Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth; This is a serious observational study case, initially received from other health professional on 18-Sep-2019, concerning a male subject which mother was enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's mother had seven previous pregnancies, five previous full-term live birth, one previous preterm live birth and one previous spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother's last menstrual period (LMP) was on 25-Jun-2018. Estimated delivery date (EDD) and corrected EDD was reported as 01-Apr-2019. The type of pregnancy was singleton. The pregnancy status of the was collected, and no MCMs were noted.   The subject's mother historical condition included bacterial vaginitis (from 07-Aug-2018 to 17-Aug-2018) and historical drug included Metrogel (metronidazole) for bacterial vaginitis. Concomitant medications included prenatal vitamins (minerals not specified (nos), vitamins nos) for pregnancy.   On 01-Aug-2018, the subject's mother underwent spinal muscular atrophy screen and cystic fibrosis mutation analysis and no MCMs were noted.   On 07-Aug-2018, 13-Aug-2018 and 27-Aug-2018, the subject's mother underwent ultrasound and no MCMs were noted.  On 15-Oct-2018, at approximately 16 weeks of gestation, the mother was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: 252664, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation. On the same day, the mother underwent ultrasound and Quad Screen and no MCMs were noted.  On 12-Dec-2018, the subject's mother developed anaemia and was treated with ferrous sulfate one tablet, twice daily, orally.  On 22-Dec-2018, the subject's mother recovered from the event of anaemia.  On 14-Feb-2019, the subject's mother developed yeast and was treated with Metrogel 0.75 % gel, twice daily, vaginally.  On 09-Jan-2019, 31-Jan-2019 and 21-Feb-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 24-Feb-2019, the subject's mother recovered from the event of yeast.  On, at 36.7 gestational weeks, mother vaginally delivered a live normal male neonate. The neonate's birth weight was 2977 grams, body length was 52.1 cm and head circumference was 33 cm. The reported appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute was 9, five minutes was 9 and at 10 minutes no data was provided. There was no MCM identified at birth.  This case is linked to case number 201904704 (corresponding mother case).  Company Comment: Reportedly, the male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flucelvax QIV. Chronology is plausible.  Mother's medical history of bacterial vaginitis and anaemia may have contributed to development of the event. Causality was confounded by therapy with multiple concomitant medications.  Foetal exposure during pregnancy is assessed as not related. For the event premature baby, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: Reportedly, the male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flucelvax QIV. Chronology is plausible.  Mother's medical history of bacterial vaginitis and anaemia may have contributed to development of the event. Causality was confounded by therapy with multiple concomitant medications.  Foetal exposure during pregnancy is assessed as not related. For the event premature baby, causal role of the suspect product cannot be totally excluded and is assessed as related.