Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This is a spontaneous case, initially received from other health professional on 11-Feb-2019, concerning a male neonate patient. The mother was 39-year-old female, with a history of two previous pregnancies in which first pregnancy was full term live birth and second pregnancy was elective abortion. The mother had no family history of offspring with major congenital malformation. No relevant maternal and paternal medical history with major congenital malformation. The mother did not use tobacco, alcohol and illicit drugs during pregnancy. The mother's current condition included asthma and urinary tract infection (since an unspecified date). The mother's concomitant medications included VITAFOL ONE for healthy pregnancy and MACROBID for urinary tract infection (from 18-Sep-2018 to 24-Sep-2018). The mother's last menstrual period (LMP) date was 02-Jun-2018. On 04-Sep-2018, non-invasive prenatal test and first trimester screening test were performed, and no congenital malformations were noted. On 08-Oct-2018, at gestational age of 18-weeks (second trimester of pregnancy) the foetus was exposed to FLUCELVAX QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose, batch number: 252232, route of administration: transplacental, anatomical location, and expiry date: not reported] for an unknown indication (explicitly coded as fetal exposure during pregnancy). The patient's mother took another course of MACROBID (from 18-Oct-2018 to 24-Oct-2018) for urinary tract infection. On 2019, 4 months after vaccination, the mother delivered a premature male neonate at 35.9 weeks gestation through caesarean. At the time of delivery, no pregnancy complications were reported. The neonate's birth weight was 3161 grams, head circumference was 35.5 cm and body length was 48.3cm. The APGAR scores were 9 (at one minute), 9 (at 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 09-Mar-2019. This case is linked to 201805976, the corresponding maternal pregnancy report and 201901534, the corresponding report for the other baby. Reporter's Comments: A male neonate patient was delivered at 35.9 weeks of gestation (preterm birth), more than 4 months after maternal receipt FLUCELVAX QIVc, at 18 weeks of gestation (considered as fetal exposure during pregnancy). Time to onset is considered implausible for the event preterm birth. Twin pregnancy, advanced maternal age (39 years) and maternal obstetrical history (multigravida) provide more plausible explanation rather than suspect vaccine. Hence, causality assessed as not related to suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event fetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant).