Sex: M
Vaccine: HEP
Symptoms: Disturbance in attention, Dyskinesia, Dyspnoea, Eye movement disorder, Gaze palsy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of breathing arrested in a male patient who received ENGERIX B pediatric. On 4th May 2016, the patient received the 1st dose of ENGERIX B pediatric. On 4th May 2016, less than a day after receiving ENGERIX B pediatric, the patient experienced attention impaired. On 5th May 2016, the patient experienced labored breathing. On 8th May 2016, the patient experienced breathing arrested (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), gaze palsy (serious criteria GSK medically significant), oral discomfort, heart rate decreased and pale skin. In May 2016, the patient experienced sleep apnea and vomiting. ENGERIX B pediatric was interrupted. On 8th May 2016, the outcome of the breathing arrested, seizure, gaze palsy and oral discomfort were recovered/resolved. In May 2016, the outcome of the labored breathing, vomiting and heart rate decreased were recovered/resolved. On an unknown date, the outcome of the sleep apnea was not recovered/not resolved and the outcome of the attention impaired was recovered/resolved and the outcome of the pale skin was unknown. The reporter considered the breathing arrested, gaze palsy, labored breathing, sleep apnea, oral discomfort, vomiting, heart rate decreased and attention impaired to be related to ENGERIX B pediatric. It was unknown if the reporter considered the seizure and pale skin to be related to ENGERIX B pediatric. Additional details were provided as follows: This case was also reported to a doctor. The case was reported by the patient's father. The patient received the vaccine right after the birth. No other vaccines were given that day. The patient after being born, was very attentive and looking around the room. On the same day, in the night, the patient was not as attentive or responding to sounds like earlier in the day. On the next day the patient reacted the same way and was inattentive. On 5th May 2016, 1 day after receiving ENGERIX B pediatric, the patient experienced labored breathing (breathing did not sound normal). To the patient's parents, it sounded like the patient was gasping for air. A doctor and a nurse told the patient's parents that what he thought was abnormal was normal, for a newborn. They did not see that it was a concern. On 7th May 2016, the parents took the patient home. Before checking out, the parents were still concerned about the patient's breathing, but the nurse that checked them out the hospital was not concerned. The parents took the patient home. On 8th May 2016, 4 days after receiving ENGERIX B pediatric, the patient experienced pale skin, mouth tightness, eyes rolled back in the head and stopped breathing. The patient's skin color had changed and was very pale. The father felt that the patient had a seizure. In May 2016, less than a month after receiving ENGERIX B pediatric, the patient experienced sleep apnea and vomiting. The patient's father took the patient to the emergency room since the hospital was close by. This case was linked with US2017GSK003449, for the same reporter.