Sex: F
Vaccine: FLUC4
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This is a serious spontaneous case reported by other health-professional and initially received on 12-Apr-2019, concerning a female neonate patient. The patient's mother had no previous pregnancies. 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 patient's mother's last menstrual period (LMP) date was 23-Jul-2018. The type of pregnancy was singleton. The pregnancy status of the patient's mother was collected, and no pregnancy complications was noted. The patient's mother concomitant medications included NESTABS DHA and folic acid for healthy pregnancy. On 10-Oct-2018, at approximately 11 weeks gestation, the patient was exposed to FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252232, dose, parent's route of administration, expiry date and anatomical location: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day (10-Oct-2018), the patient's mother had undergone cystic fibrosis mutation analysis, spinal muscular atrophy screen and fragile X test and no major congenital malformation was noted. On 18-Oct-2018, the patient's mother had undergone non-invasive prenatal testing (NIPT) and first trimester screening and no major congenital malformation was noted. On 28-Dec-2018, 2 months and 18 days after vaccination, the patient's mother experienced rash on left side. On an unspecified date after vaccination, the patient's mother experienced constipation and anaemia. The patient's mother was treated with COLACE [from 28-Dec-2018, dose: 100 mg, frequency: two times a day (bid)] orally for constipation, BENADRYL[from 28-Dec-2018, dose: 25 mg, frequency: 4 times a day (qid)] orally, hydrocortisone cream [from 28-Dec-2018, dose: 2.5 percent, frequency: 2 times a day (bid)] topically and ACTIGALL [from 08-Mar-2019, dose: 300 mg, frequency: bid] orally for left side rash and FEROSUL [from 22-Feb-2019, dose: 325 mg, frequency: once a day (qd)] orally for anaemia. On 36.9-week gestational age (as reported), the patient's mother gave birth to neonate (reported as preterm birth). The delivery method was caesarean. The infant's weight was 2750 grams, length was 48.3 cm, head circumference was 32 cm and the appearance, pulse, grimace, activity, and respiration (Apgar) score was 6 at 1 minute and 9 at 5 minutes. The patient's mother's estimated date of delivery (EDD) was reported as 29-Apr-2019. This case was linked to case 201902762 (the corresponding maternal pregnancy report). Reporter's Comments: A female neonate patient was delivered by caesarean section at 36.9 weeks (coded as premature birth), 5 months 28 days after maternal receipt of FLUCELVAX QIVc at 11 weeks of gestation(considered as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event and no evidence/ investigation suggesting the complications requiring caesarean section, causality of the event premature birth assessed as not related. The case will be further assessed upon receipt of follow up information. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the event premature birth as serious (medically significant).