syncope30
Tremor10
Psychiatric Disorders Anxiety30
Confusional State10
Fear30
Respiratory, Thoracic And Mediastinal Disorders Asthma40
Dyspnoea50
Throat Tightness30
Wheezing30
Skin And Subcutaneous Tissue Disorders Pruritus30
Rash30
Skin Exfoliation10
Urticaria10
Vascular Disorders Flushing10
Peripheral Coldness10
Shock10
Total Number of Reactions 106
Total Number of Reports75
Total Number of Fatal Reports 0

Does this answer the above question?

Yes1 person thinks so

No0 people think not

Would you like to ask a question like this yourself? Use our Freedom of Information site.