Sex: U
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Foetal growth restriction, Low birth weight baby
Clinical narrative: Low birth weight; Preterm birth at 36 weeks of gestation; Intrauterine growth restriction; Foetal exposure during pregnancy; This is an observational study case from, initially received from other health professional on 20-Jan-2020, concerning a female foetus subject. The subject's mother was 34-year-old pregnant, female subject, of body weight: 183 Ibs, height: 62 in and body mass index (BMI) 33.5  enrolled in, a prospective observational safety study.  The subject's mother's historical drugs included benzonatate and azithromycin Z-pack, both for upper respiratory infection.  The subject's mother's historical conditions included history of severe pre-eclampsia in both previous pregnancies, HELLP syndrome in first pregnancy and upper respiratory infection.  The subject's mother's current medical condition included obesity, factor V deficiency, high risk pregnancy and mild hyperemesis gravidarum.  The subject's mother's concomitant medications included betamethasone for high risk pregnancy, Phenergan (promethazine) and ondansetron, both for hyperemesis gravidarum, Lovenox (enoxaparin sodium) and Aspirin low (acetylsalicylic acid), both for factor V deficiency, prenatal vitamins (unspecified minerals and vitamins) as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's mother had two previous pregnancies of preterm live birth with one birth defect in first pregnancy including cerebral palsy and optic nerve did not form behind one eye. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's father had niece with brain anomaly. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother's last menstrual period (LMP) date was on 22-Apr-2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 27-Jan-2020. The type of pregnancy was singleton. Subject's father was 38 years old.  On 11-Jun-2019, the subject's mother underwent initial ultrasound and no MCMs were noted.  On 01-Jul-2019, the subject's mother underwent MaterniT21 and no MCMs were noted.  On 12-Aug-2019, the subject's mother underwent maternal serum alpha fetoprotein screening (MSAFP) and no MCMs were noted.  On 19-Aug-2019, the subject's mother anatomy ultrasound and it was unknown if the subject had MCMs. It was reported that the follow up was needed.  On 16-Sep-2019, the subject's mother underwent follow up ultrasound and no MCMs were noted.   On 14-Oct-2019, at approximately 25 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD ) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 259809, 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 25-Nov-2019, one month and 11 days after vaccination, the subject developed intrauterine growth restriction (IUGR).  On 18-Nov-2019, one month and four days after vaccination, the subject's mother developed hypertension, and received treatment medication labetalol.  On 23-Dec-2019, two months and nine days after vaccination, during third trimester of pregnancy, the subject's mother developed pre-eclampsia.  At 36.1 weeks of gestation, the subject's mother gave live birth to a female neonate by caesarean method. The characteristics of the neonate included birth weight: 2041 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 8 at five minutes. No MCMs were identified at the time of birth. On the same day, the outcome of the event foetal growth restriction was resolved.  On 04-Jan-2020, the subject's mother recovered from the event of pre-eclampsia.  At the time of this report, the outcome for the events of low birth weight baby and premature birth was not reported.  Per company, the events of low birth weight baby, premature birth and foetal growth restriction were considered as serious due to criterion of medical significance.  The causality assessment was not provided.  This case is linked to case number 202000601 (corresponding mother case).  Follow up received from other health professional with additional information (being process together) on 09-Mar-2020: Start, stop date and the outcome of subject's mother's event of pre-eclampsia were updated. Subject's event foetal growth restriction was updated (start and stop date were populated, the outcome changed from not reported to resolved). The narrative was amended accordingly.  Company comment: A female subject was delivered as premature baby with low birth weight, after foetal exposure during pregnancy. The mother was administered with Flucelvax QIV at gestation age of 25 weeks. Foetal growth restriction was noted on unspecified date in 2019. Causality was confounded by mother's current medical condition of obesity, factor V deficiency, high risk pregnancy and historical conditions of severe pre-eclampsia in both previous pregnancies, HELLP syndrome in first pregnancy. Reportedly, the subject's mother had two previous pregnancies of preterm live birth with one birth defect in first pregnancy including cerebral palsy and optic nerve did not form behind one eye. Due to multiple confounders, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A female subject was delivered as premature baby with low birth weight, after foetal exposure during pregnancy. The mother was administered with Flucelvax QIV at gestation age of 25 weeks. Foetal growth restriction was noted on unspecified date in 2019. Causality was confounded by mother's current medical condition of obesity, factor V deficiency, high risk pregnancy and historical conditions of severe pre-eclampsia in both previous pregnancies, HELLP syndrome in first pregnancy. Reportedly, the subject's mother had two previous pregnancies of preterm live birth with one birth defect in first pregnancy including cerebral palsy and optic nerve did not form behind one eye. Due to multiple confounders, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.