To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 9 February 2022 to Question 92799 on Coronavirus: Vaccination, in how many of the Yellow Card cases where the patient was reported to have died shortly after vaccination did the analysis show that the event would have happened regardless of the vaccine or medicine being administered.
20 April 2022
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.
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.
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.