Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Intensive care, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 4111 grams; This is an observational study case, initially received from other health professional on 15-Apr-2020, concerning a neonate male subject, whose mother was a 31-year-old, pregnant female of body weight 146 lbs, height 65 inches and body mass index (BMI) 24.3, enrolled in a prospective observational safety study.  The subject's mother's current medical condition included RhD (rhesus antigen) negative.   The subject's mother's concomitant medications included Prenatal (unspecified vitamins and minerals) for pregnancy, Rhophylac (anti-d immunoglobulin) for RhD negative and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.    The subject's mother's obstetrical history included no previous pregnancies. The subject's mother had no history of offspring with major congenital malformations (MCMs). Also, the mother had no maternal or paternal history with MCMs.   The subject's mother's last menstrual period (LMP) date was 11-Jun-2019. The estimated delivery date (EDD) was reported as 17-Mar-2020 and corrected estimated date of delivery (CEDD) was reported as 16-Mar-2020. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's father was 29 years old.   On 05-Sep-2019, the subject's mother underwent first trimester screen and nuchal translucency and no MCM was noted.   On 04-Oct-2019, at approximately 16 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261207, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunization.   On the same date, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and no MCM was noted.   On 23-Oct-2019, the subject's mother underwent anatomy ultrasound and no MCM was noted.   On 20-Nov-2019, the subject's mother underwent follow-up anatomy ultrasound and no MCM was noted.   On 11-Mar-2020, the subject's mother developed dysuria and was treated with cefpodoxime, at a dose of 100 mg, every 12 hours, via oral route.   On 18-Mar-2020,  the subject's mother recovered from dysuria and the treatment with cefpodoxime was finished.  On 23-Mar-2020, the subject's mother underwent follow-up ultrasound post date and no MCM was noted.   At 41 weeks of gestation (as reported), the subject's mother delivered a live birth male neonate, by vaginal method of delivery. The neonate's birth weight was 4111 grams, while body length and head circumference were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 (one minute), 8 (five minutes) and 8 (ten minutes). It was unknown if there were any major congenital malformations identified at birth. It was reported that the baby was transferred to NICU (neonatal intensive care unit), but no further details were provided.    On 15-Apr-2020, the subject was noted as lost to follow due to unknown information regarding major congenital malformation at birth.    At the time of this report, the outcome of event birth weight excessive' was not reported.  The of event of birth weight excessive' was assessed as serious due to medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case 202003299 (the corresponding mother case).  Company comment: Reportedly, large for dates baby were associated with Flucelvax QIV. The subject's mother was vaccinated at approximately 16 weeks of gestation. The event of was noted on delivery, 5 months 20 days later. Chronology is unsuggestive. It was reported that the baby was transferred to NICU (neonatal intensive care unit), but no further details were provided. The subject's mother's current medical condition included RhD (rhesus antigen) negative. The subject's mother's concomitant medications included Prenatal (unspecified vitamins and minerals), Rhophylac (anti-d immunoglobulin) for RhD negative and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related. Reported birth weight was 4111grams. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. Causal role of the suspect vaccine is assessed as not related for the event large for dates baby.; Sender's Comments: Reportedly, large for dates baby were associated with Flucelvax QIV. The subject's mother was vaccinated at approximately 16 weeks of gestation. The event of was noted on delivery, 5 months 20 days later. Chronology is unsuggestive. It was reported that the baby was transferred to NICU (neonatal intensive care unit), but no further details were provided. The subject's mother's current medical condition included RhD (rhesus antigen) negative. The subject's mother's concomitant medications included Prenatal (unspecified vitamins and minerals), Rhophylac (anti-d immunoglobulin) for RhD negative and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related. Reported birth weight was 4111grams. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. Causal role of the suspect vaccine is assessed as not related for the event large for dates baby.