Sex: M
Vaccine: FLUC4
Symptoms: Apgar score low, Intensive care, Meconium aspiration syndrome, Neonatal respiratory distress, Streptococcal infection
Clinical narrative: Fetal exposure during pregnancy; Thick meconium/ respiratory distress; Thick meconium/ respiratory distress; APGAR score at one minute 1, at five minutes 4; This observational study case, was received on 19-Feb-2020 from other health professional and concerned a  male, neonate, whose mother was a 22-year-old female (subject ID:), (Race:, Ethnicity:) of body weight 116 lbs, height 62 inches and body mass index (BMI) 21.2, enrolled in a prospective observational safety study.  The mother's past medical history included bacterial vaginosis, treated with metronidazole. The mother's concomitant medications included Prenatal Pixie plus iron (vitamins and minerals) as vitamin supplementation and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation.    The mother had one previous pregnancy which was spontaneous abortion. The mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 03-Mar-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 08-Dec-2019 and corrected estimated date of delivery (CEDD) of mother were reported as 14-Dec-2019. The neonate's father was a 22-year-old.  On 10-Jun-2019, the first trimester screen revealed no MCMs.   On 26-Jun-2019, the maternal serum alpha-fetoprotein screening revealed no MCMs.   On 25-Jul-2019, the anatomy ultrasound revealed no MCMs.  On 16-Oct-2019, at approximately 32 weeks of gestation (calculated per LMP), the mother was vaccinated with Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunization. The batch number reported was 261200 and expiry date was not reported.   On 04-Nov-2019, the ultrasound scan revealed no MCMs.   On 20-Nov-2019, one month and four days after vaccination, the mother was positive to group B streptococcus bacteria.  On 17-Dec-2019, the mother was treated with intravenous (IV) antibiotics of penicillin for group B streptococcus infection  At 40.4 weeks of gestation (as reported), the mother vaginally delivered a live, male neonate. The neonate's birth weight, head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 1 (one minute), 4 (five minutes) and 8 (10 minutes). The neonate was sent to Neonatal intensive care unit (NICU) because of thick meconium and respiratory distress.  On the same day, the neonate recovered from events 'APGAR score low', thick meconium and respiratory distress. The mother recovered from bacterial infection due to streptococcus, group B.  The events of thick meconium, respiratory distress and 'APGAR score low' were considered to be serious due to the criterion of medical significance by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  This case is linked to 201907205 (the corresponding mother case).  Additional information received on 01-Oct-2020 from other health professional: Penicillin added as concomitant medication. Stop dates added and outcome changed from not reported to recovered for the events thick meconium and respiratory distress. Narrative was amended accordingly.   Company comment: A male neonate experienced meconium aspiration syndrome, respiratory distress and Apgar score low after maternal receipt of Flucelvax QIV vaccine at approximately 32 weeks of gestation (considered as foetal exposure during pregnancy). Meconium aspiration syndrome occurs when stress (such as infection or low oxygen levels) causes the fetus to take forceful gasps, so that the amniotic fluid containing meconium is breathed. One month and four days after vaccination, the subject (foetus' mother) was positive to group B streptococcus bacteria. The subject was treated with intravenous (IV) antibiotics of penicillin for group B streptococcus infection. Causality was highly confounded for meconium aspiration syndrome. The events of respiratory distress and Apgar score low are expected after it. Therefore, causality is assessed as not related for all events. Foetal exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A male neonate experienced meconium aspiration syndrome, respiratory distress and Apgar score low after maternal receipt of Flucelvax QIV vaccine at approximately 32 weeks of gestation (considered as foetal exposure during pregnancy). Meconium aspiration syndrome occurs when stress (such as infection or low oxygen levels) causes the fetus to take forceful gasps, so that the amniotic fluid containing meconium is breathed. One month and four days after vaccination, the subject (foetus' mother) was positive to group B streptococcus bacteria. The subject was treated with intravenous (IV) antibiotics of penicillin for group B streptococcus infection. Causality was highly confounded for meconium aspiration syndrome. The events of respiratory distress and Apgar score low are expected after it. Therefore, causality is assessed as not related for all events. Foetal exposure during pregnancy assessed as not related per company's conventions.