Reactions to the vaccine

[Tonka]

http://www.elpais.com/articulo/soci...tes/Tamiflu/elpepisoc/20091203elpepisoc_5/Tes

Reactions to the vaccine
The Spanish Health Ministry said yesterday that it has immunized one million people against the H1N1 since the start of the campaign on 16 November. Since that date all citizens belonging to risk groups (health professionals, essential service workers, chronically ill and pregnant women) may request the vaccine.

The drug monitoring service has detected 150 suspected adverse reactions to the vaccine. Most of them are slight: fatigue, malaise, reactions at the injection site, fever, muscle aches, headaches. Health is investigating nine cases of serious adverse reactions, three allergic reactions, two cases of facial palsy, three cases of seizures and one case of fetal death in a woman of 35 who was in her first trimester. "In this period the rate of spontaneous abortions between 10% and 15%," says Health, which considers "very unlikely" that the case of incidents. Thus the rate of vaccine reactions is 0.015%, a percentage very similar to those detected by WHO (0.01%) throughout the world. So far, H1N1 has been immunized against more than 60 million people in 16 countries

 

[Tonka]

Re: Reactions to the vaccine

http://www.elfinanciero.com.mx/ElFi...cId=232054&docTipo=1&orderby=docid&sortby=ASC

Spain investigates death of fetus whose mother was vaccinated against influenza
Flu alert - Wednesday, 2 December (15:00 hrs)


They note that they have provided more than one million doses among different risk groups
Indicate that the case may be due to an adverse reaction


El Financiero en l?nea

Madrid, Dec. 2 .- The Ministry of Health and Social Policy in Spain said today that it is investigating the death of a fetus, whose mother is 35 recently vaccinated against human influenza in the first trimester of pregnancy.

In a statement, the dependency of the report presented data on vaccines administered in the campaign against the H1N1 virus began on 16 November and totaling more than one million doses provided between different risk groups.

About suspected adverse reactions to, the ministry said of the 150 cases under investigation is one of fetal death, which occurred in the first trimester of pregnancy, a period in which the rate of spontaneous abortions between 10 and 15 percent .

He explained that this is one case of suspected adverse reactions of interest from a clinical standpoint, and subject to special monitoring.

In addition to the death, in that range are three of allergic reactions, two cases of facial paralysis and three cases of seizures.

Most cases of adverse reactions' are within expectations, the information contained in the technical specifications of vaccines: fatigue and malaise, reactions at the injection site, fever, or fever, muscle and joint aches, dizziness and headaches.

According to the ministry, all of these disorders are usually resolved within a few hours without complications.

He explained that through the Human Pharmacovigilance System (SEFV-H), suspected cases are identified by the observation of undesirable events after administration of a drug.

The suspicions are reported by health professionals through autonomic pharmacovigilance centers or pharmaceutical companies themselves.

The ministry and the Spanish Agency of Medicines and Health Products developed a database to enable early detection of any risk is not known drugs once marketed.

However, he clarified that "neither the notice nor the record in the database should be considered as evidence that the drug is the cause of the event described, and therefore the information should be interpreted within a broader context and advice of experts in its management.

In Spain there have immunized more than one million persons in risk groups that are socio-health workers, people working in essential public services, over six months old with a special medical condition and pregnant women.

According to data from the World Health Organization (WHO) to date have been immunized at about 60 million people in 16 countries.

The Ministry of Health and Social Policy said that according to information received from all these countries, the profile of suspected adverse reactions to vaccines against H1N1 virus is similar to that recorded in the dose for seasonal influenza. (Con informaci?n de Notimex / JOT)