Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Delivery, Exposure during pregnancy, Gene mutation identification test negative, Glucose tolerance test abnormal, Postpartum haemorrhage
Clinical narrative: Maternal postpartum hemorrhage due to retained placenta; Maternal postpartum hemorrhage due to retained placenta; Vaccine exposure during pregnancy; This observational study case , initially received on 30-Apr-2021 from other health professional and concerned a 37-year-old pregnant, female subject of body weight 130 lbs, height 68 inches and body mass index (BMI) 19.8,  enrolled in a prospective observational safety study.  The subject's concurrent condition included pregnancy with advanced maternal age. The subject's concomitant medications included folic acid and prenatal vitamins (unspecified minerals and vitamins), both used for healthy pregnancy and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) used for vaccination.  The subject's obstetrical history included two previous pregnancies with two spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM). The subject had no paternal or maternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was reported as 03-Oct-2020. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 10-Jul-2021. The type of pregnancy was singleton.   On 01-Nov-2020, the genetic screening and cystic fibrosis mutation analysis tests revealed no MCMs.   On 30-Nov-2020, at approximately eight weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100267077.  On the same day, the ultrasound test revealed no MCMs.   On 11-Dec-2020, 23-Dec-2020 and 05-Feb-2021, the ultrasound tests revealed no MCMs.   On 23-Feb-2021, anatomy ultrasound test revealed no MCMs.   On 29-Apr-2021, ultrasound test revealed no MCMs. Also, the subject failed the initial glucose tolerance test (one-hour glucose) and then passed the three-hour glucose, meaning no gestational diabetes was noted.  At 39.7 weeks of gestation (as reported), the subject delivered female neonate via vaginal method of delivery. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate's birth weight was 4170 grams, body length: 53.3 centimetres (cm) and head circumference was 35 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was five, at five minutes was eight and at ten minutes was not reported. Also, the neonate experienced hyperbilirubinemia and received phototherapy for 24 hours post-delivery. No MCM were identified at delivery.   On the same day, the subject experienced postpartum hemorrhage due to retained placenta.  The outcome of the event 'postpartum haemorrhage' and retained placenta was not reported.  The reporter did not provide causality assessment.  The events of 'postpartum hemorrhage' and retained placenta were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked to case 202102844 (the corresponding baby case).  Case updated on 18-Jun-2021: Correction made to information received on 30-Apr-2021: Company agent causal updated from 'no' to 'yes'.   Additional information received on 06-Aug-2021 from physician with additional information received on the same day (being processed together) from other health professional: Additional reporter added. Pregnancy outcome provided. Dates for 'genetic screening' and 'cystic fibrosis mutation analysis' provided. Event 'glucose tolerance test abnormal' deleted from event tab because result for glucose tolerance test provided. Result updated for the test. 'Postpartum haemorrhage' and retained placenta added as new events. Stop date and outcome added for 'Vaccine exposure during pregnancy'. The narrative amended accordingly.  Company Comment: A 37-year-old subject was vaccinated at 8 weeks of gestation with the suspect product, Afluria QIV (explicitly coded as 'Vaccine exposure during pregnancy'). Subjects medical history was not reported. The subject's obstetrical history included two previous pregnancies with two spontaneous abortions. On the same day after delivery the subject experienced postpartum haemorrhage due to retained placenta. The subject experienced postpartum haemorrhage due to retained placenta on the same day after delivery. Causality for vaccine exposure during pregnancy is assessed as not related s per company specific guidelines. Causality for postpartum haemorrhage and retained placenta is assessed as not related due to biological implausibility.; Sender's Comments: A 37-year-old subject was vaccinated at 8 weeks of gestation with the suspect product, Afluria QIV (explicitly coded as 'Vaccine exposure during pregnancy'). Subjects medical history was not reported. The subject's obstetrical history included two previous pregnancies with two spontaneous abortions. On the same day after delivery the subject experienced postpartum haemorrhage due to retained placenta. The subject experienced postpartum haemorrhage due to retained placenta on the same day after delivery. Causality for vaccine exposure during pregnancy is assessed as not related s per company specific guidelines. Causality for postpartum haemorrhage and retained placenta is assessed as not related due to biological implausibility.