– Scottish Parliament written question – answered at on 4 November 2010.
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.
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.
Reaction (SOC) | Reaction (PT) | Number of Reports | Number of Fatal Reports |
Congenital, Familial and Genetic Disorders | Cerebral Palsy | 1 | 0 |
Eye Disorders | Photophobia | 3 | 0 |
Gastrointestinal Disorders | Nausea | 3 | 0 |
General Disorders and Administration Site Conditions | Chest Discomfort | 6 | 0 |
Chills | 1 | 0 | |
Condition Aggravated | 1 | 0 | |
Feeling Hot | 3 | 0 | |
Feeling Of Body Temperature Change | 1 | 0 | |
Malaise | 3 | 0 | |
Pyrexia | 4 | 0 | |
Immune System Disorders | Anaphylactic Shock | 1 | 0 |
Type I Hypersensitivity | 1 | 0 | |
Infections And Infestations | Herpes Zoster | 1 | 0 |
Investigations | Cell Marker Increased | 1 | 0 |
Metabolism And Nutrition Disorders | Decreased Appetite | 3 | 0 |
Musculoskeletal And Connective Tissue Disorders | Arthralgia | 1 | 0 |
Arthritis | 1 | 0 | |
Muscular Weakness | 1 | 0 | |
Neck Pain | 3 | 0 | |
Pain In Extremity | 4 | 0 | |
Nervous System Disorders | Convulsion | 2 | 0 |
Dysgeusia | 2 | 0 | |
Dyskinesia | 1 | 0 | |
Grand Mal Convulsion | 2 | 0 | |
Headache | 6 | 0 | |
Hypertonia | 1 | 0 | |
Hypoaesthesia | 2 | 0 | |
Lethargy | 3 | 0 | |
Loss Of Consciousness | 3 | 0 | |
Migraine | 1 | 0 | |
Paraesthesia | 1 | 0 | |
Sensory Loss | 2 | 0 | |
Syncope | 3 | 0 | |
Tremor | 1 | 0 | |
Psychiatric Disorders | Anxiety | 3 | 0 |
Confusional State | 1 | 0 | |
Fear | 3 | 0 | |
Respiratory, Thoracic And Mediastinal Disorders | Asthma | 4 | 0 |
Dyspnoea | 5 | 0 | |
Throat Tightness | 3 | 0 | |
Wheezing | 3 | 0 | |
Skin And Subcutaneous Tissue Disorders | Pruritus | 3 | 0 |
Rash | 3 | 0 | |
Skin Exfoliation | 1 | 0 | |
Urticaria | 1 | 0 | |
Vascular Disorders | Flushing | 1 | 0 |
Peripheral Coldness | 1 | 0 | |
Shock | 1 | 0 | |
Total Number of Reactions | 106 | ||
Total Number of Reports | 75 | ||
Total Number of Fatal Reports | 0 |
Yes1 person thinks so
No0 people think not
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