Sex: M
Vaccine: HEP
Symptoms: Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: The skin over the swollen right thigh had ecchymosis and discoloration; The skin over the swollen right thigh had ecchymosis and discoloration; The skin over the swollen right thigh had ecchymosis and discoloration; This literature marketed report has been received from the authors of a published literature article, titled as stated below concerning to a 2-day-old male. The patient's concurrent conditions included  haemophilia a (factor VII). No information was provided regarding the patient's medical history, previous drug reactions or allergies. The patient was born at 38 weeks of gestation without complications after an uncomplicated pregnancy to a primigravida who was 31 years of age at the time of birth, there was no abnormality noted at birth. There was no family history of genetic diseases, and his prenatal history was unremarkable.  The patient's mother was a hepatitis B virus carrier, therefore, unknown date (reported as "soon after birth"), the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) at a dose of 0.5 mL, administered intramuscularly on the right thigh (strength, lot #, and expiry date were not provided). The patient also received 0.1 mL of vitamin K1 intramuscularly on the right thigh. Concomitantly he received 0.5 mL of hepatitis B immunoglobulin intramuscularly on the left thigh.  On an unknown date (day 2 of the infant's life), the patient experienced vaccination site swelling, vaccination site haemorrhage and vaccination site discolouration. He was brought to the well-baby nursery with edema of the right thigh, the swelling of the right thigh was apparent at about 36 hours after the intramuscular injections. On physical examination, the skin over the swollen right thigh had ecchymosis and discoloration.  On that day, the patient was transferred to the neonatal intensive care unit (NICU) nursery. A blood culture was obtained (results not provided), and antibiotics were initiated. Peripheral intravenous (IV) fluid was infused on the left forearm and hand. The day after NICU admission (day 3 of the infant's life), ecchymosis of his left hand and forearm were noted after removal of the IV angiocatheter, bleeding at the IV site was noted to prolong. Coagulation (ie, activated partial thromboplastintime (aPTT) and prothrombin time) and platelet count studies were obtained. The aPTT was prolonged. The diagnosis of hemophilia was made after the factor VIII level confirmed the diagnosis (Patient's underlying disease). The patient received factor VIII concentrates. The ecchymosis and swelling gradually resolved without any complications. He was discharged home on day 10 of life. Within a few days of discharge, he was seen by a pediatric hematologist at the clinic, where his parents were counseled about potential problems (eg, heel sticks, vaccinations, intramuscular injection), including those that may relate to major bleeding, such as intracranial hemorrhage (ICH).  The authors considered the patient's vaccination site swelling, vaccination site haemorrhage and vaccination site discolouration to be related to hepatitis b vaccine (recombinant) (manufacturer unknown) and vitamin K1, as it would be considered in the differential diagnosis as a complication of intramuscular injection in neonates.  Literature Report:  A copy of the published article is attached as further documentation of the patient's experience.