Postvaccination bleeding in neonates: vitamin K deficiency bleeding?
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Postvaccination bleeding in neonates: vitamin K deficiency bleeding? Vitamin K deficiency bleeding (VKDB) "should be suspected in young infants presenting with bleeding including following vaccination", according to study results reported in Vaccine, and "in countries without policy of VK prophylaxis at birth including Nepal, the policy should be introduced". The retrospective study used Nepal’s adverse events following immunisation (AEFI) surveillance system in 2016-2018. There were 75 serious AEFI cases reported, which comprised 3.9 per 100 000 surviving infants or 0.37 per 100 000 vaccine doses administered. Of these, 16 cases (21.3%) involved external or internal bleeding, in patients 40–94 (median 57) days of age; 11 patients were boys. The AEFI investigation committee classified all cases as "coincidental events not causally related to the putative vaccine dose(s)". One case had a confirmed history of receiving vitamin K at birth, and 9 cases had a history of no receipt at birth. There were 14 cases with bleeding externally from a vaccine IM injection site, 0.5–48 (median 4.3) hours postvaccination; onset was within 12 hours for 11 patients (78.6%). Two patients without external bleeding who also received IM vaccination were found to have intracranial haemorrhage (ICH), along with four other cases, detected by CT scan (n=4) or autopsy (n=2). For those without external bleeding, the first symptoms were fever 72 hours postvaccination and fever with left thigh swelling 1 hour postvaccination, respectively. The other ten cases did not have CT scans or autopsies, and therefore ICH "could not be confirmed or excluded", note the authors. Ten cases received appropriate treatment with vitamin K and blood transfusion if required; two other cases only received blood transfusion. "None of these 10 cases received appropriate treatment on the first contact with a health facility", note the authors, with up to five health contacts required. Three cases fulfilled the criteria for VKBD; relevant laboratory testing was absent for 11 cases which were therefore classified as suspected VKBD. Two cases classified as non-VKBD were diagnosed as disseminated intravascular coagulation with suspected ICH and suspected inborn error of metabolism, respectively. In total, 9 patients died, including 8 of the 14 cases with VKBD or suspected VKBD. "We strongly recommend introduction of VK prophylaxis at birth in the national policy of essential newborn care", note the authors, and "all infants presenting with bleeding, including following vaccination, should be urgently evaluated". Pradhan R, et al. Vaccine safety surveillance informs public health policy beyond immunization: A case-series on bleeding following vaccination, Nepal, 2016-2018. Vaccine : 803498340 9 Aug 2020. Available from: URL: http://doi.org/10.1016/j.vaccine.2020.07.035
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Reactions 29 Aug 2020 No. 1819
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