Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Premature delivery, Prolonged labour
Clinical narrative: Failure to progress; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 21-Nov-2019 with additional information received on 25-Nov-2019 (being processed together), concerning a 27-year-old, pregnant, female subject of body weight: 210 lbs, height: 68 inches and body mass index (BMI): 31.9 enrolled in, a prospective observational safety study.   The subject's current conditions included obesity with BMI 31.9 and hypertension.  The subject's historical vaccine included Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular and tetanus vaccine toxoid) as vaccine.   The subject's concomitant medications included Baby Aspirin (acetylsalicylic acid) and labetalol, both used for hypertension and prenatal vitamins (unspecified vitamins and minerals) for obstetrical (OB) care.   The subject had three previous pregnancies with three spontaneous abortions. The subject had no maternal or paternal history with major congenital malformations (MCMs). The subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was on an unspecified date in 2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 25-Nov-2019. The type of pregnancy was singleton.   On 22-May-2019, the subject underwent first trimester screen and it was noted that the foetus was positive for Down Syndrome. However, later the subject underwent MaterniT 21 and it was within normal limits. No MCMs were noted.  On 29-May-2019, the subject underwent MaterniT 21 and no MCMs were noted.  On 09-Oct-2019, at approximately 33 weeks of gestation (per CEED), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On an unspecified date, the pregnancy complications non-reassuring fetal heart tones (FTH), failure to progress (FTP) and fetus intrauterine growth restrictions (IUGR) were noted.   On, at 37.3 weeks of gestation (as reported), the subject delivered a live male neonate via caesarean method. The neonate's birth weight was 2013 grams, body length and head circumference were not reported. The reported appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was provided at 10 minutes. Hypospadias was identified at birth as MCM. As reported, the contributing factor to neonate's hypospadias was hypertension in mother. Etiology was unknown, however, it was reported that it was possibly genetic and possible anti-androgenic exposures. Gestational age for origin of the defect was reported as 7 to 12 weeks and the origin of the defect was prior to vaccination. Other factors contributing to the MCM were unknown.  On 06-Nov-2019, the subject recovered from failure to progress.   On an unspecified date in Nov-2019, reported as after birth and during one week of age, first signs and symptoms of the hypospadias were presented.  On 13-Jan-2020, per major congenital malformation evaluation (MCME), there was no update to previous evaluation.   On 19-May-2020, per major congenital malformation evaluation (MCME), there was no update to previous evaluation.   The event of failure to progress was considered serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment to Flucelvax QIVc.   Follow up information received from other health professional on 09-Jan-2020: Additional information regarding first signs and symptoms for the event of hypospadias was provided. Narrative was amended accordingly.  Follow up information received from other health professional on 18-May-2020 and 19-May-2020: Start date reported as unknown' and stop date reported as 06-Nov-2019, for failure to progress. The event was transferred from corresponding baby case and coded to LLT Prolonged labour' in mother case. Classification Special case with no AE' was removed. TDAP deleted as concomitant medication. It was confirmed that MCME was not updated. The narrative was amended accordingly.   This case is linked to case number 201906263 (the corresponding child case).  Company Comment: A 27-year-old, pregnant subject has experienced prolonged labour approximately a month after receiving Flucelvax QIVc. The vaccine was administered at gestational age of 33 weeks. The foetus was positive for Down Syndrome and subject's medical history included obesity with BMI 31.9, hypertension and three previous pregnancies with three spontaneous abortions, which all may have contributed to development of the event. Causal relationship cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes) Vaccine exposure during pregnancy assessed as unrelated per company's conventions.; Sender's Comments: A 27-year-old, pregnant subject has experienced prolonged labour approximately a month after receiving Flucelvax QIVc. The vaccine was administered at gestational age of 33 weeks. The foetus was positive for Down Syndrome and subject's medical history included obesity with BMI 31.9, hypertension and three previous pregnancies with three spontaneous abortions, which all may have contributed to development of the event. Causal relationship cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes) Vaccine exposure during pregnancy assessed as unrelated per company's conventions.