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<p>As of 23 March 2022, the Medicines and Healthcare products Regulatory Agency (MHRA)
received 2,075 reports of suspected adverse drug reactions (ADRs) to COVID-19 vaccinations
in which the patient died shortly after the vaccine had been administered. This is
following over 140 million COVID-19 vaccinations administered in the United Kingdom.
However, an ADR report associated with a fatal outcome does not mean that the vaccine
caused the death. The MHRA assesses information received through the Yellow Card scheme
to determine the likelihood of an association between the vaccine and any suspected
ADR. This involves considering the overall pattern of reports and considering whether
there are more events than would normally be expected in the general population. However,
the MHRA does not assess whether an individual’s death was directly caused by a vaccine.</p><p>The
product information leaflets for the COVID-19 vaccines provide a list of the side
effects potentially associated with the vaccines, with warnings and precautions on
particular events to ensure that vaccine administrators are aware of specific advice
and information. Such events include anaphylaxis for all vaccines, myocarditis and
pericarditis for the Moderna and Pfizer vaccines and thrombocytopenia syndrome and
neurological events for the AstraZeneca vaccine. These warnings include a description
of the evidence for these events being associated with the vaccines, which will include
spontaneous ADR reports, such as Yellow Cards, the signs and symptoms to be aware
of and advice relating to the identification and treatment of these events, where
appropriate.</p><p>The MHRA keeps the safety of the COVID-19 vaccines under review
and will update the information leaflets for the vaccines and communicate to patients
and healthcare professionals should any new safety concerns be identified. The MHRA
does not recommend remedial action to patients.</p>
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