Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: C-reactive protein increased, Foetal exposure during pregnancy, Haematocrit normal, Haemoglobin normal, Hypothermia neonatal
Clinical narrative: Sepsis, neonatal, other specified bacteria; Foetal exposure during pregnancy; respiratory distress; Hypothermia; Feeding problems; 42 3/7 weeks born; This spontaneous prospective preganncy report was received from a physician and refers to a 1-day-old male patient.   On 16-AUG-2017, the 17-year-old mother of the patient was was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly in the right deltoid (lot # M040412, expiration date was not reported but upon internal validation established as 30-JUN-2019; strength and dose were not reported). On the same day, his mother was vaccinated with the first dose of meningococcal b rfhbp vaccine (e. coli) (TRUMENBA), intramuscularly in the left deltoid (lot # S26985; strength, dose and expiration date were not reported) and the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), intramuscularly, in the left deltoid (lot # 45539AA; strength, dose and expiration date were not reported). The mother was unaware of being pregnant. According to mother's report, on the same day, she requested oral birth contraceptive (OBC), denied being sexually active and stated that her last menstrual period was on 28-JUL-2017 (also reported as 3 weeks early July 2017). Therefore, she was given the OBC which she took during September and October in 2018. On 25-OCT-2017, the mother 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, she 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. She was sent to ultrasound and measured 38 weeks plus 3 days. Her estimated LMP was on 14-FEB-2017 and her estimated date of delivery would be 21-NOV-2017.  The mother 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.   It was 42 week and 3 days of the mother's pregnancy. The mother had an induction of labor, her membranes were raptured on 07-DEC-2017. 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 baby was born vaginally. 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 patient 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 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 patient's temperature was 36.2 Celsius degrees. The diagnosis was hypothermia, newborn. The patient 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 patient had feeding problems (unspecified). He was breastfed on demand and doing well with nipple shield. On 08-DEC-2017, the patient 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.  The outcome of respiratory distress was considered to be recovered on 08-DEC-2017. The outcome of the rest of the events was not provided. The causality assessment between the events and the suspect vaccines was not provided.  Upon internal review, the events of sepsis neonatal and neonatal respiratory distress was considered to be medically significant.  All available medical records will be provided upon request.  This case is cross referenced with the mother's case MARRS # 1802USA011087.; Sender's Comments:  US-009507513-1802USA011087: