Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Chromosome analysis normal, Delivery, Exposure during pregnancy, Ultrasound antenatal screen normal, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jul-2020, concerning a 37-year-old female, pregnant subject of body weight: 134 lbs, height: 67 inches and body mass index (BMI): 21, who was enrolled in a prospective observational safety study.  The subject's medical history included loop electrosurgical excision procedure (LEEP), narcolepsy and advanced maternal age.  The subject's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) as vitamin and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history included two previous full term live births. The subject had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The subject did not consume tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) was on 18-Jul-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 23-Apr-2020. The type of pregnancy was singleton.  On 02-Oct-2019, at gestational age of 10 weeks, calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD ) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On the same day, the subject underwent MaterniT21 and no MCM was noted.  On 04-Dec-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 26-Feb-2020, four months and 24 days after vaccination, the subject developed upper respiratory infection and started treatment for it with one tablet of  Augmentin (amoxicillin, clavulanate potassium) administered orally, twice a day and with Medrol (methylprednisolone acetate) (Pak) at dose reported as taper dose and frequency as directed.  At gestational age of 40.7 weeks (as reported), the subject vaginally delivered a male neonate. The birth weight of the neonate was 3572 g. Head circumference, length and appearance, pulse, grimace, activity and respiration (APGAR) score (at one minute, at five minutes and at ten minutes) were unknown as midwife delivered and no further information was expected. No pregnancy complications were noted. No MCM was identified at birth.  On 05-Mar-2020, the subject recovered from upper respiratory infection and finished treatment with Augmentin.  The event of upper respiratory infection was considered serious due to the criterion of medical significance, per company.  The reporter did not provide a causality assessment to Flucelvax QIV.  Company comment: A 37-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 10 weeks. The subject developed upper respiratory tract infection 4 months 24 days after vaccination. Due to treatment with Augmentin (amoxicillin, clavulanate potassium) suggestive for bacterial infection, causality between suspect product and the event is assessed as not related. Vaccine exposure during pregnancy is not related per company's conventions.; Sender's Comments: A 37-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 10 weeks. The subject developed upper respiratory tract infection 4 months 24 days after vaccination. Due to treatment with Augmentin (amoxicillin, clavulanate potassium) suggestive for bacterial infection, causality between suspect product and the event is assessed as not related. Vaccine exposure during pregnancy is not related per company's conventions.