Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Foetal exposure during pregnancy, Foetal heart rate abnormal
Clinical narrative: Fetal heart rate rhythm abnormalities; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 31-Jan-2020, concerning a female, neonate subject, whose mother was a 31-year-old female of body weight 102 lbs, height 67 inches and body mass index (BMI) 16, enrolled in a prospective observational safety study.    The subject's mother medical history included depressive disorder, Herpes simplex (on hand) and anxiety.   The subject's mother concomitant medications included: Prenatal vitamins (unspecified vitamins and minerals) as obstetrical supplementation, cyclobenzaprine for muscle spasms, valacyclovir for Herpes simplex, probiotic and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as immunization.    The mother's obstetrical history included three previous pregnancies with one full term live birth, one preterm live birth and one ectopic pregnancy. The subject's mother had no paternal history with major congenital malformations (MCMs), while maternal medical history with MCM included malignant breast cancer in mother's aunt and colon polyp in mother's grandmother. The mother did not use alcohol or illicit drugs during pregnancy, but she used cigarettes during pregnancy, as reported one-fourth pack per day.   The subject's mother last menstrual period (LMP) was on 15-Apr-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) of subject's mother were reported as 20-Jan-2020. The pregnancy was complicated with questionable abruption. The subject's father was a 34-year-old.  On 11-Jul-2019, the subject's mother underwent first trimester screen and ultrasound scan-nuchal translucency and no MCM was noted.   On 07-Aug-2019, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein screening and no MCM was noted.   On 26-Aug-2019, the subject's mother underwent anatomy ultrasound scan and no MCM was noted.    On 23-Sep-2019, at approximately 23 weeks of gestation, 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 an influenza immunization.   On the same day, the subject's mother developed folliculitis and started therapy with Bactrim (sulfamethoxazole, trimethoprim) at dose of one tablet, every 12 hours, orally.   On 30-Sep-2019, the subject's mother stopped treatment for folliculitis.   On an unspecified date in 2019, the subject's mother experienced haemorrhoids and was treated with Anusol-HC (hydrocortisone acetate) at dose of 25%, four times a day, topically, from 24-Oct-2019.  At 39 weeks of gestation, the subject's mother delivered a live, female neonate of birth weight 2863 grams vaginally after caesarean method. The characteristics of neonate, such as body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. Foetal heart rate rhythm abnormalities were noted.   At the time of initial reporting, the outcome was not reported.   The event of foetal heart rate abnormal' was considered serious due to congenital anomaly.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 201907126 (the corresponding mother case).  Foetal heart rate abnormal was noted in neonate associated with the suspect product, Flucelvax QIV. Foetal exposure during pregnancy occurred at approximately 23 weeks of gestation. Chronology is plausible. Mother's medical history of questionable placental abruption and vaginal birth may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event foetal heart rate abnormal is assessed as related (defaults to related for reporting purposes) since causal relatinship for Flucelvax QIV cannot be totally excluded.; Sender's Comments: Foetal heart rate abnormal was noted in neonate associated with the suspect product, Flucelvax QIV. Foetal exposure during pregnancy occurred at approximately 23 weeks of gestation. Chronology is plausible. Mother's medical history of questionable placental abruption and vaginal birth may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event foetal heart rate abnormal is assessed as related (defaults to related for reporting purposes) since causal relatinship for Flucelvax QIV cannot be totally excluded.