To ask the Secretary of State for Health and Social Care, in how many and what proportion of cases in which a fatal outcome was reported following covid-19 vaccination did a healthcare professional seek further information about the case; and how many and what proportion of such follow-up requests resulted in (a) further information and (b) no response being provided.
Answered on
18 July 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) acknowledge receipt of every Yellow Card report received and a team of safety experts follows up for further information as necessary, including all reports with a fatal outcome, based on the completeness, severity and clinical details provided in the report.
Responses to follow-up requests for adverse drug reaction (ADR) reports are recorded and stored with the original report on the MHRA’s ADR database. The information is then passed downstream for use in signal detection and the identification of safety concerns. The data is available for its core purpose of assessment and signal detection; however, the systems were not designed to quantify the follow-up metrics requested. As such, it is not possible to automatically generate metrics on the proportion of follow-up requests sent, or those which resulted in further information being received.