Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Congenital anomaly, Foetal exposure during pregnancy, Penis disorder
Clinical narrative: Congenital absence of foreskin; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 24-Jan-2020 with additional information received on 27-Jan-2020 (being processed together), concerning a  male, neonate subject, whose mother was a 20-year-old female of body weight 151.4 lbs, height 66 inches and body mass index (BMI) 24.4, enrolled in a prospective observational safety study.   The mother's medical history incuded nausea and bacterial vaginosis.   The subject's mother concomitant medications included Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea and metronidazole for bacterial vaginosis.   The mother had no previous pregnancies. The subject's mother had no paternal history with major congenital malformations (MCMs) but maternal history with MCMs included cystic fibrosis in cousin (as reported), congenital heart defect preemie and neonatal demise in first cousin (as reported). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 05-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 10-Jan-2020. The subject's father was a 24-year-old.  On 30-May-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 21-Jun-2019, the subject's mother underwent Maternit 21 test and no MCM was noted.   On 28-Aug-2019, the subject's mother underwent anatomy ultrasound and no MCM was noted.   On 22-Nov-2019, at approximately 33 weeks of gestation, the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261223, 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.   At 40.9 weeks of gestation, the subject's mother vaginally delivered a normal, male neonate. The neonate's birth weight was 3901 g, while head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. Congenital absence of foreskin was identified at birth. The MCM evaluation reported exact gestational age range for origin of the defect was 12-19 weeks (post conception from 14-Jun-2019 to 03-Jul-2019). Etiology was unknown and there were none confounding factors. The MCM temporal assessment stated vaccine exposure was after origin of defect.  At the time of initial reporting, the outcome of the events congenital abscence of foreskin' was not reported.  The events of congenital abscence of foreskin' was considered serious due to congenital anomaly.  The reporter did not provide causality assessment.  This case is linked to 202001128 (the corresponding mother case).  Company comment:The patient's mother was administered the suspect product, Flucelvax QIV at approximately 33 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 40.9 weeks of gestation, the patient's mother vaginally delivered male neonate who developed congenital absence of foreskin, coded as congenital anomaly. Considering the time frame of event with respect to vaccine administration, no evidence for a biological mechanism that could cause the event. Based on provided information, causal relationship between the suspect product and both events is assessed as not related.; Sender's Comments: The patient's mother was administered the suspect product, Flucelvax QIV at approximately 33 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 40.9 weeks of gestation, the patient's mother vaginally delivered male neonate who developed congenital absence of foreskin, coded as congenital anomaly. Considering the time frame of event with respect to vaccine administration, no evidence for a biological mechanism that could cause the event. Based on provided information, causal relationship between the suspect product and both events is assessed as not related.