Recommendations for countries using the AstraZeneca vaccine


According to the latest recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) of the
European Medicines Agency (EMA), the following information is provided for the groups indicated:


• The AstraZeneca COVID-19 vaccine is not associated with an increased risk of blood clotting disorders.
• There have been very rare and unusual cases of blood clots, accompanied by low platelet levels, following
vaccination. The reported cases have almost all been among women over the age of 55.
• Since COVID-19 can be extremely serious and is widespread, the benefits of vaccination to prevent COVID-
19 outweigh the risk of adverse events.
• If you have any of the following symptoms after an AstraZeneca COVID-19 vaccination:

o Shortness of breath
o Chest or stomach pain
o Swelling and cold in arms or legs
o Severe headache or worsening of pain, or blurred vision after vaccination
o Persistent bleeding
o Multiple small bruises, reddish or purple spots, or blisters of blood under the skin, seek medical
attention immediately and indicate that you were recently vaccinated.

Health Care Workers

• Cases of thrombosis and thrombocytopenia, some presenting with mesenteric veins or cerebral vein/cerebral
venous sinus thrombosis, have been reported in people who have received the AstraZeneca COVID-19
vaccine, most occurring within 14 days after vaccination. Most of the reports were among women under the
age of 55. The higher exposure of this population group may be due to the fact that those individuals have
been vaccinated at the highest rates, due to the countries' vaccination strategies.

• The number of reported events exceeds the number of expected events and expected causation, and
although this cannot be confirmed, neither can it be excluded as a possibility. However, given the rarity of
adverse events and the difficulty of establishing a baseline, since COVID-19 itself can result in
hospitalizations with thromboembolic complications, the strength of the association is uncertain.


• The EMA believes that the benefit-risk balance of vaccination remains positive, and that there is no
association, in general, with thromboembolic disorders.

• Health professionals are encouraged to be alert to possible cases of thromboembolism, DIC, or CVST
occurring in vaccinated individuals.

• Vaccinated people should be advised to seek medical help if they have symptoms of thromboembolism,
and, particularly, signs of thrombocytopenia or cerebral blood clots such as easily caused bleeding or
bruising, and persistent headache, particularly after 3 days following vaccination.


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