Sex: F
Vaccine: HEP
Symptoms: Atrial septal defect, Cardiac murmur, Cardiomyopathy, Death, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of cardiomyopathy in a neonate female patient exposed to Hepatitis B vaccine at birth. The baby received the product. Co-suspect product exposures included ZOFRAN solution for injection/infusion and VALTREX unknown. The parent's medical history included nausea and vomiting (The patient took ZOFRAN), cough and live birth (The patient had 2 previous pregnancies. Babies were born healthy). In 2013, the mother started ZOFRAN (intravenous) 4 mg at an unknown frequency. In January 2014, the mother started VALTREX (unknown) at an unknown dose and frequency. The patient experienced a drug exposure during pregnancy. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. In 2013, during her pregnancy, she had an ultrasound antenatal screen which showed a single fetus in a longitudinal lie, breech presentation. The amount of the amniotic fluid was normal. The placenta was anterior. Good fetal cardiac and extremity motion were seen. The fetus had a biparietal diameter of 5.7cm, a femur length of 4.2cm, both consistent with the gestational age of 23 weeks and 3 days. Head abdomen ratio was 1.16 and fetal heart rate was 156 beats per minute. The estimated weight based on this exam was 599+/-90g. Concomitant product exposures included medication unknown (Epidural). The neonate received Hepatitis B vaccine. At 41 weeks gestation, the patient was born via unknown delivery and weighed 2855 grams (6lbs 5oz) at birth. APGAR scores were 8 and 9, her length was 46cm and her head circumference was 33cm. Within 2 hours after the vaccination with Hepatitis B vaccine, the patient experienced cardiomyopathy (serious criteria death), shock (serious criteria death and GSK medically significant), sepsis (serious criteria GSK medically significant), respiratory distress (serious criteria GSK medically significant), tachycardia, heart murmur, metabolic acidosis and hypotension. On an unknown date, the patient experienced labeled drug-drug interaction medication error. The patient was treated with ATIVAN, phytonadione, aeptimyoclin, gentamicin, alprostadil, sodium chloride, hydrocodone bitartrate, Hydrocodine, ZOVIRAX, dopamine, epinephrine, Cefotaxima, milrinone, poractant alfa, vecuronium, sodium acetate and glucose + water (D5W). On 7th March 2014, the outcome of the drug exposure during pregnancy was unknown. On 9th March 2014, the outcome of the cardiomyopathy and shock were fatal. On an unknown date, the outcome of the sepsis, respiratory distress, tachycardia, heart murmur, metabolic acidosis, hypotension and labeled drug-drug interaction medication error were unknown. The patient died on 9th March 2014. The reported cause of death was cardiomyopathy and shock. It was unknown if the reporter considered the cardiomyopathy, shock, sepsis, respiratory distress, tachycardia, heart murmur, metabolic acidosis, hypotension, labeled drug-drug interaction medication error and drug exposure during pregnancy to be related to Hepatitis B and VALTREX. The reporter considered the cardiomyopathy, shock, labeled drug-drug interaction medication error and drug exposure during pregnancy to be related to ZOFRAN. It was unknown if the reporter considered the sepsis, respiratory distress, tachycardia, heart murmur, metabolic acidosis and hypotension to be related to ZOFRAN and VALTREX. Additional details were provided as follow from the legal department: The mother was taking ZOFRAN injection after going to the hospital at the beginning of the pregnancy for nausea and vomiting. The mother was sent home with one pill to take after leaving the hospital. She was given a prescription for the product that she did not fill. The baby was fine all through the pregnancy. The patient was given the product during the same time she was receiving an epidural. A healthy baby girl was born with no problems. The baby weighed six pounds and five ounces. The baby's APGAR scored was noted as being 8/9 after birth in the medical records. The overall health of the baby after birth was good. The baby had ZOFRAN in her system and within two hours after giving birth, the baby started to have side effects (tachycardia, respiratory distress, cardiomyopathy and metabolic acidosis). The baby's heart started to deteriorate and APGAR score began to fall. The baby suffered from tachycardia and then cardiomyopathy. During the time span from birth until March 9, 2014 the baby had metabolic acidosis before death. The doctor tried to counteract ZOFRAN with ATIVAN. After 2 days, the baby passed away from cardiomyopathy and irreversible shock. According to the death certificate the cause of death is listed as metabolic irreversible shock and did not put metabolic acidosis on the certificate. The mother also mentioned that the left ventricle was shortened and there was a hole in the heart. The mother noted all of the medications her daughter was given after birth and during the time she was in the hospital before her death. The mother believes that being given ZOFRAN by injection during the epidural was the cause of the heart problems her daughter experienced after birth leading to her death. The mother has been doing research to find out more information about the medications and possible drug interactions with the product. It is not known if she was given the generic or brand but believes that she received the brand name when she went to the hospital during the first trimester with her daughter. In her research, the mother noted that ZOFRAN and erythromycin has a drug interaction that can cause a serious reaction that can cause death. The hepatitis B vaccine can also cause a drug interaction with ZOFRAN. This is a legal significant cause according to the mother.