Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Hepatitis B surface antigen negative, Human chorionic gonadotropin positive, Induced labour, Neisseria test, Neonatal disorder
Clinical narrative: 42 3/7 weeks born; Prolonged labor; induction of labor; Maternal fever was greater than 100.4 degrees F.; ultrasound antenatal screen normal; human chorionic gonadotropin positive/blood HCG was positive in office; pregnancy test positive/ patient returned on 09-NOV-2017 reporting positive home pregnancy test; exposure during pregnancy; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 727017) on 21-FEB-2018, referring to a 17-year-old pregnant female patient. None current illness, medical history, other medications nor prior vaccinations were reported.  On 16-AUG-2017, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, intramuscularly in the right arm (lot # M040412, expiration date was not reported but upon internal validation established as 30-JUN-2019) for prophylaxis. On the same day, she also received meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), 0.5 ml (lot # U5539AA, expiration date and strength were not provided) and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA), 0.5 ml (lot # S26985, expiration date and strength were not provided) both intramuscularly, in the left arm.   On the same day, the patient requested oral birth contraceptive (OBC), denied being sexually active and stated that her last menstrual period was on 28-JUL-2017. Therefore, she was given the OBC which she took during September and October in 2018.  On 25-OCT-2017, the patient returned for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Furthermore, on an unspecified date in 2017, the patient had a positive home pregnancy test; so she returned to the physician office on 09-NOV-2017 and informed about it; subsequently a blood human chorionic gonadotropin (HCG) test was performed there and was positive. The patient was sent to ultrasound and measured 38 weeks plus 3 days. The patient's estimated LMP was on 14-FEB-2017 and her estimated date of delivery would be 21-NOV-2017. At the time of this report, the outcome of the exposure during pregnancy, ultrasound antenatal screen normal, pregnancy test positive and human chorionic gonadotropin positive was unknown; as well as the pregnancy outcome which remained pending.  The agency considered this case as non-serious. The agency did not give the causality assessment between the events and suspect vaccines.  Follow-up was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 727017) on 20-JUN-2019. Information was received from a medical assistant. The patient's was a female and her allergies included orange juice (hives). She received her vaccines in deltoids.  Follow up information has been received on 25-JUN-2019 and stated that the aware date of the previous version was corrected to 19-JUN-2019.  Follow up information has been received from a physician on 02-DEC-2020. The patient's date of birth was provided. Her historical vaccines included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA). She was a non-smoker. Her blood type was 0+. On 16-AUG-2017, the patient was vaccinated with the first dose of meningococcal b rfhbp vaccine (e. coli) (TRUMENBA). The patient was never pregnant before. She was unaware of being pregnant. She claimed she had a bleeding on 28-JUL-2017 (also reported as 3 weeks early July 2017) and she reported it was the date of her last menstrual period. She had her first prenatal visit on 14-NOV-2017 (she was tested for human immunodeficiency virus (HIV) and Syphilis then) and her last prenatal visit on 06-DEC-2017. There were not risk factors in this pregnancy. She had no infections during pregnancy. She had antibody screen negative, Hepatitis B surface antigen (HBsAg) negative, serology non-reactive, HIV negative,  group B streptococcus (GBS) negative, gonorrhea test (GC) negative and Chlamydia negative. She was Rubella immune. She had no obstetric procedures performed.  On an unknown date in December 2017, the patient was admitted to the hospital. Tocolysis occurred. On 07-DEC-2017, she had an induction of labor, her membranes were raptured on 07-DEC-2017 at 08:23 AM. Fluid was clear. The fetus was monitored externally. Maternal fever was greater than 100.4 degrees Fahrenheit. The mother received oxytocin (PITOCIN) during labor and epidural anesthesia. Also, she received three doses of ampicillin and one dose of gentamicin. Presentation of fetus was vertex. The labor was prolonged and it took 22 hours and 36 minutes. the male infant was born vaginally, spontaneously. It was 42 weeks and 3 days of pregnancy. The infant had initial respiratory distress but transitioned quickly post delivery. In the delivery room the baby was stimulated. Suctioned with a bulb. The patient had Apgar score 8 at one minute and 9 at five minutes. His birthweight was 3700 grams. His head circuit (circ) was 36.00 cm, his body temperature was 36.33 Celsius degrees; pulse rate was 134 (unit not provided), respiratory (Resp) rate was 46 (unit not provided), glucose was 61 (unit not provided), "Dia" was 41 (unit not provided), pulse oximetry (Ox) was 100 (unit not provided). On the same day, the infant was admitted to newborn intensive care unit (NICU) from newborn nursery as he had suspected sepsis and required intensive monitoring and observation for signs/symptoms of clinical sepsis. He was transferred to NICU in crib and placed on pre-warm radiant warmer (RW). His admission physical exam on 08-DEC-2017 at 15:14 showed: GENERAL: awake, alert, responsive; in no acute distress; no dysmorphic features; exam consistent with gestational age assessment; HEAD/FACE: normocephalic; sutures opposed; anterior fontanel flat; EYES: red reflex present bilaterally; EARS: normally set; internal ear exam not performed; NOSE/MOUTH/THROAT: no nasal flaring; nares patent bilaterally; no cleft; gag reflex present; NECK/THYROID: supple; LYMPHATIC: no adenopathy noted; BREAST: normal for gestational age; RESPIRATORY: no retractions noted; breath sounds clear and equal with good air exchange; CARDIO/VASCULAR: S1, S2 normal; no murmur appreciated; regular rate and rhythm; pulses equal; ABDOMEN: bowel sounds present; soft, non-tender without masses; no hepatosplenomegaly; GASTROINTESTINAL (GU)/RECTAL: testes descended bilaterally; anus patent; SKIN/HAIR: large port wine stain to right leg; BACK/SPINE: no abnormalities noted; no sacral dimple; MUSCULOSKELETAL/EXTREMITIES: no deformities noted; hips stable; moves all extremities symmetrically; NEUROLOGICAL: reflexes 2+ and symmetric; muscle tone appropriate for gestational age; White Blood Cells (WBC): 14.6 (unit not provided); Hemoglobin/Hematocrit (H/H): 16.1/48 (unit not provided); Platelet (Plt): 349000 (unit not provided); "I:T": 0.14 (unit not provided); C-reactive protein (CRP): 10.1(unit not provided), increased. At the admission, the infant's temperature was 36.2 Celsius degrees. The diagnosis was hypothermia, newborn. The infant was at risk for hypoglycaemia and required intensive monitoring and observation for need for continued thermoregulation. He received fluid administration (reported as sweetease) through peripheral intravenous catheter (right hand) and he tolerated procedure well with good pain management. RW was maintained for thermoregulation. Since 08-DEC-2017, the infant had feeding problems (unspecified). The patient was breastfeeding the infant on demand and he was doing well with nipple shield. On 08-DEC-2017, the infant started receiving gentamycin and ampicillin. On 10-DEC-2017, the patient had hearing screening (Automated Auditory Brainstem Response (AABR)) performed and he passed the test.  Upon internal review, the event of puerperal pyrexia was considered to be medically significant.  All available medical records will be provided upon request.  This case is cross referenced with the child's case MSRRS # 2012USA001391.; Sender's Comments:  US-009507513-2012USA001391: