Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Bacterial vaginosis, Caesarean section, Chlamydial infection, Drug screen positive
Clinical narrative: Bacterial Vaginosis; Anemia; Allergies; Gonorrhea; Chlamydia; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 31-May-2019, concerning a 33-year-old, adult female pregnant subject of weight 176 lbs, height 65 inches and body mass index (BMI) 29.3, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject had two previous pregnancies that included 1 full-term live birth and 1 pre-term birth. No birth defects were noted in the previous pregnancies. The subject did not have a history of offspring with major congenital malformation. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal/paternal history with major congenital malformations.   The subject's last menstrual period date was 07-Aug-2018. On an unknown date, the pregnancy status of the subject was collected, and no pregnancy complications were noted. The type of pregnancy was singleton.  On 03-Oct-2018, the subject underwent spinal muscular atrophy and cystic fibrosis mutation test and no major congenital malformation was noted. The subject did not use tobacco, alcohol during pregnancy but was positive for marijuana (in urine drug screening on 03-Oct-2018). On 03-Oct-2018, at gestational age of 8.1 weeks, the subject started taking Prenatal vitamins (Vitamins and Minerals NOS) for pregnancy.  On 04-Oct-2018, at gestational age of 8 weeks, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly coded as vaccine exposure during pregnancy).   On 04-Oct-2018, the subject underwent ultrasound and no major congenital malformation was noted. On an unspecified date, the subject also was diagnosed with bacterial vaginosis and anemia. On 15-Oct-2018, at gestational age of 9 weeks, the subject took Metrogel (Metronidazole, route of administration: vaginal, frequency: twice daily, concentration: 0.75 percent, stop date: 22-Oct-2018) for bacterial vaginosis. On 28-Nov-2018, the subject underwent Quadruple screen test and ultrasound test, and no major congenital malformation was noted. On 13-Dec-2018, at gestational age of 18.3 weeks, the subject started treatment with Ferrous sulphate (dose: 325 mg, route of administration: oral, frequency: twice daily, stop date: 07-May-2019) for anemia. On 30-Jan-2019, 3 months and 26 days after vaccination, the subject was diagnosed with Gonorrhoea and Chlamydia. On 21-Feb-2019, the subject had recovered from the events gonorrhoea and chlamydia. On 22-Mar-2019, the subject underwent ultrasound and no major congenital malformation was noted. On 02-Apr-2019, the subject started treatment with Metrogel (Metronidazole, route of administration: vaginal, frequency: twice daily, concentration: 0.75 percent, stop date: 09-Apr-2019) for bacterial vaginosis. On 22-Apr-2019, the subject underwent urine drug screening which showed positive results for marijuana. On the same day, at 36.9 weeks of gestational age, 6 months and 18 days after vaccination, the subject experienced allergies and started treatment with Zyrtec (cetirizine hydrochloride; dose: 10 mg, frequency: daily, route of administration: oral, stop date: ongoing).   The outcome of the event allergies was not recovered, for the events anemia and bacterial vaginosis was not reported.  at 39 weeks of gestational age, the subject delivered a live birth to a male neonate via caesarean method. The neonate's birth weight was 3289 grams, head circumference was 34.3 cm and body length were 52.7 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (at one minute) and 9 (at five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation noted.  The subject's estimated date of delivery and corrected estimated date of delivery was reported as 14-May-2019.; Reporter's Comments: A 33-year-old female patient experienced bacterial vaginosis, unspecified period after receipt of Flu Vaccine Cell Subunit QIV NVD. The subject also experienced gonorrhoea,chalmydial infection after more than 3 months post vaccination and hypersensitivity more than 6 months post vaccination were considered as not related to suspect vaccine due to infectious aetiology of the events and implausible temporal relationship respectively The event anaemia was assessed as not related to suspect vaccine, as the event can be explained by the physiological state of the pregnancy. 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.