Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Delivery, Exposure during pregnancy, Prolonged pregnancy
Clinical narrative: Gestational age at outcome 42.3 weeks/Post-term pregnancy; Anemia; Vaccine exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 12-Jul-2019, concerning a 24-year-old adult female pregnant patient of weight 115 pounds, 60 inches height and body mass index (BMI) 22.5.  The patient had a history of 3 previous live births (multi gravida) with no birth defects noted. The patient did not have a history of offspring with major congenital malformation. On an unknown date, the patient's family history of major congenital malformation was collected, and the patient had no maternal/ paternal history with major congenital malformations. The patient's current conditions included migraine and seizure disorder. The patient's concomitant medication included prenatal vitamins (vitamins and minerals NOS) for pregnancy.  The patient's last menstrual period date was 23-Jul-2018. The patient did not use tobacco, alcohol or illicit drugs during pregnancy. On an unknown date, the pregnancy status of the patient was collected, and no pregnancy complications were noted. The type of pregnancy was singleton.  On 05-Oct-2018, at 10 weeks of gestation, the pregnant patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived; 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 10-Oct-2018, the patient underwent ultrasound scan and alpha fetoprotein test and no major congenital malformation was noted. On 07-Feb-2019, 4 months and 2 days after vaccination, the patient developed anemia and was treated with Ferrous sulphate [dose: 1 DF, frequency: two times a day (bid), route of administration: oral, stop date: 15-May-2019].  The patient's estimated date of delivery was reported as 29-Apr-2019.  On 02-May-2019, the patient underwent ultrasound scan and no major congenital malformation was noted.   7 months and 10 days after vaccination, the patient delivered a post-term male neonate at 42.3 weeks gestation (explicitly coded as post-term pregnancy) by vaginal method of delivery. The neonate's birth weight was 2608 grams, head circumference was 33 cm and body length were 48.3 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 was noted.  The outcome of the events anemia was not reported and of the event vaccine exposure during pregnancy and post-term pregnancy was unknown.  This case is cross-linked to the case: 201904135 (baby case).; Reporter's Comments: A 24-year-old female pregnant patient was diagnosed with anaemia, 4 months 2 days after receipt of Flucelvax QIVc (considered as vaccine exposure during pregnancy). The pregnancy state of the patient provide more plausible explanation rather than suspect vaccine, hence the event anaemia assessed as not related. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The patient delivered baby at 42.3 weeks of gestation (considered as post-term pregnancy), more than 7 months post vaccination. Considering the implausible temporal relationship, the event post term pregnancy assessed as not related to suspect vaccine. The company assessed the case as serious (medically significant).