Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Bacterial vaginosis, Caesarean section, Candida infection, Condition aggravated, Exposure during pregnancy
Clinical narrative: This is an observational study case, initially received from other health professional on 25-Feb-2019, concerning a 32-year-old, adult, female pregnant subject, of height: 63.5 inches, bodyweight: 259 lbs and body mass index (BMI): 45.2, enrolled in a prospective observational safety study. The subject's historical conditions included nausea and vomiting (from 07-Jun-2018 to 08-Jun-2018) for which the patient received historical drug REGLAN. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 3 previous pregnancies of which 2 full term live births and 1 spontaneous abortion. There were no birth defects reported. The subject's current conditions included asthma and chronic hypertension. The subject's concomitant medication included methyldopa and nifedipine for hypertension, Preplus CA-PE and prenatal vitamins for pregnancy. The subject's last menstrual period (LMP) date was 25-Mar-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. On 11-May-2018, the subject underwent haemoglobin electrophoresis no major structural or congenital malformation was noted. On 15-May-2018, the subject underwent ultrasound scan and no major structural or congenital malformation was noted. On 01-Jun-2018, the subject underwent blood pressure measurement and the results indicated pregnancy induced hypertension. On the same day the patient also underwent 24-hour urine test which was negative indicating no major structural or congenital malformation. On 27-Jul-2018, the subject underwent quad screen test and the results were negative indicating no major structural or congenital malformation. On 26-Sep-2018, at gestation age of 26 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported) for an unknown indication. On 04-Dec-2018, 2 months and 8 days after vaccination, the subject experienced candidiasis. On an unspecified date in 2018, after the vaccination, the subject experienced worsening of chronic hypertension and bacterial vaginosis. The subject was treated with terconazole (0.8 percentage, hs, vaginally) (from 04-Dec-2018 to 05-Dec-2018) for candidiasis. On 05-Dec-2018, the subject had recovered from the event candidiasis. The subject was treated with METROGEL 0.75 percentage, bid, vaginal route (from 11-Dec-2018 to 19-Dec-2018) for bacterial vaginosis. 3 months after vaccination, the mother delivered a male neonate at 39.4 weeks gestation by Caesarean method. The neonate's birth weight was 3700 grams, head circumference was 34.3 cm and body length were 49.5 cm. The APGAR scores were 8 (one minute), 9 (five minutes) and there was no data for 10 minutes. At the time of delivery, no pregnancy complications were reported. At the birth, the neonate was noted with the major congenital malformations which included micropenis and microphthalmia (left eye). The factors contributing to these major congenital malformations were unknown. The outcome of the events hypertension aggravated, and bacterial vaginosis was not reported. This case is linked to 201902224 (baby case). The subject's estimated delivery date (EDD) was reported as 30-Dec-2018. Reporter's Comments: A 32-year-old, pregnant subject with current conditions (asthma and chronic hypertension) experienced candidiasis, 2 months 8 days after administration of study Vaccine (at gestation age of 26 weeks). On an unspecified day post vaccination subject experienced worsening of chronic hypertension and bacterial vaginosis. The case lacks the onset latency between vaccination and reported event of worsening of chronic hypertension, the underlying current condition of chronic hypertension and hemodynamic changes associated with pregnancy are a more possible cause rather than study vaccine and the event was assessed as not related to the suspect vaccine. However, the co-administered drugs (methyldopa and nifedipine) confound this case. Considering the inactivated nature of the suspect vaccine and infectious aetiology of the reported events (candidiasis and bacterial vaginosis) the causal role of study vaccine was assessed as not related. 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 exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).