Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Delivery, Exposure during pregnancy, Foetal non-stress test normal
Clinical narrative: Urinary tract infection; Anaemia; Vaccine exposure during pregnancy; This is a spontaneous case, initially received from other health professional on 08-Oct-2019, concerning a 16-years-old, pregnant, female patient, of body weight: 109 lbs, height: 60 inches and body mass index (BMI): 21.3.  The patient's medical history included bacterial vaginosis, which was treated Metrogel (metronidazole). The patient's concomitant medications included prenatal vitamins (mineral NOS, vitamins NOS) for pregnancy.  The patient had no previous pregnancies. The patient had no maternal or paternal history with major congenital malformations (MCMs). Also, the patient had no history of offspring with MCM. The patient did not use tobacco, alcohol or illicit drugs during pregnancy.  The patient's last menstrual period (LMP) date was on 01-Jun-2018, the estimated delivery date (EDD) was reported as 08-Mar-2019. The type of pregnancy was singleton. The pregnancy status was collected and right lateral cerebral ventricle 1.01 was reported as pregnancy complication.  On 03-Jul-2018, the patient underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCMs were noted.  On 20-Jul-2018, 17-Aug-2018 and 20-Aug-2018, the patient underwent ultrasound and no MCMs were noted.   On 19-Oct-2018, at approximately 20 weeks of gestation, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an unknown indication.   On the same day, the patient underwent Qnatal and maternal serum alpha-fetoprotein test and no MCMs were noted.  On 19-Nov-2018, the patient developed anaemia and was treated with ferrous sulfate at a dose of 325 mg, administered twice daily via oral route.  03-Dec-2018, the patient developed urinary tract infection and was treated with Augmentin (amoxicillin/clavulanic acid) 875 mg/125 mg, administered twice daily, via oral route and Macrobid (clarithromycin) at a dose of 100 mg, administered two times per day via oral route.  On 13-Dec-2018, the patient recovered from the event of urinary tract infection.  On 14-Jan-2019, 22-Jan-2019, 29-Jan-2019, 07-Feb-2019, 11-Feb-2019 and 19-Feb-2019, the patient underwent non-stress test and no MCMs were noted.  On 22-Feb-2019, the patient underwent ultrasound and no MCMs were noted.  At gestational age of 40 weeks, the patient vaginally delivered a live birth, male neonate. The neonate's birth weight was 3040 grams, body length was 52.1 cm and head circumference was 34.3 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (one minute), 9 (five minutes) and no data for APGAR score at 10 minutes was provided. There was no MCM identified at birth.  On the same day, the patient recovered from the event of anaemia.  The case was assessed as non-serious.   The reporter did not provide causality assessment.  This case is linked to case number 201905140 (corresponding child case).  Significant case correction was performed on 22-Nov-2019: report type was changed from report from study to spontaneous, suspect product recoded from study drug to Flucelvax QIV. Dose and indication for Flucelvax QIV was removed. The narrative was amended accordingly.  Follow up information received from other non-health professional on 15-Jan-2020: Reporter's details updated. No changes in the narrative.  Company comment: The subject experienced urinary tract infection and anaemia after vaccination after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnant state and young maternal age (16 years) may provide alternative aetiology for the events and medical history of bacterial vaginosis may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events urinary tract infection and anaemia is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The subject experienced urinary tract infection and anaemia after vaccination after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnant state and young maternal age (16 years) may provide alternative aetiology for the events and medical history of bacterial vaginosis may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events urinary tract infection and anaemia is assessed as unlikely related (defaults to related for reporting purposes).