Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Prenatal screening test
Clinical narrative: This is a serious spontaneous case (prospective) pregnancy case, initially received from other health professional on 26-Nov-2018, concerning a 30-year-old, adult female patient of body weight: 145 lbs, height: 63 inches and body mass index (BMI): 25.7. The patient had no previous pregnancy. The patient had no history of offspring with major congenital malformation. Also, the patient had no maternal or paternal history with major congenital malformations. The patient did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's last menstrual period (LMP) date was 12-May-2018. The type of pregnancy was singleton. The pregnancy status of the patient was collected, and no pregnancy complications were noted. On 10-Aug-2018, the patient underwent prenatal tests for cystic fibrosis which revealed no major congenital malformation. On the same day, 1st trimester screening was also performed and was noted that the patient was positive for the risk of Down's syndrome. On 18-Aug-2018, non-invasive prenatal testing (NIPT) was performed, and no major congenital malformations were noted. On 08-Sep-2018, 2nd trimester screening was performed, and no major congenital malformations were noted. The patient's concomitant medications included VITAFOL-ONE for healthy pregnancy. On 06-Oct-2018, at gestation age of 21 weeks, the patient was administered FLUCELVAX QIVc [batch number: 252232, dose, route of administration, anatomical location, expiry date: not reported] for an unknown indication. On an unspecified date, after vaccination, the patient experienced haemorrhoids and constipation. On 10-Nov-2018, the patient started the treatment with ANUSOL-HC cream (2.5 percent, bid, topically) for haemorrhoids and COLACE tablet (10 mg, bid, orally) for constipation. At the gestational age of 35.7 weeks, the patient gave birth to a male infant vaginally of weight: 2340 g, length 44.5 cm, head circumference of 30.5 cm. The patient's appearance, pulse, grimace, activity, respiration (APGAR) score at one minute and five minutes was 9 and at ten minutes was unknown. There were no pregnancy complications and major congenital malformations observed. The patient's estimated date of delivery (EDD) was reported as 16-Feb-2019. At the time of this report, the outcome of the events was not reported. This case is linked to (201900958), the corresponding baby report. Significant case amendment (26-Nov-2018): Patient's historical condition (positive for the risk of Down's syndrome) was re-coded as current condition in the patient tab. No changes were made in the narrative. Follow up received from the other health professional on 24-Jan-2019: At the gestational age of 35.7 weeks, the patient gave birth to a male infant vaginally of weight: 2340 g, length 44.5 cm, head circumference of 30.5 cm. The patient's appearance, pulse, grimace, activity, respiration (APGAR) score at one minute and five minutes was 9 and at ten minutes was unknown. Amended narrative accordingly. Significant case amendment (24-Jan-2019): The case was upgraded from non-serious to serious as new event 'premature delivery' (medically significant event) was added in the follow-up. Amended narrative accordingly. Reporter's Comments: A 30-year-old female pregnant patient experienced haemorrhoids and constipation, on an unknown date after vaccination with FLUCELVAX QIVc (vaccine exposure during pregnancy) and gave birth to a male infant vaginally at gestational age of 35.7 weeks. The company assessed the causality of the events (haemorrhoids and constipation) as not related as it can be explained by pregnancy status of the patient. 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 drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. Considering the implausible temporal relationship between vaccination and reported event of premature delivery (3 months 10 days after vaccination), no evidence for a biological mechanism that could cause the event and incidental nature of the events, the events were assessed as not related to the vaccination. The company assessed the event 'pre-mature delivery' as serious (medically significant).