Sex: F
Vaccine: FLUC4
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: This is a spontaneous case, initially received from other health professional on 13-May-2019, concerning a female neonate patient. The patient's mother was 30-year-old with body weight 164 lbs and height 63.5 inches. The obstetrical history included one spontaneous abortion, one full-term live birth and one preterm live birth. No birth defects were noted. The mother had no history of offspring with major congenital malformation. Also, no maternal or paternal history with major congenital malformations were reported. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 22-Aug-2018. The type of pregnancy was singleton. The pregnancy status of the mother was collected, and no pregnancy complications were noted. On 29-Sep-2018, at approximately 05 weeks gestation, the mother received FLUCELVAX QIVc (batch number: 252232, dose, route of administration, anatomical location and expiry date: not reported) for an unknown indication. The foetus was exposed to FLUCELVAX QIVc via transplacental route for an unknown indication. On 01-Oct-2018, the patient's mother started to take CITRANATAL 90 DHA (as reported) for healthy pregnancy. On an unspecified date, after vaccination, the patient's mother experienced rash on left arm and group B streptococcus infection. The mother was treated with hydrocortisone cream [dose: 2.5 percent, frequency: twice a day (BID), route of administration: topical, started on: 30-Oct-2018 and stopped on: 10-Nov-2018) for left arm rash and amoxicillin [dose: 500 mg, frequency: as needed (PRN), route of administration: oral, started on: 10-Nov-2018 and stopped on: 17-Nov-2018) for group B streptococcus infection. On 16-Nov-2018 and 04-Dec-2018, the patient's mother underwent first trimester screening, and second trimester screening respectively however, no major congenital malformation was noted. Approximately at 27.9 weeks gestation, the mother gave a live birth to a female neonate by caesarean method of delivery. The characteristics of the neonate included birth weight: 1200 grams, head circumference: 29 cm, length: 37.5 cm and APGAR (appearance, pulse, grimace, activity, and respiration) scores were 5 at one minute and 9 at five minutes). No major congenital malformations (MCMs) were identified at birth. The mother's estimated date of delivery (EDD) was reported as 29-May-2019. This case is linked to 201805973 (corresponding maternal pregnancy report). Reporter's Comments: A female neonate was delivered by caesarean method 27.9 weeks gestation (preterm birth) with weight of 1200 grams (low birth weight), 5 months and 5 days after receipt of FLUCELVAX QIV vaccine administered to mother at approximately 5 weeks of gestation Considering the implausible temporal relationship between vaccination and reported events, risk factors (group B streptococcus infection, gestation age at birth and maternal obstetric history of one spontaneous abortion, one full-term live birth and one preterm live birth ) and no evidence for a biological mechanism that could cause the events, the events (preterm birth and low birth weight) were assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).