Sex: F
Vaccine: MMR
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure before pregnancy, Exposure to communicable disease, Foetal disorder, Neonatal disorder
Clinical narrative: It was reported in a published article, that a female patient whose mother had no reported history of symptoms of acute rubella infection, including rash, fever, lymphadenopathy, or arthralgia, who in October 2003, was vaccinated with a dose of MMR II (manufacturer unknown) (WAES 0512USA00528). On 16-FEB-2004 the mother came into contact with people affected by a rubella outbreak, and it was reported that in utero infection of the patient likely occurred 5-7 days after exposure. On 26-MAR-2004 the mother reported to an emergency department and was determined by a urine test to be pregnant, with confirmation by a blood test. Her last menstrual period and conception were projected to have occurred on 08-FEB-2004 and 22-FEB-2004, respectively. During a routine prenatal visit, one month later, the patient was determined to be immune to rubella on the basis of presence of rubella-specific IgG antibodies. On 04-NOV-2004 the patient gave birth to a female patient weighing 5lbs, 10 oz. The estimated gestational age was approximately 38 weeks on the basis of a prenatal ultrasound performed during the first trimester of pregnancy. At birth the patient was noted to have a left eye cataract, which prompted referral to an ophthalmologist, who repaired the cataract five weeks later. A newborn hearing screen was conducted and the patient's right ear passed the screening test but the left ear required further evaluation by an audiologist. No other physical abnormalities were noted. During two subsequent well-baby visits, a head circumference of less than the fifth percentile was noted, with no other abnormalities. At an age of 10 weeks, the patient was taken to an emergency department with fever, vomiting, irritability, and poor feeding and was hospitalized. During the hospital course the patient received diagnoses of microcephaly, patent ductus arteriosus, bilateral hearing impairment, hepatosplenomegaly, and failure to thrive. It was reported that on the basis of these clinical findings congenital rubella syndrome was suspected. The diagnosis was confirmed by positive rubella IgM and positive viral cultures from urine and nasopharyngeal specimens. The genetic sequence was determined to be that of the wild-type rubella virus. Information received on 29-NOV-2005 contained the following adverse experiences: nausea (26-MAR-2004) and vomiting (26-MAR-2004). Follow up information has been received from a doctor of medicine/PHD who reviewed the case in depth and stated that this case represented a previously published case of congenital rubella occurring in an infant whose mother developed symptoms of rubella infection after an exposure eight days prior to conception. The reporter stated he considered this case to be consistent with congenital rubella syndrome (CRS) from exposure to disease and that there was no evidence that the reported abnormal pregnancy outcome was related to congenital rubella. Additional information is not expected.   [Due to memory limitations, the remainder of this text could not be compared.]  cted. Other business partner numbers include: E2005-05324. This report was previously sent to the PLA V205C on WAES 0512USA00528 on 09-DEC-2005. A copy of the published article is attached as further documentation of the patient's experience.