Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Oligohydramnios; Foetal exposure during pregnancy; This is an observational study case, initially received on 23-Mar-2020, concerning a male foetus whose mother was 28-year-old pregnant, female subject of body weight: 198 lbs, height: 63 inches and body mass index (BMI): 35.1, enrolled in a prospective observational study.  The subject's mother's current conditions included obesity with BMI 30+, asthma and polycystic ovaries.  The subject's mother's concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for pregnancy, metformin for polycystic ovarian, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) for vaccination and Albuterol HFA (salbutamol) for asthma.  The subject's mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM). Also, the subject's mother had no maternal or paternal history with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's father age was 33-years.  The subject's mother's last menstrual period (LMP) date was 25-Jun-2019. The type of pregnancy was singleton. The subject's mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 31-Mar-2020.   On 16-Sep-2019, the subject's mother underwent first trimester screen and nuchal translucency test, no MCM was noted.  On 18-Oct-2019, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein screening (MSAFP/serum markers), no MCM was noted.  On 01-Oct-2019, at approximately 14 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [Influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.  On 05-Nov-2019, the subject's mother underwent anatomy ultrasound, no MCM was noted.  On 10-Mar-2020, oligohydramnios was noted in foetus.  At 37.1 weeks of gestation (as reported), the subject's mother delivered live birth, male neonate via vacuum extraction method of delivery. The neonate's birth weight was 3203 grams, body length and head circumference were not reported and APGAR (appearance, pulse, grimace, activity and respiration) scores were at one minute: 8, five minutes: 9 and ten minutes: not reported. There were no major MCMs identified at birth.  At the time of this report, the outcome of oligohydramnios was not reported.  The event of Oligohydramnios' was assessed as serious due to criterion of medically significance, per the company.   The reporter did not provide causality assessment to Flucelvax QIV.  The case is linked to case 202002599 (mother case).  Company Comment: The event of oligohydramnios was noted in neonate subject 5 months 9 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 14 weeks. Chronology is implausible. The mother's current conditions included obesity with BMI 30+, asthma and polycystic ovaries. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: The event of oligohydramnios was noted in neonate subject 5 months 9 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 14 weeks. Chronology is implausible. The mother's current conditions included obesity with BMI 30+, asthma and polycystic ovaries. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.