Sex: F
Vaccine: FLUC4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 20-Mar-2019, concerning a female neonate patient. The patient's mother was a 39-year-old who had 3 previous pregnancies reported with two full-term live births and one spontaneous abortion. The patient's mother historical drugs included Metrogel vaginal and Terconazole for vaginitis. The historical condition of the patient's mother was vaginitis (on an unspecified date). The concomitant medication of patient's mother included Vitafol one [ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide] for healthy pregnancy. The patient had not used tobacco or alcohol during her current pregnancy. The mother's last menstrual period (LMP) date was 12-Jul-2018. At 10 weeks gestation, on 22-Sep-2018, the foetus was exposed to FLUCELVAX QIVc [route of administration: transplacental, batch number: 252232, dose, anatomical location and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On 05-Oct-2018, the patient's mother had undergone non-invasive prenatal test and no major congenital malformations were noted. On 15-Oct-2018, the patient's mother had undergone amniocentesis and no major congenital malformations were noted. On 29-Dec-2018, 3 months 7 days after vaccination, the patient's mother underwent 1-hour glucose challenge test (GCT) and was diagnosed with gestational diabetes mellitus and no major congenital malformations were noted. On 05-Jan-2019, the patient's mother had undergone 3 hours glucose challenge test (GCT) and no major congenital malformations were noted. The patient's mother gave a live birth to a female neonate at the gestational age of 34 weeks via caesarean method of delivery (reported as pre-term birth). The pregnancy complication at the time of delivery included placenta previa. The characteristics of the neonate included birth weight: 2085 grams (explicitly coded as low birth weight), head circumference: 34.5 cm, length: 41.9 cm and APGAR (appearance, pulse, grimace, activity, and respiration) scores were 9 (at one minute, five minutes and ten minutes). No major congenital malformations (MCMs) were identified at birth. The mother's estimated delivery date (EDD) was reported as 18-Apr-2019 and corrected EDD as 28-Feb-2019. The outcome of the events pre-term birth and low birth weight were unknown. This case is linked to 201805968 (mother case).; Reporter's Comments: A female neonate patient experienced preterm birth and low birth weight, 5 months 6 days after maternal receipt of Flucelvax QIVc at 10 weeks of gestation (considered as foetal exposure during pregnancy). The maternal gestation history included 2 full term delivery and 1 spontaneous abortion. The present pregnancy complications included gestational diabetes mellitus and low lying placenta (Placenta previa). The maternal historical condition included vaginitis and medications were Metronidazole and Terconazol. Despite plausible temporal relationship between vaccination and reported events, these events can be alternately explained by the maternal complication placenta previa, the advanced maternal age (39 years), multigravida, vaginitis and historical medications, rather than the suspect vaccine. The event foetal exposure during pregnancy, assessed as not related to suspect vaccine considering the intended use of suspect vaccine. The company assessed the events (preterm birth and low birth weight) as serious (medically significant).