Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby, Shoulder dystocia
Clinical narrative: Foetal exposure during pregnancy; Shoulder dystocia; Preterm birth at 35.7 weeks of gestation; This is an observational study case, initially received on 16-Jul-2020, concerning a male neonate, whose mother was a 21-year-old female, pregnant subject of body weight: 219 lbs, height: 63 inches and body mass index (BMI): 38.8, who was enrolled in  a prospective observational safety study.  The neonate's mother's medical history included bipolar disorder, obesity, type 2 diabetes mellitus, depression, anxiety and high-risk pregnancy (history of miscarriage).    The neonate's mother's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) as a vitamin, Makena (hydroxyprogesterone caproate) for high risk pregnancy (history of preterm labor), metformin and Lantus (insulin glargine), both for type 2 diabetes mellitus, and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.   The neonate's mother had two previous pregnancies with one preterm live birth and one spontaneous abortion (history of miscarriage). The mother had no history of offspring with major congenital malformation (MCM). The mother had no maternal or paternal history with MCMs. The neonate's mother did not have a prior history of use of tobacco or alcohol during pregnancy. For an unspecified amount of time during pregnancy, the neonate's mother used cannabis. The age of the neonate's father was not reported.    The neonate's mother's last menstrual period (LMP) date was 23-Aug-2019. The type of pregnancy was singleton. The neonate's mother estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 29-May-2019.  On 04-Nov-2019, at approximately 10 weeks of gestation (calculated per LMP), the neonate's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261223, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.  On 18-Nov-2019, first trimester screen and nuchal translucency were performed, and no MCM was noted.   On 26-Nov-2019, 22 days after vaccination, the neonate's mother had exposure to influenza virus and started treatment with Tamiflu (oseltamivir) at a dose of 75 mg, administered once daily, via oral route of administration.    On 17-Dec-2019, the neonate's mother underwent maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and second trimester screen and no MCM was noted.  On 20-Dec-2019, the neonate's mother underwent ultrasound check cervical length, and no MCM was noted.   On 06-Jan-2020, treatment with Tamiflu was stopped.   On 17-Jan-2020, the neonate's mother underwent anatomy ultrasound and no MCM was noted.   On 24-Apr-2020, the neonate's mother underwent ultrasound biophysical profile and no MCM was noted.   On an unspecified date in 2020, in third trimester, the neonate's mother developed severe pre-eclampsia.   On an unspecified date in 2020, an unknown amount of time after vaccination, the neonate's mother developed eclampsia.   At 35.7 weeks of gestation (as reported), the neonate's mother delivered premature live birth male neonate, by vaginal method of delivery. The neonate's birth weight was 3555 grams, while head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 at one minute and 9 at five minutes. APGAR score was not reported for ten minutes. There was no major congenital malformation identified at birth. The delivery was complicated with shoulder dystocia.  At the time of this report, the outcome of events shoulder dystocia and premature baby 33 to 36 weeks' was not reported.   The events of shoulder dystocia and premature baby 33 to 36 weeks' were assessed as serious due to the criterion of medical significance, per company.    The reporter did not provide causality assessment.  This case is linked to 201907197, the corresponding mother case.  Company comment: The neonate's mother delivered premature live birth male neonate at 35.7 weeks of gestation ,5 months and 25 days after foetal exposure to Flucelvax QIVc. The event of shoulder dystocia was noted in neonate subject during delivery. Vaccine was administered at gestation age of 10 weeks. Chronology is unsuggestive. The neonate's mother medical history of obesity, type 2 diabetes mellitus and high-risk pregnancy highly confounds causality for events. Causal role of the suspect vaccine is assessed as unrelated due to biological/ pharmacological implausibility for the events of shoulder dystocia and premature baby. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: The neonate's mother delivered premature live birth male neonate at 35.7 weeks of gestation ,5 months and 25 days after foetal exposure to Flucelvax QIVc. The event of shoulder dystocia was noted in neonate subject during delivery. Vaccine was administered at gestation age of 10 weeks. Chronology is unsuggestive. The neonate's mother medical history of obesity, type 2 diabetes mellitus and high-risk pregnancy highly confounds causality for events. Causal role of the suspect vaccine is assessed as unrelated due to biological/ pharmacological implausibility for the events of shoulder dystocia and premature baby. Foetal exposure during pregnancy is assessed as not related per company's conventions.