This is a serious spontaneous case, initially received from other health professional on 25-Feb-2019, concerning a male neonate patient. The patient's mother historical medications included Reglan (metoclopramide) for nausea and vomiting. The patient's mother historical condition included nausea and vomiting (from 07-Jun-2018 to 08-Jun-2018). The patient's 32-year-old mother had 3 previous pregnancy reported with 2 full-term live births and 1 spontaneous abortion and no birth defects were noted. The patient's mother did not have any history of offspring with major congenital malformation and no paternal or paternal history with major congenital malformations. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's current conditions included asthma and chronic hypertension. The patient's mother concomitant medications included methyldopa and nifedipine for hypertension, Prenatal vitamins [minerals nos; vitamins nos] and Preplus CA-PE for pregnancy, Metrogel (metronidazole) for vaginosis, and terconazole for candidiasis. The patient's mother last menstrual period (LMP) date was 25-Mar-2018. On 11-May-2018, the patient's mother haemoglobin (Hgb) electrophoresis was performed, and no major congenital malformations were noted. On 15-May-2018, the mother's ultrasound scanning was performed, and no major congenital malformations were noted. On 01-Jun-2018, the mother's pregnancy-induced hypertension and 24-hour urine analysis were performed, and no major congenital malformations were noted. On 27-Jul-2018, the mother's quad screen test was performed, and no major congenital malformations were noted. On 26-Sep-2018, at gestational age of 26-weeks, the foetus was exposed to FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252664, dose, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication. 3 months after vaccination, the mother delivered a male neonate at 39.4 weeks gestation by caesarean method. The neonate's birth weight was 3700 grams, head circumference was 34.3 cm and body length were 49.5 cm. The APGAR scores were 8 (one minute), 9 (five minutes) and there was no data for 10 minutes. At the time of delivery, no pregnancy complications were reported. At the birth, the neonate was noted with the major congenital malformations which included micropenis and microphthalmia (left eye). The factors contributing to these major congenital malformations were unknown. The outcome of the events was not reported. The mother's estimated delivery date (EDD) was reported as 30-Dec-2018. This case is linked to 201902223 (mother case). The reporter assessed the case as serious (major congenital malformation).; Reporter's Comments: A male neonate patient experienced micropenis and microphthalmia (left eye), 3 months after maternal receipt of FLUCELVAX QIVc at 26 weeks of gestation (considered as foetal exposure during pregnancy). Despite the plausible temporal relationship between vaccination and reported events, there is no evidence for a biological mechanism that could cause these events and also the exposure to suspect vaccine was late in pregnancy. The underlying maternal chronic hypertension provide more plausible explanation rather than suspect vaccine. The maternal infection candidiasis, bacterial vaginosis and multiple concomitant medications (TERCONAZOLE, metronidazole, nifedipine and methyldopa) are considered as risk factors. Hence, causality of events microphthalmia and micropenis, assessed as not related. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine during pregnancy.