Sex: M
Vaccine: FLUX
Symptoms: Caesarean section, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birthweight of 4774 g; This is an observational study case received on 16-Mar-2021 from other health professional and concerned a male neonate, whose mother was 18-year-old, pregnant, female subject, of body weight: 173 lbs, height: 62 inches and body mass index (BMI): 31.6, enrolled in a prospective observational safety study.   The maternal past medical history included yeast infection and vulva itching. The maternal concurrent conditions included high BMI, asthma and low potassium. The maternal past medications included Metrogel (metronidazole) for yeast infection and Nystatin triamcinolone (nystatin, triamcinolone acetonide) for vulva itching. The maternal concomitant medications included potassium chloride used for low potassium and 'OB complete one' used for healthy pregnancy.  The maternal obstetrical history included two previous pregnancies with one live birth and one spontaneous abortion. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother had no history of offspring with MCMs. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The maternal last menstrual period (LMP) date was 15-Jun-2020, the estimated delivery date (EDD) was 22-Mar-2021, while the corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The paternal age was not reported.   On 27-Aug-2020, cystic fibrosis mutation analysis revealed no MCMs.   On 28-Sep-2020, at approximately 15 weeks of gestation (calculated per LMP), the neonate's mother was administrated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, anatomical location and route of administration: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation. The batch number reported was P100239705.  On the same day, quad screen revealed no MCMs.   On 20-Jan-2021 (as reported), the neonate's mother started treatment with bacitracin, at a dose of 500 g, for topical use, two times a day for body itch.   On 26-Jan-2021, three months and 29 days after receiving Afluria QIV, the neonate's mother experienced body itch.  at gestational age of 38.4 weeks (as reported), the mother delivered live male neonate via caesarean method. The birth weight of the neonate was 4774 g, head circumference 36.5 centimetres and length 48.3 centimetres. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and for ten minutes was not reported. No pregnancy complications were noted. No MCM was identified at birth.   The outcome of the event 'high birthweight baby' was not reported.   The reporter did not provide a causality assessment.  The event of 'high birthweight baby' was considered to be medically significant by a Physician  This case is linked with the case 202101520, the corresponding mother case.  Company comment: A male neonate experienced foetal exposure to the suspect vaccine Afluria QIV. Neonate's mother was vaccinated with Afluria QIV at approximately 15 weeks of gestation. At gestational age of 38.4 weeks, the mother delivered live male neonate via caesarean method. The birth weight of the neonate was 4774 g. The maternal concurrent conditions included high BMI and obstetrical history included two previous pregnancies with one live birth and one spontaneous abortion. The event Large for dates baby is assessed as not related due to confounder (high BMI) and chronological/ biological implausibility. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A male neonate experienced foetal exposure to the suspect vaccine Afluria QIV. Neonate's mother was vaccinated with Afluria QIV at approximately 15 weeks of gestation. At gestational age of 38.4 weeks, the mother delivered live male neonate via caesarean method. The birth weight of the neonate was 4774 g. The maternal concurrent conditions included high BMI and obstetrical history included two previous pregnancies with one live birth and one spontaneous abortion. The event Large for dates baby is assessed as not related due to confounder (high BMI) and chronological/ biological implausibility. Foetal exposure during pregnancy is assessed as not related per company's conventions.