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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A retrospective study of 57 infant autopsy cases conducted at the Tokai University School of Medicine, Japan in between 2013 and 2017 described 2 male and 1 female infants, aged 3 months−1 year and 2 months, who experienced sudden infant death syndrome (SIDS) following vaccinations with Hib vaccine, pneumococcal 7 valent CRM197 vaccine conjugate and rotavirus vaccine (1 patient), Hib vaccine, Hepatitis B vaccine, pneumococcal 13 valent CRM197 vaccine conjugate, DTP poliovirus vaccine and rotavirus vaccine (1 patient) or Hib vaccine (1 patient) [routes and dosages not stated].
Case 1: A 3-month-old female infant developed cold symptoms on the day same following the administration of second combined immunisation with Hib vaccine, pneumococcal 7 valent CRM197 [PCV7] vaccine...
- Osawa M, et al. Sudden Infant Death After Vaccination: Survey of Forensic Autopsy Files. American Journal of Forensic Medicine and Pathology 40: 232-237, No. 3, Sep 2019. Available from: URL: http://doi.org/10.1097/PAF.0000000000000494 - Japan