OBJECTIVE:To characterize adverse events (AEs) after Haemophilus influenzae type b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

STUDY DESIGN:We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990, to December 1, 2013. We reviewed a random sample of reports and accompanying medical records for reports classified as serious. All reports of death were reviewed. Physicians assigned a primary clinical category to each reviewed report. We used empirical Bayesian data mining to identify AEs that were disproportionally reported after Hib vaccines.

RESULTS:VAERS received 29,747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records. The most common nondeath serious AE categories were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold.

CONCLUSION:Review of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.

OBJECTIVE: To evaluate the safety of Hepatitis B vaccine by analyzing the 10 infants death after Hepatitis B vaccination.

METHODS: Collect the reporting data from the public health emergencies report system of China Disease Prevention and Control System. RESULTS: In the 10 death cases after hepatitis B vaccination, 2 cases would be acute anaphylactic shock caused by the vaccination, and the other 8 death cases were not related to vaccination.

CONCLUSIONS: The hepatitis B vaccine of China were safety, there were very few death cases of allergic reactions following hepatitis B vaccination. We should standardize the vaccination in order to reduce the adverse events following immunization.

The association between sudden infant death syndrome and immunization is frequently discussed. Serious adverse events following vaccination have generally been defined as those adverse events that result in permanent disability, hospitalization or prolongation of hospitalization, life threatening illness, congenital anomaly or death. They are generally referred to the inherent properties of the vaccine (vaccine reaction) or some error in the immunization process (programme error). The event could also be totally unrelated but only temporally linked to immunization (coincidental event). A fatal case of a 3-month-old female infant, who died within 24 h of vaccination with hexavalent vaccine is presented. Clinical data, post-mortem findings (acute pulmonary oedema, acute pulmonary emphysema), quali-quantitative data collected from immunohistochemical staining (degranulating mast cells) and laboratory analysis with a high level of beta-tryptase in serum, 43.3 microg/l, allows us to conclude that acute respiratory failure likely due to post hexavalent immunization-related shock was the cause of death.

The simultaneous sudden deaths of twins rarely occur and therefore it has received limited attention in the medical literature. When the deaths of the twins meet the defined criteria for sudden infant death syndrome (SIDS) independently and take place within the same 24 h range it can be called as simultaneous SIDS (SSIDS). The case(s): Twin girls (3.5-month-old) were found dead by their mother in their crib, both in supine position. The infants were identical twins and delivered at a hospital by cesarean section. Both infants were healthy and did not have any serious medical history. Two days prior to the incident, the twins had received the second dose of oral polio, DPT and the first dose of hepatitis B vaccines and they had fever on the first day of the vaccination and been given teaspoonful of acetaminophen. Death scene investigation, judicial investigation, parental assessment, macroscopic and microscopic autopsy findings and the toxicological analysis did not yield any specific cause of death. The case(s) were referred to a supreme board composed of multidisciplinary medical professionals at the Institute of Forensic Medicine, Ministry of Justice, in Istanbul. The Board decided that the available data was consistent with SIDS. These SIDS case(s) are presented because twin SIDS are rare and this is the first time that a simultaneous twin SIDS have been reported in Turkey. Simultaneous SIDS cases have many implications regarding definition, diagnosis and medico-legal approach.

Experts from panels of the European Agency for the Evaluation of Medical Products have investigated whether there might be a link between hexavalent vaccines and some cases of deaths that occurred. Participants included pathologists with experience in the field of vaccines and sudden infant death syndrome who conducted autopsies. However, to the best of our knowledge, little, if any, attention was paid to examination of the brainstem and the cardiac conduction systems on serial sections, nor was the possibility of a triggering role of the vaccine in these deaths considered. Herein we report the case of a 3-month-old female infant dying suddenly and unexpectedly shortly after being given a hexavalent vaccination. Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.

Breastfeeding is the nourishment designed by nature for the newborn and the infant; however its prevalence is nowadays not optimal. The aim of this article is to review the current evidence of the benefits of breastfeeding for children and society, and to elaborate the risks associated with the replacement of lactation with baby formulas. Breastfeeding is a protective factor for several infectious, atopic, and cardiovascular diseases as well as for leukaemia, necrotising enterocolitis, celiac disease, and inflammatory bowel disease. It also has a positive impact on neurodevelopment, improving IQ and reducing the risk of attention deficit disorder, and generalised developmental and behavioural disorders. Lactation can decrease the risk of sudden infant deaths syndrome by 36% and prevent 13% of infant mortality worldwide. Breastfeeding result in direct saving on the use of infant formulas and bottles, and indirectly on associated health costs, premature deaths, and quality-adjusted life years, among others. In addition, breastfeeding is environmentally friendly; it does not leave an ecological footprint in its production and consumption. The use of baby formulas and bottles have inherent risks, because they increase the risk of oral diseases, such as mouth breathing, malocclusion, alteration of bite, and tooth decay. Finally, the intestinal microbiota, oxygenation, and thermoregulation of infants are negatively affected by their use.

In 1985 twin boys simultaneously succumbed to sudden unexpected deaths two to three hours after vaccination with diphtheria, tetanus, and pertussis vaccine (DTP). This occurrence again raises the question of whether an association of sudden infant death (SID) with vaccination is other than temporal. Taking the incidence of SID in conjunction with rates of infant vaccination in the United Kingdom, nine infants would be expected to die, each year by chance alone, suddenly within 24 hours of (and within each 24 hour period succeeding) vaccination with DTP. Twins are at a greater risk of SID than single born infants and occasionally are found dead together. A number of studies into DTP vaccination as a risk factor in SID have shown that SID is less common in vaccinated than in unvaccinated infants.