Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 18-Feb-2019, concerning a male neonate patient. The patient's 37 year old mother had 5 previous pregnancy reported with all full-term live birth. In one of the pregnancies, major congenital malformation was noted. The infant had anencephaly. The mother's current condition included headache and allergy. The patient got expose to tobacco as his mother use to consume 20 cigarettes/tobacco products per day during pregnancy (explicitly coded as fetal tobacco exposure). The concomitant medications included hydroxyzine for allergies and Metrogel for vaginitis. The mother's last menstrual period (LMP) date was 25-May-2018. On 19-Nov-2018, mother's Q Natal test was performed, and no major congenital malformation was noted. On 19-Nov-2018, at gestational age of 25-weeks, the fetus was exposed to FLUCELVAX QIVc (cell-culture-derived, route of administration: transplacental, batch number: 252664, dose, anatomical location and expiry date: not reported) (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On 26-Nov-2018, mother's ultrasound, cystic fibrosis mutation analysis, spinal muscular atrophy and haemoglobin electrophoresis were performed and no major congenital malformation was noted. On 24-Jan-2019, mother's ultrasound was performed and no major congenital malformation was noted. On 31-Jan-2019, mother's ultrasound was performed and no major congenital malformation was noted. After vaccination the mother delivered a premature female neonate at 35.9 weeks gestation (pre-term birth), vaginally. At the time of delivery, no pregnancy complications were reported. The neonate's birth weight was 2715 grams, head circumference was 31.8 cm and body length was 51.4 cm. The APGAR scores were 8 (one minute), 9 (five minutes) and there was no data for 10 minutes. There was no major congenital malformation was noted. The outcome of the events was unknown. The mother's estimated delivery date (EDD) was reported as 10-Mar-2019. This case is linked to 201901995 (mother case).; Reporter's Comments: A female neonate was delivered vaginally at 35.9 weeks gestation (coded to premature baby) to 37-year-old mother, 2 months 21 days after administration of FLUCELVAX QIV at 25-weeks of gestation (coded to foetal exposure during pregnancy). Despite the plausible temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and therefore the event of premature baby was assessed as not related to the vaccination. The maternal age, gestational history (5 previous pregnancy full-term live birth and one anencephaly), fetal tobacco exposure and co-administered drugs (hydroxyzine for allergies and metrogel) confound this case. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).