Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Grimacing, Premature baby
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 02-May-2019, concerning a male neonate patient. The patient's mother was a 29-year-old who had 2 previous pregnancies reported with two previous elective abortions. The patient's maternal and paternal history with major congenital malformations were none. The concomitant medication of the patient's mother included OB complete one (iron-folic acid-Dha-fish) for healthy pregnancy. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 14-Aug-2018. On 08-Oct-2018, at the gestational age of 8 weeks, the patient's mother received FLUCELVAX QIVc [route of administration: transplacental, batch number: 252232, dose, frequency, anatomical location and expiry date: not reported) for an unknown indication. The foetus was exposed to FLUCELVAX QIVc via transplacental route (coded as foetal exposure during pregnancy) for an unknown indication. On 05-Nov-2018, the patient's mother had undergone cystic fibrosis mutation analysis, first trimester screening and no major congenital malformations were noted. On 03-Dec-2018, the patient's mother had had undergone second trimester screen and no major congenital malformations were noted. The patient's mother experienced A1 diabetes mellitus (since 28-Feb-2019 to ongoing). On an unspecified date, after vaccination, the patient's mother went to emergency department with flu, fever and unspecified test was performed which confirmed Flu. The patient's mother was prescribed with Tamiflu (oseltamivir phosphate, 75 mg, bid, orally, from 03-Mar-2019 to 08-Mar-2019) for flu and Tylenol (paracetamol, 325 mg, every 6 hours, orally, from 03-Mar-2019 to 10-Mar-2019) for fever from emergency department. The patient's mother was asked to finish the course of Tamiflu as instructed by ER. The patient's mother gave a live birth to a male neonate at the gestational age of 36.1 weeks via vaginal method of delivery (coded as premature baby). The characteristics of the neonate included birth weight: 2693 grams, head circumference: 33 cm, length: 47 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (at one minute and five minute). No major congenital malformations (MCMs) were identified at birth. The outcome of the event premature baby was unknown. The mother's estimated delivery date (EDD) was reported as 21-May-2019. This case (201903265) is linked to 201902763 (mother case).; Reporter's Comments: A male neonate patient experienced premature birth (at 36.1 weeks of gestation), 6 months 16 days after maternal receipt of FLUCELVAX QIVc (considered as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported premature birth, the event premature birth assessed as not related. Maternal gestational diabetes is considered as confounding factor for the event premature birth. The event foetal exposure during pregnancy assessed as not related to suspect product considering the intended use of the vaccine. The company assessed the case as serious (medically significant).