Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Neonate's birth weight was 4130 grams/large for gestational age; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 06-Jun-2019, concerning a male neonate patient.   The patient's mother had no previous pregnancy. The patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother had no history of offspring with major congenital malformations. The patient's mother did not have any concurrent medical conditions during this pregnancy.  The patient's mother's last menstrual period (LMP) date was 21-May-2018. The type of pregnancy was singleton. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy. On an unknown date, the pregnancy status of the patient's mother was collected, and no major congenital malformations were noted.  On 10-Aug-2018, the patient's mother underwent first trimester screen and cystic fibrosis mutation analysis, there were no major congenital malformations noted.  On 08-Sep-2018, the patient's mother underwent second trimester screen and there were no major congenital malformations noted.  On 13-Oct-2018, at approximately 20 weeks gestation, the fetus was exposed to Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: 252232, route of administration: transplacental, dose, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication.  On 10-Nov-2018, 28 days after vaccination, the patient's mother developed anaemia. The patient's mother was treated with Ferrousul (ferrous sulfate) (dose: 325 mg, frequency: qd, route: oral, start date: 23-Nov-2018 and it was ongoing).  On 23-Nov-2018. 01 month and 10 days after vaccination, the patient's mother experienced leg cramps and was treated with Caltrate Plus-D (calcium carbonate, colecalciferol) (dose: 600 mg, frequency: qd, route: oral, from 23-Nov-2018 and it was ongoing). On the same day, the patient's mother also developed yeast infection and was treated with terconazole (dose: 0.4 percent, frequency: qd, route: topical, from 23-Nov-2018 and it was ongoing).  The outcome of the events anaemia, leg cramps and yeast infection was recovered on 15-Dec-2018.  at 38.1 gestational weeks, a live normal male neonate was delivered via caesarean method. The neonate's birth weight was 4130 grams (explicitly coded as large for gestational age), body length was 50.8 cm and head circumference were 35 cm. The reported appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute was 8, five minutes was 8 and at 10 minutes no data was provided. There was no major congenital malformation identified at birth.  The patient's mother's estimated date of delivery (EDD) was reported as 25-Feb-2019.  This case is linked to case number 201903691 (mother case).; Reporter's Comments: A male neonate born after vaccine exposure during pregnancy was diagnosed with large for gestational age during delivery at 38.1 gestational weeks. Considering the no known biological mechanism and increased maternal age, the causal role of suspect vaccine was assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).