In the period from 1 September to 31 December 2009, the Danish Medicines Agency received 22 adverse reaction reports with a total of 52 suspected side effects from Gardasil®. The majority of the adverse reaction reports are not serious and describe already known adverse reactions. 8 of the reports are classified as serious.
The adverse reactions were reported by
In this 4-month period, 95 % of the adverse reaction reports were submitted by doctors and other healthcare professionals, and the remaining 5 % were submitted by vaccinees or their relatives.
Consumption
The Danish State Serum Institute dispensed 50,890 doses of Gardasil® in the period concerned.
8 reports are classified as serious, they describe:
- One case of development of an allergic reaction during the hours after the first vaccination. The patient was given another vaccine at the same time.
- One case of an unresolved effect on the liver after the second vaccination.
- One case of facial paralysis 3 months after the second vaccination.
- One case of intermittent periods of arthritis.
- One case of inflammation of the spinal cord affecting muscular strength and the sense of touch approx. 1 month after the first vaccination.
- One case of fainting 15 minutes after the second vaccination. Subsequently, the patient experienced headache and temporary paralysis of one leg.
- One case of impaired sense of touch in the right half of the face and upper arm the day after the second vaccination. A lumbar puncture showed signs of meningitis.
- One case of severe stomach ache 2 days after the vaccination.
In the first case, there is a potential causal relationship with the vaccination, but the patient was also administered another vaccine at the same time.
In the second case, the Danish Medicines Agency is awaiting further information.
In the opinion of the Danish Medicines Agency, the last 6 cases are probably isolated cases with no clear causal relationship with the vaccinations.
Decreasing number of adverse reaction reports on Gardasil® in 2009
Gardasil® was introduced in the Danish childhood immunisation programme on 1 January 2009 with the aim of preventing cervical cancer.
The Danish Medicines Agency concludes that the adverse reactions seen so far after vaccination with Gardasil® correspond to expectations, which is also in line with observations from other European countries.
In the period from 1 January to 31 December 2009, the Danish Medicines Agency received 287 new adverse reaction reports for Gardasil® covering a total of 482 suspected side effects. Most of the adverse reaction reports are not serious and describe already known adverse reactions. 24 of the reports are classified as serious.
86 % of the adverse reaction reports have been submitted by doctors and other healthcare professionals, while 14 % have been submitted by vaccinees or their relatives. In 2009, the Danish State Serum Institute dispensed 299,650 doses of Gardasil®.
The chart below shows how the number of adverse reaction reports are distributed from 1 January to 31 December 2009.
Categorisation of side effects (adverse reactions)
The complete list of adverse reactions from Gardasil® from 1 January 2009 to 31 December 2009 is available via the factbox to the right.
As in our previous reports, we have divided the adverse reactions into five categories: reactions at the injection site, allergic reactions, psychogenic factors, other known adverse reactions and unknown adverse reactions.
The Danish Medicines Agency continues to monitor adverse reaction reports on Gardasil®.
General information about adverse reaction data
An adverse reaction report contained in the pharmacovigilance database does not necessarily mean that there is a correlation (causality) between the medicinal product and the adverse reaction.
- The Danish Medicines Agency registers information about an adverse reaction in the database even if it is only suspected that there might be a correlation between the medicinal product and the adverse reaction. Therefore, the information in the database may include actual adverse reactions from a medicinal product as well as random incidences due to e.g. a disease in the patient or another medicinal product which has been administered to the patient at the same time.
- The Danish Medicines Agency is only notified of a small proportion of all adverse reactions. Therefore, the information in the pharmacovigilance database cannot indicate the frequency of the adverse reactions.
- A single adverse reaction report may contain more than one adverse reaction. Therefore, the number of registered adverse reactions is usually higher than the number of adverse reaction reports.
- An adverse reaction is considered to be serious if it results in the patient’s death, is life-threatening, requires hospitalisation, results in significant disability, or if the patient is unable to work or go to school.
- The Danish Medicines Agency sends information about all serious adverse reactions to the marketing authorisation holder, to the European pharmacovigilance database and to the WHO.
- All reports must form part of the periodic safety update reports which the marketing authorisation holder must regularly send to the Danish Medicines Agency. A periodic safety update report describes all reported adverse reactions from all countries in which the medicinal product is marketed. The periodic safety update reports thus provide a good overview, and they form an important basis for continuous updates of the summary of product characteristics and the package leaflet.
- An unknown adverse reaction is an adverse reaction that is not yet listed in the summary of product characteristics. If it appears that it is a new, as yet unacknowledged adverse reaction, the adverse reaction will be added to the summary of product characteristics.
For further information, please contact Chief Medical Officer Doris I. Stenver, Consumer Safety Division, tel.: +45 4488 9247/mobile: +45 2246 0979 or Senior Medical Officer Maja Folkenberg, Consumer Safety Division, tel.: +45 4488 9640.
Danish Medicines Agency, 23 February 2010
