Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth; Low birth weight; This is an observational study case, initially received from other health professional on 27-Sep-2019, concerning a male, neonate subject, whose mother was 25-year-old, pregnant female subject of body weight 193 lbs, height 66 inches and body mass index 31.1, enrolled in a prospective observational safety study.  The mother's historical medical condition included bacterial vaginosis. The mother's current medical conditions included bacterial vaginosis, nausea, vomiting, Herpes simplex, hypertension, trichomoniasis, anemia, elevated alpha-fetoprotein and uterine dehiscence. The mother's historical medications included Metrogel (metronidazole). The mother's concomitant medications included: Metrogel (metronidazole) for bacterial vaginosis, Flagyl (metronidazole) for trichomoniasis, Procardia (nifedipine) for hypertension, Venofer (saccharated iron oxide) for anaemia and Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy.   The subject's mother had six previous pregnancies. Five pregnancies ended with full term live birth and one ended with pre-term live birth. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Also, the subject's mother had no maternal or paternal history with major congenital malformations. The mother's last menstrual period (LMP) date was 29-Jun-2018. Estimated delivery date and corrected estimated delivery date were 05-Apr-2019. The type of pregnancy was singleton.   On 03-Oct-2018, the subject's mother was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 252664, route of administration, expiration date and anatomical location: not reported] [explicitly coded as Foetal exposure during pregnancy'] for influenza immunisation.  At gestational age of 32.9 week, the mother delivered live birth, male neonate [explicitly coded as Birth premature'] through Caesarean method. The neonate's birth weight was 2140 grams [explicitly coded as Low birth weight baby'], head circumference and body length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). There were pregnancy complications noted which included hypertension, uterine dehiscence and preterm labor. There was no major congenital malformation identified at birth.   At the time of initial reporting, the outcomes of the events were not reported.  This case is linked to 201904853 (corresponding mother case).  Company Comment: Reportedly, the male neonate subject was delivered as premature and low birth weight baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of herpes simplex, hypertension, trichomoniasis and anaemia may have contributed to development of the events. Causality was confounded by use of multiple concomitant drugs. Foetal exposure during pregnancy is assessed as not related per company conventions. For all other events, 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 and low birth weight baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of herpes simplex, hypertension, trichomoniasis and anaemia may have contributed to development of the events. Causality was confounded by use of multiple concomitant drugs. Foetal exposure during pregnancy is assessed as not related per company conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.