Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Foetal exposure during pregnancy, Hyperbilirubinaemia neonatal, Large for dates baby, Mechanical ventilation
Clinical narrative: Foetal exposure during pregnancy; Hyperbilirubinemia in infant; Resuscitation at delivery; Birthweight of 4170 g; APGAR score 5 at one minute; This observational study case was received from other health professional on 06-Aug-2021 and concerned a female neonate, whose mother was a 37-year-old, pregnant, female subject of body weight 130 lbs, height 68 inches and body mass index (BMI) 19.8, enrolled in a prospective observational safety study.  The maternal concurrent conditions included pregnancy with advanced maternal age. The maternal concomitant medications included folic acid and prenatal vitamins (unspecified minerals and vitamins), both used for healthy pregnancy and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) used for vaccination.  The maternal obstetrical history included two previous pregnancies with two spontaneous abortions. The neonate's mother had no offspring with major congenital malformations (MCMs). The neonate's mother had no maternal or paternal history with MCMs. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The last menstrual period (LMP) date was reported as 03-Oct-2020, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 10-Jul-2021. The type of pregnancy was singleton. The paternal age was 38 years.   On 01-Nov-2020, the genetic screening and cystic fibrosis mutation analysis tests revealed no MCMs.   On 30-Nov-2020, at approximately eight weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, anatomical location and  route of administration: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100267077.  On the same day, the ultrasound test revealed no MCMs.   On 11-Dec-2020, 23-Dec-2020 and 05-Feb-2021, the ultrasound tests revealed no MCMs.   On 23-Feb-2021, anatomy ultrasound test revealed no MCMs.   On 29-Apr-2021, ultrasound test revealed no MCMs. The mother failed initial glucose tolerance test (one-hour glucose) and then passed the three-hour glucose, meaning no gestational diabetes was noted.  At 39.7 weeks of gestation (as reported), the mother delivered female neonate via vaginal method of delivery. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate's birth weight was 4170 grams, body length: 53.3 centimetres and head circumference was 35 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 5, at five minutes was 8 and at ten minutes was not reported. Also, the neonate experienced hyperbilirubinemia and received phototherapy for 24 hours post-delivery. No MCMs were identified at delivery. The neonate's mother experienced postpartum haemorrhage due to retained placenta.   On the same day, the neonate recovered from 'apgar score low' and 'resuscitation'.  The outcome of the events of 'hyperbilirubinemia newborn', 'large for dates baby' was not reported.   The reporter did not provide a causality assessment.  The events of 'hyperbilirubinemia newborn', 'large for dates baby', 'apgar score low' and 'resuscitation' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked to case 202102377 (the corresponding mother case).  Company Comment: A female neonate was born with 4170 grams, 7 months and 8 days after maternal receipt of Afluria QIV (explicitly coded as 'Foetal exposure during pregnancy'). APGAR score was 5 at one minute. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate required phototherapy for 24 hours post-delivery due to hyperbilirubinemia.  No MCMs were identified at delivery. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Causality for foetal exposure during pregnancy is not related as per company specific guidelines. Causality for all other events is assessed as not related due to biological implausibility.; Sender's Comments: A female neonate was born with 4170 grams, 7 months and 8 days after maternal receipt of Afluria QIV (explicitly coded as 'Foetal exposure during pregnancy'). APGAR score was 5 at one minute. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate required phototherapy for 24 hours post-delivery due to hyperbilirubinemia.  No MCMs were identified at delivery. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Causality for foetal exposure during pregnancy is not related as per company specific guidelines. Causality for all other events is assessed as not related due to biological implausibility.