Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Delivery, Foetal disorder, Foetal renal imaging abnormal, Maternal exposure before pregnancy, Vaginal discharge
Clinical narrative: Vaginal discharge; Vaccine exposure during pregnancy; This is spontaneous case, initially received on 24-Jan-2020, concerning a 21-year-old, female pregnant patient.  The patient's medical history included nausea and she was Rh negative.  The patient's concomitant medication included: Prenatal vitamins (unspecified vitamins and minerals) as vitamin supplementation, Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea, TDAP vaccine [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid], Rhophylac (anti-D immunoglobulin) as the patient was RhD negative.  The patient had no previous pregnancies. The patient had no paternal family history of major congenital malformation (MCM), but she had autistic cousin in maternal family history. The patient did not use alcohol or illicit drugs during pregnancy, but she consumed cigarettes.  The patient's last menstrual period (LMP) date was 14-May-2019. The type of pregnancy was singleton. The patient's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both 18-Feb-2020.   On 17-Jul-2019, the patient underwent dating ultrasound scan and no MCM was noted.  On 16-Aug-2019, the patient underwent first trimester screen and nuchal translucency. No MCM was noted.  On 09-Sep-2019, the patient underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers). No MCM was noted.  On 25-Sep-2019, the patient underwent ultrasound that was incomplete, so the result was unknown.  On 23-Oct-2019, approximately at 23 weeks of gestation (calculated per LMP), the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261223, dose: 0.5 ml, route of administration: intramuscular, 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 ultrasound and bilateral renal dilatation/pyelectasis was noted.  On 20-Nov-2019, 27-Nov-2019, 04-Dec-2019 and 18-Dec-2019, the patient underwent ultrasound and bilateral renal dilatation/pyelectasis was noted.  On 10-Jan-2020, the patient developed vaginal discharge and started treatment with 0.4 % cream terconazole applicator via vaginal route of administration.  On 17-Jan-2020 the event of vaginal discharge was resolved.  At gestational age of 39.9 weeks as reported, the patient vaginally delivered a female neonate. The birth weight of neonate was 2920 g. No data for head circumference and length were provided.  Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 7 and at five minutes was 9. APGAR score for 10 minutes was not provided. No data for pregnancy complications were provided. Foetal urinary tract dilatation was confirmed as MCM at birth.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to case 202001127 (the corresponding child case).  Follow up received from other health professional on 04-Mar-2020: Outcome of pregnancy provided. Stop date and outcome for vaccine exposure during pregnancy updated. Narrative amended accordingly.  Company comment: The subject experienced vaginal discharge after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 23 weeks. Chronology is very unsuggestive because of very long onset latency (2 months and 18 days). Pregnant state may provide alternative aetiology for the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event vaginal discharge is assessed as not related.; Sender's Comments: The subject experienced vaginal discharge after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 23 weeks. Chronology is very unsuggestive because of very long onset latency (2 months and 18 days). Pregnant state may provide alternative aetiology for the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event vaginal discharge is assessed as not related.