Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Trichomoniasis, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Postmature delivery at 42.7 weeks of gestation; Immmunological/ Allergies: Rhinitis; Allergies; Trichomoniasis; Urinary tract infection; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 10-Sep-2019, concerning a 27-year-old, female pregnant patient of body weight 240 lbs, height 71 inches and body mass index (BMI) 33.5, enrolled in a prospective observational safety study.  The subject's historical condition included trichomoniasis. The subject's current condition included increased BMI.  The subject's historical drug included Metrogel (metronidazole) for trichomoniasis.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The subject's obstetrical history noted that the subject had four previous pregnancies, one spontaneous abortion and three of full term live births with no birth defects. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was on 26-Feb-2018. The subject's estimated delivery date was reported as 03-Dec-2018, while corrected estimated delivery date was reported as 27-Dec-2018. The type of pregnancy was singleton.   On 01-Jun-2018, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy No MCMs were noted.   On 07-Jun-2018, the subject underwent ultrasound and no MCMs were noted.   On 01-Jul-2018, the subject underwent ultrasound and no MCMs were noted.   On 12-Jul-2018, the subject underwent Quad screen and ultrasound. No MCMs were noted.   On 26-Jul-2018, the subject underwent Qnatal and ultrasound. No MCMs were noted.   On 27-Jul-2018, the pregnancy status was collected, and echogenic cardiac focus was noted as pregnancy complication.   On 04-Oct-2018, at approximately 31 weeks of gestation (calculated per LMP), the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 252664, route of administration, anatomical location, expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunization.  On the same day, the subject experienced urinary tract infection and started with treatment medication Macrobid (clarithromycin) at the dose of one tablet, consumed orally, twice a day.  On 11-Oct-2018, the subject recovered from the event of urinary tract infection and stopped with treatment medication Macrobid.  On 12-Oct-2018, the subject experienced trichomoniasis and started with treatment medication Metrogel at the dose of 0.75 % of gel, consumed vaginally, twice a day.   On 22-Oct-2018, the subject recovered from the event of trichomoniasis and stopped with treatment medication Metrogel.  On 01-Nov-2018, the subject underwent ultrasound and no MCMs were noted.   On 29-Nov-2018, the subject experienced allergic rhinitis and allergies and started with treatment medications Claritin (loratadine) at the dose of one tablet, consumed orally, every morning and Flonase (fluticasone propionate) at the dose of one spray, consumed nasally, every day.  On the same day, the subject underwent ultrasound and no MCMs were noted.   On 06-Dec-2018, the subject recovered from the events of allergic rhinitis and allergies.  At approximately 42.7 weeks of gestation (as reported), the subject vaginally gave a live birth to a female neonate. The characteristics of the neonate included birth weight: 3062 grams, head circumference: 33.5 cm and body length: 47 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. There was no MCM identified at birth.   At the time of this report, the outcome for the event of postmature labour' was not reported.  The event of postmature labour' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIVc.  Follow up was received by other health professional on 17-Sep-2019: Corrected estimated date of delivery was added. Gestation period at exposure for all concomitant medications was changed. Narrative amended accordingly.  Follow up was received by other health professional on 11-Mar-2020: The stop date was reported for the events of allergic rhinitis and allergies. Accordingly, the outcome was updated for the events from not resolved' to resolved. Event ' postmature labour' changed from non-serious to serious.  Narrative was amended accordingly.  Company comment: A pregnant subject developed trichomoniasis eight days after vaccination with Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible however, the infection is very common sexually transmitted disease (STD). It is caused by infection with a protozoan parasite making causal role for the suspect product not related. It was also reported that postmature delivery ocurred  at 42.7 weeks of gestation, making causal relationship possibly related to the product. Vaccine was administered at gestational age of approximately 31 weeks and on the same day, the subject experienced urinary tract infection. The subject also developed allergic rhinitis and multiple allergies, 1 month 25 days post vaccination. Considering the implausible temporal relationship between vaccination and reported events, causality is assessed as unrelated for the events of urinary tract infection, allergic rhinitis and multiple allergies. The event of exposure during pregnancy was assessed as unrelated per company's conventions.; Sender's Comments: A pregnant subject developed trichomoniasis eight days after vaccination with Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible however, the infection is very common sexually transmitted disease (STD). It is caused by infection with a protozoan parasite making causal role for the suspect product not related. It was also reported that postmature delivery ocurred  at 42.7 weeks of gestation, making causal relationship possibly related to the product. Vaccine was administered at gestational age of approximately 31 weeks and on the same day, the subject experienced urinary tract infection. The subject also developed allergic rhinitis and multiple allergies, 1 month 25 days post vaccination. Considering the implausible temporal relationship between vaccination and reported events, causality is assessed as unrelated for the events of urinary tract infection, allergic rhinitis and multiple allergies. The event of exposure during pregnancy was assessed as unrelated per company's conventions.