Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: This is a spontaneous case, initially received from other health professional on 24-Jan-2019, concerning a male neonate patient. The patient's mother was a 30-year-old female with height 160 cm and weight 65.77 kgs. The patient's mother had no previous pregnancy. The patient's mother had no history of offspring with major congenital malformation. Also, the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The last menstrual period (LMP) date of the patient's mother was 12-May-2018. The type of pregnancy was singleton. The pregnancy status of the patient was collected, and no pregnancy complications were noted. On 10-Aug-2018, the patient's mother underwent prenatal tests for cystic fibrosis which revealed no major congenital malformation. On the same day, 1st trimester screening was also performed and was noted that the patient was positive for the risk of Down's syndrome. On 18-Aug-2018, non-invasive prenatal testing (NIPT) was performed, and no major congenital malformations were noted. On 08-Sep-2018, 2nd trimester screening was performed, and no major congenital malformations were noted. Concomitant medication included Vitafol one for healthy pregnancy. On 06-Oct-2018, at approximately 21 weeks of gestation, the patient's mother received FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, batch number: 252232, dose, route of administration, anatomical location, expiry date: not reported) for an unknown indication. The patient was exposed to the vaccine via transplacental route (explicitly coded as foetal exposure during pregnancy). On an unspecified date, after administration of vaccine, the patient's mother developed constipation and haemorrhoids. 3 months and 10 days after vaccination, a male infant was born via vaginal type of delivery with weight 2.34 kg (reported as low birth weight) at 35.7 weeks gestational week (reported as pre-term birth), length 44.5 cm and head circumference 30.5 cm. The APGAR (appearance, pulse, grimace, activity, and respiration) scores were 9 (one minute) and 9 (five minutes). At the time of this report, the outcome of the events was unknown. This case is linked to (201805958), the corresponding maternal pregnancy report.; Reporter's Comments: A neonate had preterm birth with low birth weight, more than 3 months after fetal exposure during pregnancy to FLUCELVAX QIVc. The event preterm birth have multifactorial aetiology. Considering the implausible temporal relationship between vaccination to events onset and no known biological mechanism post-vaccination, the event preterm birth with low birth weight were assessed as not related to suspect vaccine. The high risk of down syndrome during pregnancy screening can be other possible risk factor. The event foetal exposure during pregnancy was considered as not related to suspect vaccine considering the intended use of the vaccine. Company assessed the case as serious (medically significant).