Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Premature delivery, Prenatal screening test, Rash
Clinical narrative: This is a serious observational study case initially received on 28-Mar-2019, concerning a 38-year-old adult, female, pregnant subject of body weight 149 lbs, height 67.7 inches and body mass index (BMI) 22.9, 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 no previous pregnancies. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 23-Jul-2018. The type of pregnancy was singleton. The pregnancy status of the subject was collected, and no pregnancy complications was noted. The subject's concomitant medications included NESTABS DHA and folic acid for healthy pregnancy. On 10-Oct-2018, at approximately 11 weeks gestation, the subject received Flu Vaccine Cell Subunit QIV NVD (batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On the same day (10-Oct-2018), the subject had undergone cystic fibrosis mutation analysis, spinal muscular atrophy screen and fragile X test and no major congenital malformation was noted. On 18-Oct-2018, the subject had undergone non-invasive prenatal testing (NIPT) and first trimester screening and no major congenital malformation was noted. On 28-Dec-2018, 2 months and 18 days after vaccination, the subject experienced rash on left side. On an unspecified date after vaccination, the subject experienced constipation and anaemia. The subject was treated with COLACE [from 28-Dec-2018, dose: 100 mg, frequency: two times a day (bid)] orally for constipation, BENADRYL,[from 28-Dec-2018, dose: 25 mg, frequency: 4 times a day (qid)] orally, hydrocortisone cream [from 28-Dec-2018, dose: 2.5 percent, frequency: 2 times a day (bid)] topically and ACTIGALL [from 08-Mar-2019, dose: 300 mg, frequency: bid] orally for left side rash and FEROSUL [from 22-Feb-2019, dose: 325 mg, frequency: once a day (qd)] orally for anaemia. On 36.9-week gestational age (as reported), the subject gave birth to a female infant (reported as preterm delivery). The delivery method was caesarean. Infant's body weight was 3884 grams, body length was 48.3 cm, head circumference was 32 cm and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 6 at minute 1 and 9 at minute 5. The subject's estimated date of delivery (EDD) was reported as 29-Apr-2019. The outcome of the events constipation, rash and anaemia was not recovered (reported as ongoing). This case was linked to case 201903042 (baby case). Follow-up received from other health professional on 12-Apr-2019: Information regarding the pregnancy outcome was captured in the patient tab. On 36.9-week gestational age (as reported), the subject gave birth to a female infant (reported as preterm delivery). The delivery method was caesarean. Infant's bodyweight was 3884 grams, body length was 48.3 cm, head circumference was 32 cm and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 6 at minute 1 and 9 at minute 5. The event (premature delivery) was added in the event tab. The narrative and case comment were amended accordingly. Reporter's Comments: A 38-year-old pregnant subject was administered Flu Vaccine Cell Subunit QIV (vaccine exposure during pregnancy). The subject experienced rash, 2 months and 18 days after vaccination. The company assessed the causality of the event rash as not related to the study vaccine due to implausible temporal relationship between event and study vaccine. The subject also experienced constipation and anaemia, unspecified period after vaccination. Considering the pregnancy state (known risk factor) of the subject, which provide more plausible explanation rather than the study vaccine, the event anaemia assessed as not related. Considering the gestational age of the patient to the start date of the treatment for constipation (22 weeks and 4 days) pregnancy state (known risk factor) of subject provides more plausible explanation rather than study vaccine. Hence, the company assessed the causality of the event constipation as not related to the study vaccine. The event of vaccine exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The subject had a caesarean section (reported as preterm delivery) at 36.9 weeks of gestation, 5 months 28 days post vaccination. Considering the implausible temporal relationship between vaccination and reported event and no evidence/ investigation suggesting the complications requiring caesarean section, causality assessed as not related. The case will be further assessed upon receipt of follow up information. The company assessed the event premature delivery as serious (medically significant).