Sex: U
Vaccine: FLUC4
Symptoms: Cardiac hypertrophy, Cardiomegaly, Foetal exposure during pregnancy, Talipes
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 15-Mar-2019, concerning a neonate patient of unspecified gender. The mother was 33-year-old female and had 4 previous pregnancies, with 1 full-term live birth, 1 preterm live birth and 2 spontaneous abortions. There was no history of maternal or paternal congenital malformation. The mother's last menstrual period (LMP) date was 26-Jun-2018. The type of pregnancy was singleton. The mother had not used tobacco, alcohol or illicit drugs during pregnancy. At a gestational age of 6.4 weeks, the mother experienced nausea and on the same day started taking promethazine for it. On 14-Aug-2018, at a gestational age of 7.1 weeks, the mother experienced vaginitis and on the same day started taking Metrogel (metronidazole) for it. On 15-Aug-2018, the mother underwent ultrasound scan and there was no major congenital malformation noted. On 16-Aug-2018, Metrogel was stopped. On 11-Sep-2018, at a gestational age of 11.1 weeks, the mother started taking Prenatal vitamins (minerals nos, vitamins nos) indicated for pregnancy. On 18-Oct-2018, at gestation age of 16 weeks, the fetus received FLUCELVAX QIVc [batch number: 252664, route of administration: transplacental, dose, anatomical location, and expiry date: not reported] (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On the same day, the mother underwent ultrasound scan and a congenital malformation was noted (identified: club feet). On the same day quadruple screen was also performed and no major congenital malformation was noted. On 09-Nov-2018, 22 days after vaccination, at a gestational age of 19.6 weeks the mother developed hypertension and was treated with labetalol (200 mg, bid, oral, ongoing). On 14-Dec-2018, 1 month 26 days after vaccination, at a gestational age of 24.6 weeks the mother developed anemia and was treated with ferrous sulfate (325 mg, bid, oral, ongoing). On 10-Jan-2019, the mother underwent ultrasound scan, and congenital malformation was noted (identified: club feet). On 04-Feb-2019, 11-Feb-2019 and 18-Feb-2019, the mother underwent ultrasound scans, and no major congenital malformations were noted. The pregnancy complications included asymmetrical growth, mild cardiomegaly and myocardial hypertrophy in the fetus. On an unknown date, the mother was transferred and delivered by Maternal-Fetal medicine (MFM) specialist due to fetal cardiac abnormality. The mother gave live birth to a neonate at unknown weeks of gestation. The delivery method, the neonate's gender, birth weight, head circumference, length and Apgar scores were not reported. The outcome of the events was not reported. The mother's estimated delivery date (EDD) was reported as 01-Apr-2019. This case is linked to 201902746, the corresponding maternal pregnancy report.; Reporter's Comments: A neonate patient of unspecified gender was diagnosed with club feet on prenatal scan, on the same day after maternal receipt of FLUCELVAX QIVc (considered as foetal exposure during pregnancy). Considering implausible temporal relationship between the event club feet and vaccination, the company assessed the event club feet as not related to suspect vaccine. The patient was diagnosed with asymmetrical growth, mild cardiomegaly and myocardial hypertrophy, unspecified period of time post vaccination. These events lack onset latency. However, the maternal gestational history (two spontaneous abortions and 1 preterm birth), maternal history of vaginitis, anaemia and hypertension, concomitant medications metronidazole, promethazine (in early trimester of pregnancy) and labetalol were considered as risk factors for these events. Hence, causality assessed as not related to suspect vaccine. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The case will be further assessed upon receipt of follow up information. The company assessed this case as serious (medically significant).