Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion threatened, Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Foetal non-stress test, No adverse effect
Clinical narrative: Initial and follow up information has been received through the Merck regulatory pregnancy registry from a registered nurse at a health department and an unspecified family member concerning a 23 year old white female smoker who was 34 weeks pregnant with cervical incompetence, allergies to erythromycin and moxifloxacin hydrochloride (AVALOX) and had a history of premature labour from a prior pregnancy, a history of 3 pregnancies and 2 live births, a yeast infection, a threatened abortion, "ruptured membranes/delivery" and cervical dysplasia that had required a LEEP surgery, however, this procedure was not performed as the patient became pregnant.  On 14-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpus". On 21-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus". On 02-MAY-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" and "gestational age, threatened abortion". On 26-JUN-2006, the patient underwent a maternal serum alphafetoprotein (MSAFP) which revealed "in range normal". It was reported that on an unspecified date, the patient had been hospitalized due to "lower back contractions". The patient had been diagnosed with a kidney infection and was advised to see her primary care physician for a flu shot. On 17-OCT-2006, (conflicting information also reported as 20-OCT-2006), the patient went to her physician and received one dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) administered intramuscularly instead of the flu shot. Concomitant therapy included prenatal vitamins and unspecified therapies (reported as "tributylene", "suflexan" and "cyclomenzaprene"). On 16-OCT-2006 (conflicting information also reported as 20-OCT-2006), the patient was not having any adverse reaction. It was reported that the patient had already been experiencing pre-term labour, prior to receiving the shot.  The patient sought unspecified medical attention. On 24-OCT-2006, the patient received a 1 cc flu shot. On 02-NOV-2006, the patient received betamethasone (CELESTONE), 12 mg, intramuscularly to "decrease contractions". On 06-NOV-2006, the patient underwent an ultrasound which revealed "amniotic fluid index=28.4" and "rule out ruptured membranes". On 15-NOV-2006, 16-NOV-2006, and 20-NOV-2006, the patient underwent a fetal nonstress test (NST) (results not reported). On an unspecified date, the patient received acetaminophen/codeine phosphate (TYLENOL WITH CODEINE #3) for migraines.  At the time of this report, the outcome of the events were unknown.  The reporter stated that the patient had been hospitalized  "prior to receiving the hpv rl1 6 11 16 18 vlp vaccine (yeast) vaccination for an unrelated kidney infection and lower back contractions". Additional information has been requested.