Complete virus flu vaccine of a pandemic virus strain inactivated which contains an antigen in accordance with:
A/Vietnam/1194/2004 (H5N1)*** 15 microgram**
per vaccine dose (0.5 ml)
* bred in eggs
*** adjuvanted on aluminum phosphate 0.45 milligram Al3+ and hydratisized an aluminum hydroxide 0.05 milligram Al3+
Sodium chloride, sodium mono hydrogen phosphate-dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride-hexahydrate, thimerosal (50microgramm), water for injection purposes.
A H5N1 virus strain was initially used for the approval. The official data for the current production have not been presented to us yet. Presumably it is the virus strain:
A/California/7/2009 (H1N1) -like virus
Side effects that were observed in the course of clinical trials with various formulations (H5N1, H2N2 and H9N2)
(N=941) of the model vaccine:
Very frequent (=1/10),
Frequent (=1/100 bis <1/10),
Occasional(=1/1.000 bis <1/100),
Rare (=1/10.000 bis <1/1.000),
Very rare (<1/10.000),
Not known (cannot be estimated on the basis of available data).
Occasional: Nasopharyngitis, rhinitis
Very frequent: headache
Frequent: profuse sweating, bleeding of the skin
Frequent: Myalgia, arthralgia
Very frequent: Pain and redness at the injection site, fatigue.
Frequent: Swelling and hardening at the injection site, chills, fever
Occasional: Itchiness at the injection site
During the post marketing observation of interpandemic (seasonal), trivalent vaccines the following side effects were reported:
Occasional (=1/1.000 to <1/100):
General skin reactions, including pruritis, urticaria or non-specific rashes.
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