Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Dental caries, Dyspnoea, Eye movement disorder, Mass, Respiratory disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 4-month-old male patient who received PEDIARIX for prophylaxis. Co-suspect products included POLIO VACCINE for prophylaxis, ROBITUSSIN for prophylaxis, HIV VACCINE for prophylaxis, QVAR for an unknown indication, VENTOLIN HFA inhaler for asthma and Albuterol unknown for difficulty breathing. Concurrent medical conditions included asthmatic attack and allergy. In August 2013, the patient received PEDIARIX. On an unknown date, the patient received Polio Vaccine at an unknown dose, ROBITUSSIN at an unknown dose, HIV Vaccine at an unknown dose, QVAR at an unknown dose and frequency, VENTOLIN HFA at an unknown dose and frequency and Albuterol at an unknown dose and frequency. On an unknown date, less than a day after receiving PEDIARIX, less than a year after receiving Polio Vaccine and not applicable after starting VENTOLIN HFA and Albuterol, the patient experienced seizure (serious criteria GSK medically significant), choking (serious criteria GSK medically significant), eye rolling, tremor, difficulty breathing, asthma aggravated, screaming, crying, bowel movement irregularity, mass, respiratory disorder and tooth decay. The action taken with QVAR was unknown. The action taken with VENTOLIN HFA was unknown. The action taken with Albuterol was unknown. On an unknown date, the outcome of the seizure, choking, eye rolling, tremor, screaming, crying, bowel movement irregularity and mass were recovered/resolved and the outcome of the difficulty breathing, asthma aggravated, respiratory disorder and tooth decay were not recovered/not resolved. It was unknown if the reporter considered the seizure, choking, eye rolling, tremor, difficulty breathing, asthma aggravated, screaming, crying, bowel movement irregularity, mass and respiratory disorder to be related to PEDIARIX. It was unknown if the reporter considered the tooth decay to be related to VENTOLIN HFA and Albuterol. Additional details were provided as follows: This case was reported by patient's mother. The patient also received ora vaccine. Within 24 hours, after receiving PEDIARIX, the patient experienced a seizure. The reporter claimed that, the seizure occurred at night and his eyes rolled and it looked like he was choking and shaking and it lasted under 6 seconds and resolved. The reporter claimed that, he screamed and cried for 4 to 6 hours and he had irregular bowel movements for one week. Less than a month after receiving PEDIARIX, the patient also had a bump or knot on his left leg for two months which has resolved. Two months after receiving PEDIARIX, the reporter claimed that at 6 months of age, he was struggling to breathe and two years later he has respiratory disease, with breathing issues and asthma. The reporter also reported that, his teeth are bad and rotting after using VENTOLIN HFA, QVAR and Albuterol breathing treatments but she was not certain which product caused the bad teeth. The reporter claimed that he was using VENTOLIN in 2014. It was unknown if the reporter considered the seizure, eye rolling, choking, tremor, difficulty breathing, asthma, screaming, crying, bowel movement irregularity, mass, respiratory disorder, asthma and tooth decay to be related to ROBITUSSIN vaccine, HIV vaccine and Polio vaccine. It was unknown if the reporter considered the tooth decay to be related to VENTOLIN HFA, QVAR and Albuterol as well.