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GSK Admits to Serious Side Effects for AREPANRIX to Be Used in Canada

Posted by ObeMike Tuesday, November 3, 2009

source: theflucase

GSK admits to serious side effects for AREPANRIX

GSK admits to serious side effects in the package insert for AREPANRIX™ H1N1/AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine.

Note: This is written in plain sanitized language as opposed to the adverse effects as seen in the clinical trials which is medical literature. See Page 8 of the insert for adverse reactions in clinical studies to the AREPANRIX™ H1N1/AS03-Adjuvanted H1N1 vaccine.

As with all medicines, AREPANRIX™ H1N1 can cause side effects. The very common and common side effects are usually mild and should only last a day or two.

Very common (may occur with more than 1 in 10 doses): 
  • Pain at the injection site
  • Headache
  • Fatigue
  • Redness or swelling at the injection site
  • Shivering
  • Sweating
  • Aching muscles, joint pain
Common (may occur with up to 1 in 10 doses):
  • Reactions at the injection site such as bruising, itching and warmth
  • Fever
  • Swollen lympth nodes
  • Feeling sick, diarrhea 
Uncommon (may occur with up to 1 in 100 doses):
  • Dizziness
  • Generally feeling unwell
  • Unusual weakness
  • Vomiting, stomach pain, uncomfortable feeling in the stomach or belching after eating
  • Inability to sleep
  • Tingling or numbness of the hands or feet
  • Shortness of breath
  • Pain in the chest
  • Itching, rash
  • Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand
Rare (may occur with up to 1 in 1000 doses):
  • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases
  • Fits
  • Severe stabbing or throbbing pain along one or more nerves
  • Low blood platelet count which can result in bleeding or bruising

Very Rare (may occur with up to 1 in 10,000 doses):
  • Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
  • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-BarrĂ© Syndrome If any of these side effects occur, please tell your doctor or nurse immediately. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Serious Warnings and Precautions
Advise your doctor or nurse immediately if you experience these reactions shortly after receiving your injection:

  • body rash
  • tightness in the throat
  • shortness of breath

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