Content: Virus flu vaccine, inactivated, which contains an antigen of a pandemic virus strain:
(H1N1) 7.5 microgram**
per vaccine dose (0.5 ml)
* bred in vero-ells (continuous mammalian cell line)
** expressed in microgram haemaglutinin
Water for injection purposes
For the approval of the pandemic vaccine a H5N1 virus strain was used.
In the course of clinical trials with model vaccine the following adverse effects were observed in 606 people partaking in the trial (326 between the ages of 18 and 59 years and 280 older than 60 years of age).
The adverse effects are listed in accordance with the following frequencies:
Very frequent (=1/10)
Frequent (=1/100 to 51/10)
Occasional (=1/1.000 to 51/100)
Rare (=1/10.000 to 51/1.000)
Very rare (51/10.000)
Not known (frequency cannot be estimated on the basis of available data).
Infections and parasite diseases
Diseases of the blood and lymph system
Occasional: Insomnia, unrest
Diseases of the nervous system
Frequent: headache, dizziness
Occasional: Numbness, dysaesthesia
Diseases of the ear and labyrinth
Occasional: Acute loss of hearing
Respiratory diseases, of the chest and mediastinum Frequent: Sore throat and chest
Occasional: Difficulty breathing, cough, rhinorrhea, congestion
Diseases of the gastrointestinal tract
Occasional: Gastrointestinal symptoms
(such as nausea, vomiting, diarrhea and stomach pain)
Diseases of the skin and subcutaneous tissue
Frequent: Profuse sweating
Occasional: Rash, pruritus
Diseases of the muscles of the skeleton and tissue
Frequent: Arthralgia, Myalgia
General diseases and problems at the site of injection
Very frequent: Pain at the injection site
Frequent: Fever, chills, fatigue, nausea, hardening, erythema, swelling and bleeding at the injection site
Occasional:irritation of the injection site
Because the trial group was very small, rare and grave adverse effects were naturally not included! Furthermore there are no descriptions for cell-based vaccines!
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