22 Jun 2016
Management and reporting adverse eventsInformation on management and reporting of suspected adverse events following YF vaccination
The safety profiles of all medicinal products marketed in the UK are subject to continuous monitoring by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Marketing Authorisation Holder. To support these activities health professionals are requested to report the following adverse events that occur following vaccination with yellow fever vaccine:
- All cases of confirmed or suspected YEL-AND or YEL-AVD.
- All other serious adverse events, which include those that are fatal, life threatening, disabling or incapacitating, result in prolong hospitalisation, congenital abnormalities, or are medically significant.
Report these serious suspected adverse events to all of the following organisations:
- Medicines and Healthcare Regulatory products Regulatory Agency via the yellow card system at: https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals.
- Sanofi Pasteur MSD UK through their online Adverse Event Reporting Form at: http://www.spmsd.co.uk/ae/ or by calling the Pharmacovigilance Department on 01628 785291.
- National Travel Health Network and Centre (NaTHNaC) via the telephone advice line or email NaTHNaC for the attention of the NaTHNaC Senior Nurse.
In addition, health professionals caring for those who have a temperature of greater than 38.5°C lasting at least 24 hours, and occurring within 30 days of YF vaccination are encouraged to complete a report form and return it to the Robert Koch Institute in Germany who are undertaking research into these rare adverse events.
Routine initial blood tests to be considered for those with suspected YEL-AND and YEL-AVD include:
- Full blood count
- Urea and electrolytes
- Liver function tests
- Clotting profile
- Other [see below]
Additional sample specimens may be necessary to determine whether an illness is due to the YF vaccination. Laboratories should be consulted for advice on the transport requirements of specialist samples. Additional information is provided by Centers for Disease Control.
Specific clinical advice regarding management of those who are suspected of having a serious adverse event following YF vaccine administration should be sought from local specialist infectious disease units.
Guidelines on clinical procedures
- Medical letter of exemption
- International Certificate of Vaccination or Prophylaxis (ICVP)
- Record keeping and consent