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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a study conducted between 2008 to 2016, nine patients involving seven girls and two boys aged 11−16 years were described, who developed rash, fever, fatigue, vagal reaction, loss of consciousness, urticarial reaction, palpebral oedema, urticarial events, headache, syncope, dizziness, dyspnoea, allergic exanthema or conjunctivitis during treatment with human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune [Cervarix], human papillomavirus vaccine recombinant quadrivalent Merck [Gardasil] or meningococcal vaccine groups A-C-Y-W-135 conjugate [Menveo; tetravalent anti-meningococcal conjugate vaccine] for human papillomavirus viruses (HPV) infections [routes and dosages not stated].
Case 4: An 11-year-old girl developed rash, fever, fatigue during treatment...
- Tafuri S, et al. Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy). Vaccine 36: 1072-1077, No. 8, 14 Feb 2018. Available from: URL: http://doi.org/10.1016/j.vaccine.2018.01.018 - Italy